Sunday, December 3, 2023

Pfizer’s COVID-19 vaccine first to gain US approval

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Pfizer Inc. has obtained emergency U.S. clearance for its Covid-19 vaccine, becoming the first vaccine to be deployed to Americans amid the spike in hospitalizations and virus-related deaths.

The Food and Drug Administration has authorized the use of Pfizer and BioNTech SE vaccine partner Friday, according to an agency statement.

With emergency clearance, the United States becomes the last country to approve the Pfizer-BioNTech vaccine. The UK ran ahead of the US and the European Union and cleared the vaccine on December 2, and started vaccinating the elderly and healthcare workers this week. The cliché is currently being examined in the European Union.

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The FDA came under pressure from the White House for weeks to quickly clear a vaccine, including asrecentlylike Friday, when White House Chief of Staff Mark Meadows told FDA Commissioner Stephen Hahn that his job could be at stake if the agency does not do so quickly.

After a thursdayvoteby an advisory group of outside experts supporting the vaccine for use in people 16 years of age and older, the FDA was considering how to treatreportssevere allergic reactions in the UK, where the vaccine was approved earlier this month. Local officials have since told people with a history of significant allergic reactions not to get vaccinated. Marion Gruber, director of the FDA’s Office of Vaccine Research and Review, told the advisory committee on Thursday that the FDA is seeking more information on reactions from regulators in the UK.

Pfizer’s vaccine, like the one from Moderna Inc. which could also be cleared next week, uses a new technology called messenger RNA that turns the body’s own cells into factories that produce vaccines to fight the coronavirus.

In a trial involving nearly 44,000 people, the Pfizer vaccine was 95% effective in preventing symptomatic cases of Covid-19 and protecting people of all ages and ethnicities. It was able to prevent the most serious infections, according to the results of clinical trials.

Side Effects of the Pfizer Clinical Trialwere sweetand developed more frequently in younger study participants, especially those aged 55 and under, with no signs of serious safety concerns, according to an FDA staff report on Safety and Health. vaccine efficacy. After the second injection, fatigue and headache were the most common systemic reactions, occurring in 59% and 52% of younger participants, compared to 51% and 39% in those over 56 years old. allergic reactions.

It is not known whether the vaccine is effective in preventing the spread of Covid-19, according to the report from FDA staff. It is possible that the shot did not work as well in preventing cases where people were not showing symptoms, meaning that there will likely be a continued need for basic public health measures such as wearing masks and social distancing.

As the initial supply is very limited, the vaccine should first be administered to health workers and residents of long-term care facilities. Countries are calling for more doses, Sean Marett, BioNTech’s commercial and commercial director, said in an interview.

“Everyone wants all of their doses on January 2 next year, but it’s not practical,” he said in an interview. “It’s a new technology, there is no manufacturing network. We are building it.

The shot requires special freezers to be kept at very cold temperatures for up to a few days before use, which makes dispensing more complicated. Pfizer has developed special dry ice containers to facilitate storage in facilities that do not have the necessary equipment.

Among the vaccine pioneers, the Pfizer-BioNTech vaccine is the only one that has not received funding from the Operation Warp Speed ​​program led by the White House to accelerate the development, manufacture and distribution of Covid-19 injections. However, the two companies struck a $ 2 billion deal to deliver 100 million doses to the United States, with an option for another $ 500 million.

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