FDA Panel Authorizes COVID-19 Vaccines for Children 6 Months and Older

The U.S. Food and Drug Administration’s vaccine advisers voted unanimously in favor of expanding the emergency use authorizations for Covid vaccinations to include children as young as 6 months. 

Moderna and Pfizer/BioNTech have both been approved for children six months old and older. 

All 21 of the members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted yes in response to whether the benefits of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech Covid-19 vaccine when administered as a 2-dose series outweigh the risks for use in infants and children 6 months through 5 years of age. 

The FDA will now decide whether to authorize the vaccines for this youngest age group. The FDA typically follows the decisions made by the committee. 

But shots cannot be administered until the U.S. Centers for Disease Control and Prevention’s vaccine advisers vote on whether to recommend them. CDC Director Dr. Rochelle Walensky needs to sign off on the recommendation. 

The vaccine advisers of the CDC are expected to vote on Saturday. The White House has already said that shots could begin for the young age group as early as next week. 

Children younger than the age of five are currently the only group that is not currently eligible to be vaccinated against Covid. If this is approved, about 17 million kids will become eligible for Covid vaccines once they’re authorized for this age group. 

Committee members say that the benefits clearly outweigh the risks, particularly for people with young children who go to kindergarten classes or to collective child care. 

While the risk of Covid hospitalization and death is lower for young children than it is for adults, committee members said that children already get other vaccinations to protect them against diseases for which there is a low risk too. 

The number of Covid hospitalizations and deaths in children is higher than in other diseases like influenza, FDA officials said. 

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