Jump to content

Search the Community

Showing results for tags 'pfizer vaccine'.

  • Search By Tags

    Type tags separated by commas.
  • Search By Author

Content Type


  • Site Related
    • News & Updates
    • Site / Forum Feedback
    • Member Introduction
  • News
    • General News
    • FileSharing News
    • Mobile News
    • Software News
    • Security & Privacy News
    • Technology News
  • Downloads
    • nsane.down
  • General Discussions & Support
    • Filesharing Chat
    • Security & Privacy Center
    • Software Chat
    • Mobile Mania
    • Technology Talk
    • Entertainment Exchange
    • Guides & Tutorials
  • Off-Topic Chat
    • The Chat Bar
    • Jokes & Funny Stuff
    • Polling Station


  • Drivers
  • Filesharing
    • BitTorrent
    • eDonkey & Direct Connect (DC)
    • NewsReaders (Usenet)
    • Other P2P Clients & Tools
  • Internet
    • Download Managers & FTP Clients
    • Messengers
    • Web Browsers
    • Other Internet Tools
  • Multimedia
    • Codecs & Converters
    • Image Viewers & Editors
    • Media Players
    • Other Multimedia Software
  • Security
    • Anti-Malware
    • Firewalls
    • Other Security Tools
  • System
    • Benchmarking & System Info
    • Customization
    • Defrag Tools
    • Disc & Registry Cleaners
    • Management Suites
    • Other System Tools
  • Other Apps
    • Burning & Imaging
    • Document Viewers & Editors
    • File Managers & Archivers
    • Miscellaneous Applications
  • Linux Distributions


  • General News
  • File Sharing News
  • Mobile News
  • Software News
  • Security & Privacy News
  • Technology News

Find results in...

Find results that contain...

Date Created

  • Start


Last Updated

  • Start


Filter by number of...

