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  1. mRNA vaccine technology moves to flu: Moderna says trial has begun Moderna aims for one seasonal shot for flu, COVID-19, respiratory viruses RSV and HMPV. Moderna has given out the first doses of an mRNA-based influenza vaccine to participants in an early-phase clinical trial, the company announced Wednesday. Moderna ultimately plans to test the vaccine on about 180 people in the Phase 1/2 randomized, stratified, observer-blind trial. The trial will look at safety, different doses, and immune responses. The vaccine, called mRNA-1010, is designed to target four lineages of influenza viruses that circulate seasonally each year, just like the current quadrivalent flu vaccines on the market. The four virus lineages are those identified by the World Health Organization as the ones to target for disease prevention each year—seasonal influenza type A lineages H1N1 and H3N2 as well as influenza type B lineages Yamagata and Victoria. If mRNA-1010 is shown to be effective against the yearly plague in later-stage trials, Moderna aims to eventually bundle it with three other mRNA-based vaccines to create a yearly, one-stop shot. In addition to influenza, this envisioned combination shot would target two other common, respiratory viruses that circulate alongside influenza—respiratory syncytial virus (RSV) and human metapneumovirus (hMPV)—as well as the COVID-19 coronavirus, SARS-COV-2, which some experts have speculated could become seasonal. Currently, there are no licensed vaccines against either RSV or hMPV. And it's unclear if SARS-CoV-2 will become seasonal and/or if annual booster vaccines will be necessary. "We believe that the advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses, such as influenza, SARS-CoV-2 and RSV," Moderna CEO Stéphane Bancel said in a statement. "Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses." Vaccine design While the company is aiming high with its seasonal megashot, the influenza component alone stands to offer a significant improvement over current shots. To humanity's chagrin, available quadrivalent and trivalent annual flu vaccines tend to have low efficacy, generally in the range of only 40 percent to 60 percent. Some years, the vaccines' efficacy is even lower. Moderna expects it can beat those numbers. Soaring on the success of its mRNA-based COVID-19 vaccine—which had a remarkable 94 percent efficacy in late-stage clinical trials—Moderna will aim its more advanced, targeted mRNA vaccine platform to fight influenza. The company currently has three mRNA-based vaccine candidates in development. After mRNA-1010, there's mRNA-1020 and mRNA-1030. In general, mRNA vaccines work by delivering to human cells a snippet of a virus's genetic code, which is in the form of messenger RNA (mRNA). This type of RNA generally acts as an intermediary, communicating coded instructions from DNA to the cell's molecular machinery that translates the code into proteins. The mRNA snippets in the vaccines, however, communicate the blueprints for viral proteins, which the immune system can use for target practice. Once the cell's machinery translates the vaccine's mRNA code into a viral protein, the immune system uses that protein to train virus-targeting antibodies and cellular defenses. To prevent COVID-19, the mRNA vaccines include the code for a portion of the SARS-CoV-2 spike protein. Copies of this protein jut from the virus's spherical body and help the virus break into human cells. As such, they're an easy and effective target for antibodies and other immune responses. To prevent flu, mRNA vaccines could target key proteins that similarly jut from the influenza virus, namely hemagglutinin (HA or H) and neuraminidase (NA or N). Like spike, these proteins are critical for the flu virus's ability to invade human cells. But HA and NA come in different forms, which are represented in flu viruses' names as H and N (as in H1N1 and H3N2). mRNA advantages The mRNA-based vaccine strategy offers a highly precise way to target influenza viruses' HA and NA compared with current flu vaccines, which often rely on presenting whole viruses, weakened or inactivated, to the immune system. And the mRNA-based design makes the vaccines easy to tweak. If, for instance, a flu virus appears one season with a slightly different version of HA—as it very often does—the vaccine's coding would potentially take just an update to tailor that year's shot. This is a change that could be potentially be done swiftly, too. When variants of SARS-CoV-2 began raising concern earlier this year, the CEO of BioNTech—which co-developed an mRNA-based COVID-19 with Pfizer—said the company could adjust its mRNA vaccine in just six weeks, if needed. Perhaps the biggest advantage the mRNA-based strategy has over current flu vaccine, though, is that it doesn't involve eggs. Current flu vaccines are most often manufactured using fertilized hen eggs. Vaccine makers inject the virus into the eggs and allow the virus to create legions of clones. Then, vaccine makers harvest the viruses, purify them, weaken or kill them, and use them for vaccines. It's cheap and simple, and it's a method that has been used for decades. But it's also time consuming, it requires a lot of eggs, and it may not produce high-efficacy vaccines. Weak or inactivated virus vaccines lack the precision of other vaccine strategies, like mRNA or recombinant proteins. With a whole virus, the immune system may try to attack many different features of the virus, some of which may not be very useful for thwarting the invader. Flu toll Moreover, humans are, well, different from chickens. And sometimes in the manufacturing process, flu viruses can begin to adapt to their fowl conditions. This appeared to be a problem in the 2017-2018 flu season, when a circulating H3N2 flu virus strain seemed to pick up a mutation in its HA during egg-based vaccine manufacturing. The mutation may have made the virus better at infecting chicken eggs, but in the vaccine, the mutation seemed to result in people developing antibodies that weren't as good at defeating the H3N2 virus circulating in humans. That flu season, the influenza vaccine was estimated to have an overall efficacy of just 38 percent. The efficacy against type A influenza viruses specifically, which include H3N2, was just 30 percent. The 2017-2018 flu season ended up being the worst in the decade, with estimates of hospitalizations up to 810,000 and deaths up to 61,000. Still, health experts urge everyone, every year, to get their flu shot. The flu, however benign it may sometimes seem, is a devastating infectious disease. Even a low-efficacy vaccine can help. The CDC estimates that influenza has sickened between 9 million and 45 million people every year since 2010. And in each of those years, it sent between 140,000 to 810,000 people to the hospital and killed between 12,000 to 61,000 people. In addition to the human costs, the economic burden of all of that is estimated to be $11 billion per year. mRNA vaccine technology moves to flu: Moderna says trial has begun
  2. More vaccine progress: This time, it’s malaria Two recent papers describe strong protection against a difficult parasite. Enlarge / A health worker vaccinates a child against malaria in Ndhiwa, western Kenya. BRIAN ONGORO / Getty Images The development of the COVID-19 vaccines was a triumph of biotechnology. But that triumph has partly obscured the amount of luck involved in the process of vaccine development. We've been trying for decades to produce vaccines against HIV, but no amount of high-tech biology has gotten us there. Malaria is another killer that has so far resisted vaccine efforts, but this spring brought hope that we are making progress. Back in May, a small clinical trial of a relatively traditional vaccine showed an efficacy of over 70 percent. And this week, a new paper describes a very different way of generating highly effective immunity to the malarial parasite. Why is malaria so hard? Malaria has resisted vaccination for several reasons. One is that the disease is not caused by just a single infectious agent. Instead, Malaria comes from several related species in the Plasmodium genus. Plasmodium falciparum typically causes more severe illnesses and has thus been the target of most vaccine efforts. But even if we're able to prevent infections by this strain, we won't see the end of malaria. Targeting Plasmodium falciparum hasn't been a simple matter, either, as there are various regional strains that differ in ways that can be significant for immune system recognition. Even a single strain doesn't present an easy target for an immune response, though. The parasites undergo several distinct stages within the human body, with different proteins associated with each. And the parasite can alter other proteins on its surface to act as decoys that distract the immune system. That said, researchers have gradually identified a handful of proteins that are consistently present on the surface of malarial parasites and are essential for their infectivity. That information has led to the development of vaccines that attempt to generate an immune response to these proteins. Progress report In a paper published in May, a large international team of researchers gave a progress report on one of those efforts. The work involved a vaccine developed in collaboration with Novavax and uses the same technology that went into the company's successful COVID vaccine. In short, the vaccine starts by taking a Plasmodium falciparum protein and modifying it so that it clusters into virus-sized particles. These particles are then injected alongside a chemical that boosts immune responses. The team enrolled 450 infants in a malaria-prone region of Africa, with two groups given different doses of the vaccine and the third given an unrelated vaccine to serve as a control. The children were given three doses over three months, then a booster a year later. Testing showed that the two vaccine groups generated both antibodies and a T-cell response to the malarial parasite, with the levels being generally higher in the high-dose group. Antibody levels dropped slowly over time but quickly returned after the one-year booster shot. Side effects were mild and typical of those seen with coronavirus vaccines. The vaccine was very effective. Seventy percent of the participants in the placebo group ended up with a malaria infection by six months after the last of the three initial doses. In the two vaccine groups, only 29 and 26 percent of the participants did. That works out to an efficacy of 77 percent, a protection that stayed constant even as the children were followed out to a year after the third dose. Is that really a vaccine? While this news is welcome, some researchers still worry about basing a vaccine on a single protein, which could allow the malarial parasites to evolve a way of evading the immune response. Boosters using additional proteins could help manage that risk, but much of the vaccine effort has focused on using parasites that are inactivated either by radiation or genetic mutations. These would necessarily carry most of the proteins that the immune system is likely to see following an infection. Results have been mixed so far, but a paper released today describes a variant on this approach that falls somewhere between a vaccine and a controlled infection. The work relied on several overlapping factors. While resistance against most malarial drugs is widespread in wild populations, we can grow many lab strains that are still vulnerable to the drugs. Some of these drugs—called pyrimethamine—kill the parasites while they're multiplying in liver cells. This is an early, asymptomatic stage of the infection. Stopping the parasite here would mean that none of the complications of malaria will occur. The immunization was a simple extension of this idea—expose people to parasites that are vulnerable to pyrimethamine while treating the patients with the drug. This process allowed the exposed people to develop a robust immune response to the earliest stage of the infection while keeping them from reaching any of the later, more dangerous stages. The researchers tested the same approach using the now-infamous chloroquine, which kills the parasites when they start multiplying in the blood. The trial was a small safety test, with fewer than 10 people in each group (the groups used different doses of malarial parasites and one of the two drugs). And the testing involved people who were willingly infected with malarial parasites multiple times to either boost the vaccination or test its effectiveness. A more promising future? The results look promising. While low initial doses of parasites weren't very effective, seven of the eight people who received the high dose were protected from reinfection, indicating that the treatment provides sterilizing immunity. Perhaps more critically, in a group that was later infected by a different parasite strain than the one the participants were vaccinated against, protection remained strong. Seven out of nine participants avoided infection. (Since chloroquine stops the parasites later than pyrimethamine, it's not surprising that people in those groups experienced more malarial symptoms during the vaccination protocol. One person also chose to withdraw from the study due to emotional problems that have been associated with chloroquine use.) More to do There's still a lot of work to do, both in terms of optimizing the protocol and understanding how it generates sterilizing immunity without allowing the parasite to get to the most immunogenic stages of infection, when the parasite spreads in blood cells. But if the results hold up in larger tests, the prospect of cross-strain protection is incredibly important. And the drug used for this purpose, pyrimethamine, is already widely employed as a prophylactic against malarial infections in pregnant women. We're still a long way from having straightforward protection against a disease that kills nearly a half-million people every year. Both evolution and medical research regularly generate surprises; these two treatments are very early in the research phase, and evolution will kick in if either is widely adopted. But it's hard not to be excited that lasting immunity against the most dangerous form of malaria might be possible. We may need to combine and modify techniques and find ways to boost immunity and counter new strains that appear. But we'll do so knowing that failure isn't inevitable. The Lancet, 2021. DOI: 10.1016/S0140-6736(21)00943-0 Nature, 2021. DOI: 10.1038/s41586-021-03684-z (About DOIs). More vaccine progress: This time, it’s malaria
