ANN ARBOR, Mich. – The U.S. Food and Drug Administration granted an emergency use authorization for the Moderna COVID-19 vaccine Friday evening, the second vaccine to be authorized in the country.
Prior to the authorization, the FDA advisory panel voted 20-0 with one abstention on Thursday to recommend the vaccine.
Dr. A Oveta Fuller, a virologist and viral pathogen researcher at the University of Michigan, voted “No” to recommend the Pfizer vaccine. However, she said she voted “Yes” this time for Moderna.
Fuller said she voted “No” on the Pfizer emergency use authorization request last week because she felt she did not get to address key vaccine issues, or get transparency on monitoring, shedding, hyperimmunity, and other study modalities that did get address with Moderna.
“The point is that if I say that here is the bar you need to reach which was 50% efficacy, over two months of the vaccine in people, Pfizer met that. It seemed like their study was set up to meet that at the minimum but it wasn’t set up to do a whole lot else,” Fuller said. Moderna’s study met that, exceeded it. That’s the kind of planning that to me makes a difference in a study from someone that has the intentions of helping people overall versus someone who is rushing to get to a finish line.”
Local 4 News’ Paula Tutman conducted a roundtable with scientists who further discussed the vaccines. Click here to watch the roundtable.