Pfizer/BioNTech Vaccine Heads to FDA for Approval as Bay Area Awaits 1st Shipments

FDA advisers recommend authorization coronavirus vaccine

FDA advisers recommend authorization coronavirus vaccine

American Desk (Channel TT) Vaccine advisers to the US Food and Drug Administration voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech's coronavirus vaccine. Seventeen members of the Vaccines and Related Biological Products Advisory Committee voted yes, four voted no and one abstained. The Food and Drug and Administration’s authorization of Pfizer’s COVID vaccine could come within the next couple days now that a government advisory panel has voted to approve its emergency use.

 

The FDA doesn’t have to follow the advice of the panel but it usually does. At the very top of the list to get vaccinated are hospital workers.

The sprint to get the COVID-19 vaccine from the production line and into arms of the most vulnerable is nearing the finish line but there’s still a long way to go in the marathon to reach herd immunity and control the viral spread.

California will initially receive more than 327,000 of the Pfizer COVID vaccine doses. San Francisco county will be given 12,000 doses next week but there is hesitation by many to take the vaccine.

“Some nurses are concerned about the vaccines having adverse side effects,” said Jenny Rudnicki. Rudnicki said she will take the vaccine when it’s offered by her employer. “I think the evidence so far is promising and reasonable but I cannot promise you surprises won’t happen,” said Stanford professor of epidemiology Dr. John Ioannidis.

UCSF health officials told KPIX they are “strongly encouraging” all workers to get COVID vaccinations but will not mandate it. If an employee declines, that person must wear personal protective equipment.

“I don’t think it’s the best recipe to push something down one’s throat. It’s much better to say we have science and we have good data that seem to be perfectly fine,” said Ioannidis.

There are three tiers of health care workers. At the top, Tier 1 includes hospital workers and staff at skilled nursing facilities.

Local county health departments know how many doses they’ll get next week and the week after that but, in the fourth week of December, most health departments haven’t been given that information.

Stanford’s Dr. Hayley Gans is a pediatric infectious disease specialist and on the FDA advisory panel giving the green light.

"The question is never when you know everything. It's when you know enough and I think we know enough now to say that this appears to be our way out of this awful, awful mess," Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the committee, told CNN's Wolf Blitzer after the vote. "That's why I voted yes."

Dr. James Hildreth, president and chief executive officer of Meharry Medical College, said he would have hoped more minorities had been enrolled in the clinical trials of the vaccine.
"I just feel that we need this vaccine and the benefits outweigh the risks," Hildreth, a temporary voting member of the committee, told CNN.

Courtesy: CNN