Pfizer expected to seek booster approval for 16- and 17-year-olds this week

Listen
Text
  • Small
  • Medium
  • Large

COVID-19 booster shots may soon be available to 16- and 17-year-olds as Pfizer-BioNTech plans to request the FDA authorize its booster shot for that age group, The Washington Post reported Nov. 29. 

If the FDA issues an emergency use authorization, it would become the first booster shot available for use in people younger than 18. 

The drugmaker plans to submit the request within the next few days, according to two people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss the issue, the Post reports. 

The FDA told the Post that in light of the current phase of the pandemic, the agency will evaluate any EUA request in "a very timely manner." 

The CDC expanded its official COVID-19 vaccine booster recommendations Nov. 29, urging all Americans aged 18 and older to get their booster six months after completing their initial immunization series with the Pfizer-BioNTech or Moderna vaccines, or two months after the Johnson & Johnson shot. Previously, the agency recommended people aged 50 and older and adults living in long-term care facilities get their boosters shots, while all other adults "may" decide to get the dose. 

The decision comes amid growing concern over the emergence of the variant B.1.1.529, known as omicron, which has more than 30 mutations in the spike protein. While it's still uncertain how the strain may affect illness severity or the effectiveness of vaccines and treatments, U.S. health officials are betting on an uptick in vaccines and boosters as a way to mitigate omicron's potential effects. 

"I strongly encourage the 47 million adults who are not yet vaccinated to get vaccinated as soon as possible and to vaccinate the children and teens in their families as well, because strong immunity will likely prevent serious illness," CDC Director Rochelle Walensky, MD, said in a Nov. 29 statement. 

The new variant has been detected in at least 19 countries as of the early morning on Nov. 30, and while it hasn't been confirmed in the U.S., "inevitably it will be here," Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told ABC News Nov. 28.

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars