Johns Hopkins Researcher Calls out FDA, Says His Team Could Approve COVID Vaccine in an Hour

Marty Makary, a professor at the Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, has criticized the U.S. Food and Drug Administration (FDA) for its slow approval process of Pfizer's COVID-19 vaccine, saying that such approval could be completed in an hour.

In an op-ed posted on the self-described conservative political magazine The Dispatch, Makary claimed that the pharmaceutical manufacturer Pfizer had 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 sits on the shelf at the FDA awaiting authorization, about 27,000 Americans will have died," Makary wrote, saying if his data analysis team needed to review Pfizer's vaccine study of 43,000 patients, "it would take about one hour."

Johns Hopkins criticizes FDA COVID-19 vaccine approval
A professor at the Johns Hopkins University has criticized the Food And Drug Administration (FDA) for its slow approval process, saying that the approval could be completed in about an hour. This is a July 20, 2020 photo of the FDA headquarters in White Oak, Maryland. Sarah Silbiger/Getty

"Contrary to popular belief," he wrote, "the FDA process is not hands-on—it does not interview vaccine trial patients or look under a microscope at the immune cells.... The FDA and external scientists have a simple task: confirm or reject the review already conducted by the trial's independent data safety monitoring board before FDA submission."

He claims that the FDA reviews how the drug was manufactured—something that could've been reviewed and approved long before Pfizer submitted the rest of its data, Makary wrote—and conducts a statistical analysis of the outcomes of the study volunteers, including rates and severity of infections and side effects in the vaccine and placebo groups—something he said a study team could do in an hour.

"It's time the FDA adopts a sense of urgency," he wrote. "We've had Operation Warp Speed in developing vaccines but Operation Turtle Speed in reviewing the results."

In the rest of his article, he accuses the FDA of slowing down the approval process even more in October by requiring vaccine manufacturers to wait a longer period of time to follow up with vaccine recipients about their health after being inoculated.

Ultimately, he blames career officials at the FDA for the slowdown and for shutting political appointees at the FDA and the Department of Health and Human Services out of the approval process.

In August, Trump accused the FDA of hindering vaccine development so that a vaccine wouldn't be developed until after the election.

"The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics," he wrote. Trump uses the term "deep state" to describe people within government agencies who he thinks are working to undermine his success.

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

Newsweek contacted the FDA for comment.