In a hurry, the head of the FDA says the feeds are being “properly” vaccinated


WASHINGTON (AP) – The head of the agency responsible for licensing COVID-19 vaccines said on Tuesday that it would take time to “acquire this right” despite growing pressure from President Donald Trump to speed up the process.

“No one at the FDA is sitting on their hands. Everyone is working very hard to examine these applications and be able to do that. ”Stephen Hahn, head of the Food and Drug Administration, told ABC in an Instagram Live interview. “But we have to do it the right way.”

Hahn’s remarks came shortly after Trump’s chief of staff, Mark Meadows, summoned him to the White House while the agency was considering allowing the urgent use of the first vaccines that could begin the long road to defeating the coronavirus in the United States.

Trump opposed the FDA for not moving faster to approve the recordings, in part because there was no vaccine available for his loss, in part before the Nov. 3 election. He also argued that unsubstantiated allegations that drug manufacturers deliberately delayed the development of vaccines to impede re-election chances, although there is no indication that this was the case.

As he refused to accept his loss, Trump also told his close confidants that he thought the vaccination was still being run slowly to undermine his efforts to challenge the results. If the vaccine were to be delivered sooner, he argued that it would oppose the public.

Hahn withdrew from the White House meeting with his intact work, but it was a sign of pressure that the FDA had given guidance that “Dr. Hahn remains the FDA commissioner. “

Hahn said the FDA will thoroughly review each vaccine before making it available to the public.

“We’re going to make sure our scientists take the time to make the right decision,” Hahn said in a FDA statement. “It’s our job to get that right and make the right decision about the safety and effectiveness of vaccinations.”

An FDA spokesman said the agency needs to review thousands of pages of technical information by vaccine developers to ensure that the recordings are properly studied and prepared.

As for the meeting, Hahn told ABC that “an briefing was held on the issue we are discussing here, and it happened.”

The FDA was considering whether to allow two experimental vaccines that competed during development. Pfizer and Moderna are looking for “emergency use” that would allow people in high-risk groups to be vaccinated, while testing continues in the final phase.

But the meeting risked the aggravating risk that many Americans already carry about the potential effects of political pressure on vaccine development. Public health officials, including Hahn, have been trying for months to reassure them that the approval process was unaffected.

Meanwhile, a special scientific panel has addressed the urgent question of who should benefit first vaccines when available in limited quantities.

The White House did not respond to comments on the meeting with Hahn and its future at the agency. But many of the president’s helpers admit it looks particularly bad if Trump loses Hahn at the peak of vaccination approval.

Since losing his re-election offer, the president has been thinking about the pace of vaccination and believes that if Pfizer and Moderna had provided data showing that their vaccine was effective before election day, he would have won the competition. He also repeatedly complained that he had not received the credit he thought deserved to improve vaccines, and called on journalists not to pay tribute to President-elect Joe Biden for what happened at Trump class.

In the first months of his mandate, former FDA staff and outside experts criticized Hahn, a scientific researcher and former head of the hospital, for decisions that many said were surrendered to the White House and failed to defend the agency’s science-based decision-making process.

But recently, Hahn resisted pressure from the White House, including the approval of a hasty vaccination.

In October, Hahn issued strict FDA safety guidelines that virtually closed the door on Trump’s goal of releasing the vaccine by election day. And he has repeatedly testified to Congress that “science, not politics,” determines when a vaccine is available.

Despite Trump’s claims, the FDA has little control over when companies decide to seek permission from their government for their vaccinations. Each of the leading vaccine manufacturers conducts large-scale studies with thousands of people to test the safety and effectiveness of their shots.

Only an outside panel of independent experts can view the data in the study and determine how much time has been accumulated to submit it to the FDA. Pfizer filed its vaccination application on Nov. 20, and rival Moderna did so on Monday.

The FDA has scheduled public meetings to review the vaccines by Dec. 10 and Dec. 17, and is expected to decide before the end of the year whether to allow their use.

While Trump’s anger at the FDA has been penetrating for months, it has intensified after the election, according to White House helpers and a Republican close to the White House who spoke anonymously to discuss private conversations.

Trump told his friends that he thought Hahn had slowed or underlined the benefits of other therapies – despite evidence to the contrary – and “never been on the team.” And Trump, both privately and publicly, has claimed that drug manufacturers are punishing him for his efforts to reduce the price of prescription drugs, and made unsubstantiated allegations that an informal Deep State-like mascot was created with the FDA and the media to hurt him. .

Meanwhile, the administration has invited leading vaccine manufacturers, distributors and others to a “vaccine summit” next week. Not all invited companies have agreed to participate, fearing they are openly seen as politicians or exposed to Trump’s attacks.

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Miller reported from Wilmington, Delaware. Lemire reported from New York.