The U.S. Food and Drug Administration on Monday gave full approval to Pfizer/BioNTech’s COVID-19 vaccine for people age 16 and older. This is the first Covid vaccine to be fully approved by the drug regulator.
The Pfizer/BioNTech vaccine, marketed as Comirnaty, has been authorized for emergency use in the US since last December for people age 16 and older. In May, the authorization was extended to those 12 and older.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, 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,” said Acting FDA Commissioner Janet Woodcock.
Although, nearly 52% of U.S. population or 170.8 million people have received Covid-19 vaccines, today’s approval will give additional confidence to people to get vaccinated. According to a survey conducted by Kaiser Family Foundation in June, 31% of unvaccinated people said that they are more likely to get a COVID-19 vaccine once one gets full approval from the FDA.
The full approval could also make it easier for corporations, federal government and universities to make it mandatory for its employees to get vaccinated. Of the 170.8 million, over 92 million have received the Pfizer/BioNTech vaccine. Full approval for the vaccine could also open way for other vaccines to get approval.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The approval comes at at time when the delta variant is wreaking havoc in the country, with Coronavirus-related deaths increasing sharply in the country over the past month.
Last Wednesday, the Biden administration had strongly recommended booster shots for Americans who received the Pfizer-BioNTech and Moderna coronavirus vaccines. Americans will be eligible to take a third dose eight months after receiving their second dose, starting September 20.
The booster shots will be given after FDA conducts an independent evaluation and determination of the safety and effectiveness of a third dose of the vaccines.
Last week, Pfizer and BioNTech submitted phase 1 data to the FDA to support the evaluation of booster dose for future. The drugmakers noted that the data in individuals who received a third dose of their vaccine showed a favorable safety profile and robust immune responses.
A booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against the COVID-19, the companies said.
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