FDA set to announce greater restrictions for COVID-19 vaccine: Report

FDA set to announce greater restrictions for COVID-19 vaccine: Report

The Food and Drug Administration is expected to announce new standards for approving a coronavirus vaccine in an apparent attempt to shore up confidence with the American people, according to a report.

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

Additionally, trials will have to show evidence surrounding more severe cases and older people, making it unlikely that a vaccine will be finished before the 2020 presidential election. Moderna and Pfizer each started their trials in July. The enrollment process took about a month with a second round of shots being administered after three or four weeks in the trial.

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


Centers for Disease Control Director Robert Redfield previously told Congress that health care workers, first responders and others at high risk would get the vaccine first, perhaps in January or even late this year, but it was unlikely to be available more broadly before late spring or summer.

Polling has shown Americans becoming increasingly resistant to a potential vaccine. Pew Research Center reported last week that only 21% of U.S. adults say they would “definitely” get the vaccine, down from 42% in May. Meanwhile, the percentage of people who said they would “probably” or “definitely” not receive the vaccine increased 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 have said from the beggining, given the way the trials have emerged now, including the one on hold now, the projection that I’ve made — and will stick by it — is that we’ll likely get an answer if it’s safe and effective by the end of the year, likely November or December,” he said on Sept. 9.


White House Deputy Press Secretary Judd Deere told Fox News on Tuesday: “Every decision the FDA has made during the Trump Administration has maintained the agencies gold standard for safety and been data-driven to save lives, and this false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public.”

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

The Associated Press contributed to this report.

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