Covid-19 Live Updates: F.D.A. Boss highlights cases of early vaccine approval

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India reopens the New Delhi metro, even as the country sets world records for new cases. Photographs of “Covid fingers” depicted white patients for a long time.

Now

The number of internationals has exceeded 25 million.

Dr. Stephen M. Hahn, the Commissioner of the Food and Drug Administration, who has been pressured by the White House to push for coronavirus remedies, said in an interview with the newspaper that his firm would be willing to approve a vaccine. against coronavirus before. the phase 3 clinic was completed if the company deemed it “appropriate”.

Dr. Hahn told the journal that a vaccine developer can simply seek approval before the Phase 3 clinical trials, which are the most important and rigorous, are completed, but that the company will make “a scientific and medical decision. Fix knowledge “and maybe just urgently factor an authorization for the use of especially vulnerable equipment than a blanket approval.

“It will be a political decision,” he said.

Dr. Hahn’s comments, published online Sunday via the Financial Times, weren’t his first indication that the company might accelerate the implementation of a vaccine under the right circumstances, which would not be at odds with company protocols. . But the interview comes at the end of a very eventful week for the F.D.A.

Last weekend, after President Trump criticized the firm for moving too slowly to expand vaccines and medicines and accused it of being a component of the “deep state,” Dr. Hahn made the impression with Trump on a press convention in which they made an exaggerated misrepresentation. the benefits of plasma remedies for Covid-19, causing a wave of disbelief and clinical criticism.

Dr. Hahn subsequently corrected the misleading claims. On Thursday, the Department of Health and Human Services, the parent company of the FDA, terminated the contract of a public relations representative who had pleaded with Dr. Hahn to factor in the correction, and with the FDA’s chief spokesperson, who in the task of only 11 days, he got rid of his position.

Last week, The Times reported that on July 30, Treasury Secretary Steven Mnuchin and White House Chief of Staff Mark Meadows told the Speaker of the House of Representatives, Nancy Pelosi, and the Senator Chuck Schumer, the Democratic leader, that a vaccine will most likely be approved urgently before the end of the phase. 3 clinical trials in the United States, most likely late September.

The account was based on data from two other people familiar with the discussion, who said Meadows had indicated that it would likely be the one that evolved through AstraZeneca and the University of Oxford, which is lately undergoing phase 2 and phase 3 trials. in Great Britain. , Brazil and the south of the country. Africa. However, senior management officials disputed the account, claiming that MM. Meadows and Mnuchin were misinterpreted or misinterpreted.

Last week, Dr. Anthony S. Fauci, the nation’s leading infectious disease expert, told The Times of London that 3 vaccine applicants headed for Operation Warp Speed, that vaccine progression sped up. through the White House. or December were “a safe bet.” He also said, “We would get an answer before that.”

An independent advisory committee will meet Oct. 22 to discuss vaccines in development, but Dr. Hahn said the company is in a position to schedule more meetings “quickly” once a vaccine application is submitted.

China and Russia have approved vaccines pending the completion of phase 3 testing, prompting complaints from global fitness experts.

There are aspects of vaccine progression that cannot be rushed. There is no way to speed up the production of antibodies in the human body, and researchers are wary of “antibody-dependent enhancement,” in which a vaccine makes recipients more vulnerable to infection. that less. In the past, H.I.V. and dengue triggered an unforeseen improvement.

The former F.D.A. Commissioner Dr. Scott Gottlieb said in an interview with CBS’s Face the Nation that agency control may simply “bypass” the approval process. But he also said that trials can be “read early” if knowledge shows that a specific vaccine is “very effective” and such effects can allow emergency clearance for vulnerable populations.

Some experts worry that early approval could have accidental consequences. In a letter to Dr. Hahn dated August 26, the Infectious Disease Society of America, an infectious disease physicians’ group, warned that pre-final approval of a Phase 3 trial “may particularly undermine vaccination efforts. COVID-19 and seriously erode trust in all vaccines in the existing environment of vaccine reluctance.

More than 180,000 people in the United States have died from Covid-19, the disease caused by the coronavirus. But President Trump retweeted several messages overnight and Sunday morning from others who espoused fringe conspiracy theories, claiming the death toll was vastly exaggerated.

Reissued posts, decidedly at odds with the government and other counts, state that the actual number of deaths from the virus is only around 9,000, not 182,000, as many of those who died had other problems as well. fitness and maxim were age complex.

“So transparent, founded on the advice of doctors Fauci and Birx, the United States has shut down the entire economy based on 9,000 American deaths from the Chinese coronavirus,” said the summary of a story from the uncompromising conservative online page Gateway Pundit. which he retweeted through the president, attacking his own fitness advisers, Dr. Anthony S. Fauci and Dr. Deborah L. Birx.

In fact, according to experts, the official estimate of deaths would possibly underestimate the mortality attributable to Covid-19. The exact maximum figure could possibly exceed 200,000, according to a Times investigation conducted this month.

There were at least 871 new coronavirus deaths and 44,639 new cases reported in the United States on August 29, to a database maintained through the Times. Over the following week, there has been an average of 41,924 instances consistent with the day, a low of 4% from the average two weeks earlier.

The total number of in the United States is around 6 million. Globally, the workload has exceeded 25 million.

In an obvious contradiction, Trump also retweeted a message calling for the imprisonment of New York Governor Andrew M. Cuomo due to the higher death toll from the virus in nursing homes across the state. “#KillerCuomo will be in jail,” read the message from actor James Woods, a staunch supporter of the president.

The tweets were part of more than 80 presidential tweets and retweets, many of which were inflammatory comments or claims about violent clashes in Portland, Oregon, where a guy wearing the hat of a far-right pro-Trump organization fired on Saturday. after a giant organization of Trump supporters piled up on the streets.

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