  3. Malaria vaccine hailed as potential breakthrough COPYRIGHTGETTY IMAGES A malaria vaccine has proved to be 77% effective in early trials and could be a major breakthrough against the disease, says the University of Oxford team behind it. Malaria kills more than 400,000 people a year, mostly children in sub-Saharan Africa. But despite many vaccines being trialled over the years, this is the first to meet the required target. The researchers say this vaccine could have a major public health impact. When trialled in 450 children in Burkina Faso, the vaccine was found to be safe, and showed "high-level efficacy" over 12 months of follow-up. Larger trials in nearly 5,000 children between the ages of five months and three years will now be carried out across four African countries to confirm the findings. Malaria is a life-threatening disease caused by parasites that are transmitted to people through mosquito bites. Although preventable and curable, the World Health Organization estimates there were 229 million cases worldwide in 2019 and 409,000 deaths. The illness starts with symptoms such as fever, headaches and chills and, without treatment, can progress quickly to severe illness and often death. 'Major health impact' Study author Adrian Hill, director of the Jenner Institute and professor of vaccinology at the University of Oxford, said he believed the vaccine was the first to reach the World Health Organization's goal of at least 75% efficacy. The most effective malaria vaccine to date had only shown 55% efficacy in trials on African children. COPYRIGHTGETTY IMAGES Vaccines against malaria have been rolled out before, such as this one in Ghana The trials of this malaria vaccine started in 2019, long before coronavirus appeared - and the Oxford team developed its Covid vaccine (with AstraZeneca) on the strength of its research into malaria, Prof Hill said. A malaria vaccine has taken much longer to come to fruition because there are thousands of genes in malaria compared to around a dozen in coronavirus, and a very high immune response is needed to fight off the disease. "That's a real technical challenge," Prof Hill said. "The vast majority of vaccines haven't worked because it's very difficult." However, he said the trial results meant the vaccine was "very deployable" and "has the potential to have a major public health impact". 'Tool for saving lives' In a pre-print study with The Lancet, the research team - from Oxford, Nanoro in Burkina Faso and the US - reported the trial results of R21/Matrix-M, after testing a low and high dose of the vaccine in children, between May and August, before peak malaria season. The vaccine showed 77% efficacy in the higher-dose group and 71% in the lower-dose group. Halidou Tinto, professor in parasitology and the principal trial investigator at the Clinical Research Unit of Nanoro, Burkina Faso, said the results were "very exciting" and showed "unprecedented efficacy levels". "We look forward to the upcoming 'phase III' trial to demonstrate large-scale safety and efficacy data for a vaccine that is greatly needed in this region." In Africa, there have been more deaths from malaria than from coronavirus in the past year. The Serum Institute of India, which has manufactured the vaccine, says it is confident of delivering more than 200 million doses of the vaccine as soon as it is approved by regulators. Biotechnology company Novavax provided the adjuvant for the vaccine, an ingredient which is used to create a stronger immune response. Malaria is one of the leading causes of childhood mortality in Africa and Prof Charlemagne Ouédraogo, minister of health in Burkina Faso, said the new data showed that a new malaria vaccine could be licensed "in the coming years". "That would be an extremely important new tool for controlling malaria and saving many lives," he said. Source: Malaria vaccine hailed as potential breakthrough
  4. Pause of J&J vaccine was the right call, say 88% of polled Americans Poll results contradict concerns that the pause added to hesitancy. Enlarge / General exterior view of the head office of Janssen pharmaceutical company on April 15, 2021 in Leiden, Netherlands. About 88 percent of Americans support the pause of Johnson & Johnson’s COVID-19 vaccine, and the pause did not increase vaccine hesitancy, according to fresh data from the Axios-Ipsos Coronavirus poll. The finding is likely to hearten public health experts, who have faced criticism and concern that the pause could erode confidence in vaccine safety and fortify already high-levels of vaccine hesitancy in the country. The Centers for Disease Control and Prevention, along with the Food and Drug Administration, recommended a pause in the use of the Johnson & Johnson vaccine on April 13 after linking the one-dose vaccine to six cases of a rare blood-clotting condition, one of which was fatal. The six cases occurred among more than 6.8 million people given the vaccine, suggesting that if the blood clots are, in fact, a side effect of the vaccine, they are an extremely rare side effect. Many experts defended the pause by arguing that the hiatus and full evaluation of the potential serious side effect—even if it’s only a one-in-a-million occurrence—prove that stringent safety monitoring and precautions are in place. Americans largely appear to agree. In the latest poll, the market research firm Ipsos first asked if people had heard of the pause. An impressive 91 percent of respondents said they had. Of those who said they were aware of the pause, 88 percent responded “Yes” to the question: “Do you believe the FDA and CDC are being responsible by recommending a pause on the distribution of the Johnson & Johnson vaccine?” The poll was conducted between April 16 and 19 by Ipsos, which drew on a nationally representative probability sample of 1,033 general population adults, ages 18 or older. For questions posed to all 1,033 people, the margin of sampling error is ±3.3 percentage points at the 95 percent confidence level. Impotent pause The poll also suggested that the Johnson & Johnson pause has not increased or decreased vaccine hesitancy. As in every other previous poll going back to last August, Ipsos pollsters asked everyone: “How likely, if at all, are you to get the first-generation COVID-19 vaccine, as soon as it’s available?” A total of 70 percent said they were likely to get a vaccine or had already gotten a vaccine, while a total of 30 percent said they were “not very likely” or “not at all likely” to get a vaccine. The total of 70 percent in the “likely/already had” category is basically unchanged from recent polls. In the poll conducted between April 2 and 5, a total of 71 percent of respondents fell into that category, while the total was 69 percent during the poll conducted between March 19 and 22. The same lack of change was seen in the “not likely” category, which also wobbled between an insignificantly different 29 percent and 30 percent in the two previous polls. Moreover, the numbers are significantly better than the peak of vaccine resistance seen in a late September poll. That’s when only 37 percent said they were likely to get vaccinated and 63 percent said they were not likely to get vaccinated. Cliff Young, president of Ipsos US Public Affairs, told Axios that “People are unfazed” by the Johnson & Johnson vaccine pause. “The way forward is about the vaccine, so if there’s any stumble, people are going to pay attention to it—but it hasn’t had an impact thus far" on people’s willingness to get the vaccine. “Not sustainable” The same results were found in a focus group of vaccine-hesitant Trump voters, according to a report by The Washington Post. Frank Luntz, a longtime GOP communications expert, held the focus group over Zoom on Sunday, involving 17 conservative participants. Throughout the pandemic, Republicans and conservatives have been among the most consistent groups to tell pollsters that they are unwilling or hesitant to get a COVID-19 vaccine. In a recent Kaiser Family Foundation poll, a total of 35 percent of Republicans surveyed said they would definitely not get vaccinate or only get vaccinated if vaccination was required. The Johnson & Johnson vaccine pause is not changing their thinking one way or the other, according to the focus group. The group largely shrugged off the pause and questioned why the CDC and FDA halted use for a potential side effect that is so rare, the Post reported. “A lot of people might want to take the Johnson & Johnson vaccine versus the others, because it’s one shot versus two,” said a focus-group participant identified as Cathy from Pennsylvania. An epidemiologist who helped convene the focus group further noted to the Post that “we didn’t see folks really concerned with the pause in the J&J vaccine.” Instead, focus group members were more concerned about recent reports that Pfizer CEO Albert Bourla suggested people may need to get a COVID-19 booster shot within a year. “I feel like this is not going to end," said a focus-group participant identified as Erzen from New York. "I mean, we’re just going to be shot up and shot up and shot up. We can’t live like this. This is not sustainable.” Source: Pause of J&J vaccine was the right call, say 88% of polled Americans
  5. Facebook, Twitter reportedly partner with White House on vaccine push The social media giants are reportedly going to help get the word out about eligibility. Facebook and Twitter are reportedly going to help the White House get the word out about COVID-19 vaccine eligibility. Sarah Tew/CNET The White House has reportedly enlisted the aid of social media to promote information about vaccine eligibility. The Biden administration has partnered with Facebook and Twitter in a media blitz to promote President Joe Biden's new deadline for states to make all US residents 16 and older eligible for the COVID-19 vaccine, Axios reported Sunday. Biden had originally tasked states with opening eligibility to all adults by May 1 but later revised that target to April 19. The media push comes amid word that half of all adults in the US have received at least one COVID-19 vaccine shot. Across the country, nearly 130 million people 18 or older have received at least one dose of a vaccine, or 50.4% of the total adult population, the Centers for Disease Control and Prevention reported. The White House, Facebook and Twitter didn't immediately respond to requests for comment. Source: Facebook, Twitter reportedly partner with White House on vaccine push
  6. India's second wave hits the whole world through vaccine export curbs Facing a brutal new wave of coronavirus cases, India on Thursday made anyone over 45 eligible for vaccination. But the scramble to vaccinate as many people as possible has also meant sharply curtailing exports. Why it matters: The hopes of vaccinating the world have largely fallen on the shoulders of India, a vaccine manufacturing powerhouse and home to the world’s largest producer, the Serum Institute. Until recently, India was exporting most of the doses it was producing — a mix of donations to neighbors and other friendly nations, sales to countries like Saudi Arabia and the U.K., and contributions to the global COVAX initiative. Indian-made vaccines have gone to 82 countries. Then, after a long lull, cases began to surge. They are now at their highest point since mid-October and are continuing to climb precipitously. Vaccine exports, which had been ramping up, suddenly fell sharply. Rather than supplying the world, the Serum Institute appears to have redirected nearly its entire supply to the homefront. Driving the news: India has not imposed an export ban and will continue to supply doses, including to COVAX, a government source tells Axios. But given "domestic requirements," the source added, "there is some recalibration of the supply schedules.” Another official, speaking to Reuters, put it more bluntly: “Right now we are dealing with an emergency situation. Whatever we have, we will use it,” the official said. The government aims to vaccinate a minimum of 400 million people, up from 56 million at present (just 4% of the population), the official told Reuters. By the numbers: India has exported 6 million doses over the last three weeks, with less than 2 million of those going to the COVAX initiative. That’s down from 31 million in the three prior weeks, of which 16 million went to COVAX That’s a crippling setback for COVAX, which is a critical source of vaccines for low-income countries, particularly in Africa. COVAX had expected 71% of its first wave of distribution to consist of AstraZeneca doses produced at the Serum Institute, according to a preliminary forecast. A spokesman for Gavi, the vaccine alliance, said shipments expected in March and April had been delayed, and COVAX is now “in talks with the government of India in the hope of ensuring some supplies are completed during April.” What to watch: If this is anything more than a temporary delay, “that would be catastrophic,” African CDC director John Nkengasong told reporters Thursday. He said Africa would likely fall short of its vaccination targets this year. The big picture: The world currently has four major sources of vaccines. The U.S. is the second-largest producer, just ahead of India, but isn't exporting at all. China is currently the top producer and top exporter, according to Airfinity, focusing less on the domestic rollout in part because the virus remains under control in the country. The EU, meanwhile, has exported around 40% of its supply to date, but it's in the midst of a vigorous debate about whether and how to curb exports. Source: India's second wave hits the whole world through vaccine export curbs
  7. Trial started for vaccine against one of the scariest coronavirus variants The vaccine is being developed "out of an abundance of caution," Fauci says. Enlarge / A vial of the current Moderna COVID-19 vaccine. Researchers have given out the first jabs of a tweaked version of Moderna’s COVID-19 vaccine, one aimed at fighting one of the most concerning coronavirus variants—the B.1.351 variant, first identified in South Africa. The jabs are part of an early trial of the tweaked vaccine, which is being run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The agency aims to enroll around 210 healthy adults in the trial by the end of April. “The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States,” NIAID Director Anthony Fauci said in an announcement. “Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.” Data so far on the B.1.351 variant (aka 501Y.V2) suggests that it may be about 50 percent more transmissible than earlier versions. It also appears to evade immune responses from previous infections and current vaccines. Experiments in the lab found that it took about six times the amount of antibodies from recovered COVID-19 patients to neutralize the variant, compared with the amount needed to neutralize an earlier version of the virus. The variant also appeared to knock back Johnson & Johnson’s vaccine; the vaccine appeared 72 percent effective at preventing symptomatic COVID-19 in the US but was only 64 percent effective in South Africa while the B.1.351 variant was widely circulating. B.1.351’s concerning abilities likely stem from key mutations in its spike protein, the protruding protein that juts from the outside of SARS-CoV-2 viral particles. The virus uses the spike protein to bind to and gain entry into human cells. Some of the most potent antibodies against the virus bind to the spike, where they can physically block the virus from binding cells. Tweaks and tests The original Moderna vaccine works by delivering to human cells the genetic code for the SARS-CoV-2 spike in mRNA form. Once delivered, our cells read the code and make their own spike protein, which is used to train immune responses to spot and destroy any invading SARS-CoV-2. For the tweaked version of the vaccine, researchers at Moderna simply incorporated key mutations from the B.1.351 variant's spike protein into the mRNA code used in the vaccine. As Fauci mentioned in his statement, it’s unclear how necessary these variant-specific vaccines will be, given that current vaccines do provide some protection. However, with SARS-CoV-2 still widely circulating in the US and worldwide, the virus has ample opportunities to continue mutating. With every new infection, there are more chances for mutations and new variants to arise, which in turn increases the chances that variant-specific vaccines will be a fixture in our future. To understand how variants might fit into current vaccine use, the new NIH trial is testing 10 different vaccine regimens. Approximately 60 of the 210 people the institute aims to enroll will be people from the original Moderna vaccine trial, who were first immunized against COVID-19 last year. Some of those people will get a single booster shot with just the variant-specific vaccine, while others will get a booster that contains a mix of the original vaccine and the variant-specific vaccine. The remaining 150 people in the trial will be those who have not received any COVID-19 vaccines yet. Two groups of 15 will get three shots at varying dosages, 28 days apart: two doses of the original vaccine, then a variant-specific booster. Two groups of 20 will get just two shots at varying dosages of the variant-specific booster. Two groups of 20 will get two shots at varying dosages: a dose of the original vaccine and then a variant-specific booster. Lastly, two groups of 20 will get two shots, each with mixtures of both the original and variant-specific vaccine at varying dosages. Researchers will then monitor the participants for safety issues, side effects, and immune responses against SARS-CoV-2 viruses. Source: Trial started for vaccine against one of the scariest coronavirus variants
