Johns Hopkins researcher calls FDA, says team could approve COVID vaccine in an hour

© Sarah Silbiger / Getty
A professor at Johns Hopkins University criticized the Food And Drug Administration (FDA) for its slow approval process, saying the approval could be completed in about an hour. This is a July 20, 2020 photo of the FDA headquarters in White Oak, Maryland.

Marty Makary, professor at Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, criticized the United States Food and Drug Administration (FDA) for its slow process of approving the COVID-19 vaccine from Pfizer, claiming that such an approval could be completed in an hour.

In an editorial published on the self-proclaimed conservative political magazine The Dispatch, Makary claimed that pharmaceutical maker Pfizer submitted data detailing the safety and effectiveness of its vaccine on November 22. However, he continued, the FDA scheduled a meeting to review Pfizer’s data for nearly three weeks later on December 10.

“As Pfizer’s application is on the shelf at the FDA awaiting clearance, approximately 27,000 Americans will have died,” Makary wrote, saying that if his data analysis team needed to revisit the study of Pfizer vaccine on 43,000 patients, “it would take about an hour.

“Contrary to popular belief,” he wrote, “the FDA process is impractical – it does not interview patients in vaccine trials or look under a microscope at immune cells … The FDA and external scientists have a simple task: to confirm or reject the independent review already performed by the independent data safety oversight committee of the trial before submission to the FDA. “

He claims the FDA is looking at how the drug was made – something that could have been reviewed and approved long before Pfizer submitted the rest of its data, Makary wrote – and is performing a statistical analysis of the results of volunteers from the. study, including the rates and severity of infections and side effects in the vaccine and placebo groups – which he said a study team could do in an hour.

“It’s time for the FDA to embrace a sense of urgency,” he wrote. “We had Operation Warp Speed ​​to develop vaccines, but Operation Turtle Speed ​​to look at the results.

In the remainder of his article, he accuses the FDA of slowing the approval process even further in October by forcing vaccine manufacturers to wait longer to track their health with vaccines after being inoculated.

Ultimately, he blames career officials at the FDA for the slowdown and for excluding political appointments from the FDA and Department of Health and Human Services from the approval process.

In August, Trump accused the FDA of obstructing vaccine development so that a vaccine would not be developed until after the election.

“The deep state, or whoever, at the FDA, makes it very difficult for drug companies to get vaccines and therapeutics tested,” he wrote. Trump uses the term “deep state” to describe people in government agencies that he says are working to undermine his success.

Nonetheless, on Friday, FDA Commissioner Stephen Hahn confirmed the White House’s claim that 20 million people will receive a COVID-19 vaccine before the end of 2020.

Newsweek has contacted the FDA for comment.

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