FDA approves COVID-19 shots for children as young as 6 months

The FDA authorized Moderna and Pfizer COVID-19 shots for children as young as 6 months.

The authorization comes after a committee of independent vaccine experts vote unanimously to recommend the shots after reviewing safety and effectiveness data.

Pfizer’s three-dose vaccine was authorized for children 6 months to 4 years old, while Moderna’s two-dose version was authorized for children 6 months to 5 years old. In addition, Moderna’s vaccines were authorized for school children from kindergarten through high school. Prior to this, Pfizer was the only option for these groups.

The CDC must still vote on guidelines for pharmacies and doctor offices before children can start receiving shots, but the Biden administration expects vaccines to be available as soon as Tuesday.

Pfizer has said that two doses of its vaccine were about 28 percent effective in preventing disease, while three doses were 80%effective. Moderna’s vaccine was about 51% effective in children 6 months to 2 years old and 37% effective in children 2 to 5.

Studies show that the Omicron variant of the virus greatly reduced the effectiveness of the vaccines to prevent symptomatic infection in young children, just as it did for adults.

Dr. Robert M. Califf, the FDA’s commissioner, said in a statement, “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.”

The federal government has made 10 million Pfizer and Moderna doses available to state and local authorities.

The most common side effects from the vaccines were pain at the injection site, irritability and crying, loss of appetite and sleepiness, according to the FDA. There were no cases of myocarditis in Pfizer’s or Moderna’s trials.