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The US drug regulatory agency FDA announced this Friday (11) emergency use approval of the Covid-19 vaccine developed by the pharmaceutical companies Pfizer and BioNTech. With that, America become the fifth country to authorize the use of this immunizer.
The announcement follows the recommendation of an advisory body that recommended the vaccine for emergency use in those 16 and older. To initiate vaccination, another US federal agency, the CDC, must give the final opinion. The expectation is that this will happen in the next few days.
The Pfizer vaccine has already been approved by the UK, Canada, Bahrain and Mexico. The British regulatory agency was the first to approve the use of the vaccine, last week. The United Kingdom started its vaccination campaign on Tuesday (8).
This Thursday, a expert committee – made up of independent researchers, doctors and pharmaceutical representatives – yes met to evaluate a recommendation to the FDA. It is from there that the agency can decide whether or not to authorize the application of the immunizer.
The agency had previously submitted a favorable opinion on the vaccine earlier this week, confirming its safety and efficacy.
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Countries that have already approved the vaccine
The UK and Bahrain approved the use of the immunizer last week, but only the UK started its vaccination campaign. The vaccination campaign for the British began on Tuesday, provided free of charge by the public health service (NHS).
A 90-year-old woman, Margaret Keenan, was the first to receive the dose.
Health Canada, the agency that regulates vaccines in the country, approved the Pfizer vaccine Wednesday. After reviewing the data, Canadians concluded that the vaccine is safe and effective. And now it can be applied nationwide, in an emergency, to people over 16 years of age.
Hours before the FDA announced approval of the vaccine, Mexican regulator Cofepris launched the immunizer Pfizer on Friday.
In early November, pharmacists announced that their candidate vaccine it is 95% effective in preventing Covid-19, according to initial data from the study of the third and final phase of the test. The data was also published in the scientific journal “New England Journal of Medicine.”
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In practice, if a vaccine is 95% effective, it means saying that 95% of people who receive the vaccine are protected against that disease.
Pfizer reported that plans to produce up to 50 million doses of vaccine in 2020 worldwide and 1.3 billion doses by the end of 2021.
In July, The United States closed an agreement with laboratories to buy 100 million doses later this year, for $ 1.95 billion (about $ 10.1 billion).