Professor Jonathan Sterne presents to US Food and Drug Administration on COVID-19 boosters

  • 17 September 2021

Professor Jonathan Sterne, Deputy Director of the National Institute for Health Research Bristol Biomedical Research Centre (NIHR Bristol BRC), has presented evidence to the US Food and Drug Administration (FDA) on COVID-19 vaccination boosters today, Friday 17 September.

The presentation is part of the FDA’s advisory committee meeting to discuss Pfizer-BioNTech’s application for a COVID-19 booster in the US. The meeting can be publicly viewed online. Professor Sterne’s presentation is titled ‘Real world effectiveness of COVID-19 vaccines’.

The presentation follows on from a recently published Lancet Viewpoint opinion piece by a group of authors including Professor Sterne. In the piece, the authors summarised current evidence on vaccine efficacy, which does not appear to show a need for boosting in the general population, because efficacy of the existing vaccines against severe disease remains high. The authors argued that even if humoral immunity, measured by neutralising antibody titres, appears to wane, this does not necessarily predict reductions in vaccine efficacy over time. Additionally, reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease.

Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, said:

“The administration recently announced a plan to prepare for additional COVID-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses.

“The process for authorizing or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting data pertaining to safety and effectiveness to the agency to support this use. The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making. Should the data received from other manufacturers raise unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions.

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines. The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”