Found 8 results

  1. The committee roundly rejected approving boosters for everyone 16 and up. A committee of independent advisors for the Food and Drug Administration has voted unanimously (18 to 0) in favor of authorizing a booster dose of the Pfizer/BioNTech COVID-19 vaccine for people aged 65 and older, as well as people at high risk based on an underlying medical condition and/or occupational exposure (e.g., healthcare workers). The booster doses are recommended to be given at least six months after completion of the primary two doses. If the FDA moves forward with the advisory committee's recommendation—which it likely will—boosters will be offered to those two groups based on an Emergency Use Authorization. Prior to voting in favor of authorization for the two groups, the committee rejected the idea of approving boosters for all people ages 16 and up with a resounding vote of 16 to 2 against. Generally, the committee—Vaccines and Related Biological Products Advisory Committee (VRBPAC)—felt there was simply too little safety data to make an assessment, particularly for young males at highest risk of developing a rare COVID-19 vaccine side effect of inflammation of or around the heart (myocarditis and pericarditis). In addition, the committee felt there was not convincing data that overall vaccine protection from severe disease, hospitalization, and death has waned to the extent that a booster shot is necessary. "A third dose is likely beneficial," Ofer Levy, a voting VRBPAC member and infectious disease expert at Harvard, said after voting against boosters for all. "That's already true for the immunocompromised. It's likely beneficial, in my opinion, for the elderly and may eventually be indicated for the general population. I just don't think we're there yet in terms of the data." The votes came after a tumultuous all-day meeting in which advisory committee members seemed to chafe at the expectation that they would green-light boosters for the general population. Last month, the Biden Administration announced ahead of the FDA's review that it was prepared to roll out boosters for the vaccinated starting the week of September 20. The announcement reportedly prompted frustration and anger inside the regulatory agency, leading two high-ranking vaccine regulators to announce their resignations. Vaccine effectiveness One of those resignations was Marian Gruber, the now-outgoing director of the FDA's Office of Vaccines Research and Review. At the opening of today's proceedings, she thanked her staff, noting that it was likely her last VRBPAC meeting. In her opening remarks, she emphasized that the decision of whether to approve a booster dose hinges on determining if it's "safe," which "involves weighing whether its benefits outweigh its risks." For younger males, that leaves the tricky question of whether the potentially increased risk of myocarditis/pericarditis would be outweighed by the potential benefits of a third dose, given that younger males are already at lower risk of severe disease than older groups and still appear to have high levels of protection from the two primary doses. CDC epidemiologist Sara Oliver presented a synthesis of data suggesting that vaccine efficacy against infection has declined over time, but protection against hospitalizations has remained strong. Comparing pre-delta vaccine efficacy in adults aged 18+ to the latest post-delta data, the range of vaccine efficacy against infection fell from 72 to 92 percent pre-delta to a range of 39 to 84 percent post-delta in July. For hospitalization, vaccine efficacy prior to delta ranged from 84 to 97 percent, dropping to a range of 75 to 95 percent in July after delta. Critically, when the agency's analyses just looked at older populations rather than all adults together, vaccine effectiveness still appeared strong, with an efficacy of over 88 percent in people aged 75 and above. However, Dr. Oliver noted data from Qatar suggesting that protection from hospitalization declined in people aged 60 and over after 25 weeks from vaccination, though the confidence intervals were extremely wide. Similarly, experts from Israel presented data suggesting that vaccine efficacy continues to wane over time, with elderly groups seeing less protection against severe disease. Israel is ahead of the US by about three months in getting a large chunk of its population vaccinated. Thus, the country is seen as a bellwether of vaccine effectiveness. In light of data suggesting widespread waning of protection, Israel rolled out a booster shot on July 30 to all those 16 and over, beginning with the elderly. In the time since, Israel data suggests the boosters stymied confirmed cases in people over 60 and provided a more than 10-fold reduction in relative risk of severe disease in that age group. Unfortunately, there hasn't been enough time since boosters were rolled out to younger males to generate useful data on safety that could inform a decision in the US. Data concerns In another presentation at the meeting, statistician Jonathan Sterne of the University of Bristol warned against taking real-world vaccine efficacy estimates at face value due to a variety of confounding factors. Those include differing characteristics of people who get vaccinated compared with those that don't, as well as past COVID infections providing some protection in the unvaccinated. Vaccine efficacy estimates can be influenced by the timing of people's vaccinations, the risk factors each group may have, the waves of infection, and how waves are timed with vaccinations. Many of these factors could add up to make vaccine effectiveness appear lower than it actually is. For instance, people who were first in line to get a vaccine included those with compromised immune systems, thus increases in infection and severe disease could perhaps represent the problem of poor immune responses in those populations rather than a significant waning of protection overall. In addition, it's important to note that Israel defines severe disease differently than the US, counting people with high respiratory rates and blood-oxygen levels below 94 percent. In the US, studies often define severe disease as those requiring hospitalization or