‘start saving lives’
Trump push got FDA to give authorization for Pfizer vaccine
FDA Commissioner Dr. Steven Hahn approved an emergency use authorization for Pfizer’s coronavirus vaccine after being pressured by the White House to move or hand in his resignation.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said Hahn in a statement.
The coveted approval came late Friday allowing millions of doses to be shipped immediately around the United States and vaccinations to be administered as soon as Monday or Tuesday.
President Trump said in a video address late Friday, “Today our nation has achieved a medical miracle. We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history. It will save millions of lives and soon end the pandemic once and for all.”
Trump and Chief of Staff Mark Meadows had pressed Hahn to pick up the pace or face being shown the door.
Trump tweeted Friday that the FDA is a “big, old, slow turtle.”
He added, “Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!”
The FDA had notified Pfizer Friday morning that it intended to issue emergency use authorization for the company’s coronavirus vaccine, but that key decision needed to come before the shots could commence.
“Following (Thursday’s) positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” read a Friday morning press release from the Food and Drug Administration.
The FDA also said it had notified the Centers for Disease Control and Prevention and Operation Warp Speed so the entities could execute their distribution plans.
An EUA is not the same as an FDA approval, but still allows for the vaccine doses to be administered.
The Vaccines and Related Biological Products Advisory Committee met Thursday and voted to recommend emergency use authorization for Pfizer’s mRNA vaccine which has an efficacy rate of 95%.
Pfizer has an agreement to supply the United States with 100 million initial doses of the vaccine with an option to order more.
The VRBPAC will meet again on Thursday to discuss Moderna’s coronavirus vaccine which could also quickly get emergency use authorization.
Meanwhile, the United States government on Friday purchased an additional 100 million doses of Moderna’s vaccine bringing its confirmed order to 200 million doses, the company announced. About 20 million doses will be delivered by the end of the month.