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An international, multi-billion-dollar race is underway to develop a COVID-19 vaccine, and progress is moving at record speed, but with nationalistic, competitive undertones. If and when an effective vaccine is invented, its production will require an unprecedented effort to vaccinate people across the globe. However, for the country that invents a safe and effective vaccine, at least in the urgent short term, it will be politically difficult to export vaccines before their own population is immunized. “The only solution,” vaccine development scientist Sandy Douglas told The New York Times, “is to make a hell of a lot of vaccine in a lot of different places.” But how? Having the public sector fund contracts with vaccine makers is a key component to meeting this future, unprecedented, distribution challenge. But in the United States, there seem to be some disturbing trends. We are faculty affiliated with two University of Massachusetts campuses. Ford studies environmental microbiology and infectious disease and is former director of the Institute of Global Health at UMass Amherst. Schweik studies how humanity can leverage the internet to collaborate and share innovations toward solving pressing societal problems. COVID-19 is such a problem. Public sector vaccine R&D contracting Early-stage vaccine R&D often relies on substantial public sector investment, and this is certainly the case for COVID-19. There are at least 26 vaccines undergoing human trials, nine of which are in Phase 3. If results demonstrate safety and effectiveness, regulators will approve a vaccine license that will allow the organization that invented it to begin manufacturing and distribution. In the United States, there are many firms with active COVID-19 vaccine R&D contracts financed with large sums of taxpayer money. For example, the company Moderna, which has a vaccine in Phase 3 trials, has received a contract valued at approximately US$955 million. Contracts like these typically fall under the jurisdiction of the Bayh-Dole Act of 1980, a law that grants the inventing firm exclusive license over the product patent. But this law also provides safeguards – “march-in rights” – that allows the federal government to withdraw the exclusivity license if the patented invention is not made available to the public under “reasonable terms.” Overpricing – essentially asking taxpayers to pay twice for the vaccine, once supporting research and development and then again for purchasing the actual vaccine – would be an example of a situation where march-in rights could apply. In that scenario, the federal government could revoke the exclusive rights from the inventing firm and grant new licenses to other companies to proceed with manufacturing and distribution. There is, however, an alternative mechanism called “Other Transaction Agreements” (OTA) that allows federal agencies to enter into legally binding R&D contracts which fall outside of the standard types overseen by Bayh-Dole provisions. OTA-based contracts, therefore, are exempt from the “march-in” safety provisions established by Bayh-Dole. Several current vaccine and other COVID-19-related R&D contracts fall under OTAs. In these cases, U.S. government agencies made an explicit choice to arrange OTAs with these companies. Consequently, pharmaceutical companies receiving funds could potentially charge unreasonably high prices for their COVID-19 treatment or vaccine, and the U.S. Federal Government has no “march-in” recourse to revoke the exclusive license to sell the taxpayer-funded vaccine. Under OTAs, America’s large financial investments in COVID-19 vaccine development could allow firms control over how their inventions are sold, manufactured and distributed. But to be fair, at least one company – Johnson & Johnson – who received an OTA contract has publicly stated: “We have from the beginning decided we are going to do this not for profit so that the vaccine becomes affordable and available on a global scale as quickly as possible.” Open sharing of innovations: A case from the industrial revolution But if society needs to rapidly invent and deliver a vaccine – a global public good – with taxpayer money, why are U.S. federal agencies establishing OTAs that relinquish the government’s ability to share and deploy these inventions and production processes with the world? We believe that as the U.S. federal government considers future funding to support vaccine manufacturing, policymakers and agency officials need to craft contracts with the suppliers that mandate open sharing of all vaccine production, quality control and distribution. Schweik has studied open source software that comes with an associated copyright license that promotes free and broad sharing. This licensing dates back to the mid-1980s. The invention of the “General Public License,” sometimes