FDA Advisory Committee to Develop Master Protocols for COVID-19 Vaccines
The FDA last week said it is developing master protocols for safety and effectiveness outcomes it intends to study for coronavirus vaccines. It will post the draft versions of those protocols for public comment and will eventually publish the final versions and final study reports online. The agency plans to identify and monitor 10 to 20 safety outcomes of interest, which will be done alongside the CDC and other government partners.
The announcement was made at a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, where the agency’s considerations for continuing blinded phase 3 trials after an Emergency Use Authorization (EUA) is issued were discussed.
Members of the expert panel expressed concerns about making sure minority and pediatric populations will be adequately represented in COVID-19 vaccine trials. Cody Meissner, chief of Pediatric Infectious Diseases at Tufts Children’s Hospital, called for pediatric patients to be evaluated as a distinct group because the disease impacts them differently.
Most members of the committee believe that the continuation of blinded phase 3 trials is essential, while some said there are ethical considerations.
Luigi Notarangelo, head of the National Institute of Allergy and Infectious Diseases’ laboratory of clinical immunology and microbiology, said that the “continuation of blinded phase 3 trials is absolutely critical, and we should do all that we can to make sure that they continue.”
Acting Committee Chairman Arnold Monto, an epidemiology professor at the University of Michigan, echoed the same sentiments, arguing that “unblinding destroys the whole purpose of a randomized trial.” He did, however, acknowledge the ethical dilemma of granting an EUA while continuing to give trial participants placebos.
The FDA may also conduct its own studies, including ones for general effectiveness and duration of protection. The FDA, the Centers for Medicare and Medicaid Services and the CDC have extensive experience in assessing the effectiveness of vaccines, Anderson said, having created several effectiveness studies for influenza and shingles vaccines.