PRESS RELEASE (10/21/20): Dr. David Berger On FDA Vaccine Approval Committee Failure to Solicit Public Input Despite Widespread Concerns
October 21, 2020
Dr. David Berger of Wholistic Pediatrics & Family Care comments on FDA’s actions concerning public input on COVID-19 vaccine
TAMPA, Fla. October 21, 2020 — 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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Dr. David Berger (“Dr. David”), a Board Certified Pediatrician with over 20 years of experience as a clinician, has developed a national reputation in wholistic pediatric primary care. Dr. David is considered Tampa Bay area’s leading authority on medical cannabis for adults and children, and is one of the nation’s most experienced pediatricians using medical cannabis to help facilitate the treatment of children with chronic conditions.
Dr. David graduated from The Medical College of Pennsylvania in 1994 and completed his pediatric residency at the University of South Florida/Tampa General Hospital where he first began utilizing wholistic therapies. Dr. David has been in private practice since 1997 and in 2005 opened Wholistic Pediatrics & Family Care, his medical practice in Tampa, Florida. In 2010, Dr. David was appointed Assistant Professor at the University of South Florida College of Nursing. In 2016, he launched Wholistic ReLeaf to help qualified patients become certified to use medical cannabis.