FDA expands use of Pfizer-BioNTech vaccine, authorizes booster in children ages 12 to 15

The U.S. Food and Drug Administration (FDA) amended the emergency use authorization for the Pfizer-BioNTech novel coronavirus (COVID-19) vaccine to expand its use to include a single booster dose for children 12 through 15 years of age.

The FDA determined that a single booster dose of the Pfizer-BioNTech vaccine provides continued protection against COVID-19 and the associated serious consequences that can occur outweigh the potential risks for children in this age group.

The agency also reviewed data from Israel, including safety information from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least five months following completion of the primary two-dose vaccination series. The data shows there are no new safety concerns following a booster in this population.

In addition, the FDA shortened the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to at least five months for those ages 12 and older.

According to the agency, peer-reviewed data from multiple laboratories indicate that a booster greatly improves an individual’s antibody response to be able to counter the omicron variant. The change to administer the booster at five months, rather than six, after completing a vaccination series, provides better protection sooner, outweighing known and potential risk.

The agency also expanded the vaccine use to allow for a third primary series dose for certain immunocompromised children ages 5 through 11 years.

Children 5 through 11 years of age who have undergone solid organ transplants, 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 series, according to the FDA. A third dose has been authorized for this group.

Children 5 through 11 years of age who are fully vaccinated and not immunocompromised do not need a third dose as part of the primary series, at this time, according to the FDA.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “In particular, the omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines. With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster, and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”