intensive care or those who die as a result of their infection. Pfizer presented its own case for boosters, showing US data suggesting that protection against infection has waned but that protection against hospitalization has not. The company argued that Israel's data foreshadows waning and suggests that boosters will prevent upticks in severe disease and death among vaccinated people. As for safety, Pfizer and the FDA gave separate presentations that picked through Pfizer's data on safety, which only involved 306 people between the ages of 18 and 55. The data suggests that a third dose boosted antibody levels to levels comparable if not greater than was seen following second doses. Likewise, side-effects from a third dose were similar to what was seen after a second dose, with the most common effects including pain at the injection site, fatigue, headache, chills, and muscle pain. Overall, VRBPAC was swayed by the data from Israel suggesting that older people may soon become more vulnerable to severe disease, hospitalization, and death and that booster doses can safely increase protection. But with such little safety data on the younger groups and without a clear and growing risk of severe disease in those younger groups, the members were unconvinced that boosters should be offered to all people ages 16 and up at this time. Final decisions In their final deliberations, the members landed on those ages 65 and older as well as people at high risk. The cutoff and definitions are shaky. The committee did not have decisive data on what age group to draw the line at, with some committee members suggesting those above 50 or 60. In the end, the FDA reworded the final voting question, which included the cutoff of 65. Additionally, the committee felt it was necessary to include people at high risk of severe disease from underlying conditions, given the possibility of further waning and the need to protect healthcare systems from being overwhelmed. Who might qualify under those terms is yet to be defined by an advisory committee for the Centers for Disease Control and Prevention—the Advisory Committee on Immunization Practices—which is set to meet September 22. In a similar vein, the VRBPAC felt it was important to include those at high risk of infection due to occupational exposure, given that booster shots may reduce the risk of infection and transmission. With hospitals across the country strained and buckling under the weight of the delta coronavirus wave, the committee wanted to ensure that healthcare workers, frontline workers, and teachers could have maximum protection—again—to protect the overall healthcare systems. Though the decision today may disappoint some hoping for a blanket green light for boosters, the committee was pleased that it followed the science and resisted any pressure from the Biden administration. "I think this should demonstrate to the public that the members of this committee are independent of the FDA and that, in fact, we do bring our voices to the table," Archana Chatterjee, a voting VRBPAC member and Dean of Chicago Medical School. Moving forward, VRBPAC chair Arnold Monto noted that if the booster doses are authorized using an EUA, it will be easy to revisit data in the near future to determine if and when boosters for wider groups may be needed. FDA advisors green-light Pfizer boosters for people 65+ and at-risk groups
  2. The full approval applies to a two-dose regimen for those ages 16 and up. The Food and Drug Administration has granted full approval of the Pfizer/BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty (koe-mir’-na-tee), the agency announced Monday. The vaccine's full approval—or Biologics License Application (BLA)—applies for use of a two-dose regimen, given three weeks apart, in people ages 16 years and older. It is the first BLA to be issued for a vaccine against COVID-19. The vaccine will still be available under an Emergency Use Authorization (EUA) for adolescents ages 12 to 15 and for use as a third booster dose in certain people with compromised immune systems. The name Comirnaty—already in use elsewhere, including Europe—is a mash-up of "COVID-19 immunity" and "mRNA" that is meant to evoke the word "community." “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," acting FDA Commissioner Janet Woodcock said in a statement. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.” In the US, over 200 million doses of Comirnaty have been administered since it initially earned an EUA on December 11, 2020. The BLA document submitted by Pfizer and BioNTech this May "builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made," the FDA said. The agency also noted that it conducts its own data analyses to determine safety and efficacy. In a tweet, Pfizer CEO Albert Bourla said the company and BioNTech were celebrating the approval. "It is our hope that this news will instill even further public confidence in our vaccine and the science that made it possible," Bourla added. Safety review Amid another devastating and entirely preventable wave of the deadly pandemic, the full approval is expected to spur more vaccination mandates by universities, healthcare systems, and other employers. Though the federal Equal Employment Opportunity Commission determined in May that employers can indeed mandate COVID-19 vaccination under the EUA given reasonable accommodations, some have suggested a full approval could give employers more confidence in issuing mandates. Still, mandates or not, the approval alone may sway some vaccine holdouts. Previous polling by the Kaiser Family Foundation found that 31 percent of unvaccinated people would be more likely to get their shots if a vaccine earned full approval. In the announcement Monday, the FDA also took the time to try to ease concerns and dispel myths about the vaccine. The agency noted that the mRNA vaccine works by providing to human cells a genetic code for a snippet of the pandemic coronavirus SARS-CoV-2. From there, the cells translate the code into a protein that can essentially be used as target practice by the immune system. "The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19," the FDA noted. "The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into—nor does it alter—an individual’s genetic material." Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, also emphasized how rigorously the agency looked over the plethora of safety data accumulated so far. “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine," he said. "We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities. We have not lost sight that the COVID-19 public health crisis continues in the US and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US." Pfizer and BioNTech submitted the BLA document in May of this year, and the FDA granted it a priority review in July. The FDA is also reviewing a BLA submission for Moderna's similar mRNA-based COVID-19 vaccine, and full approval could come in the coming weeks. This post has been updated. FDA approves Pfizer’s COVID-19 vaccine, now called Comirnaty
