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Wednesday, September 23, 2020

Trump says he might reject stricter FDA vaccine guidelines


President Donald Trump said Wednesday that the White House may not approve tougher FDA guidelines for authorizing the emergency use of any coronavirus vaccines.

The FDA has reportedly drawn up the stricter emergency authorization standards and sent them to the White House Office of Management and Budget for review.

"That has to be approved by the White House," Trump said of the FDA guidance. "We may or may not approve it."

Trump also suggested that the FDA's decision to revise the standards, first issued in June, "was a political move more than anything else."

Four vaccines are now in the final stage of clinical trials in the United States — studies that are designed to determine whether any of the shots are effective at preventing coronavirus infections.

Trump has repeatedly predicted that a vaccine will be ready for wide use by Election Day, contradicting top government health officials who say that a shot won't be ready until late 2020 at the earliest. The president's hard charge for a vaccine has prompted fears that his administration will rubber-stamp a shot based on political calculations rather than scientific data.


Faced with a steady stream of polls showing shrinking public confidence in the coronavirus vaccine race, FDA Commissioner Stephen Hahn has sought to reassure Americans that any shot his agency greenlights will be safe and effective.

"I will fight for science," Hahn told a Senate committee on Wednesday morning. "I will fight for the integrity of the agency, and I will put the interests of the American people before anything else."

He told senators that "FDA will not authorize or approve a vaccine we won’t be confident in giving to our families."

Hahn said last week that his agency would be issuing the tougher emergency-use guidance for coronavirus vaccines, although that updated advice has not been made public.

But hours after the FDA chief's Senate appearance on Wednesday, Trump questioned the need for those updated guidelines at his press conference.

"I have tremendous trust in these massive companies that are so brilliantly organized in terms of what they've been doing with the tests," he said. "I don't see any reason why [a vaccine] should be delayed further because if they delay it a week or two weeks or three weeks, you know, that's a lot of lives you're talking about."

And a Trump adviser, Scott Atlas, who spoke at the press conference, disputed remarks made by CDC Director Robert Redfield at the Wednesday Senate hearing.

Redfield said that preliminary results from "the first round" of a CDC survey examining the coronavirus' spread found that roughly 90 percent of the American public was still susceptible to infection. The agency published those results, which cover the early months of the pandemic, in July.

Redfield added that the CDC study was ongoing.

Atlas — a neuroradiologist without experience in public health, infectious disease or immunology — said the CDC chief "misstated something" and relied on old data. Atlas also criticized the CDC study for using the presence of coronavirus antibodies in a person's blood as a proxy for immunity.

The body produces antibodies in response to infection, so having antibodies to the novel coronavirus is a sign that a person has been exposed to it. But scientists don't know what level of antibodies might confer immunity to reinfection. And there are signs that immune cells called T cells may also protect against the virus.

In his critique of Redfield, Atlas mentioned studies that have examined the role of T cells in fighting Covid-19. He also suggested that exposure to related viruses may help safeguard against infection by the novel coronavirus.

"The combination of those make the antibodies a small fraction of the people who have immunity," Atlas said.

That notion, also put forth by Sen. Rand Paul at the Senate hearing, was shot down by the government's top infectious disease expert, Tony Fauci. Fauci said that no study has found evidence of such "cross immunity" from earlier exposure to other coronaviruses.



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