The decision follows a 14-0 vote among members of an expert panel advising the agency.
The Centers for Disease Control and Prevention has approved the use of Pfizer-BioNTech‘s COVID-19 vaccine for children ages five to 11 years.
The decision follows a 14-0 vote among members of an expert panel advising the agency. CDC Director Rochelle Walensky’s signature on the recommendation sealed the approval, expanding the vaccine’s reach to around 28 million children in the U.S.
COVID-19 cases can lead to severe problems for children, including hospitalizations, inflammatory syndromes (MIS-C), deaths, and so-called “long COVID,” which manifests symptoms for months. The Delta variant spread increased case numbers fivefold as more children and adolescents were hospitalized.
The effect of Pfizer-BioNTech’s vaccine on the 5 to 11 age group is similar to what was seen in adult clinical trials, which showed 91% effectiveness. The most common side effect was a sore arm, with other adverse reactions primarily mild and self-limiting. In a statement, the CDC said that the vaccine has undergone “the most intensive safety monitoring in U.S. history” and will continue to be monitored.
“Vaccinating children will help protect them from getting COVID-19 and, therefore, reducing their risk of severe disease, hospitalizations, or developing long-term COVID-19 complications. Getting children vaccinated can help protect them against COVID-19, as well as reduce disruptions to in-person learning and activities by helping curb community transmission,” said the agency.
Distribution across the country has already begun this week for pediatric vaccinations, with the goal to roll out in full capacity by November 8. By then, thousands of pediatric health care providers across the U.S., such as clinics, pharmacies, federally-qualified health centers and more, will be ready to administer doses to the 5 to 11 age group.
“We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” commented Dr. Walenksy.
In August this year, the CDC issued approval for the use of the same vaccine for ages 16 years and up under the brand name COMIRNATY. It is also being used for the 12 to 15 age group. In September, the U.S. Food and Drug Administration approved emergency use authorization (EUA) for the vaccine as a booster dose in individuals aged 65 years and up and ages 18 to 64 within certain high-risk groups. The booster is given at least 6 months after the primary series has been completed.
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