  3. Pfizer vaccine doesn’t need ultra-cold storage after all, company says The pharma giant and partner BioNTech have asked FDA to revise the vaccine's label. Enlarge / A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. Getty | JEAN-FRANCOIS MONIER In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all and can be kept stable at standard freezer temperatures for two weeks. The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine. If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries. “We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the US and around the world,” Pfizer CEO Albert Bourla said in a statement. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.” Balmy future Currently, the vaccine is labeled as requiring storage between -80°C and -60°C (-112°F to ‑76°F) for up to six months. But it can also be refrigerated for up to five days at standard refrigerator temperature (2⁰C and 8⁰C (36⁰F and 46⁰F)). The ultra-cold requirement cooled enthusiasm for the vaccine when the FDA first granted it emergency authorization for use. Only specialized facilities, such as hospitals and research labs, tend to have freezers equipped to maintain such cold temperatures, raising concerns about how easily it would be to get the vaccine into people’s arms. Prior to the vaccine’s rollout, Pfizer and BioNTech tried to ease those anxieties, emphasizing their expertise and existing cold-chain infrastructure. The two companies developed specially designed, temperature-controlled thermal shippers filled with dry ice to maintain a temperature of -70°C ± 10°C. The containers included GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment as they made their way to distribution sites. Vaccine doses could be kept in the thermal containers for up to 30 days if the dry ice was refilled every five days. If approved, the new storage conditions would allow the vaccine to be kept at a mere -25°C to -15°C (-13°F to 5°F)—a temperature range any standard freezer can handle—for up to two weeks. And the vaccine doses can then be kept at standard refrigerator temperatures of 2⁰C to 8⁰C for five days on top of that. The companies report that as they continue testing the limits of the vaccine, they expect the expiration dates could be extended as well. Pfizer vaccine doesn’t need ultra-cold storage after all, company says
  4. Pfizer's Covid-19 vaccine appears to work against mutation in new coronavirus strains, study finds (CNN) A new study provides early evidence that a Covid-19 vaccine might be effective against two new coronavirus strains first identified in South Africa and the UK, despite a concerning mutation. The two strains share a mutation known as N501Y that scientists worry could allow the virus to evade the immune protection generated by a vaccine. In research posted online Thursday, scientists found that antibodies from people who had received the Pfizer/BioNTech vaccine showed "no reduction in neutralization activity" against a version of the virus that carries the N501Y mutation, which they created in the lab. In order to do this, researchers tested the virus against blood from 20 people who had received two doses of the vaccine as part of a clinical trial. The N501Y mutation is located in the coronavirus' spike protein -- the same structure targeted by vaccines. The virus uses this protein to enter the cells it attacks. This particular mutation appears to help the virus attach to human cells, which may partly explain why these new strains appear to be more transmissible. But it is just one of many mutations in both strains that scientists have worried could make the virus less susceptible to vaccines or treatments. The study -- conducted by researchers at Pfizer and the University of Texas Medical Branch -- does not test the full array of these mutation, nor has it been peer-reviewed. While viruses are expected to mutate -- often in ways that are neutral or even harmful to the virus -- experts say the whole is not merely the sum of the parts: Some mutations are known to interact with one another, occasionally changing the shape or function of structures like the spike protein. "A limitation of this study is that the mutation was tested in isolation," Deborah Dunn-Walters, chair of the British Society for Immunology's taskforce on Covid-19 and immunology, said in a statement. She noted that mutations that may have a compound effect "should be tested together." Because people usually make more than one type of antibody against a virus, experts say it's unlikely such a mutation would render the virus completely resistant to a vaccine. However, experts aren't so sure the new strains will have no impact at all. "We will need to see actual protection from new variants in participants in the clinical trials that are still running to be sure the vaccine is equally effective," Alexander Edwards, associate professor in biomedical technology at University of Reading's school of pharmacy in the UK, said in a statement. Neither Edwards nor Dunn-Walters was involved in the new research. If a virus is more transmissible or less susceptible to a vaccine, experts say that could also raise the bar for the number of people who would have to be vaccinated to achieve herd immunity. In a statement last month, Pfizer said it had performed similar tests on "multiple mutant strains. To date, we have found consistent coverage of all the strains tested." It will be important to continue "monitoring of the significance of changes for vaccine coverage," the researchers wrote in the new paper. That's because of "the possibility that a future mutation ... might necessitate a vaccine strain change." Both Pfizer's and Moderna's vaccines use genetic technology that would allow the vaccines to be quickly adapted to account for mutations, they noted. In a statement Friday, BioNTech said it and Pfizer "are encouraged by these early, in vitro study findings," but stressed that "further data are needed" to track the how effective the vaccine is at preventing disease caused by new variants. Source: Pfizer's Covid-19 vaccine appears to work against mutation in new coronavirus strains, study finds
