Pfizer's COVID-19 booster application set for high-stakes FDA advisory committee review in 2 weeks

Pfizer sign
The drugmaker submitted phase 3 data in August showing that people who received a third dose five to eight months after their second shot generated three times more antibodies. (Tracy Staton)

Amid weeks of debate over COVID-19 boosters, the White House has released plans to quickly roll out follow-up shots while some experts have voiced serious concerns. At a meeting later this month, outside FDA vaccine advisers will get a chance to have their say. 

The FDA is hosting an advisory committee meeting on Sept. 17 to discuss Pfizer’s application for COVID-19 booster shots, or a third dose for those who are fully vaccinated with the original two-shot regimen. The drugmaker in late August submitted phase 3 data showing that people who received a third dose five to eight months after their second shot generated three times more antibodies compared with after their second dose.  

Under President Joe Biden’s booster plan—unveiled last month—the U.S. is set to start administering third COVID-19 vaccine doses during the week of Sept. 20 if the FDA and CDC give the go-ahead. That means the Sept. 17 advisory committee meeting only gives the agency a few days to make its final decision to fulfill the president's plan.

After the White House released its booster plan, World Health Organization officials and others blasted the proposal, questioning both the scientific merits and the morality of administering third doses to Americans while many people around the globe have yet to receive a first dose. 

Responding to the plan, the WHO’s emergencies chief Michael Ryan compared the effort to handing out “extra life jackets to people who already have life jackets, while we’re leaving other people to drown.” 

RELATED: Biden administration's push for COVID boosters raises concerns about the science and morality of the plan 

Others in the medical community have questioned the data supporting boosters. Anna Durbin, a vaccines researcher at Johns Hopkins, previously told Stat News she doesn’t “think it’s based on scientific evidence that a booster is needed.”  

At a meeting earlier this week, CDC vaccine advisers said they need more data to recommend boosters for all Americans, The Hill reports. The advisers said they could probably support boosters for residents of long-term care facilities and healthcare workers.

Pfizer and Moderna have suggested for months that COVID-19 vaccine effectiveness eventually wanes and that recipients can benefit from a third dose. Johnson & Johnson also recently touted its own booster data. 

The U.S. isn't alone in its booster push. Israel has already started offering third mRNA doses, while Germany, England and France plan to administer them this month.

As the FDA works through tough booster questions, the agency was hit this week with news that it’s losing two key vaccine leaders. FDA Office of Vaccines Research and Review Director Marion Gruber, Ph.D., and Deputy Director Phillip Krause, M.D., are set to leave in late October and November, respectively.  

RELATED: Key vaccine leaders departing FDA as COVID-19 booster questions linger

The booster debate started this spring but hit high gear this summer as the delta variant took hold in the U.S. For COVID-19 vaccine companies, analysts see boosters as a way to extend revenues beyond initial vaccination regimens, and it's likely that billions of dollars are on the line.