Pfizer and its partner BioNTech have submitted data to the US Food and Drug Administration for emergency use authorization of its COVID-19 vaccine for children ages 6 months through 4 years, the companies announced Tuesday.
Data on a third dose of the vaccine for kids under 5 will be available in the coming months, the companies said, and will complete the authorization of what’s expected to be a three-dose vaccine series for the youngest age group.
A committee that advises the FDA will meet on Feb. 15 to discuss whether to authorize Pfizer’s COVID-19 vaccine for kids under 5, the agency said Tuesday. Once given the green light from the FDA, a committee that advises the US Centers for Disease Control and Prevention typically meets to discuss whether to recommend a vaccine series. Then, if the CDC accepts the recommendation, parents of babies and preschoolers will be able to start the process of vaccinating their children against COVID-19.
are already eligible for a COVID-19 vaccine.
While a previous trial found two doses of the vaccine effective in children 6 months to 2 years, two shots failed to promote a strong immune response in children age 2 to 4 years. This prompted the company to start testing a three-dose version of the vaccine for children under age 5. But while regulators wait on data to authorize three doses of the vaccine (with data probably not available until this spring) public health officials are moving to get two doses authorized so younger kids can be fully vaccinated sooner.
Pfizer’s vaccine for children under age 5 is 3 micrograms, or one-tenth the size of the company’s vaccine for people 12 and up. The vaccine for kids ages 5 to 11 is one-third the adult size.
There were no safety concerns reported in Pfizer’s trial for children under 5, the company said in December. If three doses of the vaccine for children is proven effective, the company will submit that data to the FDA for authorization of the full three doses.
Given the hiccup of the two-dose vaccine series in 2 to 4 year olds, Pfizer’s submission to the FDA comes a little sooner than what public health officials had previously estimated. But it reflects extremely high numbers of COVID-19 cases in children caused by the omicron variant, and concerns over side effects following infection in young kids, including multi inflammatory syndrome.and
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