FDA to announce bigger restrictions on COVID-19 vaccine: report


The Food and Drug Administration is expected to announce new standards for the approval of a coronavirus vaccine in an apparent attempt to build trust with the American people, according to a report.

The Washington Post reported on Tuesday that two people familiar with the problem said the FDA will ask manufacturers to follow clinical trial participants for at least two months in order to obtain emergency clearance.

Additionally, trials will need to show evidence for the most severe cases and the elderly, making it unlikely that a vaccine will be completed before the 2020 presidential election. Moderna and Pfizer both began trials in July. The registration process took about a month and a second round of vaccines was administered after three or four weeks of testing.

The White House has indicated that a vaccine could be approved by November. President Trump told “Fox & Friends” earlier this month that approval could come in “a few weeks.” He also told a press conference that distribution could begin in October.


Centers for Disease Control director Robert Redfield previously told Congress that healthcare workers, first responders and others at high risk would receive the vaccine first, possibly in January or even at the end of this year, but it was unlikely to be available more widely until late spring or summer.

A poll has shown that Americans are becoming increasingly resistant to a potential vaccine. The Pew Research Center reported last week that only 21% of American adults say they would “definitely” receive the vaccine, up from 42% in May. Meanwhile, the percentage of people who said they would “probably” or “definitely” not receive the vaccine rose from 27% to 49%.

Dr Anthony Fauci, one of Trump’s top advisers, also said the administration could see results for a vaccine before the end of the year.

“I’ve said all along, given how the trials have emerged now, including the one that’s currently on hold, the projection I’ve made – and I’ll stick with it – is that we’ll probably have an answer if that’s for sure. and effective by the end of the year, probably in November or December, ”he said on September 9.


White House Deputy Press Secretary Judd Deere told Fox News on Tuesday, “Every decision made by the FDA during the Trump administration has maintained the agencies’ gold standard for security and was based on data to save lives, and the false narrative that the media and Democrats have created that politics influences approvals is not only bogus but a danger to the American public. ”

He added: “President Trump believes that all Americans should have access to proven, safe and affordable treatment options and that rapid research, development, testing and scientific approvals are emblematic of President Trump’s top priority. : the health and safety of the American people. ”

The Associated Press contributed to this report.


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