The U.S. Food and Drug Administration Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-olds

20/12/2021

On 12 December, the U.S. Food and Drug Administration (FDA) expanded eligibility for use of a single booster dose of the Pfizer-BioNTech or Comirnaty vaccine for individuals 16 and 17 years of age at least six months after completion of a primary vaccination series with one of these vaccines.  

 

In the time since Pfizer initially submitted safety and effectiveness data to the FDA on a single booster dose following the two-dose primary series, additional real-world data have become available on the increasing number of cases of

COVID-19, in the U.S., and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis

(inflammation of the outer lining of the heart) following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.

These additional data enabled the FDA to reassess the benefits and risks of the use of the vaccine in a wider population. The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech or Comirnaty COVID-19 vaccine, in terms of providing protection against COVID-19 and the associated serious consequences that can occur, including hospitalization and death, outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age.

 

For more information, visit: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-updatefda-expands-eligibility-pfizer-biontech-covid-19-booster-dose-16-and-17

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