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CDC, FDA authorize bivalent COVID-19 vaccine for kids ages five, under

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CDC, FDA authorize bivalent COVID-19 vaccine for kids ages five, under

Certified Pediatric Nurse Practitioner Mallory Gray draws up a dose of Pfizer-BioNTech COVID-19 vaccine during DeKalb Pediatric Center’s vaccine clinic on May 12, 2021. On May 10, 2021 the U.S. Food and Drug Administration expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents age 12 through 15. Photo by Dean Hesse.

Atlanta, GA — The Centers for Disease Control and Prevention has expanded use of the updated, bivalent, COVID-19 vaccines for children ages six months through five years old, following action from the Food and Drug Administration earlier this month.

Children ages six months through five years old who previously completed a Moderna primary series are eligible to receive a Moderna bivalent booster two months after their final primary series dose, according to a press release from the CDC.

Children ages six months through four years who are currently completing a Pfizer primary series will receive a Pfizer bivalent vaccine as their third primary dose. Children in this age group who have completed their three-dose primary series with the original Pfizer vaccine won’t be eligible for a booster dose of the updated vaccine at this time.

Updated COVID-19 vaccines are formulated to protect against some of the more recently circulating viruses. COVID-19 vaccines are critical to providing ongoing protection as immunity wanes, and the virus continues to mutate.

The vast majority of children in this age group have not received any doses of a COVID-19 vaccine. The CDC is working to increase parent and provider confidence in COVID-19 vaccines and improve uptake among the 95% of children who are not vaccinated or who have not completed the COVID-19 vaccine primary series.

On Dec. 8, the FDA amended the emergency use authorizations of the COVID-19 vaccines for young children, according to a press release from the FDA.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so – especially as we head into the holidays and winter months where more time will be spent indoors,” said FDA Commissioner Dr. Robert M. Califf. “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

Vaccines remain the best defense against the most devastating consequences of COVID-19, such as hospitalization and death, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” Marks said. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

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