The U.S. Medicines Agency has signaled that it intends to approve Pfizer and BioNTech's Covid-19 vaccine soon under pressure from the White House to quickly fire the starter gun at the country's first coronavirus sting.
Stephen Hahn, the agent for the Food and Drug Administration, and Peter Marks, the director of the FDA in charge of vaccine surveillance, said in a statement Friday that they had informed Pfizer that the regulator was “moving quickly to completion and granting an emergency use will work towards approval, "the day after an advisory group decided to recommend the vaccine, they receive approval.
The U.S. regulatory agency has also notified the Centers for Disease Control and Prevention and Operation Warp Speed, the government's program to accelerate the development of a vaccine, so they can prepare for the vaccine to be distributed, within 24 hours of receiving it approval can take place.
Alex Azar, secretary for health and human services, said Americans could get the vaccine as early as Monday or Tuesday next week.
“Recently the FDA informed Pfizer that they intend to get approval for their vaccine. While we are negotiating with Pfizer over the next few days about the information doctors need to prescribe it appropriately, we should see approval of this first vaccine, ”he told ABC's Good Morning America program.
The FDA has sought to show that it is careful, thorough, and transparent in order to counter allegations that the regulatory process has been politicized – and to ensure that enough people are ready to take the vaccine.
In a sign of regulatory pressure, President Donald Trump, who has frequently complained about the time it took to get a vaccine approved, wrote on Twitter that the FDA is still a "big, old, slow one." Turtle "is.
"Stop playing and save lives !!!" he added.
White House chief of staff, Mark Meadows, called Dr. Hahn to urge him to approve the vaccine as soon as possible.
The Washington Post reported that Mr. Meadows was Dr. Hahn had threatened with his work if the supervisory authority did not issue a permit by the end of the day. The FDA said in a statement that this was an "untrue representation" of the conversation.
A 17-strong majority of the panel's scientists voted for the motion Thursday evening, agreeing that the vaccine's benefits outweighed the risks of using it in people aged 16 and older, while four voted against and one abstained.
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The Advisory Committee raised concerns about whether it should be approved for 16- and 17-year-olds, so the FDA may discuss exactly who the emergency approval covers.
During Thursday's discussions, Cody Meissner, a pediatric professor at Tufts University Medical School, argued that there needs to be more information about the inflammatory response in younger people, noting that not many subjects between the ages of 16 and 17 were involved in the study participated.
The FDA could also try to figure out what advice to include on possible allergic reactions after the UK regulator warned that people with a significant history of allergic reactions should avoid the sting.
As the FDA continued its decision-making process, a committee of experts met to advise the Centers for Disease Control and Prevention on how to administer the Pfizer vaccine, if approved.
Doran Fink, associate director of the FDA's vaccines office, told the committee Friday that part of the regulator's deliberations has focused on whether to issue warnings regarding patients with allergies.
The US government offers to ramp up production of the Pfizer / BioNTech vaccine to procure an additional 100 million doses. According to a person familiar with the matter, Operation Warp Speed is looking to double their pre-order through June 2021.
Pfizer's shares rose 2 percent to $ 42.58 in pre-market trading in New York and BioNTech was up 1 percent to $ 130.86.