  5. Teens fully protected by Pfizer’s COVID-19 vaccine, company says Vaccinated adolescents had higher levels of neutralizing antibodies than older groups. Enlarge / Jonathan, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine at Clalit Health Services, in Israel's Mediterranean coastal city of Tel Aviv on January 23, 2021. Adolescents ages 12 to 15 were completely protected from symptomatic COVID-19 after being vaccinated with the Pfizer/BioNTech mRNA vaccine in a small Phase III clinical trial, Pfizer reported in a press release Wednesday. The company also said that the vaccine was well-tolerated in the age group, spurring only the standard side effects seen in people ages 16 to 25. The vaccine is already authorized for use in people age 16 and over. The vaccine appeared more effective at spurring defensive immune responses in adolescents ages 12 to 15 than in the 16- to 25-year-old group, producing even higher levels of antibodies that were able to neutralize SARS-CoV-2. In a measure of neutralizing antibodies, vaccinated youths in the new trial had geometric mean titers (GMTs) of 1,239.5, compared with the GMTs of 705.1 previously seen in those ages 16 to 25, Pfizer noted. The trial involved 2,260 adolescents ages 12 to 15, of which 1,131 were vaccinated and 1,129 received a placebo. There were 18 cases of symptomatic COVID-19 in the trial, all of which were in the placebo group. In today’s press release, the company trumpeted that the vaccine demonstrated “100 percent efficacy.” The trial was not primarily designed to assess efficacy, however. It was primarily assessing relative immune responses, so it will require more data to fully evaluate efficacy. Additionally, Pfizer and BioNTech have only released top-line trial results, not the full data from the trial, which has not been peer-reviewed. Last year, a Phase III trial involving more than 46,000 people found the vaccine to be 95 percent effective at preventing symptomatic COVID-19 in adults. The hardy immune responses and demonstrated protection in the new adolescent trial are positive signs. Pfizer and BioNTech are now planning to submit the data to the US Food and Drug Administration, as well as regulators in the European Union, to expand use of the vaccine to adolescents. “We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Albert Bourla, Pfizer’s CEO, said in the press release. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.” Last week, the companies announced the start of trials looking at safety and immune responses in infants and children ages 6 months to 11 years. The trial splits the children into three groups: ages 6 months to 2 years, 2 to 5 years, and 5 to 11 years. First doses went to children in the 5- to 11-year-old group last week, and the companies plan to start the 2- to 5-year group next week. Source: Teens fully protected by Pfizer’s COVID-19 vaccine, company says
  6. FDA advisers give thumbs up to Pfizer vaccine, paving way for authorization If the FDA signs off on the recommendation, vaccine distribution could begin in days. Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. Getty | JUSTIN TALLIS 98 with 60 posters participating The COVID-19 vaccine developed by Pfizer and BioNTech should be granted an Emergency Use Authorization from the US Food and Drug Administration, according to a committee of independent experts advising the agency. The committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—made the recommendation today in a vote of 17 in favor, 4 against, and 1 abstain. Specifically, committee members voted in the affirmative to the question: Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older? If the FDA follows the recommendation and grants authorization, the vaccine will be widely accessible to people 16 years and older, and distribution of the vaccine will likely begin in the coming days. Distribution The federal government inked a deal with Pfizer and BioNTech in July, which guarantees the country 100 million doses—enough to vaccinate 50 million people—with an option to purchase an additional 500 million doses. The federal government has said it expects to get 25 million doses from Pfizer this month, as well as 15 million doses of vaccine from Moderna, whose EUA request will be reviewed by the VRBPAC next week. Pfizer and BioNTech have said that they expect to produce up to 50 million vaccine doses in 2020 globally and up to 1.3 billion doses by the end of 2021. VRBPAC’s vote followed a daylong public meeting reviewing all of the data from Pfizer/BioNTech’s nearly 44,000-participant Phase III trial. Last month, the companies announced that the trial indicated the vaccine is 95 percent effective at preventing symptomatic COVID-19. Pfizer and BioNTech submitted a request for the EUA on November 20. On Tuesday, the FDA released its own briefing documents from its review of the detailed data submitted by Pfizer and BioNTech. The agency endorsed the efficacy and safety of the vaccine, writing in the briefing that it appeared “highly effective” and had a “favorable safety profile.” Reactions and discussion In today’s meeting, committee members brought up reports from the UK that the vaccine had sparked severe allergic reactions in two people who received the vaccine. