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FDA authorizes COVID-19 vaccine for kids 6 months and older

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FDA authorizes COVID-19 vaccine for kids 6 months and older

RN Eareina Black draws up a dose of pediatric Pfizer COVID-19 vaccine during a free vaccination clinic for 5 to 11-year-olds at the City Schools of Decatur Central Office board room on Friday, Dec. 10. Photo by Dean Hesse.

Atlanta, GA — The U.S. Food and Drug Administration authorized emergency use of the Moderna and Pfizer COVID-19 vaccines on June 17 for children as young as six months old.

The FDA has determined that the known potential benefits of the Moderna and Pfizer vaccines outweigh the known and potential risks in children, according to a press release from the FDA.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

The Pfizer vaccine is administered as a primary series of three doses. The first two doses are administered three weeks apart, and the third dose is administered at least eight weeks after the second dose for kids ages 6 months through four years old.

The Moderna vaccine is administered as a primary series of two doses, one month apart, to those 6 months through 17 years old. The vaccine is also authorized to provide a third primary dose at least one month following the second dose for those 6 months to 17 years old who are immunocompromised.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”

The Centers for Disease Control and Prevention, in May, expanded the eligibility of the COVID-19 vaccine booster doses to everyone ages five and older. The CDC now recommends that children ages five through 11 should receive a booster dose five months after their initial Pfizer vaccination series, according to a press release from the CDC.

The CDC additionally strengthened its recommendation that those 12 and older who are immunocompromised and those 50 and older should receive a second booster dose at least four months after their first.

“Today [May 19], I endorsed ACIP’s vote to expand eligibility for COVID-19 vaccine booster doses,” said Dr. Rochelle Walensky, CDC director. “Children 5 through 11 should receive a booster dose at least 5 months after their primary series. Vaccination with a primary series among this age group has lagged behind other age groups leaving them vulnerable to serious illness. With over 18 million doses administered in this age group, we know that these vaccines are safe, and we must continue to increase the number of children who are protected. I encourage parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations.

With cases increasing, it is important that all people have the protection they need, which is why, today, CDC has also strengthened another booster recommendation. Those 50 and older and those who are 12 and older and immunocompromised should get a second booster dose.”

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