  8. Countries urge drug companies to share vaccine know-how A member of production checks cell growth and viability of a bioreactor sample under an inverted microscope inside the Incepta plant on the outskirts of Dhaka in Bangladesh Saturday Feb. 13, 2021. (AP Photo/Al-emrun Garjon) PARIS (AP) — In an industrial neighborhood on the outskirts of Bangladesh’s largest city lies a factory with gleaming new equipment imported from Germany, its immaculate hallways lined with hermetically sealed rooms. It is operating at just a quarter of its capacity. It is one of three factories that The Associated Press found on three continents whose owners say they could start producing hundreds of millions of COVID-19 vaccines on short notice if only they had the blueprints and technical know-how. But that knowledge belongs to the large pharmaceutical companies who have produced the first three vaccines authorized by countries including Britain, the European Union and the U.S. — Pfizer, Moderna and AstraZeneca. The factories are all still awaiting responses. Across Africa and Southeast Asia, governments and aid groups, as well as the World Health Organization, are calling on pharmaceutical companies to share their patent information more broadly to meet a yawning global shortfall in a pandemic that already has claimed over 2.5 million lives. Pharmaceutical companies that took taxpayer money from the U.S. or Europe to develop inoculations at unprecedented speed say they are negotiating contracts and exclusive licensing deals with producers on a case-by-case basis because they need to protect their intellectual property and ensure safety. Critics say this piecemeal approach is too slow at a time of urgent need to stop the virus before it mutates into even deadlier forms. WHO called for vaccine manufacturers to share their know-how to “dramatically increase the global supply.” “If that can be done, then immediately overnight every continent will have dozens of companies who would be able to produce these vaccines,” said Abdul Muktadir, whose Incepta plant in Bangladesh already makes vaccines against hepatitis, flu, meningitis, rabies, tetanus and measles. All over the world, the supply of coronavirus vaccines is falling far short of demand, and the limited amount available is going to rich countries. Nearly 80% of the vaccines so far have been administered in just 10 countries, according to WHO. More than 210 countries and territories with 2.5 billion people hadn’t received a single shot as of last week. The deal-by-deal approach also means that some poorer countries end up paying more for the same vaccine than richer countries. South Africa, Mexico, Brazil and Uganda all pay different amounts per dose for the AstraZeneca vaccine — and more than governments in the European Union, according to studies and publicly available documents. AstraZeneca said the price of the vaccine will differ depending on local production costs and how much countries order. “What we see today is a stampede, a survival of the fittest approach, where those with the deepest pockets, with the sharpest elbows are grabbing what is there and leaving others to die,” said Winnie Byanyima, executive director of UNAIDS. In South Africa, home to the world’s most worrisome COVID-19 variant, the Biovac factory has said for weeks that it’s in negotiations with an unnamed manufacturer with no contract to show for it. And in Denmark, the Bavarian Nordic factory has capacity to spare and the ability to make more than 200 million doses but is also waiting for word from the producer of a licensed coronavirus vaccine. Governments and health experts offer two potential solutions to the vaccine shortage: One, supported by WHO, is a patent pool modeled after a platform set up for HIV, tuberculosis and hepatitis treatments for voluntary sharing of technology, intellectual property and data. But no company has offered to share its data. The other, a proposal to suspend intellectual property rights during the pandemic, has been blocked in the World Trade Organization by the United States and Europe, home to the companies responsible for creating coronavirus vaccines. That drive has the support of at least 119 countries and the African Union but is adamantly opposed by vaccine makers. Pharmaceutical companies say instead of lifting IP restrictions, rich countries should simply give more vaccines to poorer countries through COVAX, the public-private initiative WHO helped create for more equitable vaccine distribution. The organization and its partners delivered its first doses last week in very limited quantities. But rich countries are not willing to give up what they have. Ursula Von der Leyen, head of the European Commission, has used the phrase “global common good” to describe the vaccines but the European Union imposed export controls on vaccines, giving countries the power to stop shots from leaving. On her first day as director-general of the WTO, Nigeria’s Ngozi Okonjo-Iweala said the time had come to shift attention to the vaccination needs of the world’s poor. “We must focus on working with companies to open up and license more viable manufacturing sites now in emerging markets and developing countries,” she told the organization’s members. “This should happen soon so we can save lives.” The long-held model in the pharmaceutical industry is that companies pour in huge amounts of money and research in return for the right to reap profits from their drugs and vaccines. Last May, Pfizer’s CEO Albert Bourla described the idea of sharing IP rights widely as “nonsense” and even “dangerous.” Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers, called the idea of lifting patent protections “a very bad signal to the future. You signal that if you have a pandemic, your patents are not worth anything.” Advocates of sharing vaccine blueprints argue that, unlike with most drugs, taxpayers paid billions to develop vaccines that could help end the world’s biggest public health emergency in living memory. “People are literally dying because we cannot agree on intellectual property rights,” said Mustaqeem De Gama, a South African diplomat involved in the WTO discussions. Paul Fehlner, the chief legal officer for biotech company Axcella and a supporter of the WHO patent pool board, said governments that poured billions of dollars into developing vaccines and treatments should have demanded more from the companies they were financing from the beginning. “A condition of taking taxpayer money is not treating them as dupes,” he said. Last month, Dr. Anthony Fauci, the leading pandemic expert in the United States, said all options need to be on the table, including improving production capacity in the developing world and working with pharmaceuticals to relax their patents. “Rich countries, ourselves included, have a moral responsibility when you have a global outbreak like this,” Fauci said. “We’ve got to get the entire world vaccinated, not just our own country.” It’s hard to know exactly how much more vaccine could be made worldwide if intellectual property restrictions were lifted. But Suhaib Siddiqi, former director of chemistry at Moderna, said with the blueprint and technical advice, a modern factory should be able to get vaccine production going in at most three to four months. “In my opinion, the vaccine belongs to the public,” said Siddiqi. “Any company which has experience synthesizing molecules should be able to do it.” Back in Bangladesh, the Incepta factory tried to get what it needed to make more vaccines in two ways, by offering its production lines to Moderna and by reaching out to a WHO partner. Moderna did not respond to requests for comment about the Bangladesh plant, but its CEO, Stéphane Bancel, told European lawmakers the company’s engineers were fully occupied on expanding production in Europe. “Doing more tech transfer right now could actually put the production and the increased output for the months to come at great risk,” he said. “We are very open to do it in the future once our current sites are running.” Muktadir said he fully appreciates the extraordinary scientific achievement involved in the creation of vaccines this year, wants the rest of the world to be able to share in it, and is willing to pay a fair price. “Nobody should give their property just for nothing,” he said. “A vaccine could be made accessible to people — high quality, effective vaccines.” ___ Maria Cheng reported from Toronto. Jamey Keaten in Geneva, Jan M. Olsen in Copenhagen, Denmark, Al-Emrun Garjon in Dhaka, Bangladesh, and Andrew Meldrum in Johannesburg, South Africa, contributed to this report. ___ Source: Countries urge drug companies to share vaccine know-how
  9. Draft landscape of COVID-19 candidate vaccines Overview These landscape documents have been prepared by the World Health Organization (WHO) for information purposes only concerning the 2019-2020 global of the novel coronavirus. Inclusion of any particular product or entity in any of these landscape documents does not constitute, and shall not be deemed or construed as, any approval or endorsement by WHO of such product or entity (or any of its businesses or activities). While WHO takes reasonable steps to verify the accuracy of the information presented in these landscape documents, WHO does not make any (and hereby disclaims all) representations and warranties regarding the accuracy, completeness, fitness for a particular purpose (including any of the aforementioned purposes), quality, safety, efficacy, merchantability and/or non-infringement of any information provided in these landscape documents and/or of any of the products referenced therein. WHO also disclaims any and all liability or responsibility whatsoever for any death, disability, injury, suffering, loss, damage or other prejudice of any kind that may arise from or in connection with the procurement, distribution or use of any product included in any of these landscape documents. WHO Team: R&D Blueprint Number of pages: 9 Download draft landscape documents (401.7 kB) Source
  10. Russia offers its untested COVID-19 vaccine for free to UN officials The World Health Organization declined to comment on whether this was a good idea. Enlarge / Russian President Vladimir Putin address the 75th session of the United Nations General Assembly, via teleconference call, in Moscow on September 22, 2020. Getty | MIKHAIL KLIMENTYEV 125 with 67 posters participating Some United Nations staff are likely brushing up on their Russian—specifically how to say “Thanks, but no thanks” in the nicest way possible. On Tuesday, Russian President Vladimir Putin offered UN staff free doses of the country’s COVID-19 vaccine, Sputnik V, which has not completed clinical trials for efficacy and has not been thoroughly vetted for safety. Still, Putin suggested that his offer was prompted by the desire to give the people what they want: “Some colleagues from the UN have asked about this, and we will not remain indifferent to them,” he said during a speech Tuesday at this year’s (virtual) General Assembly. Putin made headlines last month after announcing that Russia has granted regulatory approval for the (limited) use of Sputnik V, the first country in the world to do so. He even boasted that one of his daughters had received her first dose of the vaccine. But public health experts were quickly skeptical of the move, seeing it as merely a political stunt to give the appearance that Russia was “winning” the race to develop a vaccine against the pandemic coronavirus, SARS-CoV-2. At the time, the vaccine had only been tested in two small clinical trials, involving just 76 people total—and the data from those small trials had not yet been released. No comment Russian researchers have since published that data in the journal The Lancet. The results indicate that Sputnik V spurred potentially protective immune responses and did not cause any severe side effects. However, outside researchers were quick to note oddities in the data, including that different samples generated suspiciously identical or near-identical results. Sputnik V has now moved into larger trials with tens of thousands of people. These will test whether the vaccine is safe in a larger number of people and actually protects against infection from SARS-CoV-2. But any clear results are months away. The lack of data does not seem to trouble Putin, who was happy to distribute the vaccine to UN staff. “Any one of us could face this dangerous virus. The virus has not spared the staff of the United Nations, its headquarters, and regional entities,” Putin said in a prerecorded speech from Moscow, according to the AP. “Russia is ready to offer UN workers the necessary, qualified help, and in particular we propose to supply our vaccine for free to employees of the organization and its subsidiaries who volunteer for vaccination.” UN spokesperson Stephane Dujarric told the AP that “We thank President Putin for his generous offer, which will be studied by our medical services.” Dr. Margaret Harris, spokesperson for the World Health Organization, which is an agency within the UN, declined to comment. Russia offers its untested COVID-19 vaccine for free to UN officials
