FDA Authorizes Pfizer Booster For Children 5 And Older

In the first week of 2022, the U.S. Food and Drug Administration (FDA) authorized the use of Pfizer-BioNTech COVID-19 single booster shot for individuals between the age of 12 and 15 years. The federal agency has now lowered the age bracket for subjects that are eligible for a booster shot. In an update to the emergency use authorization (EUA) rules governing the Pfizer-BioNTech COVID-19 vaccine, the U.S. FDA has announced that individuals 5 years or older can also get the booster shot administered for added protection against the SARS-CoV-2 virus.

In its press release, the agency says that "individuals 5 through 11 years of age at least five months after completion of a primary series" of COVID-19 vaccine rounds are eligible for getting the booster shot. The U.S. FDA notes that the vaccination policy update comes in the wake of an ongoing randomized placebo-controlled trial that resulted in a positive antibody response to the booster shot for participants who received it seven to nine months after completing the two-dose primary vaccination series of the Pfizer-BioNTech COVID-19 vaccine.

In order to test the efficacy of the single Pfizer-BioNTech COVID-19 vaccine booster dose for children between 5 and 11 years of age, the agency monitored 400 children who received it anywhere between five to nine months after the primary series of dosages that involved two jabs. Coming to the side effects part of the booster shot, the U.S. FDA lists fatigue, headache, chills, fever, muscle or joint pain, pain, swelling, and redness at the injection site.

Talking about the decision, FDA Commissioner Robert M. Califf noted more kids have fallen ill and been hospitalized in the Omicron wave, complete with the risk of long-term effects on body systems even after a mild illness. With an official nod for the administration of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine to children as young as 5 years of age, the agency aims to provide a stronger line of defense against COVID-19.

Pfizer, on the other hand, estimates that more than 8 million children in the age group of 5 to 11 years have completed the primary series of COVID-19 vaccination and are eligible for a booster shot. Citing data from a clinical trial, the company claims that the booster dose of the Pfizer-BioNTech COVID-19 vaccine can produce antibodies that are capable of neutralizing both the Omicron variant as well as the wild-type COVID-19 virus.