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U.S. FDA releases stricter guidelines for COVID-19 vaccine developers

Author : Pankaj Singh | Published Date : 2020-10-08 

The U.S. FDA (Food and Drug Administration), has reportedly released new guidelines for the pharmaceutical companies that are developing the COVID-19 vaccine, a step that was kept on hold for approximately two weeks by top officials of the White House. The new guidelines make it highly unlikely for the companies to release a vaccine on or before Election Day.

The move, that was authorized by the White House Office of Management and Budget, is seemingly marking a sudden reversal in the White House’s stance that comes a day after The New York Times report claimed that top White House officials, including the chief of staff, Mark Meadows, were blocking the new vaccine development guidelines. Top FDA officials were apparently caught off-guard after learning that the new guidelines had been released.

The new guidelines, which are formulated without the force of law, are calling for the collection of comprehensive safety data from the final stages of different clinical trials prior to the granting an emergency authorization.

U.S. President, Donald Trump, on Tuesday evening, showed disappointment on White House’s decision to let the guidelines through and also claimed that the released guidelines were a plot against his re-election prospects.

The U.S. FDA, since the beginning of the COVID-19 pandemic, has been claiming that it is looking for ways to expedite vaccine development without compromising on safety. The regulatory authority first released a set of guidelines in June 2020, in an effort to provide vaccine developers a better idea as to how it will decide if a potential vaccine is acceptable, either for a full license or for emergency use authorization.

As of date, four vaccines are in the final stages of testing, which is referred to as a Phase 3 trial. Additionally, a fifth vaccine is expected to enter the Phase 3 trial in this month.

Source credit: https://www.nytimes.com/2020/10/06/health/covid-vaccine-guidelines.html

About Author

Pankaj Singh

Pankaj Singh

Endowed with a post graduate degree in management and finance, Pankaj Singh has been a part of the online content domain for quite a while. Having worked previously as a U.K. insurance underwriter for two years, he now writes articles for fractovia.org and other online portals. He can be contacted at- [email protected] | https://twitter.com/PankajSingh2605

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