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Pfizer And BionTech Receive FDA Authorization Of COVID-19 Vaccine Booster For Individuals 12 Years Of Age And Older

Published: 01/03/2022 14:56 GMT
BioNTech SE - ADR (BNTX) - Pfizer and Biontech Receive U.S. FDA Emergency Use Authorization of Covid-19 Vaccine Booster for Individuals 12 Years of Age and Older.
First Emergency Use Authorization in United States for a Covid-19 Vaccine Booster in Adolescents 12 Through 15 Years of Age.
Today's FDA Action Also Reduces Time Between Completion of Primary Series and Booster Dose for All Eligible Individuals, and Authorizes a Third Primary Series Dose for Individuals 5through 11 Years of Age With Certain Kinds of Immunocompromise.
Pfizer and Biontech Fulfill Their Goal to Deliver 1 Billion Doses of Their Covid-19 Vaccine to Low- and Middle-income Countries in 2021.companies Continue to Supply Vaccine, Including Booster Doses, Under Their Existing Supply Agreement With U.S. Government, Which Continues Through April 2022.companies Expect to Deliver an Additional 1 Billion Doses to These Nations in 2022.
Doses Are Part of Pfizer and Biontech's Previously Announced Pledge to Provide 2 Billion Doses of Covid-19 Vaccine to Low- and Middle-income Countries Between 2021 and 2022.
Submissions to Pursue Regulatory Approvals in Us, Eu, Uk, Canada Where Emergency Use Authorizations Or Equivalent Were Initially Granted Are Planned.
Single Booster Dose of Vaccine May Be Administered at Least 5 Months After Completion of a Primary Series of Pfizer-biontech Covid-19 Vaccine Or Comirnaty® (covid-19 Vaccine, Mrna) to Individuals 12 Years of Age and Older.