Commenting on the slow approval process for Pfizer’s COVID-19 vaccine, Marty Makary, Professor at 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 for Pfizer’s COVID-19 vaccine, saying that such approval could be completed in an hour.
Makary claimed in an article in the self-described conservative political journal The Dispatch that on November 22, the pharmaceutical manufacturer Pfizer submitted data detailing the safety and efficacy of its vaccine. He went on to say, however, that the FDA had scheduled a meeting to review Pfizer’s data for almost three weeks later on December 10.
” As Pfizer’s application is on the shelf awaiting FDA approval, about 27,000 Americans will have died,” Makary wrote, saying that if his data analysis team had to review Pfizer’s vaccine trial with 43,000 patients, “it would take about an hour.
“Contrary to popular belief,” he wrote, “the FDA process is not practical – it does not interview patients in the vaccine study or look at immune cells under a microscope…. The FDA and external scientists have a simple task: they must confirm or deny the review that was already conducted by the independent Data Safety Monitoring Board of the study prior to FDA submission”.
He claims that the FDA is reviewing how the drug was manufactured – something that could have been reviewed and approved long before Pfizer submitted the rest of its data, Makary wrote – and is conducting a statistical analysis of the results of the volunteers in the study, including the rates and severity of infection and adverse events in the vaccine and placebo groups – something that a study team could have done in an hour, he says.
“It’s time for the FDA to adopt a sense of urgency,” he wrote, “We had Operation Warp Speed in vaccine development, but Operation Turtle Speed in reviewing the results.
Later in 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 after vaccination to inform vaccine recipients about their health status.
Ultimately, he blames career officials at the FDA for the slowdown and for excluding political representatives at the FDA and the Department of Health from the approval process.
In August, Trump accused the FDA of hindering vaccine development so that a vaccine would not be developed until after the election.
“The deep state, or whoever, over at the FDA makes it very difficult for drug companies to get people to test the vaccines and therapeutics,” he wrote. Trump uses the term “deep state” to describe people within the government agencies that he believes are working to undermine his success.
Nevertheless, FDA Commissioner Stephen Hahn on Friday confirmed the White House claim that 20 million people will receive a COVID 19 vaccine before the end of 2020.
Washington Newsday has asked the FDA for its opinion.