- Bernd Deposman Gear
- BBC
Pfizer’s vaccine against Govt-19 is approved by the U.S. Food and Drug Administration and is the first vaccine to be officially licensed in the United States.
The vaccine was approved for emergency use, but the new approval only allows 16-year-olds and older to use it in two doses at three-week intervals.
This approval is expected to get vaccinated by employers and companies across the country.
It comes amid reluctance among U.S. citizens to get vaccinated.
The U.S. Food and Drug Administration said in a statement that its approval review included data on 44,000 people and determined the effectiveness of the vaccine, which is now marketed as 91 percent “govt.”
Janet Voodcock, executive commissioner of the Food and Drug Administration, said the public can “be very confident” that the vaccine meets high standards for safety, efficacy and product quality.
Emergency use of the vaccine is still approved for children 12 to 15 years of age.
U.S. officials provide the measure to their citizens at no charge.
The U.S. Food and Drug Administration initially granted Pfizer a temporary permit, usually granted if it determines that the benefits of a substance outweigh its potential side effects during a public health emergency.
The Food and Drug Administration must provide information on how, where it was prepared and other clinical trial data for the licensing process.
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 prevalence of delta mutants has increased vaccination rates in some areas severely affected in recent weeks.
The fastest approval of the vaccine in the more than 100 – year history of food and drug administration came just four months after the Pfizer-Biotech license application was submitted in early May.
Survey data provided by the “Kaiser Family” Foundation at the end of last June found that about 30 percent of unvaccinated Americans said they would accept the vaccine if it was approved.
This percentage rises to 50 percent among Americans who take the “wait and see” approach to vaccination.
Institutions, health care organizations, universities and other organizations are now expected to announce the need to get the vaccine as the country begins to return to normal life.
The U.S. military says the vaccine will be mandatory for 1.3 million active military personnel, subject to food and drug administration approval.
Data show that more than 92 million Americans, and more than half of all, have been vaccinated against the Pfizer vaccine.
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