  11. Untested COVID-19 vaccine, Sputnik V, begins 40,000-person trial next week Russia skipped trials to grant approval and claim breakthrough. Enlarge Aurich Lawson / Getty Images 269 with 120 posters participating After hastily granting approval last week for a COVID-19 vaccine that has yet to enter rigorous clinical trials, Russia has now announced plans to give the vaccine to more than 40,000 volunteers in a trial that starts next week. The “previously planned post-registration” injections are part of a “randomized, double-blind, placebo-controlled multicenter clinical study” of the vaccine, dubbed Sputnik V, according to an August 20 press release from the Russian Direct Investment Fund, which has financially backed the development of the vaccine. The more than 40,000 people for the trial will be recruited from more than 45 medical centers, the press release added. On August 11, Russian President Vladimir Putin announced that Sputnik V had won regulatory approval, making it the first COVID-19 vaccine in the world to achieve domestic approval. Putin hailed Sputnik V as a breakthrough and even announced that one of his daughters had already received one dose of the two-dose vaccine. “I know it has proven efficient and forms a stable immunity,” Putin said, noting that Sputnik V had passed necessary testing. Officials have reportedly pledged to vaccinate millions in the coming months. But researchers and public health experts are deeply skeptical of the vaccine and Putin’s claims. To date, Sputnik V is only known to have been tested in a total of 76 people in two small clinical trials—neither of which was designed or able to assess if the vaccine can protect against the pandemic coronavirus, SARS-CoV-2, which causes COVID-19. The data for those small, early trials are not published in a scientific journal, nor have they been made public. Stable breakthrough? Typically, vaccines earn approval after successfully making it through three phases of trials, which have progressively larger groups of participants. That is, trials usually start with just dozens of people to test safety (phase I), then move to hundreds of people to continue testing safety and immune responses (phase II), then to tens of thousands to see if the vaccine is actually protective (phase III). Sputnik V appears to have only gone through the early stages of phase I and II trials, the outcomes of which are still unknown. Moreover, the approval certificate the Russian government granted allows Sputnik V to only be given to “a small number of citizens from vulnerable groups,” according to a Ministry of Health spokesperson who spoke with ScienceInsider. The certificate further stipulates that the vaccine cannot be used widely until January 1, 2021, likely after larger trials are completed. The World Health Organization has reportedly begun discussions with Russia to try to ascertain what data it has on the vaccine so far—and what it still needs to collect to show efficacy. A senior WHO official emphasized to the AP that when it comes to a COVID-19 vaccine, “it’s essential we don’t cut corners in safety or efficacy.” The newly announced trial may provide some answers on safety and efficacy in the months to come. But for now, there’s little information. The new trial is not registered on Clinicaltrials.gov, a database of clinical trials conducted around the world. (The earlier two clinical trials on Sputnik V were registered). Beyond Sputnik V, there are 129 other vaccines in clinical trials, including six in phase III trials, according to the latest tally by the WHO. There are also 139 other vaccine candidates in pre-clinical development. Untested COVID-19 vaccine, Sputnik V, begins 40,000-person trial next week
  12. China moves forward with COVID-19 vaccine, approving it for use in military Early trial data suggests that vaccine is safe, but efficacy still unclear. Enlarge / Chinese President Xi Jinping learns about the progress on a COVID-19 vaccine during his visit to the Academy of Military Medical Sciences in Beijing on March 2, 2020. Getty | Xinhua News Agency 31 with 28 posters participating China has approved an experimental COVID-19 vaccine for use in its military after early clinical trial data suggested it was safe and spurred immune responses—but before larger trials that will test whether the vaccine can protect against SARS-CoV-2 infections. This marks the first time any country has approved a candidate vaccine for military use. China’s Central Military Commission made the approval June 25, which will last for a year, according to a filing reported by Reuters. The vaccine, developed by biotech company CanSino Biologics and the Chinese military, is a type of viral vector-based vaccine. That means researchers started with a viral vector, in this case a common strain of adenovirus (type-5), which typically causes mild upper respiratory infections. The researchers crippled the virus so that it doesn’t replicate in human cells and cause disease. Then, they engineered the virus to carry a signature feature of SARS-CoV-2—the coronavirus’s infamous spike protein, which juts out from the viral particle and allows the virus to get a hold on human cells. The idea is that, when the harmless vaccine virus is injected into the body, it will essentially present the SARS-CoV-2 spike protein to the immune system, which can then develop anti-SARS-CoV-2 responses. Those include antibodies, which are Y-shaped proteins that surveil the body and detect previously encountered germ invaders by key features. Once a germ is detected, neutralizing antibodies can glom onto the germ and prevent it from sparking an infection. In a Phase 1 safety trial involving 108 people, the vaccine—dubbed Ad5-nCoV—proved safe and was able to spur the production of neutralizing antibodies and other immune responses. However, the study, published in The Lancet, also detected a potential foil for the vaccine candidate: in people who had been infected with Ad5 in their past, the vaccine didn’t generate as strong of a response to SARS-CoV-2’s spike protein. This may be because their immune systems quickly recognized the adenovirus and focused their responses on the viral vector, rather than the nefarious spike. CanSino said it had since completed a larger Phase 2 trial, looking at safety and efficacy, but has yet to release results, according to the South China Morning Post. The paper also noted that CanSino has reached an agreement with the Canadian government to conduct Phase 3 trials there. Those trials will look at efficacy and potential side effects in an even larger group of people. In the meantime, CanSino declined to say if members of the Chinese military would be required to receive the experimental vaccine or if it would be optional, according to Reuters. According to the latest tally by the World Health Organization, there are 17 COVID-19 vaccine candidates in clinical trials and 132 others in pre-clinical development. Many vaccines are being developed in China, but with the now-limited spread of the coronavirus there, researchers are working to conduct vaccine trials elsewhere, in areas still seeing heavy transmission. China moves forward with COVID-19 vaccine, approving it for use in military
  13. COVID-19 vaccine must protect 50% of people for approval, FDA says FDA sets rules for vaccine approval amid concern of hastiness and political pressure. Enlarge / Stephen Hahn, Commissioner of Food and Drugs at the US Food and Drug Administration (FDA), speaks during a Senate Health, Education, Labor and Pensions Committee hearing on June 30, 2020, in Washington, DC. Getty | Al Drago 59 with 49 posters participating Any experimental COVID-19 vaccines aspiring to earn regulatory approval from the Food and Drug Administration will need to prevent or decrease the severity of disease in at least 50 percent of people, the agency announced Tuesday. The criterium is part of a larger set of guidelines released by the agency for developing a vaccine to halt the spread of pandemic coronavirus, SARS-CoV-2—which causes COVID-19 and is now accelerating in much of the country after months of sustained devastation. With the guidelines, the FDA tried to dispel fears that the rush to develop a COVID-19 vaccine may come at the expense of adequate safety testing. “We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19,” FDA Commissioner Stephen Hahn said in a statement. “While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards.” Exceptions The agency also hopes to assuage concerns that it has succumbed to political pressure from the Trump administration in making regulatory decisions during the pandemic—eschewing its reliance on efficacy and safety data. Most notable is the case of hydroxychloroquine, a malaria drug known to have severe potential side effects, including triggering potentially fatal heart arrhythmias. Despite a lack of evidence for its efficacy against COVID-19, President Trump touted the drug as a “game changer” and even admitted to taking it himself. The FDA made the unusual decision to issue an Emergency Use Authorization (EUA) for hydroxychloroquine and the related drug, chloroquine, in late March. The EUA allowed doctors to use the drugs to treat COVID-19 patients outside of clinical trials, despite the lack of the evidence. As data piled up that the drugs are ineffective against COVID-19 and come with serious risks, the FDA revoked the EUA in mid-June. Though political leaders, health experts, and media reports have suggested the Trump administration influenced the FDA’s initial decision to issue an EUA, Hahn has denied this. In a Congressional hearing June 23, he testified that “I have not felt political pressure nor has the FDA to make any decision in any specific direction.” He echoed the point in today’s announcement of the vaccine guidelines, saying “We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data.” In the announcement, the FDA noted that, although the guidelines lay out what’s needed for full approval, the agency may still consider issuing an EUA to candidate COVID-19 vaccines on a “case-by-case” basis. The agency said it would consider an EUA based on “the target population, the characteristics of the product, and the totality of the relevant, available scientific evidence, including preclinical and human clinical study data on the product’s safety and effectiveness.” COVID-19 vaccine must protect 50% of people for approval, FDA says
  14. Key Points Uber shares rose 9% on Monday on optimism that a Covid-19 vaccine is on the way. Last week, the stock jumped 34%, as investors cheered the passage of California’s Proposition 22, which will allow Uber to keep classifying drivers as contractors. Revenue has been slumping and losses mounting, but the company says its margins are headed in the right direction. Investors are suddenly optimistic about Uber. Shares climbed over 9% on Monday and were poised to close above their $45 IPO price for the first time since June 2019, the month after the company went public. The move comes despite last week’s Q3 earnings report showing a second straight quarter of declining revenue, with another drop expected this period, and a cumulative net loss of $5.8 billion for the year so far. Monday’s rally came after drugmakers Pfizer and BioNTech indicated their Covid-19 vaccine is more than 90% effective, raising optimism that demand for consumer services like ride-sharing may soon return in force. The gains follow last week’s 34% jump, sparked by the passage of California’s Proposition 22, which will allow Uber to continue classifying its drivers as contractors instead of employees. Lyft shares soared 22% on Monday, following a 31% increase last week. However, while Uber’s stock has erased its post-IPO losses and finally generated some gains for investors, Lyft remains almost 50% below its debut price from last year. Uber and Lyft this year The difference between the companies is food delivery. Uber has partly offset declines in its core ride-sharing business this year through Uber Eats. That service recorded gross bookings growth of 134% in the third quarter while Uber’s ride-hailing division sank by 53%. Still, the delivery business lost $183 million on an adjusted basis, after a deficit of $232 million in the second quarter. Richard Kramer, an analyst at Arete Research, told CNBC in August that Uber was likely to “slip into a net debt position” in the next quarter because of its cash burn rate. Reasons for optimism Uber and its proponents believe the company’s profitability outlook is improving even with the challenges of the pandemic. The negative margin in the delivery business shrank to 16.1% in the third quarter from 26.2% in the second quarter and 59.4% in the first. Meanwhile, its positive adjusted margin in ride-sharing grew to 17.9% in the third quarter from 6.3% the prior period, though still down from 23.5% in the first three months of the year. Factor in those developments and then look to a not-too-distant future that includes open bars and restaurants, some live events, and workers commuting to and from the office, and there’s at least a sensible narrative for investors to bet on the company. “Ultimately, we view a rides recovery as ‘when’ not ‘if’ and now represents a source of upside in 2021 if/when mass availability of a vaccine can jumpstart travel/social-related ridesharing demand,” analysts at Guggenheim wrote in a report on Friday, before the latest update on vaccine development. They have a buy recommendation on the stock. Analysts at Canaccord Genuity, who also have a buy rating, take a similar view. They wrote last week that, “given recovery trends and a more optimistic outlook for Covid vaccines, it seems likely that Uber’s mobility business will be posting strong growth against easy comps by mid-2021, suggesting the stock may begin working more decisively.” However, should the economy reopen in a way that resembles the pre-pandemic world, what does that mean for Uber Eats, which is growing rapidly because consumers aren’t going to restaurants? As Arete’s Kramer said in August, “You either have people taking rides to restaurants or staying at home and ordering takeaway, but you don’t tend to have both at the same time.” Add it all up and Uber still has to show it can make money. Source
  15. Moderna says its COVID-19 vaccine is 94.5 percent effective in early analysis The company announced preliminary results on Monday Photo Illustration by Rafael Henrique/SOPA Images/LightRocket via Getty Images Moderna’s COVID-19 vaccine candidate is 94.5 percent effective, according to early data released by the company in a press release. That’s slightly higher than the efficacy reported by Pfizer and BioNTech; they announced a 90 percent efficacy for their vaccine candidate last week. Both Moderna and Pfizer said they plan to ask the Food and Drug Administration for authorization within a few weeks. The data still hasn’t been published or reviewed by outside experts. These efficacy readings are higher than many experts were expecting, though. The FDA said it’s looking for vaccines that were at least 50 percent effective. “Aspirationally, you would like to see 90, 95 percent, but I wasn’t expecting it. I thought we’d be good, but 94.5 percent is very impressive,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told The New York Times. In this initial evaluation, Moderna said that there were 90 cases of COVID-19 in the clinical trial group that received the placebo and only five cases in the group that were given a vaccine. The company also checked to see how many of the cases were severe, and it found 11 severe cases in the placebo group but none in the group receiving the vaccine. There were no serious safety concerns with the vaccine, but participants reported some side effects like fatigue, headache, or pain at the injection site. They generally passed quickly. Moderna had the first vaccine to enter clinical trials in March. Only 63 days after the genetic sequence of the virus was posted online, the company injected the first volunteer with its vaccine candidate. It was able to move so quickly because it used a gene-based technology to create its vaccine. Those types of vaccines are relatively simple to create once researchers know the viral gene they’re trying to target. Pfizer and BioNTech’s vaccine was built using the same method. The two are made from tiny pieces of mRNA, which gives the human body instructions to produce copies of the coronavirus spike protein. Then, the immune system learns to defend against that protein. Gene-based vaccines are the long-promised future of vaccine development, but they’ve never been approved for use in people by the FDA. The early successes of the Moderna and Pfizer vaccines are a promising sign for the method. Moderna also announced today that its COVID-19 vaccine can be stored at refrigerator temperatures (between 36 and 46 degrees Fahrenheit, or 2 to 8 degrees Celsius) for up to 30 days, which should help make storage and distribution of this vaccine easier. One worry with gene-based vaccines is that they are extremely fragile and have to be stored at ultracold temperatures. Pfizer and BioNTech’s vaccine has to stay at -70 degrees Celsius (-94 degrees Fahrenheit), giving Moderna a slight logistical edge. Previously, Moderna thought its vaccine could only stay in a refrigerator for seven days. The longer window “would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world,” Juan Andres, chief technical operations and quality officer at Moderna, said in a press release. Moderna said it would have 20 million doses of its two-shot vaccine available by the end of 2020 and 500 million to 1 billion doses in 2021. The United States government has a deal with the company for 100 million doses of its vaccine through “Operation Warp Speed,” a federal program aimed at accelerating COVID-19 vaccine development. That’s in addition to the 600 million doses of the Pfizer vaccine purchased by the US, 50 million doses of which could be available this year. That vaccine also takes two shots. Meanwhile, the US is seeing record numbers of COVID-19 cases each day, with no end in sight. Even with this promising data, a vaccine won’t be available to most people for a few months at the very least. That makes protective measures like wearing masks and avoiding gatherings all the more important as the vaccines move into the authorization process. The more people who make it through the next few weeks of the pandemic, the more who could benefit from these vaccines. Correction November 16th, 8:50AM ET: An earlier version of this article reversed the number of cases found in the placebo and vaccine groups. We regret the error. Moderna says its COVID-19 vaccine is 94.5 percent effective in early analysis
