FDA to make COVID-19 vaccine approval more difficult


BREAKING: FDA to make it harder to approve coronavirus vaccine, which could block Trump’s plan to get vaccinated before polling day

  • FDA is expected to announce new, stricter requirements for a COVID-19 vaccine as early as this week, anonymous sources told the Washington Post
  • Stricter guidelines will make it more unlikely that a company working on a plan can get it approved before election day on November 3.
  • US confidence in the safety of a potential COVID-19 shot has plummeted with continued pressure from Trump to rush approval before “a very special date”

The United States Food and Drug Administration (FDA) is set to release new, stricter requirements for its approval of a coronavirus vaccine, a move that could wipe out the chances of a vaccine obtaining emergency use clearance before election day, according to the Washington Post.

Regulators could release the new approval standards as early as this week, and will do so publicly in an effort to bolster Americans’ eroded confidence in the United States to ensure the safety of a COVID-19 vaccine.

President Trump and his Operation Warp Speed ​​initiative have been pushing for months to get a coronavirus vaccine approved by November 3.

But according to a new Axios poll, less than 40% of Americans now say they would receive a vaccine against the coronavirus, with most citing fears about its safety, prompted by the Trump administration’s concerted efforts to speed up the process. development.

By strengthening the Emergency Use Authorization (EUA) standards that allowed hydroxychloroquine to spread into the market, the FDA will now require vaccine companies to continue tracking trial participants for at least two months after receiving a second dose of a vaccine (if needed), an anonymous source told The Post.

This stipulation alone could easily postpone the data submission deadline for the EUA until the election of Pfizer and Moderna, who only started registering participants for their end-stage trials at the end. of the month of July.

FDA regulators should tighten approval requirements for a COVID-19 vaccine, which could make it impossible to obtain emergency use authorization before polling day

A source familiar with the matter, but who asked to remain anonymous, said the FDA plans to add a requirement that data from a vaccine trial will not be complete enough for the agency to consider approval if at at least five participants in the placebo group develop COVID-19 problems[FEMININE[FEMININE

This will be a key measure of the effectiveness of a vaccine against a virus that not only has spread like wildfire, but has killed more than 200,000 Americans.


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