FDA’s Peter Marks Testifies About Updating Vaccines to Address COVID-19 Variants

Top U.S. health officials, including an FDA regulator testified on Capitol Hill this week that real-world evidence from people vaccinated against COVID-19 and data from ongoing trials will be used to decide how vaccines should be updated to handle variant strains.

Vaccine developers, such as Pfizer, BioNTech, Moderna, Johnson & Johnson and Novavax, are all conducting or considering starting trials of booster shots aimed at targeting specific variants.

Peter Marks, director of the FDA’s Center for Biologics Evaluation, said the FDA has begun collecting data regarding vaccine safety from its various surveillance systems, which include the Vaccine Adverse Event Reporting System (VAERS) the FDA co-runs with the Centers for Disease Control and Prevention (CDC). That system enables the gathering of data on vaccine side effects but importantly does not establish what causes an adverse event.

In addition, the FDA is combing through data collected by the Centers for Medicare and Medicaid Services, which provides insight into key safety data for specific populations, such as older adults.

At issue is whether vaccines can maintain their effectiveness against COVID-19 variants, such as those identified in the UK, South Africa, Brazil and California, a concern for health officials and the general public worried about reduced or ineffective protection.

Marks was joined this week by Rochelle Walensky, director of the CDC; and Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases, in testifying before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations. ― Jason Scott