Pfizer-BioNTech COVID-19 vaccine endorsed at shambolic advisory committee meeting
Thursday’s FDA advisory committee meeting on the Pfizer-BioNTech COVID-19 vaccine could have been the shining culmination of a historic development program, but it failed to live up to its promise. If the meeting had been handled correctly, Dec. 10, 2020, would be remembered as the day a jury of scientists and physicians publicly weighed the evidence, declared that a vaccine safely and effectively protects individuals against COVID-19, and reassured Americans about the integrity and quality of the vaccine’s development and review.
Instead, as a result of poor meeting management, the public was left with no explanation for why four of the committee’s 22 voting members voted that the benefits of the BNT162b vaccine do not outweigh its risks for individuals 16 years of age and older, or why one member abstained.
Just as importantly, the 17 members who voted in favor of the proposition were not given an opportunity to explain their votes. Many of them did not speak at all during the meeting — and those who did speak were often barely audible or forgot to unmute their microphones.
The acting chairman of the committee, Arnold Monto, had said that he would give members an opportunity to explain their votes, which is a common practice at advisory committee meetings. Instead, Monto, a professor of public health and epidemiology at the University of Michigan School of Public Health, abruptly ended the meeting after the vote.
FDA and its advisers did not address some of the public’s most pressing questions, especially why the agency has not completed its review while residents of the U.K. and Canada have already received access to the vaccine.
Confusion about the meeting was compounded by a press release President-elect Joe Biden issued moments after the vote in which he and his wife Jill Biden incorrectly stated that FDA had approved the vaccine. The release was subsequently corrected.
Despite the flawed meeting, the vote by the Vaccines and Related Biologic Products Advisory Committee sets the stage for FDA to quickly grant an emergency use authorization, a decision that will mark a turning point in the most ambitious and intense effort to apply science and technology to defeat an existential threat since World War II.
Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NASDAQ:BNTX) plan to submit a BLA in April, Pfizer representatives said at the meeting.
FDA officials said at the meeting that approval of a BLA for a COVID-19 vaccine would not automatically preclude the issuance of emergency use authorizations for other COVID-19 vaccines. EUAs could be granted if manufacturing capacity of approved vaccines was insufficient to meet demand or to a vaccine that protected a limited population that was not well-served by approved products.
Underlining the urgency of the meeting, Aron Hall, co-leader of CDC’s Epidemiology Task Force, told the committee that reports of the numbers of Americans infected with SARS-CoV2 underestimate the actual spread of the disease. CDC estimates that 52.9 million Americans have been infected and 44.8 million have fallen ill from COVID-19, he reported.
Concerns over adolescents
Although the meeting was terminated before committee members explained their votes, at least some of the “no” votes seemed to have been triggered by concerns that there are insufficient data to support use of the vaccine in individuals who are 16 and 17 years old.
Archana Chatterjee, who voted “no,” said that “among all the scientific data presented, the thinnest was for the 16- and 17-year-olds.” Chatterjee, a pediatrician, is dean of the Chicago Medical School at Rosalind Franklin University.
Following the meeting, Chatterjee said in a statement that she supports use of the vaccine in adults 18 and older. She added that “unfortunately there wasn’t an opportunity to explain my vote at the meeting. I considered voting to abstain, but thought it would be important for the FDA to make note of the concerns of those of us who noted ‘no’.”
Other “no” votes were cast by Michael Kurilla, director of the Division of Clinical Innovation at NIH’s National Center for Advancing Translational Sciences; A. Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School; and David Kim, director of the Division of Vaccines at the HHS Office of Infectious Disease and HIV/AIDS Policy. Kurilla, Fuller and Kim did not explain the reasons for their votes.
H. Cody Meissner, professor of pediatrics at Tufts University School of Medicine, abstained. Meissner expressed concerns about the strength of the safety data in 16- and 17-year-olds.
Other advisory committee members who expressed concern about the paucity of data about 16- and 17-year olds, including Mark Sawyer, professor of clinical pediatrics at the University of California San Diego School of Medicine, voted “yes.”
One of the pediatricians on the committee, Paul Offit, said he believed concerns about 16- and 17-year-olds are not warranted. “We have seen certainly reports, as well as kids in the hospital, who have had cardiac anomalies as 16- and 17-year-olds,” Offit, professor of pediatrics at the Children’s Hospital of Philadelphia, said. “If you can prevent this disease safely and effectively, we have clear evidence of the benefit. All we have on the other side is theoretical risks.”