The FDA could authorize a coronavirus vaccine later this week. The move would come at a crucial time in the pandemic, as public health officials say the United States is likely to face its worst public health crisis in history this winter.
Miamimundo / telemundo51
An FDA advisory group is scheduled to meet Thursday to review Pfizer’s vaccine.
The FDA is scheduled to convene a meeting of its Vaccine and Related Biological Products Advisory Committee, known as VRBPAC, on Thursday to review Pfizer’s COVID-19 vaccine with German drugmaker BioNTech for emergency use authorization.
Committee member James Hildreth told NBC’s “Weekend Today” Saturday that authorization could come as of Friday.
The emergency use authorization means that the FDA will allow some adults to receive the vaccine while the agency continues to evaluate the data. It is not the same as a full approval, which can usually take months. The FDA granted emergency authorization for Gilead Sciences’ remdesivir in May before giving full approval in late October.
Two days before the meeting, the FDA is expected to release a roughly 100-page document evaluating data from the companies’ clinical trials, said Dr. Paul Offit, a voting member of the advisory committee, offering a look at the agency’s opinion on the vaccine. .
“The public will see everything we see,” said Offit, who is also the director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.
The vaccine couldn’t come at a more crucial time. Hospitals in the US have a higher burden of COVID patients than ever before, and the outbreak in the country is poised to set even grimmer records this week. Dr. Deborah Birx, the White House coronavirus response coordinator, warned Sunday that the escalation of the coronavirus is likely to be the most difficult event in US history.