FDA Wants More Data On 3rd COVID Shot For Kids: How Ohio Is Impacted

OHIO — The FDA paused Pfizer-BioNTech's emergency application to expand access to its COVID-19 vaccine for young children under 5.

News of the pause came just one day after Ohio medical officials announced statewide preparations to roll vaccines out to children 6-months-old through age 4. State officials have already started working with 3,800 vaccine providers to prepare for an emergency approval of doses for young children, said Dr. Bruce Vanderhoff, director of the Ohio Department of Health.

"There's no doubt children are generally less likely than adults to become severely ill with COVID-19, but we need to remember they most certainly can and unfortunately do become ill, even seriously ill, and can suffer lasting complications from the virus," Vanderhoff said during a news conference Thursday.

Three Doses For Children 6 Months To 4 Years

The Food and Drug Administration postponed a meeting planned for next week to publicly debate the request to give Pfizer time to collect more data on the efficacy of a three-dose series of the vaccine for children ages 6 months to 4 years. A third dose "may provide a higher level of protection in this age group," the company said in a statement.

The nation's 18 million children under 5 are the only age group not yet eligible for vaccination. Dr. Peter Marks, the FDA's vaccine chief, asked their parents to be patient and said the decision to delay approval was part of the agency's circumspect review and high scientific standards.

"We take our responsibility for reviewing these vaccines very seriously because we're parents as well," Marks told reporters in a teleconference.

Pfizer anticipated a third dose would likely be needed based on early data that showed a two-dose course for children 5 and older was less effective at preventing COVID-19 in kids ages 2-5. Adding a third dose to the series is supported by findings that show booster shots significantly improve protection in other age groups, the company said.

Pfizer filed its application with the FDA earlier this month and, on Tuesday, CEO Albert Bourla told CNBC the chances the FDA would approve vaccines for young children were "very high."

Pfizer said more data is generated daily because infection rates remain high in young children, especially due to the recent omicron surge.

That data is expected in early April.

The FDA didn't elaborate on the data it is asking Pfizer to provide, except that it involved a third dose.

"We believe additional information regarding evaluation of a third dose should be considered as part of our decision-making," the agency said in a statement.

As of Sunday, more than 7.1 million Ohioans had received at least one dose of a COVID-19 vaccine. However, only 24 percent of Ohio children (ages 5 to 11) had received a COVID-19 vaccine, the state health department reported.

The Associated Press contributed to this article.