referred to as a viral or reciprocal license, meant that should an improvement be made, the new software version automatically inherits the same license as its parent. We believe that in a time of a global pandemic, a safe and effective COVID-19 vaccine should be licensed with General Public License-like properties. It turns out, in the early days of the Industrial Revolution, in an effort to rapidly develop standardized small arms parts, the U.S. Army and the Springfield Massachusetts Armory gave contractors open access to designs of new manufacturing equipment with the explicit requirement that if they improved the machines or processes related to them, they had to share these innovations with the national armories and their rival contractors. If these organizations did not comply, they would likely be denied future contractual opportunities. In essence, the armory established a contracting policy similar to General Public License invented roughly 150 years later, which then led to rapid innovation. A pandemic requires open source sharing Fortunately, some pharmaceutical companies, national governments, nonprofits like the Bill & Melinda Gates Foundation and international organizations like the Coalition for Epidemic Preparedness Initiatives – which supports vaccine development – are putting policies in place that embrace openness and sharing rather than intellectual property protection. Coalition for Epidemic Preparedness Initiatives officials have stated that all of their funding agreements require that “appropriate vaccines are first available to populations when and where they are needed to end an outbreak or curtail an epidemic, regardless of ability to pay.” That’s an important start. However, when there is a safe, effective COVID-19 vaccine, the U.S. and other national governments need to create contractual agreements with firms that provide fair and reasonable funding to cover their costs or even some reasonable profit margin while still mandating the open sharing of the processes for vaccine production, quality assurance and rapid global distribution. Of course, rapid global distribution is only the initial goal. To be sustainable, a critical mass of developing country vaccine manufacturers will be necessary, together with a support system for these manufacturers that provides regulatory guidance and access to new formulations. The longer-term goal must be to build sustainable vaccine manufacturing capacity within low- and middle-income countries. This requires a support system leveraged through the WHO and associated organizations such as Gavi to provide regulatory guidance and access to new formulations through this open source process. Source
steven36 posted a topic in General NewsGENEVA (Reuters) - Ten COVID-19 vaccines could be available by the middle of next year if they win regulatory approval, but their inventors need patent protection, the head of the global pharmaceutical industry group said on Friday. Vaccines by Pfizer and BioNtech, as well as Moderna and AstraZeneca have shown promising results in large clinical trials, but there is no question of “cutting corners”, said Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). “So far 3 we have 3 out of 3 were hits. I would expect that we will see something similar with Johnson & Johnson, I would expect that we would see similar positive results with Novavax, and many others, Sanofi Pasteur, GSK are in there, Merck,” he said. ‘Big Pharma’ and biotech firms have invested heavily in research and development and in boosting manufacturing during the pandemic to be able to roll out vaccine doses, Cueni told a Geneva news briefing. It would be a mistake to lift patent protection to allow compulsory licensing and try to make vaccines requiring such complex quality assurance without expert staff and quality control procedures, he said. “We will hopefully by the next summer have probably 10 vaccines which have proven their value. But all of them really need to be submitted by rigorous scientific scrutiny by the regulators.” At the World Trade Organization (WTO), India and South Africa have proposed allowing a temporary waiver to allow compulsory licensing for patented products during the pandemic. The United States, European Union and Switzerland and others have rejected it, trade officials say. Cueni, asked about the proposal, said: “For me this questioning of IP is really primarily politics, but it’s politics which is not helpful because it would send very negative signals in terms of disrespect to the system which allowed the world to react so fast and so responsibly.” Vaccine manufacturing plants often need 50 quality assurance staff making hundreds of checks during production, he said, emphasising that the companies would not exploit the pandemic. Cueni said that IFPMA archives showed there had never been a compulsory license granted for a vaccine and pointed to the difficult technology and know-how. Nearly every member company had committed to “not-for-profit” or socially responsible pricing during the pandemic, he added. Source
