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- Bernd Debusmann Equipment
- BBC
published photo, Getty Images
Pfizer’s Covid-19 vaccine has been approved by the United States Food and Drug Administration, becoming the first vaccine to be officially licensed in the United States.
The vaccine had been cleared for emergency use, but the new approval means permission to use it in two doses, three weeks apart, for people 16 years of age and older.
The approval is expected to boost uptake of the vaccine by employers and institutions across the country.
It comes amid a state of reluctance among US citizens to get vaccines.
And the United States Food and Drug Administration said in a statement that its review of approval included data on 44,000 people and determined the effectiveness of the vaccine, which will now be marketed as “Komernati,” at 91% for the prevention of Covid.
published photo, Getty Images
Janet Woodcock, acting commissioner of the Food and Drug Administration, said the public “can be very confident” that the vaccine meets high standards of safety, efficacy and build quality.
Emergency use of the vaccine is still allowed for children aged 12 to 15 years.
The US authorities provide the doses to their citizens free of charge.
The United States Food and Drug Administration initially granted Pfizer temporary clearance, usually granted if it determines that a product’s benefits outweigh its potential harm during a public health emergency.
The licensing process requires companies to provide the Food and Drug Administration with information on how and where the product was manufactured, along with other clinical examination data.
Critics have called on the Food and Drug Administration to speed up the approval process given the country’s low vaccination rates earlier this year, and the spread of the delta mutant has already boosted vaccination rates in some of the most popular areas. hard hit in recent weeks. .
The approval came less than four months after Pfizer-Biontech submitted a license application in early May, the fastest vaccine approval in the Food and Drug Administration’s more than 100-year history.
And survey data released at the end of June by the Kaiser Family Foundation showed that about 30% of unvaccinated Americans said they would accept the vaccine if allowed.
The percentage rises to 50 percent among Americans who take a “wait and see” approach to getting vaccinated.
Businesses, health systems, universities and other organizations are now expected to announce mandatory vaccination as the country begins to return to normal life.
The U.S. military also said the vaccine would become mandatory for 1.3 million active-duty soldiers, subject to Food and Drug Administration approval.
Data shows that more than 92 million Americans, more than half of the total, have received the Pfizer vaccine.
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