I know the clinical trials for the Moderna mRNA vaccine involved 80,000 people. The pages that were generated could have exceeded the height of the Sears Tower — a 1,450-foot skyscraper in Chicago.
There are two ways to get a vaccine green-lighted by the FDA: with an Emergency Use Authorization (EUA) or by applying for a license through a Biologics License Application (BLA). The FDA allowed the use of the shots with just two months of safety data under an EUA. The only difference really between the emergency use and the licensure is that volunteers are observed for a longer period of time to see the duration of protection, and if there might be rare adverse events that occurred down the road. Dr. William Schaffner, Professor of infectious diseases at Vanderbilt University Medical, said, “By now, over 75 million people [at that time of Schaffner’s statement] have been vaccinated in the United States with these vaccines, and we have had only one serious adverse type of reaction occur,” referencing the issue of anaphylaxis, “It occurs about two to four times for every million doses administered...so these are really not only very effective vaccines, but wonderfully safe vaccines.”
Dr. Arnold Monto- Professor of epidemiology at University of Michigan School of Public Health and acting chair of the FDA’s Vaccines and Related Biological Products Advisory Committee:
“The question that comes to our committee is in balance — are the benefits much greater than the risk? And that’s what we vote on. We say that the benefits of vaccination far outweigh the risks, given the situation we’re in now. It is an emergency use, and that’s why they don’t go ahead and fully license it at this point, because they know that it is unusual, but so is the pandemic. And the proof of the pudding is the fact that it’s worked.”
The FDA approval process is likely to take months. There are multiple decisions along the way, including negotiations with the companies about what goes on the product label and how the companies can advertise the shots. It is “highly likely” that the Pfizer-BioNTech and Moderna vaccines will be fully approved by the FDA as early as the second half of this year, said Lawrence Gostin, director of the World Health Organization’s Collaborating Center on National and Global Health Law. The shots, he said, have already demonstrated to be safe and highly effective in millions of Americans.
FDA approval could convince more “reasonable people,” or about 70% of the population, that the shots are safe and effective, said Dr. Paul Offit, of the FDA’s Vaccines and Related Biological Products Advisory Committee. The remaining 30% likely can’t be convinced and have to be compelled through other means like employee perks, he said.
People think there is a difference in data quality between approval under emergency use authorization, but there really isn’t, he said. “The only real difference is the length of follow-up for efficacy,” Offit said.
Be hard to approve something that killed thousands of American.