mood posted a topic in General NewsHow COVID-19 vaccines were developed in record time, without compromising safety The unprecedented scale of COVID-19 spurred massive global cooperation.(ABC: Edwina Seselja) When Ebola exploded across West Africa in 2014, it took more than five years to get a vaccine approved by drug regulators. Fast forward to 2020, and researchers were able to develop multiple protective coronavirus vaccines and get them authorised within 12 months of the virus being discovered. It's a spectacular and unparalleled scientific achievement — and promises to help bring the pandemic under control. But it's left some people wondering: if vaccines normally take years to develop, just how did we get here so fast? Previous research and pandemic prep Years of research and new vaccine technologies meant we were already a few steps ahead.(ABC: Edwina Seselja) It can be tempting to think that COVID-19 vaccine development kicked off when the pandemic did. In reality, scientists had spent years building vaccine technologies that could be quickly adapted to emerging viral threats — sometimes known as 'Disease X'. Thanks to funding bodies like the Coalition for Epidemic Preparedness (CEPI), researchers at Oxford University had been working on a vaccine that could be quickly tweaked to target COVID-19. The technology involves using a harmless common cold virus (that infects chimpanzees) and engineering it to carry proteins of other viruses you want to protect against. The research meant that as soon as the genetic sequence of SARS-CoV-2 (the virus that causes COVID-19) became available, the Oxford team was able to use the virus's genetic blueprint to modify their vaccine and begin testing it in clinical trials. Similarly, development of a different vaccine approach, using mRNA technology — used in both Pfizer's and Moderna's COVID-19 vaccines — allowed researchers to work much faster than if they had relied on traditional vaccine methods, such as using weakened or inactivated parts of the virus. Like the Oxford vaccine, the mRNA vaccines could be made fast because they only required the genetic sequence of SARS-CoV-2, and not a sample of the actual virus. Billions of dollars in funding Extra resources and financial gambles allowed research and manufacturing to begin quickly.(ABC: Edwina Seselja) Vaccine research costs money — a lot of money — and often this can be difficult to secure. Less so in a pandemic, it turns out, and in the face of widespread social and economic devastation. Thanks to billions of dollars from governments, the private sector, and funding bodies like CEPI, researchers had access to immediate and substantial funding for COVID-19 vaccines. This meant multiple clinical trials were launched quickly, and pharmaceutical companies were able to manufacture and stockpile vaccines before they even knew if they were effective. In normal circumstances, drug companies never hedge their bets like this — it would be too costly if their vaccine failed and the doses had to be scrapped. But in a pandemic, having the right infrastructure in place and vaccine doses ready to go is critical, so governments assumed bigger financial risks. Less bureaucracy, and back-to-back trials Vaccine research is expensive, which means clinical trials are usually slow to progress.(ABC: Edwina Seselja) One of the reasons vaccine development normally takes so long is because the testing process itself — specifically, the time in between the different phases of clinical trials. First, the vaccine needs to be tested in cells in the lab, and then it must be shown to be safe and protect against infection in animals. Next, researchers have to get approval to study the vaccine in humans, and secure funding to start the first of three phases of human trials. Phase 1: Testing in a small number of humans. This part is about making sure the vaccine is safe. Phase 2: More testing in humans — does the vaccine trigger strong immune responses? Phase 3: Testing in a larger number of humans to confirm its efficacy and safety. Each phase usually involves writing grant applications and recruiting hundreds if not thousands of people. At each stage, pharmaceutical companies also want to assess the data and work out if the vaccine is worth pursuing. All of this can take years. While the COVID-19 vaccines have gone through the same rigorous safety checks, the clinical trials have been prioritized, so there's been little waiting around. Thanks to significant funding injections and lots of people willing to take part in research, scientists have been able to run clinical trials in parallel — e.g. recruiting for phase 3 while they're still finishing phase 1 — rather than do things sequentially (and slowly). This, in addition to getting data to drug regulators earlier, has shaved months if not years off the process. Most importantly, it hasn't compromised the safety of the vaccines. A bit of luck that it was a coronavirus The scientists working on COVID-19 vaccines had experience with other coronaviruses.