When will the FDA discuss emergency authorisation for booster doses and covid-19 vaccines for younger children?

Last week President Joe Biden was pictured receiving a booster shot of Pfizer’s covid-19 vaccine in the White House, a signal that the administration is putting new emphasis on distributing booster shots to those who are eligible.

“Let me be clear, boosters are important,” Biden told those gathered. “The most important thing we need to do is get more people vaccinated.”

However as it stands, much like with the initial two doses of vaccine treatments, the Food and Drug Administration (FDA) have not yet granted authorisation for everyone. In October two crucial meetings will be held by the FDA to establish whether additional booster shots should be approved, and whether children aged 5-11 should be able to get vaccinated against covid-19.

14-15 October – Janssen and Moderna Vaccine Boosters

The first of the two meetings will discuss whether vaccines produced by Moderna and Janssen can be issued as a booster dose, as has already been the case for the Pfizer shot. Both vaccines are authorised for emergency use in those aged 18 and over but this would broaden the range of booster shots on offer and, the White House hopes, quicken the uptake.

Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “The available data make clear that protection against symptomatic covid-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations.”

26 October – Pfizer approval for children younger than 12

Currently the Pfizer vaccine is approved for use on adults and children aged between 12 and 18, but with children now back in schools there is a renewed focus on getting more young people vaccinated. Some school districts have announced their intention to introduce a vaccine mandate for older children and the FDA is now considering broadening the age range for the Pfizer shot.

An advisory committee meeting will be held on 26 October to discuss Pfizer’s results, ahead of an expected request from the pharmaceutical company to grant emergency use authorisation for children aged 5-11.

Acting FDA Commissioner Dr Janet Woodcock promised to “conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults.”