FDA Authorizes COVID-19 Vaccinations For Babies, Toddlers

LONG ISLAND, NY — The U.S. Food and Drug Administration authorized emergency use Friday of the Moderna and Pfizer-BioNTech COVID-19 vaccinations for children ages 6 months through 5 years.

For the Moderna COVID-19 vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older, a release said.

For the Pfizer-BioNTech COVID-19 vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.

The Centers for Disease Control and Prevention still must green light the vaccinations but they could commence as soon as next week once that authorization is granted, officials said.

According to the FDA, after "rigorous and comprehensive" evaluation and analysis, it was determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweighed the risks in the pediatric populations authorized for use for each vaccine.

Prior to making the decision to authorize the vaccines for the younger children, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations, the release said.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. 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,” said FDA Commissioner Robert M. Califf, M.D. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

According to the FDA, the vaccine is administered in three doses, with the initial two doses given three weeks apart followed by a third dose given at least eight weeks after the second dose.
The need still exists for vaccinations, the FDA said.

"Although the peak of the Omicron wave appears to have slowed, other Omicron subvariants such as BA.2, BA.2.12.1, BA.4, and BA.5 are increasingly being reported in several states. Currently,Connecticut, Illinois, Massachusetts, New Jersey, New York, and Vermont have increasinginfection rates higher than at the peak of the delta variant wave. While rates of COVID-19 casesin children less than 5 years of age, who are currently ineligible for vaccination, are down from the peak of the Omicron wave, COVID-19-associated hospitalizations among US children less than 5 years of age are now 1.6 times higher than among children 12 to 17 years of age and 5.4 times higher than children 5 to 11 years of age," the FDA said recently.

Overall, administering three doses of the vaccine provided a "strong immune response" to COVID-19 and variants, including Omicron, briefing documents said.

In May, the FDA also green-lighted COVID-19 booster shots for kids ages 5 to 11.

The FDA amended the emergency authorization for the Pfizer-BioNTech vaccine, authorizing the booster dose.

Under the authorization, the booster can be given at least five months after the kids completed the initial vaccine series.

In May, with the numbers of new cases of COVID-19 spiking across Long Island and across New York, the Centers for Disease Control and Prevention elevated the risk of transmission to "high" in many counties, including both Suffolk and Nassau Counties — with officials urging people to once again mask up in all indoor locations.

And last week, Gov. Kathy Hochul said while numbers are trending downward across the board, Long Island had the highest COVID-219 positivity rate statewide.

Hochul has urged every New Yorker over 5 to get vaccinated, and everyone over 12 to get boostered, if eligible.

"These tools have made the difference," she said.

Pfizer-BioNTech said in April that a clinical trial involving 140 children showed the booster shot improves children's immunity both against the original strain of the coronavirus and the omicron variant.

Children under 5 are the only Americans for whom vaccines have not been available. Both Pfizer and Moderna have had clinical trials underway to determine the best vaccine regimen for babies, toddlers and preschoolers.