White House officials reportedly blocked new, stricter FDA guidelines on approving a COVID-19 vaccine

Pharmacist Michael Witte, left, gives Rebecca Sirull, right, a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Sirull is the third patient to receive the shot in the study

AP Photo/Ted S. Warren

• Top White House officials blocked new health safety guidelines for the emergency release of a coronavirus vaccine, The New York Times reported Monday.
• The guidelines, submitted at the end of September by the Food and Drug Administration, suggested collecting another two months of data to ensure the safety and efficacy of a vaccine, according to The Times report.
• The stricter guidelines "would almost certainly guarantee that no vaccine could be authorized before the election on November 3" had they been approved, according to The Times.
• In light of the White House response, the Food and Drug Administration was pushed to resort to other options to "ensure that vaccines meet the guidelines," including "sharing the standards with an outside advisory committee of experts."
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White House officials blocked new, stricter health safety guidelines proposed by the FDA on approving a coronavirus vaccine, The New York Times reported Monday.

Guidelines sent from FDA commissioner Dr. Stephen Hahn at the end of September were stalled in the office of White House Chief of Staff Mark Meadows, effectively barring the new federal guidelines for emergency release of the vaccine.

On September 23, Meadows questioned the need for follow-up data that would push back the release of the vaccine, a senior administration official told The Times, and "said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency's career scientists," citing The Times report.

As such, the stricter guidelines "would almost certainly guarantee that no vaccine could be authorized before the election on November 3," according to The Times.

In light of the White House response, the Food and Drug Administration was pushed to resort to other options to "ensure that vaccines meet the guidelines," including "sharing the standards with an outside advisory committee of experts."

The news broke as President Donald Trump left Walter Reed Medical Center, where he stayed over the weekend to undergo tests and treatment following his COVID-19 diagnosis, though his doctor said he is not yet out of the woods.

As of Monday, more than 210,000 people have died from the coronavirus in the US alone, with nearly 7.5 million confirmed infections in the country, according to data from Johns Hopkins University.

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