Infectious Disease

FDA Approves Pfizer BioNTech Booster Syringes for Older Adolescents

December 09, 2021

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Marks and Woodcock do not report any relevant financial information.

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The FDA on Thursday approved booster doses of the Pfizer-BioNTech COVID-19 vaccine for children ages 16 and 17.

The revised emergency approval – which provides older teens with the third dose of the vaccine at least 6 months after their first series – came 3 weeks after FDA approved the booster of Pfizer BioNTech and Moderna vaccines for all adults.

The FDA has given Pfizer and BioNTech emergency approval for their boosters for teenagers aged 16 and 17. Source: Adobe Stock

“The Pfizer-BioNTech COVID-19 vaccine has been available to people ages 16 and older for nearly a year, and its benefits have been shown to significantly outweigh the potential risks.” Peter Markus, mD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

Pfizer and BioNTech said this week that laboratory tests showed that the vaccine “may not provide adequate protection against the Omicron variant of SARS-CoV-2,” but that a third dose neutralized the variant that had two doses versus the original Virus strain is comparable.

“Since we first approved the vaccine, new evidence suggests that the vaccine’s effectiveness against COVID-19 wears off after the second dose of vaccine for all adults and for those aged 16 and 17,” said Marks. “A single booster dose of the vaccine for those vaccinated at least 6 months previously will help ensure continued protection from COVID-19 in this and older age groups.”

Older adults and other high-risk individuals have been eligible for COVID-19 booster vaccinations since September. At that time, the FDA’s Advisory Committee on Vaccines and Related Biological Products (VRBPAC) voted not to issue a blanket recommendation for booster syringes for everyone 16 and over. Thursday’s approval was not preceded by a VRBPAC meeting because, according to the FDA, “the agency previously convened the committee for extensive discussions on the use of booster doses of COVID-19 vaccines and concluded after considering Pfizer’s EEA application came “that the motion does not raise any questions that would benefit from additional discussion by the committee members.”

Acting FDA Commissioner Janet Woodcock, MD, said the news was welcome in anticipation of the winter holidays.

“Vaccination and a booster if needed, as well as other preventive measures such as masking and avoiding large crowds and poorly ventilated rooms remain our most effective methods of combating COVID-19,” Woodcock said in the press release. “As both the Delta and the Omicron variants continue to spread, vaccination remains the best protection against COVID-19.”

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