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, said that the agency is looking into more information about the reactions. But she added that the agency’s own safety analysis had been aware of the potential problem, though the agency didn’t regard it as a severe problem. She noted that the FDA has been working with Pfizer to develop administration guidance for the vaccine, which would warn against giving the vaccine to anyone who has known allergic reactions to any components of the vaccine. Some committee members raised concern over the limited data on how effective the vaccine is at preventing severe disease—there were only 10 cases reported in the trial so far; nine in people who received a placebo, and one in a person who received the vaccine. However, the impressive efficacy rate in general was enough to sway the committee that an emergency authorization was warranted. Overall efficacy is indicative of efficacy against severe disease, several committee members noted. Last, the committee debated whether the EUA should cover people aged 16 and 17, which would allow that group to access the vaccine initially. Pfizer’s Phase III study only included people aged 18 and above. Some argued that 16- and 17-year-olds tend to have the same efficacy and safety profiles as young adults. However, people 16 to 17 are relatively unlikely to get severely ill from COVID-19 and are also unlikely to be high up on the list to get the first doses of vaccine. In the end, the majority of the committee agreed with the authorization question as it was, including 16- and 17-year-olds. Trial participants In addition to the data, the committee heard opinions and discussed downstream effects of an EUA, such as how the federal government will monitor safety and efficacy moving forward and plans for distribution. A particularly difficult issue to grapple with is how the EUA will affect ongoing trials and trial data. The committee considered whether participants of the Pfizer/BioNtech Phase III trial who were randomly assigned to get a placebo should now be automatically given the vaccine. On one hand, the participants put their health at risk to help test the vaccine, which may warrant giving them immediate access to the vaccine. On the other hand, with limited vaccine inventory, vaccinating trial participants would mean they would essentially jump the line ahead of people in groups deemed more at risk and in need of vaccine. Those they would jump ahead of include frontline health workers and medically vulnerable people in long-term care facilities. In addition, vaccinating people in the placebo group could “unblind” participants, who then may be less likely to participate in trial follow-ups. Up to this point, participants have not been told whether they received the vaccine or a placebo. The longer the placebo group stays in the trial and unvaccinated, the more data the companies can collect on long-term efficacy and safety issues in comparison to the vaccinated group. Looking forward A proposed revision to the trial under the EUA is to keep trial participants blinded and vaccinate them in the order in which they would receive the vaccine if they were not part of the trial—or after six months, whichever is shorter. Trial participants would then still be followed for two years after they received their second dose. It’s unclear, for now, if Pfizer will follow this plan. In the meantime, Pfizer will also be working to collect efficacy and safety data on pediatric populations. The company will also be looking at whether the vaccine prevents asymptomatic infections, which it hopes to have data on early next year. In addition, Pfizer expects to have data from animal studies in the coming days relating to safety and efficacy in pregnant and breastfeeding people. FDA advisers give thumbs up to Pfizer vaccine, paving way for authorization
  7. The Physics of Materials at Minus 80 Degrees Celsius Pfizer's new vaccine has to be stored at extremely low temperatures. Here's how things work when it gets that cold. Photograph: Getty Images It's a hopeful sign. Pfizer announced that its Covid-19 vaccine could be 90 percent effective. That could really help us get past this darned pandemic. But there's a catch. The vaccine is based on mRNA (messenger RNA)—this reads the DNA in the nucleus of a cell and transports the instructions to the cytoplasm where proteins are produced. The problem is that the mRNA is normally short lived. It either interacts with oxygen or folds onto itself and then doesn't do its job. So if you want to use it in a vaccine, you need to make the mRNA last longer. That means you have to keep it cold. Really cold. The standard storage temperature for these types of vaccines is –80 degrees Celsius. Yup. So, that means we have to talk about cold stuff. Let's do it. How Cold is –80 Degrees Celsius? Maybe you aren't too familiar with temperature units in Celsius—I hear you. Honestly, there's nothing really wrong with the Fahrenheit unit of temperature (except that I can never remember how to spell it). The advantage of the Celsius unit is that it's easier to calibrate. The original method was to use the freezing point of water as 0°C and the boiling point of water as 100°C. However, the value of 1°C was later redefined to be determined from the Boltzman constant—a fundamental constant that gives a relationship between the average kinetic energy of particles and the temperature of a system. If you know two corresponding temperature values in both °C and °F, you can set up an equation that converts from Celsius to Fahrenheit. You can also use your basic algebraic skills to change this into an equation that takes the temperature in Fahrenheit and converts to Celsius. Here are those two equations. Illustration: Getty Images So, if you put in a temperature of –80°C you get a temperature of –112°F. Yeah, that's pretty cold. But here is my favorite temperature: minus 40. There are two great things about –40. First, you don't have to specify if it's in Celsius or Fahrenheit since –40°C = –40°F (go ahead and check it for yourself). The second awesome thing about –40 is that it's the temperature on the surface of Hoth (from Star Wars V: The Empire Strikes Back). OK, maybe not everyone agrees about the temperature on Hoth, but this is the value used on the Star Wars episode of MythBusters so I'm going to stick with it. How Do You Get Stuff Down to –80 Degrees Celsius? The simplest