One of the stranger episodes in a rush to get a COVID-19 vaccine is the FDA’s apparent lack of urgency to meet regarding the Emergency Use Authorization for a vaccine.
On November 20, Pfizer submitted safety and efficacy data related to its COVID-19 vaccine. Rather than schedule a prompt meeting to review the data, the FDA at that time announced it would convene on December 10 to review the data.
Johns Hopkins University School of Medicine professor Marty Markary argued in The Dispatch that the delay is unnecessary,
As a Johns Hopkins scientist who has conducted more than 100 clinical studies and reviewed thousands more from the scientific community at large, I can assure you that the agency’s review can be done within 24 to 48 hours without cutting any corners. They just need to work harder.
Contrary to popular belief, the FDA process is not hands-on—it does not interview vaccine trial patients or look under a microscope at the immune cells. It’s doing a statistical analysis and looking at data. For the vaccine trial, the data set is small and straightforward. If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour.
There may be very good scientific reasons to delay the review for three weeks, but Anthony Fauci has come close to saying that the delay is essential to reassure vaccine skeptics. According to a CNN story on Fauci’s comments to Fox News,
“The way the FDA is, our FDA is doing it, is the correct way,” Fauci said in an interview on Fox News.
“We really scrutinize the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine,” he said.
“I think if we did any less, we would add to the already existing hesitancy on the part of many people to take the vaccine because they’re concerned about safety or they’re concerned that we went too quickly.”
. . .
“So, it’s almost a damned if you do and you’re damned if you don’t, because if you go quickly and you do it superficially, people are not going to want to get vaccinated.”
Fauci initially criticized the UK for approving the Pfizer vaccine so quickly, but then walked back those claims, telling NBC News that “The Brits are good, they know what they’re doing, they’re really pros.”
Writing for Marginal Revolution, Alex Tabarrok argues that if the delay is intended to signal that the vaccine is safe, that this is likely an approach that will fail.
If the intent is to simply reassure hestitant Americans that the vaccine is safe by unnecessarily prolonging the review period, Alex Tabarrok at Marginal Revolution notes that this is an unconsionable practice that is unlikely to succeed.
Second, there is no guarantee that the risk averse, fearful and scientifically illiterate will be convinced by extra FDA investigation and there is plenty of evidence that they won’t be. Dozens of well-done studies have found no link between vaccines and autism. The scientific evidence that vaccines don’t cause autism is very strong. Yet many people don’t care. Moreover, I bet there is a significant overlap between those who think or fear that vaccines cause autism and those who fear a COVID vaccine. Will a few weeks of extra FDA investigation win these people over? No. More science won’t end science denialism.
Third, rather than alleviating fear, FDA delay may increase fear. People may reason, if the FDA is taking this long to review the evidence when thousands of people are dying every day it must be a hard decision. Delay also makes the vaccine less useful and less obviously useful. Thus, if vaccines come too late people will say that we were reaching herd immunity anyway and that vaccines are useless.