FDA authorizes Pfizer boosters for children ages five to 11

May 19, 2022 /

Children who have received two doses of the vaccine are now eligible to receive their COVID-19 booster at least five months after their second shot; as of now, this is the only vaccine available to children ages five to 11.

“The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children five through 11 years of age to provide continued protection against COVID-19,” said Dr. Robert M. Califf, the FDA’s Commissioner.

The Centers for Disease Control and Prevention (CDC) will meet to discuss whether they are going to recommend the booster dose to children five to 11.

Doctor Califf said that even though COVID-19 has been less critical to kids it is still crucial for them to receive the vaccine and the booster.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” said Califf.

A CDC study showed that two Pfizer doses reduced the risk of Omicron infection by 31 percent among those five to 11. According to Pfizer, they said the clinical trial showed that this extra booster shot produced a robust immune response in children five to 11 and did protect against both the omicron variant and other variants.

“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” said Califf.

According to the CDC, a third shot could help children’s immune defenses, but the impact of a third shot will probably be limited. Only 28 percent of children in this age group are fully vaccinated.

“Since authorizing the vaccine for children down to five years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Health officials continue to urge people to get vaccinated and get their booster shot as that is the best way to protect themselves and others.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children five through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” Marks said.

Moderna has also requested for a second COVID-19 booster shot for everyone 18 and older, but the FDA still has not made a decision about this request.

“If your child is eligible for the Pfizer-BioNTech COVID-19 vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death,” said Califf.

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