Sunday, September 19, 2021

Tag: FDA

HEALTH
Overnight Health Care: White House presses FDA chief over COVID-19 vaccine | Committees reach bipartisan deal to protect patients from surprise medical bills

Welcome to Friday’s Overnight Health Care.



a man wearing a suit and tie: Overnight Health Care: White House presses FDA chief over COVID-19 vaccine | Committees reach bipartisan deal to protect patients from surprise medical bills | Sanders, Hawley vow fight next week over stimulus checks


© Getty Images
Overnight Health Care: White House presses FDA chief over COVID-19 vaccine | Committees reach bipartisan deal to protect patients from surprise medical bills | Sanders, Hawley vow fight next week over stimulus checks

FDA authorization of Pfizer’s COVID-19 vaccine candidate is expected soon, but the White House is pushing the agency to move even quicker. Meanwhile, the Trump administration is buying another 100 million doses of a similar candidate from Moderna. And a surprise billing fix might happen after all.

Let’s start with the COVID vaccine:

White House presses FDA chief over COVID-19 vaccine

Top Trump administration officials are turning up the heat on the Food and Drug Administration (FDA) to quickly authorize emergency use of the country’s first coronavirus vaccine.

White House chief of staff Mark Meadows phoned FDA Commissioner Stephen Hahn on Friday and pushed him to clear

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HEALTH
White House threatens FDA chief’s job over vaccine approval

WASHINGTON — White House chief of staff Mark Meadows on Friday pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of the day or face possible firing, two administration officials said.

The vaccine produced by Pfizer Inc. and its German partner BioNTech won a critical endorsement Thursday from an FDA panel of outside advisers, and signoff from the agency — which was expected this weekend — is the next step needed to get the shots to the public.

The FDA is not required to follow the panel’s guidance, but the devastation caused by the virus makes the vaccine’s authorization almost certain.

Meadows spoke to Hahn by telephone Friday, according to a senior administration official who was familiar with the call but was not authorized to discuss private conversations.

The chief of staff also told Hahn his job was

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HEALTH
NY Gives OK to Pfizer Vaccine Ahead of Final FDA Approval; NYC Opens Command Center on Monday



a person wearing a costume: A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images


© Bloomberg via Getty Images

A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images


What to Know

  • The FDA’s vaccine advisory panel approved Pfizer’s COVID vaccine — one of the final steps before millions of doses of the shot can be delivered across the country
  • New York Gov. Andrew Cuomo said the state will receive its first deliveries of COVID-19 vaccine Sunday or Monday as the pandemic is landing more patients into hospitals across the state
  • New York City is slated to receive an estimated 72,000 doses — the most for any region in the state. Long Island will receive the second highest
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HEALTH
The Health 202: The FDA could okay the first coronavirus vaccines any time now

Advisers to the Food and Drug Administration have agreed Pfizer’s coronavirus vaccine is safe enough to use.

At the end of a day-long meeting yesterday, the 15-member Vaccines and Related Biological Products Advisory Committee was asked to consider this statement: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risks for use in individuals 16 years of age and older?”

The members voted 17-to-4 in favor of that statement, with one member abstaining.

The vote makes it all but certain the FDA will authorize the vaccine on an emergency use basis within hours or days, kicking off an unprecedented effort to inoculate enough Americans to stop the rampaging pandemic, my colleagues Laurie McGinley and Carolyn Y. Johnson write.

If as expected, the FDA follows quickly with an emergency authorization, the shots will start being moved to the states within 24

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