The US Food and Drug Administration (FDA) grants full approval for the BioNTech/Pfizer Covid vaccine


Covid-19 Vaccine Updates

The US Food and Drug Administration has given full approval for the BioNTech/Pfizer Covid-19 vaccine, in a move that could encourage reluctant people to get vaccinated.

Since December, a two-dose BioNTech/Pfizer injection has been given under an emergency use authorization, given the urgent need for a vaccine to combat the pandemic.

Monday’s decision gives full approval to an mRNA injection for use in people over 16 years of age, the first Covid-19 vaccine to receive that designation. It continues to be used in children 12 to 15 years of age, and as a booster injection for people with compromised immune systems, under emergency clearance.

“As the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards of safety, efficacy, and manufacturing quality that the FDA requires for an approved product,” Janet Woodcock, acting president of the FDA, said in Monday statement.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, FDA approval of the vaccine may now instill additional confidence in obtaining the vaccine.”

The approval comes as employers increasingly seek proof of complete vaccination from their employees and clients.

Late vaccination rates have recently risen in some states where the highly contagious delta variant has increased infections and hospitalizations, primarily among those who did not receive the vaccine.

The US Food and Drug Administration said its evaluation of the vaccine’s effectiveness included data from 20,000 vaccine recipients and 20,000 placebo recipients, while its safety was analyzed from data from 22,000 people from both groups.



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