FDA Briefs Select Subcommittee Members on Current Vaccine Landscape
Washington, D.C. (September 15, 2021) — Today, the Members of the Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James E. Clyburn, were briefed on the status of the coronavirus vaccine landscape in the United States by Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA).
Chairman Clyburn said in opening the briefing:
“The surge in cases we have seen this summer—driven by the Delta variant—should be alarming to everyone. Thankfully, the Biden Administration’s historic vaccination effort has helped to protect more than 179 million Americans who are now fully vaccinated. We know that the vast majority of hospitalizations and deaths today are among the unvaccinated. This underscores why we must keep doing everything we can to get more Americans vaccinated.”
Dr. Marks shared the following with Select Subcommittee Members during the briefing:
FDA Is Evaluating Compelling Data Suggesting Booster Shots May Provide Robust Protection and Help Prevent Continued Spread of the Virus
- Dr. Marks stated there is “irrefutable” evidence that the immunity conferred by the vaccines wanes over time. He noted that waning antibody response is a particular concern in individuals over 65 who are at high risk of severe outcomes from the coronavirus, but that the evidence also shows waning immunity in younger individuals over time.
- He highlighted “very compelling data” from Israel, which began administering booster shots in July, suggesting that booster shots may counteract waning efficacy, reduce the risk of severe disease, and provide more durable immunity. Data suggest that booster shots may also reduce continued spread of the coronavirus—helping to prevent the emergence of a new variant that could evade current vaccines.
FDA’s Authorization of Vaccines for Children Ages 5 to 11 Could Come Soon
- Dr. Marks stated that the clinical trial data for the administration of coronavirus vaccines in adolescents aged 5 to 11 should be sent to FDA this fall, noting that Pfizer publicly reported they will provide the data to FDA “as early as the end of September.” He stated that FDA is “absolutely committed” to moving as quickly as possible to evaluate the data, because of the need to make vaccines available for elementary school aged children as soon as possible.
- Dr. Marks noted that clinical trials for the use of the vaccines in children 4 and under are ongoing. Although he acknowledged that some trials are “nearing completion,” he explained that the data for the under 5 population is not expected to be transmitted to FDA until late in the year.
The Biden Administration Did Not Pressure FDA on Booster Shot Plan
- Dr. Marks denied that the White House put pressure on FDA to approve booster shots for the general population. He stated that the Biden Administration’s plan for administering booster shots was “always contingent” on FDA’s review and approval—making clear that any claims to the contrary are unfounded.
- Dr. Marks told Members that FDA is “highly motivated” to move “as quickly as possible” and “get these products through as fast as we could” to “help save lives,” and that FDA will follow its standard, independent review process to fully evaluate the safety and efficacy of the booster shots, stating: “We are going to make sure that our evaluation is done correctly.” He emphasized that if booster shots are approved, the public can be assured that “they have met our standards.”