The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss Pfizer-BioNTech’s supplemental Biologics License Application for administration of a third dose, or “booster” dose, of the COVID-19 vaccine for all persons 16 years of age and older last Friday.
The staff of the FDA declined to take a stance on whether to back booster shots of Pfizer’s Covid-19 vaccine in their report to the VRBPAC, saying U.S. regulators haven’t verified all the available data.
Pfizer’s application to amend their license for their vaccine was based on observational data from Israel rather than actual clinical trials or studies. FDA staff said observational studies have suggested declining efficacy of the Pfizer vaccine over time against symptomatic infection while others have not.
The committee (VRBPAC) voted 16-2 to NOT recommend amending Pfizer’s vaccine license to include a 3rd booster shot for all populations. Later that afternoon, the Committee voted to recommend that the Commissioner add and Emergency Use Authorization (not approval) for the booster in folks 65+ and those with medical conditions that put them at substantial risk. That recommendation was largely symbolic, as clinicians can already use the Pfizer vaccine off-label.
The CDC’s Advisory Committee for Immunizations Practices will likely meet next week to decide whether to recommend the booster to the elderly and those with medical conditions that put them at risk. At some point, the ACIP will need to meet and make a recommendation for persons that had the Janssen & Moderna vaccines (regarding boosters). Clinicians and patients increasingly have questions about whether elderly persons that got the Janssen vaccine get a Pfizer booster.
Editorial Notes: Another global health equity is at play when it comes to routinely providing booster shots with little if any clinical benefit when persons in the developing world haven’t even had an opportunity to get a single dose yet. For example, only 1.3% of persons in Africa have been vaccinated. Even if FDA ends up approving the Pfizer booster, the CDC and ACIP should examine those global health equity issues before recommending a booster to already protected Americans, when those doses could and should go to developing nations.
I believe that the Biden Administration learned (or should have learned) an important lesson this week. Several weeks ago the Surgeon General and the CDC and NIH Directors expressed full-throated support for universal boosters before data supported that decision. As we saw last week, that support was not only premature, but it short-circuited the normal approval process.
