The FDA advisory panel that voted 17-0 on Wednesday to recommended Pfizer’s COVID-19 vaccine for children 5-11, despite acknowledging the lack of safety data and a 99.998% survival rate from infection, included a half-dozen members with ties to the pharmaceutical giant.
Among the members were a former vice president of Pfizer Vaccines, a recent Pfizer consultant, a recent Pfizer research grant recipient, the mentor of a current top Pfizer vaccine executive, the operator of a center that distributes Pfizer vaccines and the chairman of a Pfizer data group, reported the National File.
Another member proudly posted a photo of himself taking a Pfizer vaccine, and others were already on the record supporting COVID-19 shots for children.
Recent FDA Commissioner Scott Gottlieb is on Pfizer’s board of directors.
The members with Pfizer ties:
- Acting chairman Dr. Arnold S. Monto of the University of Michigan School of Public Health was a paid Pfizer consultant as recently as 2018.
- Dr. Gregg Sylvester, chief medical officer for Seqirus Medical Affairs, previously served as a vice president for Pfizer Vaccines, where he launched Pfizer vaccines, including one for children.
- Dr. Archana Chatterjee, dean of the Chicago Medical School, was sponsored by Pfizer for a research project related to vaccines for infants between 2018-2020.
- Dr. Myron Levine of the University of Maryland School of Medicine mentored Raphael Simon, the senior director of vaccine research and development at Pfizer, as a post-doctoral fellow.
- Dr. James Hildreth, president and chief executive officer of Meharry Medical College, disclosed he has more than $1.5 million in relevant financial interests, including his work as president of Meharry Medical College, which administers Pfizer Coronavirus vaccines.
- Dr. Geeta K. Swamy, a professor of obstetrics and gynecology at Duke University, is chairman of the Independent Data Monitoring Committee for the Pfizer Group B Streptococcus Vaccine Program, a committee sponsored by Pfizer. According to Duke, Swamy serves as a co-investigator for the Pfizer COVID-19 vaccine trial.
Among the supporters of COVID vaccines for children are Drs. Ofer Levy of Boston Children’s Hospital; Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine; Dr. Jay Portnoy, professor of pediatrics at the University of Missouri-Kansas City School of Medicine; and Dr. Melinda Wharton, acting director for the National Center for Immunization and Respiratory Diseases.
The National File cited a report last December by FDANews stating that FDA advisory committee members “in the past have frequently been the target of heavy politicking by industry representatives of whatever drug they were considering for a recommendation at in-person meetings.”
“That process has been somewhat altered by the fact that during COVID-19, meetings are being held virtually,” said FDANews, which focuses international regulatory, legislative and business news regarding the life science community. “But it’s likely that behind-the-scenes pressuring still goes on. The industry defends the attempts to influence committee members as simply efforts to best present their case.”
On Tuesday, committee member Rubin, editor-in-chief of the New England Journal of Medicine, expressed the concern of many members about “a side effect that we can’t measure yet,” referring to the heart inflammation condition called myocarditis.
But he concluded there was no other way forward.
“We’re never going to learn about how safe the vaccine is unless we start giving it,” he said. “That’s just the way it goes.”
Pfizer’s briefing document, issued before the hearing, says on page 10 “the number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination.”
“Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis.”
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