TAMPA, Fla. — First, it was Pfizer– now, Thursday, Moderna gets a turn.
An FDA panel of medical experts will scrutinize data from Moderna’s COVID-19 vaccine trials before voting on whether to recommend the Emergency Use Authorization (EUA) of the vaccine.
Last week, the same panel voted 17 to 4 with 1 abstention recommending the EUA of the Pfizer vaccine. Americans started getting vaccinated Monday morning.
During that nine-hour meeting last Thursday, the panel consisting of independent epidemiologists and infectious disease specialists heard from doctors and professors from around the country in a one-hour public hearing.
Dr. David Berger, a Tampa-based pediatrician was one of the speakers. He took a few minutes to address building vaccine confidence and ensuring informed consent. Berger’s request to speak again was accepted and he’ll be giving a similar presentation Thursday ahead of the Moderna vote.
Berger is passionate about vaccine transparency from both the government and the drug companies as a means to educate the public and build vaccine confidence.
“I’m going to be going into more detail about not just about vaccine hesitancy but the real steps that government and manufacturers can be taking to get information out to people in a transparent way. And for people to be able to see the data,” Berger told 10 Tampa Bay Wednesday.
Berger is the Senior Medical Advisor for the Vaccine Considerations Project, a newly-formed group working to organize COVID-19 vaccine health and safety concerns of the medical community, epidemiologists, public health experts, and the general public.
So far, the group primarily consists of University of Miami Public Health graduate students working to compile data and ensure health and safety are at the forefront of the vaccine evaluations being undertaken by the FDA.
Dr. Berger says they are recruiting medical students and public health graduate students from around the country.
“The primary mission of the group is to gather as much information and have it available to people so that they’re making the informed consent decision if they’re going to take a vaccine,” Berger added.
The FDA meeting starts at 9 a.m. Thursday. The panel will vote to recommend the Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older.