Pfizer and BioNTech Receive FDA EUA of COVID-19 Vaccine Booster for Individuals 12 Years and Older

Jan 3, 2022 By MarketDepth

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Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) reported that the United States Food and Drug Administration has expanded the Emergency Use Authorization of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 and older. The booster dose is the same dosage strength as the dose approved in the primary series. “The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”

“The booster vaccination increases the level of immunity and improves protection against COVID-19 across all age groups that have been authorized to receive one. In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron.”

Ugur Sahin, M.D., CEO and Co-founder of BioNTech

 Evidence from the Ministry of Health of Israel on the administration of over 4.1 million third doses of the Pfizer-BioNTech COVID-19 Vaccine given a minimum of 5 months after the primary series revealed no new safety concerns in adolescents 12 through 17 years of age.