Tipsheet

FDA Advisory Panel Recommends Approval of Moderna Vaccine

Days after Pfizer's vaccine candidate was granted emergency use authorization by the FDA and the first vaccinations of the drug were administered in the United States, an advisory panel of experts has recommended Moderna's vaccine candidate for FDA approval.  

On Thursday, the Vaccines and Related Biological Products Advisory Committee voted 20-0 to recommend the vaccine be made available in the United States. The recommendation comes after several hours of discussion over the vaccine's documented safety and efficacy. 

"The evidence that has been studied in great detail on this vaccine highly outweighs any of the issues we’ve seen," said Dr. Hayley Gans of Stanford University Medical Center.

Moderna filed for FDA approval on Nov. 30 after its vaccine candidate proved to be over 94 percent effective against the virus in clinical trials. The vaccine also demonstrated 100 percent efficacy against the development of severe disease, according to Science Magazine. 

Drugmaker Moderna received $1 billion of funding through Operation Warp Speed for the development of its vaccine. Heath and Human Services head Alex Azar said Wednesday that the Trump administration has secured nearly six million doses of Moderna’s vaccine for immediate release.

On Friday, the FDA awarded an emergency authorization to Pfizer's coronavirus vaccine. The day before, the same independent FDA advisory panel voted 17 to 4, with one abstention, to approve the Pfizer vaccine. In final clinical trial, the Pfizer vaccine developed with BioNTech was shown to be over 95 percent effective. Pfizer is working with the federal government to provide 100 million doses of the vaccine free to the public by March 2021. The first doses of the vaccine have been administered in recent days.