FDA authorizes Pfizer booster to people aged 16 and 17

The US FDA has approved single Covid 19 vaccine boosters for people aged 16 and 17 who have received the first two immunisations. This is dependent on having received the Pfizer-BioNTech vaccine a minimum of six months prior.

The Booster was approved for distribution to 18-year olds in November of this year under similar conditions. There are only two vaccinations now available for those in the 16-17 age bracket (Pfizer-BioNTech and Comirnaty), this means that the booster they get six months after the second jab should be one of those two options.

Pfizer is evaluating the recognised hazards of myocarditis and pericarditis in post-authorization/post-marketing trials.

Jane Woodcock, an FDA Commissioner, said that “Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”

Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, said that “The Pfizer-BioNTech COVID-19 Vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks. New evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group. A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.”