The Food and Drug Administration (FDA) announced on Monday three updated recommendations regarding the Pfizer-BioNTech COVID-19 vaccine, including expanded emergency use of the Pfizer booster shot authorized for children aged 12 to 15. It’s the first booster in the US to be approved for this age group.
The FDA also shortened the minimum time recommended between the second Pfizer jab and a Pfizer booster dose by a month for all eligible ages, based on the agency’s analysis of multiple laboratory studies as well as real-world data from Israel. Previous recommendations said to wait six months between the second and third shot. Now, anyone 12 or older is eligible to receive a booster shot if at least five months have elapsed since their second Pfizer dose. The booster can be either mRNA-based vaccine made by Pfizer or Moderna.
A booster shot is still recommended for all adults who received their second Moderna shot at least six months ago, or one Johnson & Johnson shot at least two months ago.
The last amendment the FDA made to its recommendations is to approve a third dose, which is not technically a booster, of the Pfizer vaccine for certain immunocompromised children ages 5 through 11. Children in this age bracket “who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise, may not respond adequately to the two-dose primary vaccination,” the FDA said in a statement. Only children in this age group who are immunocompromised are authorized for this third shot.
On Tuesday, the US Centers for Disease Control and Prevention announced it supports the FDA’s decision to shorten the wait between initial Pfizer shots and an mRNA booster, and the third series dose for immunocompromised children. The CDC’s independent panel of expert advisers will convene on Wednesday to discuss booster authorization for 12 to 15 year-olds.
The updated recommendations “ensure people are able to get a boost of protection in the face of Omicron and increasing cases across the country, and ensure that the most vulnerable children can get an additional dose to optimize protection against COVID-19,” CDC Director Rochelle Walensky said in a statement. “If you or your children are eligible for a third dose or a booster, please go out and get one as soon as you can.”
These updated recommendations come at a time when infection rates in the country are surging, largely thanks to the Omicron variant, recently exceeding a daily average of 400,000 cases, according to The New York Times. With growing numbers across the country, especially in children, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told CNN that regulators are quickly working to gather pertinent information—“with appropriate speed but with the appropriate data in hand.”