Why isn't Pfizer's COVID-19 vaccine OK'd yet? White House calls in FDA chief Hahn to explain: Axios

Throughout the pandemic, White House officials have twisted arms at the FDA—and sometimes succeeded. Now, in the final months of the Trump administration, agency chief Stephen Hahn, M.D., has been summoned to explain the timing of its review of Pfizer’s COVID-19 vaccine, Axios reports. 

White House chief of staff Mark Meadows called Hahn in for a 9:30 a.m. meeting Tuesday to explain why the agency hasn't moved faster on the review, sources told the publication. Ahead of the meeting, Hahn told the news outlet that “career scientists have to make the decision, and they will take the time that’s needed to make the right call on this important decision." 

Some people in the Trump administration are “complaining the FDA is not working around the clock to get things approved,” one source told Axios, prompting Meadows to call the meeting. 

Pfizer and its partner BioNTech submitted their COVID-19 vaccine to the FDA on Nov. 20, and the vaccine is set for a public advisory committee hearing Dec. 10. Operation Warp Speed chief Moncef Slaoui previously told CNN an authorization could come as early as Dec. 11, and that 20 million Americans could get vaccinated in December.  

Getting a vaccine from starting gate to finish line that quickly would be an unprecedented scientific accomplishment, but there’s a still a feeling inside the White House that the FDA has slow-walked the review, according to Axios. An FDA spokesperson told the publication there are thousands of pages of data and details that “must be divided up and reviewed by experts from different disciplines.” Then, the program can enter an overall review. 

"We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision,” the FDA spokesperson told Axios. “It is our job to get this right and make the correct decision regarding vaccine safety and efficacy." 

It’s only the latest instance of White House officials getting involved in scientific processes at the FDA. Early in the pandemic, officials pressured the regulator and others in government to support the malaria drug chloroquine, according to a complaint from ousted BARDA director Rick Bright. The FDA eventually issued—and then retracted—an emergency use authorization for the medicine. 

Then, over the summer, President Donald Trump tweeted that 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.” In the tweet, the president suggested his political opponents were hoping to delay the vaccine until after the election. 

After Pfizer unveiled interim efficacy results on November 9, Trump reiterated his attack on the FDA. The president demanded HHS secretary Alex Azar “get to the bottom” of the situation, the Washington Post reported.