Saturday, December 9, 2023

United States clears Pfizer / BioNTech’s Covid-19 vaccine

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The United States has approved the Pfizer / BioNTech Covid-19 vaccine on an emergency basis, with the first injections to be given within 24 hours.

the Food and drug administrationThe decision on this pandemic has been one of the most politically difficult of the pandemic, which has claimed more than 280,000 lives in the United States.

Critics had accused outgoing President Donald Trump of trying to push through approval ahead of last month’s presidential election, while Trump recently criticized Pfizer and the FDA for moving too slowly, including calling agency one “Big, slow old turtle” earlier Friday.

Speaking to the Financial Times, Ugur Sahin, chief executive of BioNTech, said it was “extremely exciting” to see countries prepare to deploy the vaccine.

“Most of the time you focus on what’s next. . . maybe next summer we can relax and try to recap what happened, ”he said.

The United Kingdom has become the first country to authorize Pfizer vaccine last week, but the FDA said it wanted to wait until after group of external experts met on Thursday to discuss data from the trial. Some 17 experts voted in favor of the motion that the benefits of the Pfizer / BioNTech vaccine outweigh its risks in people 16 years and older. Four voted against and one abstained.

Dr Sahin added that he appreciated the “transparency” of the FDA’s approach. “Each company has its own way of dealing with such an important subject,” he said.

The vaccine is based on messenger ribonucleic acid technology, or mRNA, a new approach that uses a genetic code, developed by BioNTech. Pfizer struck a deal with the German company in March to test and market the product, and the pair will share the costs and benefits 50/50.

The US government paid nearly $ 2 billion to pre-order 100 million doses – enough for 50 million people – in July, shortly before the start of the Phase 3 trial. But like other countries Supplied in the fall, the United States may have to wait until next summer to get more doses.

The United States has pre-orders for several other vaccines, including Moderna jab, which could be approved as early as next week.

The emergency use authorization is not a full approval, which can take a few months. However, this will allow wide distribution.


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