  16. Nepal approves AstraZeneca COVID-19 vaccine for emergency use FILE PHOTO: Vials of AstraZeneca's COVISHIELD, coronavirus disease (COVID-19) vaccine, are seen before they are packaged inside a lab at Serum Institute of India, Pune, India, Nov. 30, 2020. REUTERS/Francis Mascarenhas/File Photo KATHMANDU/NEW DELHI (Reuters) - Nepal on Friday granted approval for AstraZeneca’s COVISHIELD vaccine against the coronavirus, the government said, following a meeting with neighbouring India, a major manufacturer of the shot. “Conditional permission has been granted for emergency use authorization of COVISHIELD vaccine against COVID-19 in Nepal,” the Department of Drug Administration said. Nepal has reported 266,816 cases and 1,948 deaths from COVID-19, according to official data. The announcement follows a meeting between India’s foreign minister S. Jaishankar and his Nepali counterpart Pradeep Kumar Gyawali on Friday where “close cooperation” on the pandemic was discussed, according to a statement by India’s foreign ministry. The statement added that Nepal requested that India supply the Himalayan nation with vaccines, without providing further details. India, one of the world’s leading drugmakers, has already begun the manufacture of AstraZeneca’s vaccine, as well as COVAXIN, developed by Bharat Biotech International with a state-run institute. It begins its own vaccination drive on Saturday. Source: Nepal approves AstraZeneca COVID-19 vaccine for emergency use
  17. Researchers close in on 'universal' flu vaccine as COVID-19 fight takes priority Researchers may be one step closer to a universal flu vaccine, even as COVID-19 takes priority. File Photo by Roger L. Wollenberg/UPI | License Photo Jan. 8 (UPI) -- Researchers believe they are one step closer to a "universal" flu vaccine, even as concerns over the seasonal virus move to the back burner during the COVID-19 pandemic. T cells found in the lungs may hold the key to long-lasting immunity against influenza A, the more common and often more severe form of the virus, according to the researchers behind a study published Friday by Science Immunology. These cells, which the researchers call resident helper T cells, help the body initiate antiviral responses against new influenza strains even after experience with only one type of the virus, the researchers said. This type of "generalized" immune response, against all virus strains, is not possible with the currently available yearly vaccine formulations, they said. The findings come at a time when the winter flu season has been much quieter than normal across the United States. Only six states -- Arizona, Georgia, Mississippi, Nevada, Oklahoma and South Carolina -- are reporting "low" flu activity, according to data released Friday by the U.S. Centers for Disease Control and Prevention. The rest of country is reporting "minimal" flu-related activity at this time, as 0.1% of all throat and nasal samples tested come back positive for the seasonal virus, the agency said. However, the World Health Organization has asked countries to remain on alert for outbreaks of the so-called "bird flu," which usually involves a strain of influenza A, particularly in light of ongoing outbreaks in India. "T helper cells could be an interesting starting point for longer-lasting flu vaccinations," David Schreiner, co-author of the Science Immunology study, said in a statement. It might be possible to supplement annual flu vaccines with drugs that promote the formation of these T helper cells, said Schreiner, a professor of biomedicine at the University of Basel in Switzerland. Using mice infected with influenza A, he and his colleagues found that resident helper T cells remain in the lungs for a long time after a bout of the flu. One type of these cells releases substances to equip other immune cells with deadlier "weapons" in the fight against the virus if it returns, the researchers said. Another type assists in the production of antibodies, or cells created by the immune system to fight off viruses, in the lungs, they said. Vaccines designed to stimulate the production of these cells in the lungs could be effective against multiple strains of the flu, according to the researchers. "It makes sense that the body keeps a reservoir of these cells in the tissues affected by the infection, where the same or similar pathogens could invade again," study co-author Nivedya Swarnalekha, a doctoral student at the University of Basel, said in a statement. Since the end of September, clinical and public health laboratories across the country have tested more than 500,000 throat and nasal samples for seasonal influenza, the CDC reported Friday. Just over 1,000 of them have tested positive for the virus, with about 40% of them involving strains of influenza A, the agency said. Less than 2% of all doctor and hospital visits across the country through Jan. 2 were related to the flu, the CDC estimates. Source: Researchers close in on 'universal' flu vaccine as COVID-19 fight takes priority
  18. Hall of shame — “Shkreli Award” goes to Moderna for “blatantly greedy” COVID vaccine prices Moderna used $1 billion from feds to develop vaccine, then set some of the highest prices. Enlarge / COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left). Drew Angerer / Florian Gaertner / Getty Images 147 with 97 posters participating One of the leading developers of COVID-19 vaccines has now been placed in the ranks of people like Martin Shkreli—the disgraced pharmaceutical executive infamous for jacking up the price of an old, life-saving drug by more than 5,000 percent. He is now serving an 84-month prison sentence from a 2017 conviction on fraud counts unrelated to the drug pricing. Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. The awards, announced annually for four years now, go to “perpetrators of the ten most egregious examples of profiteering and dysfunction in health care.” Award judges cited Moderna’s pricing of its COVID-19 vaccine, which was developed with $1 billion in federal funding. Still, despite the tax-payer backing, Moderna set the estimated prices for its vaccine significantly higher than other vaccine developers. In August, the company set the estimated price range of $32 to $37 per dose, making the two-dose regimen $64 to $74 per person. At the time, pharmaceutical giant Pfizer and its partner BioNTech—which now have the other US-authorized COVID-19 vaccine—had inked a deal with the US government to supply doses at $19.50 each, for a two-dose regimen of $39 per person. Notably, Pfizer and BioNTech developed their vaccine without any federal funding. Also, Johnson & Johnson had a deal to supply the US government with doses of its vaccine—still in the works—at a rate of $10 per dose. In November, amid criticism, Moderna reportedly lowered its estimated cost to range in price from $25 to $37 per dose. And, in the end, it signed a deal with the US government to provide the vaccine at a price of $15 per dose, or $30 for a two-dose regimen per person. Still, the Lown Institute’s judges wrote that, “given the upfront investment by the US government, we are essentially paying for the vaccine twice.” Award judge Deborah Blum added, “This is so blatantly greedy from a company that has no track record in producing vaccines and built its current one with taxpayer help.” Blum is a Pulitzer Prize winning science journalist and director of the Knight Science Journalism program at the Massachusetts Institute of Technology. Moderna made another appearance on the award list. Judges noted that Dr. Elizabeth Nabel, CEO of Brigham and Women’s Hospital and a member of Moderna’s board, penned an op-ed in February defending high drug prices. Nabel did not disclose her role at Moderna in the op-ed. She also faced questions of conflicts-of-interest after Brigham and Women’s Hospital was selected as a trial site for Moderna’s vaccine. Award judges noted that Nabel had received $487,500 in Moderna stock options and other payments in 2019 and sold $8.5 million worth of Moderna stock in 2020 after the company’s stock nearly quadrupled amid fanfare around its COVID-19 vaccine. Nabel resigned from Moderna's board amid criticism in July. Moderna did not immediately respond to Ars’ request for comment. “Shkreli Award” goes to Moderna for “blatantly greedy” COVID vaccine prices
  19. It’s going to take a lot longer to make a COVID-19 vaccine than a treatment Scientists have a head start on treatments Photo by Sylvain Lefevre / Getty Images Scientists and drug companies are racing to develop and test treatments and vaccines that address COVID-19, the disease caused by the novel coronavirus. Work on both is progressing at an unprecedented speed — but researchers are starting essentially from scratch on vaccine development, so the process is going to take a long time. Treatments, on the other hand, were further along when the outbreak started and might be available sooner. “They’re in vastly different situations right now,” says Florian Krammer, a professor and vaccine development expert at the Icahn School of Medicine at Mount Sinai. Both treatments and vaccines are important for a robust and effective response to the outbreak. Treatments help people after they already have a disease; in the case of COVID-19, researchers hope to treat the around 15 percent of COVID-19 patients who have non-mild symptoms. Vaccines, on the other hand, help prevent people from getting sick in the first place. Scientists started work on drugs to treat coronaviruses during the SARS and MERS outbreaks, but because the outbreaks died down, the job was never completed. Now, they’re able to dust off that old research and start building on it. The leading candidate is a drug called remdesivir, which was developed by the pharmaceutical company Gilead. Research showed that it could block SARS and MERS in cells and in mice. In addition, remdesivir was used in a clinical trial looking for treatments for Ebola — and therefore, it had already gone through safety testing to make sure it doesn’t cause any harm. That’s why teams in China and the US were able to start clinical trials testing remdesivir in COVID-19 patients so quickly. There should be data available showing if it helps them get better as soon as April. If it proves effective, Gilead would presumably be able to ramp up production and get the drug in the hands of doctors fairly quickly, Krammer says. The vaccine development process will take much longer. Experts say that it will be between a year and 18 months, or maybe longer, before they’re available to the public. One of the strategies for creating a vaccine involves making copies of one part of the virus (in this case, the bit that the novel coronavirus uses to infiltrate cells). Then, the immune system of the person who receives the vaccine makes antibodies that neutralize that particular bit. If they were exposed to the virus, those antibodies would be able to stop the virus from functioning. The pharmaceutical company Moderna is the furthest along in the process; it already has that type of vaccine ready for testing. A trial in 45 healthy people to make sure that it’s safe will start in March or April and will take around three months to complete. After that, it’ll have to be tested in an even larger group to check if it actually immunizes people against the novel coronavirus. That will take six to eight months. And then, it’ll have to be manufactured at a huge scale, which poses an additional challenge. Making vaccines is always challenging. Developing this one is made more difficult because there has never been a vaccine for any type of coronavirus. “We don’t have a production platform, we have no experience in safety, we don’t know if there will be complications. We have to start from scratch, basically,” Krammer says. It was much easier to make a vaccine for H1N1, known as swine flu, which emerged as a never-before-seen virus in 2009. “There are large vaccine producers in the US and globally for flu,” Krammer says. Manufacturers were able to stop making the vaccine against the seasonal flu and start making a vaccine for this new strain of flu. “They didn’t need clinical trials, they just had to make the vaccine and distribute it,” he says. There won’t be a vaccine done in time to hold off any approaching outbreak of COVID-19 in the US or in other countries where it’s still not widespread. That’s why treatments are so important: along with good public health practices, they can help blunt the impact of the disease and make it less of an unstoppable threat. The best experts can hope for is that a vaccine can help prevent other outbreaks in the future if the novel coronavirus sticks around. Source: It’s going to take a lot longer to make a COVID-19 vaccine than a treatment (The Verge)
