Pfizer-BioNTech on Tuesday asked the Food and Drug Administration to expand the use of its Covid-19 vaccine to children ages 6 months to 5 years.
The application included data on the safety and effectiveness of two doses of the vaccine, though the company says that it plans on submitting data for a third dose in the coming months. The third dose will be considered part of the primary vaccination series, the company said.
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Pfizer's request will be considered by the FDA, which will review the data and could grant emergency use authorization for the age group by the end of February, a person with knowledge of the plan told NBC News.
The FDA's advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet on Feb. 15 to offer guidance on the pediatric doses. The panel also convened in October to discuss Pfizer's request to authorize its vaccine for kids 5 to 11.
“As hospitalizations of children under 5 due to Covid-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer CEO Albert Bourla said in a statement.
There are an estimated 19.5 million children under age 5 in the U.S. and Puerto Rico, according to NBC News data.
Children under 5 are the only group in the U.S. ineligible to receive a Covid vaccine. While the disease is not as severe in children as it is in adults, many kids in this age group have been hospitalized and some have died, said Dr. Sean O’Leary, vice chair of the committee on infectious diseases for the American Academy of Pediatrics.
"With vaccination, these hospitalizations and deaths will be essentially entirely preventable," he said.
A survey released Tuesday from the Kaiser Family Foundation found three in ten parents of children under 5 say they’ll get their child vaccinated right away once a vaccine is authorized for the age group, up from one in five in July.
Pfizer is currently asking the FDA to review two doses of the vaccine, given three weeks apart. The dosage is lower — at 3 micrograms — than the 10 microgram doses given to kids 5 to 11 and the 30 microgram doses given to everyone ages 12 and up.
The company said Tuesday that there were no safety concerns reported with the first two doses.
The company disclosed in December that two doses didn’t generate a strong enough immune response in an ongoing trial of children ages 2 to under 5.
The third shot is still being tested but it would be identical to the first two shots and would be given at least two months after the second dose, according to the company.
In the meantime, federal regulators believe two doses should provide enough — though less than ideal — protection against the omicron variant, the source familiar with the planning said.
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