Cuomo says he thinks the FDA might authorize Pfizer’s vaccine on Thursday, with New Yorkers getting shots ‘as soon as this weekend’


FILE PHOTO: New York Governor Andrew Cuomo speaks at his daily briefing at New York Medical College during the outbreak of the coronavirus disease (COVID-19) in Valhalla, New York, U.S., May 7, 2020. REUTERS/Mike Segar
New York Gov. Andrew Cuomo speaks at a coronavirus briefing at New York Medical College in Valhalla, New York, May 7, 2020. Mike Segar/Reuters
  • New York Gov. Andrew Cuomo said on Wednesday he thinks Pfizer and BioNTech’s vaccine could receive FDA emergency authorization on Thursday. 

  • That’s the day an independent advisory panel will vote on whether to recommend an emergency use authorization for the vaccine. 

  • Although several top health officials have said they expect the vaccine to get authorized on Thursday, at least one FDA official has said the process could take up to a week after the panel’s vote. 

  • Visit Business Insider’s homepage for more stories.

New York Gov. Andrew Cuomo said on Wednesday that he thinks the US Food and Drug Administration might authorize Pfizer and BioNTech’s coronavirus vaccine candidate on Thursday. 

At a briefing in Albany, Cuomo said if the FDA does authorize the vaccine candidate tomorrow, a panel of New York-based health experts would then convene immediately to review and approve the vaccine on the state level. 

Cuomo did not specify the source of his information about the prospective authorization timeline,  but he noted that FDA officials had recently briefed members of the New York state panel.

“They’ve already been speaking to the FDA about the process,” he added.

Cuomo also said that New York is expecting a delivery of 170,000 doses “as soon as this weekend.”

“First priority will be for nursing home residents & staff and high-risk hospital workers,” he wrote in a tweet on Wednesday. 

Some experts think Pfizer’s vaccine could get authorized on Thursday, following an independent panel’s vote

The reason Cuomo is expecting authorization so soon is that on Thursday, the FDA is scheduled to convene an independent panel known as the Vaccines and Related Biological Products Advisory Committee. The group will assess Pfizer’s vaccine candidate after viewing presentations from the FDA, getting an update on the coronavirus pandemic, and listening to information about the vaccine’s safety and effectiveness.

Following a question-and-answer period, the panel will vote on whether to endorse the FDA’s plan to grant emergency authorization. The FDA usually follows the advice of the advisory panel, but isn’t required to do so.

Following the vote, it’s possible the agency could issue an emergency use authorization that same day.

James Hildreth, a member of the advisory panel, told NBC’s “Weekend Today” on Saturday that he expects the FDA to authorize the Pfizer vaccine as soon as Thursday, the day the committee votes. 

“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,” he said.

However, Peter Marks, who is leading the FDA’s vaccine vetting process, said the agency could take up to a week to consider the information after Thursday’s panel meeting. It is Marks and career scientists at the FDA – not Cuomo or Hildreth or outside experts – who make the final decision on authorization. 

“It will depend on the discussion at the advisory committees,” Marks said last week at an event hosted by the American Medical Association, according to Politico. He added that the agency aimed to move quickly but was “not compromising on safety.”

“We’re getting there as fast as we can because we understand people are losing their lives to this virus, but we also understand that the only way we can save more lives is to get a large proportion of the population to take the vaccine,” Marks said. 

Moncef Slaoui
Moncef Slaoui, chief adviser to Operation Warp Speed, speaks in the Rose Garden of the White House, November 13, 2020. AP Photo/Evan Vucci

Meanwhile, Moncef Slaoui, the head of Operation Warp Speed, has said he expects the FDA to approve the shot as early as Thursday or Friday.

“The first vaccine shipment will happen on the day after the vaccine is approved,” Slaoui said in a CBS News interview on Sunday. “That’s how we planned it. If the vaccine is approved on the 10th or the 11th, the minute it’s approved, the shipments will start.”

Stephen Hahn, head of the FDA, told NPR on Tuesday he expected the agency to make a decision “shortly after” the Thursday meeting, though he didn’t specify a date. Alex Azar, Secretary of Health and Human Services, told ABC on Sunday that the authorization could come “within days” of the committee meeting. 

Avery Hartmans contributed reporting. 

Read the original article on Business Insider





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