  20. Everything You Need to Know About Coronavirus Vaccines As Covid-19 spreads, the pressure is on for drugmakers to get a vaccine to market. But it's not that easy. Since vaccine candidates started being developed in January, a version approved for public use won’t be available until the end of summer 2021, at the earliest. And that’s if nothing goes wrongPhotograph: Maria Toutoudaki/Getty Images It’s been fewer than three months since a novel coronavirus emerged in China, causing fever, coughing, and, in severe cases, pneumonia. Since then, the disease known as Covid-19 has swept into 72 countries, infecting nearly 93,000 people and killing more than 3,000. What makes the coronavirus scary enough to cause a worldwide run on face masks and lead countries to lock down whole megacities and ban travelers isn’t that it’s super deadly. So far, the World Health Organization estimates Covid-19’s fatality rate to be about 3.4 percent globally, which is still lower than other recent coronavirus outbreaks, including SARS and MERS. (That said, it appears to be more fatal than flu, which has a case fatality rate of around 0.1 percent.) And it’s very contagious. Still, most people who get Covid-19 will recover in a week or two, without need for hospitalization. What has people panicked is that it’s new. In the US and other developed countries, particularly in the global north, mystery illnesses don’t strike that often. People are used to having answers and a plan for avoiding getting sick. In these places, vaccines have already eliminated infectious diseases that were once common, including polio, hepatitis, and the measles. If you get your flu shot every year, the worst thing you’ll usually pick up is a case of the common cold. Which is perhaps why Americans can’t seem to wait to get their hands on a Covid-19 vaccine. President Donald Trump told pharmaceutical executives and public health officials in a White House meeting on Monday that he wants one ready before the election in November. For the record, that would be impossible. Developing vaccines that are safe and effective takes time, investment, and good science. Developing a vaccine for a coronavirus like the one that causes Covid-19 comes with even more challenges. But at least 30 companies and academic institutions are trying. Here’s your guide to everything you need to know about those efforts. Check back often—we’ll be keeping it updated with any notable progress or setbacks. What’s In a Vaccine? Vaccines all work on the same basic principle: Scientists try to make something that closely resembles a pathogen, and then expose a person’s immune system to it through a small dose administered as an injection. Ideally, the immune system develops a strong memory of the pathogen, so that the next time the person is exposed, their body will mount an attack before the infection can take hold. The trick is to do this without making the person seriously ill from the vaccine itself. There are a few different methods for making vaccines, but they all must strike this delicate balance. One way to make a vaccine is to weaken, or attenuate, the microorganism while still keeping it alive. The most common method for doing this is growing several generations of the pathogen in environments other than human cells, so that it evolves away from causing disease in humans. By repeatedly culturing live viruses or bacteria in animal cells, scientists can essentially create a bunch of mutants. Then it’s a matter of selecting the mutant strains that can replicate in human cells but don’t cause disease like their wild ancestor. The trick is that these imposters still have to look enough like the original virus to accurately train the immune system to fend it off. Examples of attenuated vaccines include those for measles, mumps, and tuberculosis. Another type is called an inactivated vaccine, which is made from a dead version of the whole virus or bacteria after it’s been killed with heat or chemicals. This type of vaccine can also be made using smaller pieces of the microbe, which by themselves are not considered alive. One common approach is to locate the protein that a virus uses like a key to get into human cells, which is usually on its surface. Once scientists know the genetic code for this protein, they can paste it into bacteria or yeast and use these microbial factories to produce huge quantities of it to be used as the basis of the vaccine. The protein alone is often enough to be easily recognized by the immune system and to trigger a defense on subsequent exposure. Alternately, sometimes scientists will genetically modify the virus instead, swapping bits of the disease-causing pathogen into a harmless virus shell. These types of inactivated vaccines almost always require multiple doses, because they’re not as good at stimulating the immune system as a live microbe. But they come with a lower risk of severe reactions. Examples of inactivated vaccines include those for polio, rabies, and hepatitis A and B. All the approved vaccines on the market use one of these two techniques. But newer methods still in development may get their debut with the Covid-19 outbreak. One such promising technology is nucleotide-based vaccines. Nucleotides are the chemical building blocks that make up genetic material, both DNA and RNA. The virus that causes Covid-19, known as SARS-CoV-2, consists of a strand of RNA enclosed in a spike-covered capsule. It uses these spikes to invade human lung cells. Vaccine makers can copy the genetic instructions for making these spikes and package them up into a shot. Once inside the body, human cells will make the viral proteins, which the immune system will then recognize as foreign. It will produce antibodies against them and learn how to attack any future invaders carrying these protein spikes. When Will a Covid-19 Vaccine Be Ready? On Tuesday, National Institute of Allergy and Infectious Diseases director Anthony Fauci told US senators, “It will take at least a year and a half to have a vaccine we can use.” That might seem like an eternity for public health officials staring down a probable pandemic. But if true, it would actually set a record. Most vaccines take between five and 15 years to come to market, says Jon Andrus, an adjunct professor of global vaccinology and vaccine policy at the Milken Institute of Public Health at George Washington University. The reason it usually takes so long comes down to a combination of factors. The first is getting a candidate vaccine that’s ready to test. This part of the vaccine development process, known as discovery, used to take years of careful benchtop biology. Scientists had to isolate and grow viruses in the lab. But now, with genetic sequencing, new protein-visualizing microscopes, and other technology advances, it’s possible to skip that step. Arriving at a vaccine candidate can sometimes be done in weeks. All those advances, though, can’t speed up the time it takes to meticulously monitor how well these candidate vaccines work in people. Clinical trials, a prerequisite for bringing a vaccine to market, are the real bottleneck. Each happens in three stages. Phase 1 involves just a few dozen healthy volunteers, and is meant to evaluate whether the vaccine is safe. That takes about three months. If the healthy volunteers don’t suffer any adverse effects, it’s on to Phase 2. This time, several hundred people will get the shot, ideally in an area experiencing a Covid-19 outbreak, so scientists can gather data on how well it spurs the production of antibodies and fends off the disease for these trial subjects. That’s another six to eight months. If everything still looks good, Phase 3 is to recruit a few thousand people in an outbreak zone and repeat the experiment. That’s another six to eight months—if you don’t have any problems recruiting patients or with your vaccine supply. Then a regulatory agency, like the US Food and Drug Administration, has to review all the data before making a decision about whether to approve the vaccine. That can take months to a year. If you’ve been doing the math, this means that, since vaccine candidates started being developed in January, a version approved for public use won’t be available until the end of summer 2021, at the earliest. And that’s if nothing goes wrong. “Constricting the whole timeline of going from concept to a product that can be distributed into a year or two is really a herculean endeavor,” Andrus says. Only a handful of companies have vaccine candidates ready to move into human testing, but more than 30 have joined the race. Even if one of these companies does pull off the Thirteenth Labor, they’re left with a novel product that still requires manufacturing and distribution. “The first question we should be asking is: Does this producer have the capacity to scale it up?” asks Andrus. If not, a limited supply will force public health officials to make tough decisions about rationing out a vaccine. Isn’t There Any Way to Speed It Up? In general, these timelines are very difficult to compress. The last thing drugmakers and regulators want is to rush out a subpar product and create—rather than solve—a public health crisis. Making vaccines is so cost-intensive and high risk that most pharmaceutical firms don’t do it anymore. Today, the vaccine business is dominated by just four companies: Pfizer, Merck, GlaxoSmithKline, and Sanofi. Since they’re the ones with the kind of capacity required to fight a global pandemic, they’re the ones that have to be convinced it’ll be worth it. Covid-19 might seem like a sure bet now. But outbreaks are unpredictable. SARS disappeared just four months after it caused a global panic. The companies that had begun developing vaccines against it had to abandon their trials because there just weren’t enough patients. Similar disease cycles help explain why it took so long to get an Ebola vaccine, which was only approved last December despite dozens of outbreaks since it first emerged in 1976. Plus, government funding and pharmaceutical industry interest tend to evaporate once the sense of emergency fades away. No one wants to make a product that’s not going to be used. But there are some things governments can do to encourage vaccine makers to take up the challenge despite its riskiness, including providing grants and other financial incentives to spur their involvement. In the US, a division of the Department of Human & Health Services known as the Biomedical Advanced Research and Development Authority often plays the role of incentivizing medical countermeasures against an outbreak. BARDA has so far funded four projects to address Covid-19, including two vaccines, in partnership with Johnson & Johnson and Sanofi. In recent years, an international nonprofit called Coalition for Epidemic Preparedness Innovations, or CEPI, has also raised money to invest in vaccine research. So far, it has committed more than $66 million to vaccine development efforts against Covid-19. The fact that Big Pharma players have already taken an interest doesn’t mean that a vaccine will arrive any faster. But it does suggest that these companies believe Covid-19 will be around for the long term, and may be willing to lend their manufacturing muscle to ensure that a vaccine, when it arrives, can be produced en masse. A Potential Wrinkle There’s another factor that makes developing a vaccine against coronavirus a particularly tricky endeavor, says Peter Hotez, a vaccine researcher and dean of the National School of Tropical Medicine at Baylor College of Medicine. That’s something called “immune enhancement.” In the 1960s, scientists at the National Institutes of Health were working on a vaccine against respiratory syncytial virus, or RSV, a common, very contagious virus responsible for most of the colds that infants and toddlers get. During clinical trials, some children who received the vaccine later went on to get terribly sick when they caught RSV in the wild. The vaccine produced an exaggerated immune response, causing extensive damage in their bodies. Two kids died. Decades later, when SARS hit, researchers including Hotez began working on a vaccine. But in early tests with lab animals, they saw something that raised a red flag. The animals’ immune cells were attacking their lungs, causing damage like what had been described in the RSV trials. “That alerted everyone in the coronavirus research community that there was potential for immune enhancement,” says Hotez. His group, which includes collaborators from the New York Blood Center, adapted its strategy. Instead of producing the entire spike protein, they built just a tiny piece of it—the piece that actually latches onto human cells, called the receptor binding domain. With this approach, Hotez says, when they tested in animals they saw immune protection but without the undesirable enhancement. The prototype vaccine they developed wasn’t able to attract any investment after the SARS outbreak dissipated. But now, the group is currently submitting proposals to fund human testing of the vaccine, which has been sitting in a freezer in Texas since the mid-2000s. Because the virus that causes Covid-19 uses the same receptor as SARS to attack human lung cells, they believe it might offer some protection. But it will be important to come up with a clinical trial design that includes additional, longer-term monitoring of patients to watch out for potential immune enhancement. Hotez says any vaccines designed to fend off Covid-19 will likely have to do the same. “That’s going to really complicate things and slow them down,” he says. “I don’t think anyone’s going to have something ready in 12 to 18 months.” Who’s Making a Covid-19 Vaccine? Almost everyone! Here’s a breakdown of the 30+ candidates in development (so far), starting with those that are making nucleotide-based vaccines. Moderna Boston-based biotech unicorn Moderna is perhaps best known for working on personalized cancer vaccines. But the company has a history of responding to public health threats, including the 2015 Zika outbreak. In collaboration with scientists at the National Institutes of Allergy and Infectious Disease, and with funding from CEPI, Moderna has already produced an RNA-based vaccine which codes for a stabilized form of the SARS-CoV-2 spike protein. On February 24, the company shipped doses of its candidate, mRNA-1273, to the NIAID Vaccine Research Center, where a Phase I safety trial is set to begin as early as April. CureVac Like Moderna, crosstown rival CureVac uses lab-made mRNA to spur the production of coronavirus proteins, triggering immune cells to produce antibodies against it. And, like Moderna, it got a grant from CEPI to apply its technology to SARS-CoV-2. CureVac representatives have said the company expects to have a candidate ready for human testing within a few months. Inovio This Pennsylvania-based biotech uses a slightly different technology, using DNA instead of RNA to make medicines. It has also received funding from CEPI to develop a DNA-based vaccine against Covid-19. In January, the company started preclinical testing of its candidate, called INO-4800. It has so far produced 3,000 doses for trials to be conducted in patients in the US, China, and South Korea. The first of these is scheduled to begin in the US at the end of April. Applied DNA Sciences / Takis Biotech Applied DNA, a New York–based company, announced in March it is partnering with Rome, Italy–based Takis Biotech to deliver its own DNA-based vaccine candidates against Covid-19. The companies plan to have four versions available to test in mice by later this month. Zydus Cadlia India-based pharmaceutical firm Zydus Cadila announced in February it had initiated two approaches for developing a Covid-19 vaccine. Like Inovio and Applied DNA, the first involves using a ring of DNA designed to produce coronavirus protein once inside the human body. The second deals with genetically manipulating an attenuated recombinant measles virus so that it will induce antibodies against Covid-19. Company officials have not announced timelines for human testing. Stermina Therapeutics This is another mRNA vaccine project, based at Shanghai East Hospital of Tongji University. The CEO of Stermina told Chinese state media at the end of January that manufacturing has already begun, and doses could be ready for human testing sometime in March. Imperial College London A team of British scientists are currently testing their own DNA-based vaccine in mice at labs in Imperial College London. The researchers are looking for funding partners to advance the candidate into human testing later this year. Several other companies are also developing protein-based vaccines. These include: GlaxoSmithKline (GSK) One of the world’s leading vaccine manufacturers, GSK is lending its technology to a Chinese firm called Clover Biopharmaceuticals to work on a coronavirus vaccine. Through the partnership, Clover will be producing viral proteins, and GSK will be providing its proprietary effectiveness-boosting compounds, known as adjuvants. Neither