It is the first Covid-19 vaccine to receive full approval, and will now be marketed as Comirnaty, the FDA said in a statement
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The US Food and Drug Administration (FDA) on Monday gave full approval to the Pfizer-BioNTech Covid-19 vaccine. It is the first Covid-19 vaccine to receive full approval, and will now be marketed as Comirnaty, the regulator said in a statement. It will be used for the prevention of Covid-19 disease in individuals 16 years of age and older. At the same time, the two-shot mRNA- based vaccine will continue to be available under emergency use authorisation (EUA), including for individuals 12 through 15 years of age.
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It will also be used for the administration of a third dose in certain immunocompromised individuals, FDA said. "The FDA's approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic," Acting FDA Commissioner Janet Woodcock said in the statement. "While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorisation, as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," she added.
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According to the FDA, a full approval of the vaccine may instill additional confidence and remove hesitancy in the minds of people to get vaccinated. The Pfizer-BioNTech Covid-19 Vaccine was granted EUA for use in individuals 16 years of age and older on December 11 last year. The authorisation was expanded to include those 12 to 15 years of age this year. Comirnaty contains messenger RNA (mRNA), a kind of genetic material, used by the body to make a mimic of one of the proteins in the virus that causes Covid-19.
It has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. "We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty's safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research.
The approval is expected to pave the way for a series of vaccination requirements by public and private organizations, The New York Times reported. Many schools and universities across the country preparing for students to return to campus, have signaled that they will pursue a vaccine mandate as soon as the vaccines gain full federal approval. Federal and state health officials are also hoping that full approval will win over those who had been reluctant to roll up their sleeves for a vaccine only authorised for emergency use.
For the 45 per cent of unvaccinated Americans who say they will definitely not get the vaccine, full approval could trigger new restrictions, including limitations on employment and an increase in health insurance premiums, the report said. Meanwhile, the regulators continue to review Moderna's application for full approval for its Covid vaccine. The US drug maker is planning to submit its data in support of a booster shot in September, the report said.
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