The U.S. Food and Drug Administration approved the Pfizer-BioNTech coronavirus vaccine for use in people 16 and older on Aug. 23. Describing FDA approval as “the gold standard,” U.S. President Joe Biden, heralded the moment as “a key milestone in our nation’s fight against COVID.”
This milestone was achieved as a result of the unprecedented pace of vaccine development. The Pfizer-BioNTech vaccine moved from concept to pivotal clinical trial to the FDA granting an emergency use authorization in record time. Since Dec. 11, 2020, 205 million doses of the vaccine have been administered in the U.S., and more than 26 million in Canada.
But what’s the difference between an FDA emergency use authorization and full approval? And what impact is FDA approval likely to have on unvaccinated people, doctors, organizations and the pharmaceutical industry?
With surging numbers of cases and hospitalizations driven by the Delta variant, the hope is that FDA approval will provide a timely boost to vaccination rates. President Biden urges unvaccinated Americans to get the Pfizer COVID-19 now that it has full FDA approval.
President Biden appealed directly to those yet to receive the vaccine: “If you are one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened. The moment you have been waiting for is here. It is time for you to go and get your vaccination.”
What is emergency use authorization?
In the event of a public health emergency, an emergency use authorization allows the FDA to make an unapproved medical product available for use. The FDA may grant such authorization provided the available evidence makes it “reasonable to believe that the product may be effective” and there is “no adequate, approved and available alternative.” Importantly, the authorization is limited to the duration of the health emergency.
Recognizing that COVID-19 vaccines would be administered to millions of healthy people, the FDA set a high evidentiary bar for authorization. Evidence supporting the vaccine’s safety and efficacy from a well-conducted clinical trial with at least two months of followup is required.
The FDA’s emergency use authorization of the Pfizer-BioNTech vaccine was based on review of a clinical trial with 44,000 people, half of whom had received the vaccine and half the placebo. The trial demonstrated the vaccine prevents 95 per cent of symptomatic COVID-19. Under emergency use authorization, the FDA can provide more timely access to urgently needed drugs and medical products.
What does FDA approval add?
FDA approval is based on review of a biologics license application, the standard mechanism for the review of novel drugs and vaccines. The product must be demonstrated to be “safe, pure and potent.” For coronavirus vaccines, this means completion of well-conducted clinical trials with six months of followup as well as review of the manufacturing process.
For the Pfizer-BioNTech vaccine, the FDA reviewed 340,000 pages of data supporting the vaccine’s safety and efficacy — about three times the amount of data contained in the application for emergency use. Additionally, the FDA inspected manufacturing facilities and negotiated the labelling information.
The FDA’s approval of the vaccine will likely affect unvaccinated people, organizations, doctors and the pharmaceutical industry.
FDA approval has sent a clear message that the Pfizer-BioNTech vaccine is both safe and effective. Evidence from clinical trials and surveillance of roughly 92 million vaccinated Americans provide a robust foundation for this claim.
The hope is that FDA approval will entice some of the 85 million eligible but unvaccinated Americans to get the shot. Maryland School of Public Health professor Sandra C. Quinn explains that “full approval takes away that ‘Oh, it’s experimental’ kind of language. For some people, it might make a difference. They will feel more confident and comfortable.”
How much of a difference might FDA approval make? A June 2021 poll conducted by the Kaiser Family Foundation COVID-19 Vaccine Monitor found “three in 10 unvaccinated adults, rising to about half of those in the ‘wait and see’ group, say they would be more likely to get vaccinated if one of the vaccines … were to receive full approval from the FDA.”
What impact does FDA approval have on doctors? The main difference is that once a drug or vaccine is approved for use, physicians are free to prescribe it for off-label indications, which are uses other than those specifically approved.
Dr. Eric Topol, professor of molecular medicine at non-profit Scripps Research, worries that FDA approval of the Pfizer-BioNTech vaccine “will usher in millions of prescriptions by doctors.” Booster shots for fully vaccinated healthy adults would run ahead of FDA’s review of boosters expected in September.
Acting FDA Commissioner Janet Woodcock describes the prospect of physicians prescribing vaccine to children as “of great concern.” The proper dose of vaccine and its safety in children under 12 has yet to be established, and widespread prescribing may undermine ongoing clinical trials.
FDA approval of the Pfizer-BioNTech vaccine has green-lighted vaccine mandates across government and the private sector. Although FDA approval may not be legally required for vaccine mandates, cautious employers put potential mandates on hold awaiting approval.
Monday’s announcement thus triggered a wave of vaccine mandates. The Pentagon announced that it is “moving ahead with plans to require all active-duty troops to be vaccinated.” New York City’s Department of Education will now require all employees to be vaccinated. Oil producer Chevron will mandate vaccination for all field workers.
FDA approval allows a drug company to market a drug or vaccine for approved indications. Further, unlike an emergency use authorization that is time limited, approval is open-ended.
The short-term impact of approval for the Pfizer-BioNTech vaccine is likely to be minor simply because it is already in use globally. Pfizer-BioNTech currently has contracts with the United States for one billion doses and the European Union for 1.8 billion doses. Canada’s agreement with Pfizer guarantees 65 million doses over the next two years.
FDA approval of the Pfizer-BioNTech vaccine does, however, make it more difficult for a new vaccine to be granted an emergency use authorization. Recall that such an authorization requires that there be no approved alternative. Any new vaccine will be unable to meet this requirement, and this will give existing approved or authorized vaccine makers a strategic advantage.
Finally, FDA approval is an endorsement of the novel messenger RNA vaccine platform. Novel mRNA vaccines against influenza, malaria and even cancer are currently in development. In the long term, this may be the greatest boon for pharma companies using this technology.
ABOUT THE AUTHOR
Charles Weijer, Professor of medicine, epidemiology & biostatistics, and philosophy, Western University. Weijer is a leading expert on the ethics of randomized controlled trials. Publications on the duty of care in clinical research, the ethical analysis of study benefits and harms, and empowering communities in research have been broadly influential. From 2008 to 2013 Charles co-led a collaboration that produced the first international ethics guidelines for cluster randomized trials. From 2014 to 2018 he collaborated with Dr. Adrian M. Owen on a project exploring the ethics of functional neuroimaging after severe brain injury. Charles’ current work explores ethical issues in pragmatic randomized controlled trials that evaluate health interventions in real-world conditions to better inform patients, health providers and health systems managers. This project, funded by the Canadian Institutes of Health Research, brings together a research team comprising philosophers, biostatisticians and trialists from five countries. Charles led the writing team for the World Health Organization guidance on “Ethical Considerations for Health Policy and Systems Research,” published in 2019. In 2020, he served on the WHO Working Group for Guidance on Human Challenge Studies in COVID-19. Charles held the Canada Research Chair in Bioethics from 2005 to 2019. In 2008, Charles worked with philanthropist Dr. Joseph Rotman to found the Rotman Institute of Philosophy, which is dedicated to fostering collaboration between the humanities and the sciences, and served as the Institute’s first director. In 2014, he received Western’s Hellmuth Prize for Achievement in Research, and, in 2016, he was elected to the Royal Society of Canada.
This article is courtesy of The Conversation.