company has provided a testing timeline. Novavax Novavax got a jump on the competition from its previous work developing vaccines against SARS and MERS. The Maryland-based company announced in February that it had generated several candidates comprised of recombinant protein nanoparticles derived from the SARS-CoV-2 spike protein. Company representatives said they expect to complete animal testing soon and move to the first phase of human trials by the end of spring 2020. Altimmune Unlike its competitors, this Maryland-based company is developing a vaccine that gets sprayed into patients’ noses, not injected into their arms. Best known for its nasal-spray flu vaccine, Altimmune announced in February that it had completed the design and prototyping of a vaccine against Covid-19 and is now advancing it toward animal testing and manufacturing for human trials. Vaxart This Bay Area biotech is the only one so far developing an oral vaccine against Covid-19. In January, the company announced plans to generate candidates based on the published genome of SARS-CoV-2, but no further timelines have been released. Expres2ion This Denmark-based biotech firm is leading a European consortium of vaccine developers to tackle Covid-19. It uses insect cells from fruit flies to produce viral antigens. The company aims to test its candidate vaccine in animal models later this year. Generex Biotechnology Four companies in China have contracted with Florida-based Generex to develop a vaccine using the company’s proprietary immune-activating technology. Company representatives say it could have a candidate ready for human trials as early as June. Vaxil Bio This Israeli immunotherapy company normally specializes in cancer. But last month representatives announced they had discovered a combination of proteins they believe will be an effective vaccine against Covid-19. The company plans to start manufacturing doses for initial testing and looking for partners to scale up further if that goes well. iBio This Texas-based biotech company uses modified relatives of the tobacco plant to grow viral proteins for vaccines. The company is partnering with a Chinese vaccine maker to put its “FastPharming” platform to work on a Covid-19 vaccine. Company officials expect to have a candidate ready for animal testing later this summer. Baylor College of Medicine / New York Blood Center Peter Hotez’s group is pushing for funding to test their SARS vaccine against the Covid-19. He says they already have about 20,000 doses ready to be deployed for clinical trials. These researchers are simultaneously working on developing a new vaccine from scratch, based on the binding receptor domain of the new virus, SARS-Cov-2, but that will take several years to develop. University of Queensland A team of Australian researchers, with funding from CEPI, have developed a vaccine candidate they say is ready to move forward into human testing. It relies on a “molecular clamp” technology invented in the lab of molecular virologist Keith Chappell, which helps stabilize viral proteins so they have the same shape they’d have on the surface of the virus. The group is now intending to ramp up production for clinical trials. University of Saskatchewan Canadian health authorities have given university researchers the green light to start working on a vaccine against Covid-19. They’ve used the virus’s published genome sequence to begin building protein-based candidates and are now waiting for live versions of the virus to begin testing in animal models. University of Oxford / Advent Srl A team of researchers at the University of Oxford’s Jenner Institute had been working on a vaccine against MERS, which they quickly tailored to the new coronavirus, SARS-CoV-2. In February, the scientists signed an agreement with Italian vaccine maker Srl to produce the first 1,000 doses of the new vaccine, ChAdOx1, to supply human trials. And a few more are developing viral vector-based strategies: Sanofi One of the so-called Big Four, Sanofi has been working with BARDA since 2004 on pandemic preparedness, including against SARS. The company has expanded this arrangement to focus on a Covid-19 vaccine using the company’s recombinant DNA platform, which involves swapping in parts of the coronavirus’ RNA with genetic material from a harmless virus. Sanofi expects to have a vaccine candidate to test in animals within six months. Human testing could begin sometime in 2021. Johnson & Johnson Johnson & Johnson is expanding on the company’s past work with BARDA to develop an Ebola vaccine to pursue a vaccine against Covid-19. With funding from the government agency, the company’s plan is to deactivate the virus, producing a vaccine that triggers an immune response without causing infection. The company has not released any information regarding development timelines. Geovax Labs / BravoVax Atlanta-based GeoVax signed an agreement in January to work with BravoVax, a private company Wuhan, China, to jointly develop a vaccine against Covid-19. Under the collaboration, GeoVax will be providing its proprietary platform—a modified pox virus that can be designed to express viral proteins from SARS-CoV-2. Tonix In February, this New York–based biopharma startup announced it is collaborating with the nonprofit Southern Research to develop a live, modified horsepox virus modified to express protein fragments from SARS-CoV-2. Company officials have not released any further timelines. CanSino Biologics Chinese vaccine-maker CanSino is reportedly developing a viral vector-based vaccine against Covid-2019 but no further information is available at this time. Greffex The CEO of this Houston-based genetic engineering company announced last month that they have completed the design of a vaccine against Covid-19. The company has not released any information about its lead candidate, but Grefex reportedly makes adenovirus-based vector vaccines involving a harmless virus that can be genetically tweaked to express foreign genes, like one for the SARS-CoV-2 spike protein. And last but not least, is the only company attempting to attenuate a live SARS-CoV-2 virus: Codagenix This New York–based biotech firm is collaborating with the Serum Institute of India to co-develop a live, attenuated vaccine against Covid-19. Rather than using blunt forces like heat or chemicals to kill the virus, Codagenix uses a “deoptimization” strategy to manipulate the virus into a version that can still replicate but won’t cause disease. The Serum Institute of India will be in charge of the scale-up. Codagenix representatives expect to have a vaccine candidate ready for animal testing this spring, with human testing progressing by this summer. Source: Everything You Need to Know About Coronavirus Vaccines (Wired)
  21. The vaccine will be used in pilot programs in three countries, under careful watch. Enlarge / A health surveillance assistant (HAS) gets malaria vaccine from its bottle into an injection to be administered to a child at the beginning of the malaria vaccine implementation pilot program at Mitundu Community Hospital in Malawi's capital district of Lilongwe on April 23, 2019. Getty | Amos Gumulira Sometimes, a vaccine is a slam dunk. Take the 97.5-percent-effective Ebola vaccine, for instance, or the 97-percent-effective measles vaccine. Other times, a vaccine is a dud, however, offering little to no protection and clearly destined for the dustbin. Then there is a third group: the vaccines that fall in the middle. They might protect some, but far from all. The fate of these vaccines is less certain—an open question, in fact. Such is the case of the world’s first malaria vaccine, which on Tuesday, April 23, was cautiously added to routine vaccinations in the African nation of Malawi as part of a pilot program. Ghana and Kenya will also introduce the vaccine in coming weeks. The vaccine, known as RTS,S, is only about 39-percent effective at preventing malaria—and that’s only in children who receive four separate doses. It’s only 29-percent effective at preventing the most severe forms of the mosquito-borne disease. Still, with more than 200 million malaria cases worldwide each year and 435,000 deaths, even modest efficacy could translate to tens of thousands of lives saved. “This is a landmark moment,” Kate O’Brien told reporters during a press conference Tuesday. She’s the director of the Department of Immunization, Vaccines and Biologicals at the World Health Organization. RTS,S is a “vaccine of firsts,” she added. It’s the first malaria vaccine to show such efficacy after decades of research and dozens of other candidates. It’s also the first to reach young, vulnerable children in a routine vaccination program. RTS,S has been in the works for more than 30 years. It was created in 1987 at GlaxoSmithKline and works by containing a fragment of a protein from the malaria parasite Plasmodium falciparum. That fragment prompts the immune system to attack after a mosquito first delivers the parasite into the bloodstream and before the parasite has the chance to infect the liver. That’s where it can mature, spawn, and reemerge to infect red blood cells and cause disease symptoms. From 2009 to 2014, researchers tested RTS,S in a Phase III clinical trial across seven countries in Africa, where 250,000 children die from the parasitic infection each year. Data from nearly 15,500 infants and children in the trial indicated that the vaccine is only about 39 percent effective. Whether that efficacy rate will hold up in real-world settings remains to be seen. Still, with malaria’s steep death toll and no other vaccine candidates on the horizon, public health experts made the tricky call to recommend rolling out RTS,S beyond the trials—but they’re doing so cautiously. Researchers will carefully follow the pilot vaccination programs in the three countries, where they will track efficacy, safety, and how well parents do at bringing their children in for all four vaccine doses. The results will steer policy decisions on whether the vaccine should be used elsewhere in the future. “We believe that this may be yet another tool—an imperfect tool with a modest efficacy—just like all of our other malaria control tools—but which, when used imperfectly, may actually have massive impact,” Pedro Alonso, director of WHO’s Global Malaria Program, said. The other tools used against malaria include insecticide sprayed indoors, bed nets, and improvements in malaria testing and treatments. “We’re dealing with a very, very hard organism,” Dr. Alonso added, speaking of the P. falciparum parasites that cause the disease. These are “really complex organisms,” he said, and we don’t know how long it will take researchers to come up with a better vaccine. The pilot programs aim to reach around 360,000 children a year across the three countries. It is set to last for five years, at which point public health experts will assess the future of RTS,S. Source: Cautious rollout of the world’s first malaria vaccine, which is 39% effective (Ars Technica)
  22. The latest Ebola outbreak is bad—but it would be far worse without this vaccine. Enlarge / A nurse working with the World Health Organization (WHO) shows a bottle containing Ebola vaccine at the town hall of Mbandaka on May 21, 2018 during the launch of the Ebola vaccination campaign. Getty | Junior D. Kannah An experimental vaccine against the Ebola virus is 97.5 percent effective at preventing the disease, protecting well over 90,000 people in the massive, ongoing outbreak in the Democratic Republic of the Congo, according to preliminary data. The outbreak has flared since last August, involving 1,264 cases (1,198 confirmed; 66 probable) and 814 deaths (748 confirmed, 66 probable), making it the second-largest Ebola outbreak recorded. So far the outbreak has stayed within the DRC’s North Kivu and Ituri provinces, which sit on the eastern side of the country, bordering South Sudan, Uganda, and Rwanda. But, response efforts have been severely hampered by community distrust of public health campaigns. One result of this distrust has been several attacks by militants on medical facilities, injuring medical staff and, in one case, killing a police officer. Some public health experts fear the outbreak will continue to spread without new strategies and more aid, possibly across nearby borders. Still, the outbreak could have been far worse if it had not been for an experimental vaccine. The rVSV-ZEBOV-GP Ebola vaccine, made by Merck & Co, contains a live attenuated virus harmless to humans that researchers genetically engineered to carry an Ebola glycoprotein. Ebola usually uses this protein to interact with human cells, but in the vaccine, it triggers the human immune system to generate powerful antibodies to attack the virus. Early tests of the vaccine seemed to confirm this, suggesting it is safe and effective. And a World Health Organization Strategic Advisory Group of Experts (SAGE) has given responders the greenlight to use the vaccine during outbreaks, based on an Expanded Access/Compassionate Use protocol. As in the last outbreak, health responders are currently unleashing it in a ring vaccination strategy, which aims to immunize those in contact with known Ebola cases and contacts of those contacts—creating social rings of immunization to protect the most vulnerable and prevent the spread of disease. This was the same vaccination strategy used in the eradication of smallpox, the only human disease to ever be fully wiped out. Though Ebola spreads from animals—thus couldn’t be eradicated from a human vaccination campaign alone—the strategy is considered the most effective at quickly and efficiently extinguishing any flare ups and outbreaks. That appears to be the case in the current outbreak, according to the preliminary data released by WHO and DRC researchers (PDF). Between August 1, 2018 to March 25, health responders mapped out 679 rings around 776 of the 951 confirmed and probable cases during that time period. They vaccinated nearly 94,000 people, including nearly 29,000 healthcare and front-line responders in that time period (more have been vaccinated since then). Of those vaccinated, only 71 people fell ill with Ebola. Most of those cases (54 of 71) were in high-risk contacts—those thought to be most likely to come down with the virus based on exposure. Moreover, most of them (56 of 71) occurred within 10 days of being immunized, before the vaccine is thought to induce full protection. Only 15 of the nearly 94,000 people vaccinated became ill after that 10-day period, and all of them survived the infection, which usually has a fatality rate of around 50 percent. Looking at the rings overall, researchers found that Ebola was able to move through only about 9 percent of the vaccinated rings (60/679 rings), and only about two percent of those rings included cases after the 10-day period. Last, only two vaccinated people out of the 68,279 vaccinated people listed as “contacts-of-contacts” fell ill with the virus. This suggests that the vaccine and the vaccination strategy were highly effective at preventing the spread of the disease. In all, based on calculations comparing Ebola’s spread through vaccinated and unvaccinated rings in the outbreak, researchers estimated the virus’ attack rate was 0.017 percent among the vaccinated and 0.656 percent among unvaccinated. That yields an estimated efficacy rate of 97.5 percent. In a meeting late last week, WHO experts assessed the outbreak overall and determined that it did not constitute a “Public Health Emergency of International Concern,” though they still expressed “deep concern” over the virus’ continued spread. They called for continued vaccination and a redoubling of efforts to work with communities to stamp out the disease. Source: As Ebola outbreak rages, vaccine is 97.5% effective, protecting over 90K people (Ars Technica)
