FDA Vaccine Approval Committee Fails to Solicit Public Input Despite Widespread Concerns

TAMPA, Fla., Oct. 21, 2020 /PRNewswire/ -- According to recent surveys, nearly 50% of Americans say they are unlikely to get a COVID-19 vaccine when it becomes available. The main reasons cited are concerns about potential negative side effects and a lack of trust and transparency in the approval process. Nonetheless, the FDA failed to adequately solicit public input ahead of their upcoming open committee meeting about the vaccine approval process, which will take place Thursday, October 22. The media has a civic duty to notify the public of this week's committee meeting and the government's failure to earnestly seek public comment.

Dr. David Berger, a Tampa pediatrician focusing on neurodevelopmental and immunological conditions, was frustrated to learn about the meeting less than 36-hours before the public comment deadline, and after the deadline had passed to request a formal presentation to the committee.

"The FDA did not make a good faith effort to notify the public they were accepting comments," said Dr. Berger. "Only thirty-four people, myself included, submitted comments to the advisory committee. If the FDA wants buy-in from the public, it must get input from patients and physicians who have valid questions and concerns about the potential benefits and risks of potential COVID-19 vaccine options."

Despite short notice, Dr. Berger rushed to meet the October 15 deadline for public comments. In his formal letter he urged the committee to: (1) be fully transparent about clinical trials, (2) provide ongoing observation and reporting of adverse clinical trial events; (3) ensure adequate representation of diverse populations; and, (4) accurately report on vaccine protective rates.

Dr. Berger also produced a YouTube video and social media campaign to notify the public about the upcoming FDA meeting and the formal comments he submitted on behalf of his patients.

Widespread concern about the FDA vaccine approval process recently led the State of California to declare it will not allow the distribution of COVID-19 vaccines before its own safety review.

"For the COVID vaccine program to be successful," Dr. Berger says, "it is imperative the government listen to public opinion and take necessary steps to curb concerns about safety and transparency."

The FDA online web conference meeting will be available to view this Thursday, October 22, at:

Dr. Berger is available for further public comment.

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SOURCE Wholistic Pediatrics & Family Care

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