3 Consequences of Full FDA Approval of the Pfizer Vaccine

A wave of vaccine mandates has started. The FDA's full OK today may have an effect on the unvaccinated with a wait-and-see attitude and could, according to one expert, open the door to off-label use of the vaccine by clinicians.

It has been 256 days since the FDA issued an emergency use authorization (EUA) for the Pfizer. Today, the agency gave the vaccine full approval status, a decision many heralded as a milestone in the vaccination campaign against the epidemic.

“Full FDA approval of the Pfizer vaccine is another step forward — to convince more people to get vaccinated, to facilitate mandates, and to save more lives,” tweeted former CDC director Tom Frieden, M.D.

Others were also enthusiastic.

A wave of vaccine mandates

The Justice Department issued a ruling on July 6 that the EUA status does not prohibit public or private entities from imposing vaccine mandates and the

federal Equal Employment Opportunity Commission came to the same conclusion. Legal challenges to mandates have not been successful, including brought against Houston Methodist Hospital.

Still, some employers have held back or have made mandates contingent upon full approval. After the approval on Monday, the Pentagon announced that Defense Secretary Lloyd J. Austin will be setting vaccine guidelines for the country’s 1.4 million active duty soliders, according to the New York Times. New York City Mayor Bill de Blasio and New Jersey Gov. Patrick Murphy announced vaccine mandates for school employees in their respective jurisdictions.

“We have SO much data on the safety and effectiveness of these remarkable vaccines. Approval will boost confidence for companies, schools, and others who want to create a safe space for requiring vaccinations,” tweeted Ashish K. Jha, M.D., M.P.H., dean of the Brown University School of Public Health. In early August, Jha published an opinion piece in Time magazine admonishing the FDA to act faster on the Pfizer’s application.

It is open question, though, whether organizations requiring vaccination will need to have a frequent testing option for those who won’t get vaccinated. Some commentary on Tweeter today suggested that full approval means that employers and others won’t need to offer the testing option on a routine basis.

More of the wait-and-seers may get vaccinated

Vaccine hesitancy is a complicated, shifting phenomenon and it shouldn’t be confused with outright opposition to the vaccine. According to Kaiser Family Foundation polling done in July, about 30% of unvaccinated adults said they would get vaccinated if one of the vaccines had full approval, and half those with a “wait-and-see” attitude said they would. It remains to be seen, though, whether they will act on those sentiments or find other reasons to get vaccinated.

Possible off-label use

Georgetown Law Professor Lawrence O. Gostin pointed out in a Twitter thread today that full approval means that physicians are on safe legal and regulatory ground to use the vaccine off-label. As a practical matter, that is probably going to mean patients asking for, and getting, a“booster” dose beyond the two that are currently indicated. HHS officials said last week that a booster shot will be made available starting September 20, but with off-label use, some clinicians and patients may jump the queue.