way to get something cold is to put it in thermal contact with another object that's even colder. But you might not be able to find something colder than –80°C (although there is one option that I will get to in a little bit). That means you have to use a different cooling method. Probably the most common refrigeration method is the same one your refrigerator uses. You can understand how this works with a very simple demo using a rubber band—so go get one. OK, you have your rubber band (hopefully). Take it and stretch it with your hands, and keep it stretched. Now touch the stretched rubber band to your lip (which is very sensitive to temperature changes). You should be able to feel the rubber band is warmer than room temperature. Don't let the rubber band relax, just keep it stretched for a little while (30 seconds at least). It should cool off back down to room temperature. The next part is the best. Finally let that rubber band return to its normal length. Touch it back to your lip and you can feel the rubber band is now cold. So, here's what happened. Stretching the rubber band makes it warm up. If you just let it return back to its original length right away, nothing interesting happens. However, by letting the stretched rubber band cool down to room temperature, it still decreases in temperature when it returns to its relaxed state—but now it ends up colder than room temperature. This is exactly what a refrigerator does—except not with rubber bands. Instead it uses some type of liquid gas called a refrigerant (there are many different chemicals you could use here). You could start with the refrigerant as a gas and compress it until it becomes a liquid. This compression makes the refrigerant warm up. The next step is to let the compressed refrigerant cool off on the outside of the refrigerator. Now you can put the refrigerant inside the fridge and let it expand back into a gas, and it cools off—much colder than room temperature. That's how you keep your food cold. But what's different about the –80 degree freezer for vaccine storage? It turns out that it's pretty much impossible to get the inside temperature of the freezer down to –80°C with your normal refrigerant. Instead, you need TWO sets of refrigerants. It's sort of like a freezer inside of a freezer. The outer freezer is pretty much like the one in your kitchen. The inner freezer uses a different refrigerant (maybe isopropyl alcohol) so that when it's compressed, it can cool off inside of the normal freezer. But having two compressors is what makes these more expensive. Oh, do you want to see a picture? Courtesy of Rhett Allain This is the freezer in the biochemistry lab at Southeastern Louisiana University. Now you know what it looks like. Dry Ice I told you there was something you might be able to find that was at –80°C, and it's dry ice—solid carbon dioxide. To make dry ice, you start with carbon dioxide gas. This carbon dioxide gas is then cooled and compressed into liquid carbon dioxide. Then, when the liquid carbon dioxide is removed from pressure, it turns into a gas again. But this phase transition also decreases the temperature and gets it cold enough to freeze at –80°C to become a solid. But solid carbon dioxide does some weird stuff at atmospheric pressure (a pressure of 1 atm)—when it warms up, it goes straight from a solid to a gas without first becoming a liquid. This is called sublimation. I mean, that's weird. Since it doesn't turn into a liquid, it's not wet. Yes, that's where the name "dry ice" comes from. Can H2O do this too? Yup. We like to think of the freezing and melting point of water as being at some set temperature—but it's not. It also depends on the pressure. So, it helps to make a plot of temperature vs. pressure for different chemicals. We call this a phase diagram. Here is what that would look like for H2O. Illustration: Rhett Allain There's a lot in that diagram, so let me point out some important things. Take a look at that horizontal dotted line. That is the line that corresponds to atmospheric pressure (that's the pressure we live with on the surface of the Earth). If you look at the graph on the left side along the dotted line, this would be cold stuff and the water would be a solid (we call that ice). At point A, the temperature is 0°C and this is the temperature of a phase transition from solid to liquid. Point B is at 100°C and that's the phase transition from liquid to gas. But what about point C? That's called the triple point. If you reduce the pressure you can have solid, liquid, and gas phases all at the same time. For water, this is at a temperature of 0.1°C with a pressure of 0.006 atmospheres. It's pretty cool—check it out in this video. You can see how carbon dioxide is different by looking at the phase diagram. It looks something like this. Illustration: Rhett Allain If you look at the dotted line for a pressure of 1 atmosphere, it's now below the triple point. That means that a solid will make a phase change straight into a gas. That's the dry ice thing. But if you increase the pressure up to about 5 atmospheres, you CAN get solid carbon dioxide to make a phase transition into the liquid phase. As a bonus, I am going to show you this liquid carbon dioxide. Here's how you can do it. Put dry ice into a plastic container that is sealed at both ends. I'm going to use a clear plastic drinking straw. As the dry ice warms up, it changes into a gas as dry ice likes to do. However, this carbon dioxide gas has nowhere to go, and this increases the pressure inside of the straw. Eventually the pressure gets so high that liquid carbon dioxide is formed. But ultimately the pressure gets too high and the straw explodes. It's not a big explosion—it's just a straw. Here, check it out. I just think this is really cool. Usually when you have liquid carbon dioxide, it's in a metal pressure tank and you can't actually see it. Well, at least I had never seen it before I did this experiment. But What About the Covid-19 Vaccine? Yes, this is the logistical problem that's facing us right now. It's going to be quite difficult to ship and then store the vaccine so that it can be distributed. This is going to take a combination of the ultra cold freezers and storage in dry ice. But either way, it seems as though we really need a vaccine to get past this pandemic. Like any hero, it needs a side kick which, in this case, is super cold refrigeration. The Physics of Materials at Minus 80 Degrees Celsius
