Pfizer’s Covid-19 Vaccine Could Be Authorized by the FDA this Week
As deaths from coronavirus continue to mount in the U.S., many are paying close attention to headlines on when vaccines may start becoming available.
Public health officials say the U.S. is likely to face its worst public health crisis in history this winter.
Dr. Deborah Birx, the White House coronavirus response coordinator said on Sunday to NBC’s “Meet the Press”, “This is not just the worst public health event. This is the worst event that this country will face, not just from a public health side.”
“This fall/winter surge is combining everything that we saw in the spring with everything we saw in the summer — plus the fall surge going into a winter surge. I think that’s why Dr. Redfield made this absolute appeal to the American people,” she explained.
This week we could see pharma giant Pfizer’s Covid vaccine get FDA authorization.
The FDA is scheduled to convene a meeting of its Vaccines and Related Biological Products Advisory Committee, known as VRBPAC, on Thursday in order to review Pfizer’s Covid-19 vaccine with German drug maker BioNTech for emergency use authorization.
James Hildreth, a member of the FDA committee, told NBC’s “Weekend Today” this past weekend that an authorization could come as early as Friday.
“If the FDA commissioner decides to issue approval, the EUA, on that day when the vote is taken, as early as Friday of next week we could see vaccinations happening across the country,” said Hildreth.
With emergency use authorization, the FDA would allow some adults to receive the vaccine as the agency continues to evaluate data. This is not full approval which can sometime take months.
The FDA is expected to release two days prior to the meeting, a roughly 100-page document evaluating the companies’ clinical trial data, according to Dr. Paul Offit, a voting member of the advisory committee and the director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
“The public will see everything that we see,” said Offit.
If the FDA committee formally votes to OK the vaccine, the FDA could announce its authorization “within days,” said Health and Human Services Secretary Alex Azar to ABC News’ “This Week” this past Sunday.
“But it’s going to go according to FDA’s gold-standard process, and I’m going to make sure it does,” he added.
Pfizer submitted its Covid vaccine data to the FDA on Nov. 20th.
Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.