  23. Coronavirus: Latest data shows vaccine reduces transmission - Hancock There is "early data" showing a reduction in transmission in people who have had a coronavirus vaccine, the health secretary has said. Matt Hancock said hospital admissions were falling "much more sharply" than they were in the pandemic's first wave. The government aims to offer a first jab to all adults in the UK by the end of July, with one in three adults already vaccinated, Mr Hancock said. Boris Johnson will unveil his plan for ending England's lockdown on Monday. The PM is due to hold a final meeting with senior ministers later, to finalise the details, before presenting them to MPs in the Commons on Monday afternoon. He will lead a Downing Street briefing in the evening. A further 9,834 coronavirus cases were recorded in the UK on Sunday and 215 more people have died within 28 days of a positive Covid test, according to the government's daily figures. The UK's devolved nations have the power to set their own restrictions, and have been moving at different speeds: In Scotland, the government hopes to publish a route out of lockdown next week, but First Minister Nicola Sturgeon has urged people not to book Easter holidays In Wales, First Minister Mark Drakeford has announced up to four people from two different households can exercise outdoors together from Saturday; he said he hoped the "stay-at-home" requirement could end within three weeks, with some non-essential shops and hairdressers possibly reopening at the same time Northern Ireland's health minister has played down the prospect of restrictions being eased in time for Easter - a review of current measures will take place on 18 March As part of the road map, Public Health England will publish new data on the impact of vaccines on transmission rates. Mr Hancock told the BBC's Andrew Marr Show on Sunday that he was "absolutely delighted" with the progress of the vaccine rollout. But he added that while hospital admissions were falling, the number of people in hospital - currently around 18,000 - was still "far too high". The health secretary reiterated the government's new plan to offer a jab to adults aged 50 and over and those in the top nine priority groups by 15 April, followed by all adults by the end of July. The government's previous target was to offer all adults the first dose by September, but the PM has said he wants the rollout to "go further and faster". Mr Johnson has said that this would give vulnerable people protection "sooner" and help to further ease lockdown restrictions across the country. When will it be my turn to be vaccinated? How many people have been vaccinated so far? What are the UK's lockdown rules and when will they end? However, the order of priority for the under-50s has yet to be outlined by the Joint Committee on Vaccination and Immunisation (JCVI). Prof Adam Finn, a member of the JCVI, told BBC Breakfast earlier that he expected a public announcement would be made on vaccine priorities at some point in the next week. Lockdown has reduced cases more than some believed was possible - and now there are the early indications the vaccination programme is having an impact too. Despite this, it looks likely the government will announce a very gradual lifting of restrictions in England on Monday. Why the caution? Even if rates rebound only a little, there are still large numbers of vulnerable people. Nearly half of hospitalisations have been in the under-70s, for example. What is more, high levels of infection at a time when vaccines are being rolled out and immunity being built provides the perfect breeding ground for new variants. Mutation may be unavoidable in the long-term, but encouraging them at this point would, many experts believe, be foolish. The problem is that there are so many unknowns. Will the arrival of spring help keep the virus at bay? Will the UK variant mean the re-opening of schools has a significant impact on infection levels? But, on the flip side, being too cautious will prolong the costs of lockdown. It is, to say the least, a tricky balancing act. So far, more than 17 million people have received a vaccine since the rollout began in December last year. Mr Hancock said ministers were "confident" the vaccine worked effectively against the old strain of the virus and the so-called Kent variant. However, he warned the government did "not yet have the confidence" the jab was "as effective" against the South Africa variant and the variant first seen in Brazil, but that enhanced contact tracing and stricter border controls were reducing the cases of those variants in the UK. The latest data showed "around a dozen" new cases of the South African variant in the UK, with an overall total of around 300 cases, Mr Hancock added. Asked if the spread of the South Africa variant was "shrinking", he said: "I think that's a good summary yes". Meanwhile, Prof Peter Openshaw, a member of the New and Emerging Respiratory Virus Threats Advisory Group (Nervtag), told BBC Radio 4's Broadcasting House programme that vaccine transmission data was "looking really good", but scientists still needed to estimate by how much the vaccine interrupted transmission. Source: Coronavirus: Latest data shows vaccine reduces transmission - Hancock
  24. Scary 22% vaccine efficacy in South Africa comes with heaps of caveats South African data on AstraZeneca vaccine is as iffy as it is scary. Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. Dismal preliminary data on AstraZeneca’s COVID-19 vaccine in South Africa—where the B.1.351/ 501Y.V2 coronavirus variant is spreading widely—led the government there to rethink its vaccination rollout and raised further international concern about the variant. But the small study has so many limitations and caveats, experts caution that drawing any conclusions from it is difficult. The study, which has not been published or peer-reviewed but presented in a press conference Sunday, began in June and enrolled only around 2,000 participants, about half of which received a placebo. Early in the study—before B.1.351 emerged—the vaccine appeared over 70 percent effective at preventing mild-to-moderate cases of COVID-19. That is largely in line with the conclusion of an international Phase III trial released by AstraZeneca and vaccine co-developer Oxford University, which showed mixed results for the replication-deficient adenovirus-based vaccine but an overall efficacy of around 70 percent. But toward the end of the year—when cases of B.1.351 began taking off—the South African results shifted dramatically. The overall efficacy of the vaccine dropped to just 22 percent against mild-to-moderate COVID-19. In an analysis comparing efficacy solely in cases known to be due to B.1.351, the vaccine fared even worse, showing an abysmal efficacy of just 10 percent. On first glance, those numbers are startling, and they suggest that the B.1.351 variant rendered the otherwise effective vaccine nearly useless. But, with a closer look, those numbers are almost uninterpretable. The trial was just too small to produce statistically solid results. Thus, each efficacy calculation has huge confidence intervals. For instance, the vaccine’s ending efficacy of 22 percent—based on a total of 42 coronavirus infections in the trial—had a plausible estimate range of between -50 percent effective and 60 percent effective. Lingering questions The study also was not designed to answer the critical question of whether the vaccine can prevent severe disease, hospitalization, and death. The people enrolled in the trial were relatively young—median age of 31—with very low rates of underlying conditions. Both of those factors make people far less likely to develop severe COVID-19 and die from the disease. Experts emphasize that preventing severe disease and death is the most crucial goal of vaccines—not preventing transmission or mild illnesses. Last month, Johnson & Johnson announced that its vaccine—which is an adenovirus-based vaccine, like AstraZeneca’s—was only 57 percent effective against moderate and severe COVID-19 in South Africa. But, experts applauded the finding that it was 85 percent effective at preventing severe disease and death. And the company reported that no one vaccinated in its Phase III trial ended up being hospitalized or dying from the disease. Many experts championed the not-yet-authorized vaccine as a potential new tool for ending the pandemic. The critical looming question now is whether AstraZeneca’s vaccine will likewise protect against severe disease and death in cases involving B.1.351, which has now been detected in more than 30 countries. Given the uncertainty, researchers and officials in South Africa said on Sunday that they would, for now, pause the rollout of AstraZeneca’s vaccine, which was authorized for use in the European Union on January 29. (It has not yet been submitted to the US Food and Drug Administration for authorization.) South Africa had recently begun offering it to health care workers. Instead, officials there are now looking into the possibility of a phased rollout, which might involve vaccinating just 100,000 people and monitoring them over some time to look at hospitalization rates. If the vaccine looks effective at that point, they would then roll the vaccine out further. “Put very simply, we don’t want to end up with a situation where we vaccinated a million people or two million people with a vaccine that may not be effective in preventing hospitalization and severe disease,” Salim Abdool Karim, the co-chair of South Africa’s Ministerial Advisory Committee on COVID-19, said in a press conference Monday. Source: Scary 22% vaccine efficacy in South Africa comes with heaps of caveats
  25. How long will the Pfizer and AstraZeneca vaccinations remain protective against COVID-19? The Federal Government plans to start distributing COVID-19 vaccines next week.(Getty Images: Sinology/Science Photo Library) Next week, the Pfizer vaccine rollout will begin and the first COVID-19 jab on Australian soil will take place. The Pfizer option will be given to priority groups (which includes quarantine workers and people living in aged care facilities) but most Australians will get the yet-to-be-approved Oxford-AstraZeneca jab. Health Minister Greg Hunt yesterday announced Australians would begin receiving the vaccine from February 22, with 60,000 doses to be rolled out across the country by the end of the month. But how long will these vaccines last? Can Australians expect to roll up their sleeves every year or so to get a booster shot? Here's what we know — and don't know — about how long the Pfizer and AstraZeneca vaccines will protect us after we've been inoculated. How long do vaccinations usually remain effective? There's no "typical" timeframe that a vaccine will protect us for — it's different for every vaccine. To recap, vaccines help your develop an immunity to a virus without you having to contract it and get sick. "Most vaccines, and we hope the COVID vaccine, produce a much higher level of immunity than natural infection," Burnet Institute professor of international health Michael Toole said. But not all vaccines do this in the same way or protect us for the same period of time. The two-dose measles-mumps-rubella (MMR) vaccine, for example, contains a weak, live version of the viruses and works so well that it offers lifelong protection. "Measles — the protection is lifelong, smallpox lifelong, other vaccines needs boosters after a while, typhoid fever, hepatitis," Professor Toole said. How long will the COVID vaccines remain effective? It's too early to tell. There's a lot more research about the efficacy of COVID-19 vaccines — meaning how well a vaccine prevents someone from getting the virus — than about the lifespan of the vaccines themselves. As University of Sydney professor of medical microbiology James Triccas explained, this is because we're only a year into the pandemic and researchers are tracking the longevity of people's immune responses in "real time". In December, Moderna published a study that showed their COVID-19 vaccine still showed good immune responses four months after the date of vaccination — results which Professor Triccas said were encouraging. "That's the best I've seen in terms of how far they've measured out," he said. Research also shows the Pfizer and AstraZeneca COIVD vaccines protect against disease, hospitalisation and death, Professor Triccas added. Both Professor Triccas and Professor Toole said we simply don't know how long the COVID-19 vaccines will last — although we may have a clearer picture by mid-year. "That's the short and only answer really because we just don't know," Professor Toole said. "We haven't been rolling out the vaccine long enough to monitor how long and how well it protects people from infection." Why do some vaccines need a booster and others don't? This depends on how our bodies respond to the vaccine. For example, the MMR vaccine offers lifelong protection against measles. Professor Toole says this is because live vaccines are "more of less the same as being infected" and it's been proven that people don't get measles twice. The MMR vaccine protects against three major diseases — measles, mumps, and rubella — which most Australians get as kids.(AP: Seth Wenig, File) Measles is also a stable virus and doesn't mutate — unlike COVID-19, which has already evolved into different variants. Professor Triccas says it's difficult to predict which vaccines will be longer-lasting, but it is helpful to look at what happens following infection with the virus itself, because vaccines "tend to mimic" that response. That's because vaccines aim to induce the same immune response your body develops when fighting off the actual virus. But not all immune responses are as strong as one which fights off measles. "For other viruses and bacteria, just the nature of the immune response that develops after the infection or after the vaccination does not last as long and you need to boost it," Professor Triccas said, which is why some vaccines need a booster shoot to keep you protected. If the Pfizer and AstraZeneca COVID-19 vaccines don't last long, Professor Toole says the most "likely outcome" is we'll need a booster jab or an annual shot that's adapted to fight off different variants. Will I feel sick after the COVID vaccine? According to clinical trials, yes, you may feel a bit unwell after the jab — especially after the second one. The US Centers for Disease Control describes these as "normal signs that your body is building protection". Think of it as a positive sign — the vaccine is doing what it's meant to and helping your body develop immunity to the virus. "In around about one in 10 people who receive the vaccine, they'll get soreness, redness at the site of the injection, plus maybe a low fever or a headache," Professor Toole said. "One in 100 will get more severe side-effects after the second dose — nausea, poor appetite — maybe some gastric upset." It's also important to remember these side effects are temporary, most last no more than a couple of days and patients recover without any problems. Will the vaccine protect from COVID straight away? No. You will need two doses of the vaccine to be properly protected. And it's worth remembering that the vaccine won't necessarily stop you from getting COVID and spreading it, but will help your body not to get sick if you do contract it. Source: How long will the Pfizer and AstraZeneca vaccinations remain protective against COVID-19?
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