Vaccines Could Be Coming Soon For Kids 6 Months To 5 Years

NEW YORK — The U.S. Federal Drug Administration released briefing documents Sunday stating that small doses of the Pfizer/BioNTech COVID-19 vaccination appeared safe for children aged 6 months to 5 years old.

The FDA posted similar documents for the Moderna vaccination for kids under 6.

The news could open the door to children ages 6 months to 5 receiving the COVID-19 vaccinations by as early as next week, according to ABC News, which said a meeting is scheduled for Wednesday where experts will vote on whether to make vaccines available to the 18 million children impacted.

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 increasing
infection rates higher than at the peak of the delta variant wave. While rates of COVID-19 cases
in 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 documents said that the vaccinations meet the guidance for safety data expectations, comparing the age group from 6 months to less than 5 years to young adults 16 to 25 years of age.

Overall, administering three doses of the vaccine provided a "strong immune response" to
COVID-19 and variants, including Omicron, the 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 are not available. Both Pfizer and Moderna have had clinical trials underway to determine the best vaccine regimen for babies, toddlers and preschoolers.

Pfizer paused its application for approval of the vaccine for children under 5 after the FDA asked for more data. Moderna has asked regulators to approve vaccines for young children.