Opinion: The FDA's mRNA vaccine full approval reviews are moving plenty fast. Start the mandates now
As the US continues to enjoy a surplus of protective Covid vaccines, some experts are hoping that a transition from EUA to full approval status for the two mRNA vaccines will boost the public’s trust in them and in turn, amp up the country’s vaccination levels just in time to block the resurgence of Covid that we’re seeing elsewhere driven by the Delta variant.
While such a quick up-shift may have that immediate effect, let’s not lose sight of the fact that the FDA is likely to review the Pfizer/BioNTech and Moderna vaccines in record time. And their massive trove of real-world safety and manufacturing data don’t make that easy. Even still, the FDA is planning its Covid vaccine approval reviews to last about half the time (3-4 months) that it currently takes the agency to sign off on a priority drug/vaccine application (6 months), and just a fraction of the time for a non-expedited new drug application (12 months).
There’s no question the agency should pick up the speed for both Pfizer and Moderna’s applications. Employers may be more willing to push for mandates once the vaccines are fully approved. Let’s not forget the reason we’re in this enviable position, with almost 160 million people fully vaccinated in the US in just a little more than a year and a half since the pandemic began: The FDA was able to move quickly on the stellar efficacy data at hand from both vaccines, and ensure the manufacturing process was robust enough and could be replicated in a way to make all of those hundreds of millions of doses safely and efficiently.
A rubber stamp push from EUA to full approval doesn’t help the millions of Americans who still haven’t been vaccinated, may be hesitant, or may be entirely opposed to the idea just because of the EUA status. And as the EUA to full approval transition is coming, employers across the country need to stand strong and require vaccinations so we can remain protected. As lawyers have indicated, there’s nothing illegal about requiring the administration of vaccines under EUAs.
Eric Topol, professor of molecular medicine at Scripps Research, recently authored an op-ed in the New York Times, calling on the FDA to fully approve the mRNA vaccines now, noting that they “have overwhelmingly been proved safe and effective by clinical trials, independent research and the experience of millions of people around the world who received them.”
But FDA’s reviews of Pfizer’s and Moderna’s vaccines have so far lasted less than 3 months. And there is nothing in the EUA or real-world data for either the Moderna or the Pfizer/BioNTech vaccine that should bring pause or somehow suggest either vaccine’s clinical data package isn’t equal to other, mandated vaccines that have already won full approval.
And while some seem to suggest the FDA is dragging its feet, the size (thousands of pages long) and complexity of a full approval package should not be taken lightly. If the FDA needs to take longer to ensure the vaccines are manufactured properly enough to win a full approval, so be it.
As FDA’s top vaccine official Peter Marks made clear from the very beginning, the vaccines were cleared at a higher bar than the other treatments winning EUAs, and the American public should be just as confident in the vaccines under EUAs as under full approvals.
For those who remain unvaccinated, Marks and Janet Woodcock reiterated the urgent need to move now, even with the very rare myocarditis risk in mostly younger men, as part of a stakeholder call last week. The CDC also made clear on Tuesday evening that more than half of all cases in the US are now the result of the Delta variant, which originated in India.
“The Delta variant is rising in this country and its incidence may double every week or so, and experts expect it will be the dominant variant within a month or so,” Woodcock said. The time to get vaccinated is now, with or without a full approval.