  8. Jenny Hamilton, 57, is a former police officer who now works in location security for the film industry and lives in Atlanta. She's a participant in the Pfizer vaccine trial, which recently developed the world's first effective coronavirus vaccine in record time. After receiving the first two injections, Hamilton says she experienced what felt like a cold — low-grade fevers, fatigue, and muscle aches. Hamilton kept a diary of her symptoms and found it comforting when a study coordinator would call or text to see how she was feeling; she'll continue to keep the diary for two years. "I'm excited that others will be able to have some protection," Hamilton told Business Insider. This is what her experience has been like, as told to Lauren Lee. Jenny Hamilton said she didn't think twice about getting involved in the trial. My family member is a nurse who got COVID-19 in probably early to mid-May. We kind of expected it because she visits a lot of people in assisted living facilities and nursing homes, so we figured she was waiting for the shoe to drop. It was very sobering for us as a family. She ended up getting a mild form, which was lucky for us. She has asthma and a couple of other preexisting conditions that put her at higher risk for a more serious outcome. Since we were exposed in January, I've always viewed the pandemic as a once-in-a century pandemic. I'd been thinking about what I could do to help, even though I'm basically a walking, high-risk category for COVID. I have asthma and Hashimoto's, an autoimmune condition. I was actively seeking to become part of this. First and foremost, it's a monumental opportunity to be able to help your fellow citizens and be able to be in a position to further a therapeutic or vaccine that will keep people from dying. I really didn't think twice about it. It was something I sought after and I did it mainly because both of my sisters are nurses. They didn't make it easy. I looked for information on where the trials were being conducted and waited for details to come out on how I could sign up for a trial. I had heard other people signed up to participate and I wanted to know where they were getting that information. There are three facilities in the Atlanta area that are doing the study. I'm part of the one by the Clinical Research Atlanta in Stockbridge, Georgia. I finally went to their website and filled out a small survey. I was called the next day. I was finally accepted into the trial in mid-August. I'm taking part in the Pfizer trial, where we get two doses. They asked me a bunch of questions and tested me for COVID as part of the test. They drew blood and they gave me the first injection. At that point, I didn't know I was getting the placebo or vaccine, but I knew that night, I started getting really tired. The next day I was really exhausted, and then I started having a fever. My temperature was 99, almost 100 degrees, for two-and-a-half to three days. After the first injection, I waited three weeks and got another injection in the beginning of September. It was the same scenario — I was really tired the next day. It was a little more severe, where I didn't even feel like getting up to fix something to eat. I just laid in bed and slept most of the day and still had a low-grade fever for two or three days as well. After that, I'm fine. I'm currently in the third phase of the study. I got the blood draw a month after I did the last injection and will get another blood draw in March to determine if I have antibodies — or different responses with platelets and white blood cells — to determine what my body's response is. They request for you to fill out a diary. Every time you get an injection, you're supposed to detail in your responses of what your side effects are for seven days: What your temperature is, aches, pains, and on a scale, how severe they are. If you got more than moderate on any of the questions you have, a study coordinator would reach out. For example, one of my questions was about tiredness. When I put "severe" on tiredness, the study coordinator texted me soon after and wanted to get an idea of how I was doing. The same thing happened when my temperature was elevated for a longer period of time after the second injection. She basically said the side effects for this particular vaccine are usually more severe with the second injection than the first, so this was normal. They're very good about following up with you. It'll prompt you with certain entries in your diary to call your study coordinator. She calls right away, wants to make sure you're okay, and determines how severe your reactions are. Those are the kinds of things I found comforting. Other than that, they don't really talk to you. They just say if you feel bad, you can call at any time. Or if you feel like you want to withdraw from the study, you can call immediately and they'll talk you through that. They try to mitigate situations where someone is feeling scared or anxious. I've never felt any of that, because this situation was like having a slight cold. Even though I'm in the last phase, the study is going to last for two years. I'll have to fill out a diary once a week at least for two years. They want you to fill out a diary to see if you have any symptoms or feel like you've gotten COVID-19. If you do, they give you a test to do a nasal swab and pick it up. The way they were explaining to me, the last blood draw they'll do is in March. Even though it feels like I have another layer of protection, I still wear my mask. I'm actually careful. I have gone out to eat occasionally, but since the whole pandemic, it's made my perception change. I look down on restaurants that don't enforce mask-wearing and social distancing. I make sure I'm socially distancing myself in places. It's wonderful that it looks like the trial is getting close to producing a successful candidate for the vaccine. I'm excited that others will be able to have some protection. Source
  • Create New...