If the U.S. Food and Drug Administration does not grant Emergency Use Authorization to the COVID-19 vaccine developed by Pfizer and BioNTech, the White House will demand the resignation of FDA Commissioner Stephen Hahn.
If the U.S. Food and Drug Administration does not grant Emergency Use Authorization to the COVID-19 vaccine developed by Pfizer and BioNTech, the White House will demand the resignation of FDA Commissioner Stephen Hahn.
According to the Washington Post, which cited anonymous sources, the demand came straight from Chief of Staff Mark Meadows. The nation has been awaiting a green light for the vaccine following the overwhelming support of an FDA advisory committee. On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 17-4 in favor of the vaccine’s authorization for individuals ages 16 and above. The four nay votes were related not to concerns about the overall safety or efficacy of the virus, but to the inclusion of 16 and 17-year-olds in the EUA. The nay votes did not believe there was enough evidence to support the inclusion of those adolescents.
During an appearance on Good Morning America today, Health and Human Services Secretary Alex Azar said the FDA has told Pfizer to prepare for an EUA, but provided no timeline for when that would be announced. The nation has waited with bated breath for a reliable vaccine against COVID-19 and is getting antsy knowing a light at the end of the pandemic tunnel can be seen.
In a statement this morning, the FDA said it informed Pfizer it will “rapidly work toward finalization and issuance of an emergency use authorization,” the Post added.
As of this morning, the Johns Hopkins COVID-19 dashboard shows there have been 15,721,790 confirmed diagnoses of the virus in the United States, with 293,633 related deaths. Over the past 10 days, the nation has recorded more than 1,000 COVID-19 related deaths per day, with more than 3,000 deaths reported Wednesday.
The Post reports that Meadows was the one who allegedly made the threat to Hahn, but President Donald Trump has used his Twitter account to hammer home his own disgust with the lack of EUA following the AdComm vote on Thursday.
“While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam (sic) vaccines out NOW Dr. Hahn,” Trump tweeted this morning. “Stop playing games and start saving lives!!”
Trump followed that tweet up with one that said he wants to “stop the world from killing itself.”
Over the past several months Trump has urged the FDA to authorize the use of multiple therapeutics against COVID-19, including antibody treatments and the EUA for convalescent plasma. He also expressed anger the FDA would not accelerate potential authorization of a vaccine ahead of the Nov. 3 election. When the FDA authored a more stringent guidance for Emergency Use Authorization of a vaccine due to political pressure, Trump called the new guidance a “political move.”
Trump has also shared his annoyance that he is not receiving the credit he believes he deserves for vaccine development. Earlier today he even tweeted a claim to Varney& Co. on the Fox Business Network that he should get the credit for the vaccine.
Phase III data submitted by Pfizer and BioNTech showed the company’s vaccine candidate BNT162b2 demonstrated a 95% efficacy in clinical trials.
Upon approval of the vaccine, representatives from Operation Warp Speed indicated that millions of doses of the mRNA vaccine acquired by the U.S. government will roll out within a matter of hours. The first ones slated to receive doses include frontline healthcare workers and older Americans living in long-term healthcare facilities.
On Monday, the first doses of Pfizer and BioNTech’s vaccine began to be administered to U.K. citizens following authorization in that country last week.