(ABC: Edwina Seselja) Before 2020, most of us had never heard of the word 'coronavirus'. But for people in the health and science community, the term was nothing new. Coronaviruses are a well-known family of viruses, thought to be behind up to a third of all common colds, and responsible for the SARS epidemic in 2003, and MERS outbreak in 2012. Previous work on SARS-CoV, MERS-CoV, and other common human coronaviruses meant researchers weren't totally starting from scratch with SARS-CoV-2. They already had some understanding of the virus's biology, including its all-important spike protein. Previous research had demonstrated the spike protein was essential to the virus gaining a foothold in the body, and a ripe target for an effective vaccine. Source: How COVID-19 vaccines were developed in record time, without compromising safety
Anxiety Is the Real Cause of Fainting That Was Linked to Covid-19 Vaccines, CDC Experts Say Empty vials of the Johnson & Johnson covid-19 vaccine used at the Klerksdorp hospital in South Africa on February 18, 2021 Photo: Phill Magakoe (Getty Images) A cluster of people who came down with symptoms possibly linked to covid-19 vaccines likely actually experienced a brief bout of anxiety, researchers with the Centers for Disease Control and Prevention say. In early April, several reports emerged that people in at least five different vaccination sites in the U.S. experienced almost immediate symptoms after vaccination, all in different states. These symptoms predominantly included fainting, as well as dizziness, lightheadedness, and rapid breathing. The incidents, which all involved people vaccinated with the Johnson & Johnson one-dose vaccine, led to the temporary shutdown of several sites, and both local health officials and the CDC pledged to look into the matter. Ultimately, CDC officials looked at 64 cases documented across five vaccination sites between April 7-9 and interviewed providers who were present on-site at the time. They also looked at real-world safety data collected through the Vaccine Adverse Event Reporting System. Despite some people visiting the hospital afterward and the incidents shutting down four of these sites, none of the symptoms were deemed to be serious in severity, and most patients felt better within 15 minutes. 17 people experienced fainting, while more than half felt lightheaded and dizzy and about a third experienced nausea and/or vomiting. Thirteen patients also told staff members beforehand that they had fainted in the past due to a fear of needles or vaccines. The results of the CDC’s investigation were published Friday in its Morbidity and Mortality Weekly Report (MMWR). Fainting and similar short-term symptoms are well-known to sometimes happen after vaccination. And there doesn’t seem to have been anything found in the CDC’s investigation of these cases or in the safety data that points to any other cause of these symptoms besides anxiety. In their report, the authors noted that these incidents happened before the recent reports of a rare blood clotting condition possibly linked to the Johnson & Johnson vaccine became public (after a brief pause, the use of the vaccine was restarted, now with a warning about the risk). Because the J&J shot is a single dose, it’s possible that people who are more likely to be anxious about vaccines would also opt for it more often, which could then account for the higher incidence of vaccine-related fainting associated with the shot. It’s also possible that the early media coverage of the first incidents on April 7 (or just seeing someone faint in person) only raised people’s anxiety further. That said, one of the first members of the public to take the Pfizer vaccine last December—a nurse in Tennessee—famously fainted right after. At the time, the nurse pointed out that she had a history of fainting. As the authors put it, “the stress of an ongoing pandemic might also increase anxiety surrounding covid-19 vaccination.” Of course, fainting and these other symptoms can still be a scary experience, no matter the cause. And just because anxiety may be the root cause of these cases, that doesn’t mean there isn’t a real risk worth caring about. For that reason, the authors recommend that people are routinely monitored after vaccination for at least 15 minutes—not just for the possibility of fainting but other rare symptoms that could appear post-vaccination, such as a strong allergic reaction. Source: Anxiety Is the Real Cause of Fainting That Was Linked to Covid-19 Vaccines, CDC Experts Say