Each week, OMRF Vice President of Research Dr. Rod McEver opens “Adam’s Journal” to answer a medical question from Adam Cohen, OMRF’s senior vice president & general counsel and interim president.
Since December, health providers have been administering Covid-19 vaccinations to Americans. But the U.S. Food and Drug Administration still hasn’t given full approval to any of the vaccines. What’s the delay? When can we expect this to happen, and what will FDA approval mean if and when it happens?
Dr. McEver Prescribes
All three currently available vaccines – Pfizer, Moderna and Johnson & Johnson – are being administered under what’s known as emergency use authorization. The FDA granted these authorizations because we were (and are) facing a public health emergency, and the agency did so based on preliminary data the companies submitted showing the vaccines were safe and effective.
However, to receive full approval, the companies must gather significantly more safety and effectiveness data from clinical trials over at least six months. Pfizer and Moderna have both done this (in May and June, respectively) and submitted that information to the FDA, and J&J has indicated it will do so as well.
Those applications are hundreds of thousands of pages long, and regulators must review all of them. That’s not a trivial process. According to the director of the FDA’s Center for Biologics Evaluation Research, for vaccines, the agency aims to complete this process within eight months for priority reviews.
That said, the data are extremely positive, and the FDA has said it’s taking an all-hands-on-deck approach here. So, I’m expecting approval to come significantly faster, with The New York Times reporting that agency officials have set a deadline of Labor Day.
Approval won’t change much for people who want to get the vaccine: It will still be available through doctor’s offices and pharmacies, and it will still be free.
But for those who’ve been reluctant to get shots, this additional level of scrutiny may give them the comfort they need to roll up their sleeves. Similarly, it might serve as the tipping point for employers who, up until now, have been reluctant to require workers to get vaccinated.
Let’s also hope it quiets some of the misinformation that’s fueled this fourth wave of infections.
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