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The US regulator has signaled its intention to approve the Pfizer / BioNTech vaccine soon, as the government prepares to roll out doses of the Covid-19 vaccine as soon as it is cleared.
Stephen Hahn, the Commissioner of the Food and Drug Administration, and Peter Marks, director of the FDA division responsible for vaccine oversight, said in a statement Friday that they had informed Pfizer that the regulator “will work quickly on the finalization and issuance of emergency use. authorization, ”a day after an advisory group voted to recommend approval of the vaccine.
The US regulator has also notified the Centers for Disease Control and Prevention and Operation Warp Speed, the government program to speed up vaccine development, so they can prepare to distribute the vaccine, which can be done within 24 hours after receipt of authorization.
Alex Azar, secretary of health and human services, said Americans could start receiving the vaccine as early as Monday or Tuesday next week.
“A short while ago, the FDA informed Pfizer that it intended to move towards authorization for its vaccine. So in the next few days, as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately, we should see approval for this first vaccine, ”he told ABC. Hello america program.
The FDA has been keen to show that it is careful, thorough and transparent in countering accusations that the approval process has been politicized – and trying to ensure that enough people are willing to take the vaccine.
In a sign of the pressure the regulator is facing, Donald Trump, who has frequently complained about the time it took to approve a vaccine, wrote on Twitter that the FDA is still a “big, old and slow tortoise”.
“Stop playing games and start saving lives !!!” he added.
A majority of 17 people among the panel scientists voted for of Thursday night’s motion, agreeing that the benefits of the vaccine outweighed the risks of use in people 16 and older, while four voted against and one abstained.
The advisory board has expressed concerns about whether it should be cleared for 16 and 17 year olds, so the FDA could discuss exactly who the emergency use clearance will cover.
During Thursday’s discussions, Cody Meissner, professor of pediatrics at Tufts University School of Medicine, argued that more information was needed on the inflammatory response in younger people, stressing that he There were not many subjects aged 16 and 17 in the trial.
The FDA could also try to determine what advice to include on potential allergic reactions after the British regulator warned that people with a significant history of allergic reactions should avoid jab.
The US government proposes to try to boost production of the Pfizer / BioNTech vaccine as it attempts to procure an additional 100 million doses. Operation Warp Speed ​​would like to double its pre-order by June 2021, according to a person familiar with the matter.
Shares of Pfizer rose 2 percent to $ 42.58 pre-trading in New York and BioNTech gained 1 percent to $ 130.86.
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