FDA Emails Show Pressure Vaccine Officials Were Under
New emails released by FDA provide a glimpse of a frustrated senior FDA vaccine official arguing why her office could not “compress” its review activities any more to further expedite the 8/23/2021 approval of Pfizer-BioNTech’s Covid-19 vaccine Comirnaty for use in individuals 16 years of age and older. Previously, the vaccine had been available under an emergency use authorization, and FDA was under pressure to grant the first full approval of a Covid vaccine because public health officials believed this would boost vaccinations in the vaccine-hesitant population.
A week after Comirnaty was approved, the official, CBER Office of Vaccines Research and Review (OVRR) director Marion Gruber, announced her retirement, and her deputy, OVRR deputy director Philip Krause, announced he was also leaving the agency (see earlier story). At the time, the untimely departures signaled trouble with how the agency and Biden Administration were handling Covid-19 vaccine reviews and approvals.
A 7/21/2021 email (see page 181) from Gruber to CBER director Peter Marks and FDA acting commissioner Janet Woodcock has Gruber arguing why the 9/15/2021 target action date could not be shortened. She said OVRR “believes that public confidence in Covid-19 vaccines would not be served by rushing our review and evaluation of the submitted data.” She also raised alarms about settling the agency’s pediatric plan, saying it was “becoming increasingly complex in light of increasing evidence of association of this vaccine and development of myocarditis…”
In reaction to Gruber’s email, Marks emailed Woodcock and acknowledged that the dispute will be unveiled in a future Freedom of Information Act request and urged her to tell Gruber that her office needs to challenge themselves to “maximally expedite a high-quality review.” Marks also told Woodcock that he was disappointed by the office leadership’s “lack of urgency and responsiveness to the public health imperative… That is my problem, and I will deal with it in due course.”
As it got closer to the revised and earlier 8/23/2021 approval target date, another email (see page 49) from Marks to Woodcock expressed more frustration, with him saying he was not “optimistic that we will make it, particularly because the supervisors seem to be treating this like a conventional review/learning exercise, rather than an all hands on deck, work together to get it done.” He told Woodcock he was going to talk to his staff to remind them that during the public health emergency, “adhering to our usual standards for safety and effectiveness means just that — it does not mean that we are bound by our usual process… I will also tell the team that we are just going to continue working on this every day until it is done.”
A week later, Pfizer’s Comirnaty received its traditional approval, and a week after that, Gruber and Krause announced their departures.