The availability of COVID- 19 vaccinations for children under 5 has been delayed after federal regulators decided more time was needed to evaluate additional data.

The U.S. Food and Drug Administration had initially urged Pfizer-BioNTech to apply for emergency use authorization of an extra-low-dose vaccine for children ages 6 months to 4 years old even though it remained unclear whether they would need two or three doses.

But on Friday the FDA reversed course and said it wanted Pfizer to provide additional data on how well a third shot works for the age group, and postponed a committee meeting scheduled for Tuesday. Pfizer said it expects to have the data by early April.

In the meantime, the FDA said the best way to protect younger children in school or day care is to continue social distancing and masking, and for family members and caregivers to get vaccinated and boosted.

The postponement comes as daily coronavirus cases across the U.S. and in Hawaii continue to fall.

On Friday the state Department of Health reported eight new coronavirus-related deaths and 707 new infections statewide, bringing Hawaii’s totals since the start of the pandemic to 1,247 fatalities and 230,238 cases.

The statewide average of new daily cases dropped to 796 Friday, down 64% from two weeks ago, while the average positivity rate fell to 7.8%.

DOH said progress is being made on keiki vaccinations, with about 48,000, or 40.6%, of children ages 5-11 having initiated vaccinations, and 39,000, or 32.8%, having completed two doses.

The first COVID-19 vaccines were administered to children ages 5-11 in Hawaii during the first week of November at Kapiolani Medical Center for Women & Children. Only the Pfizer vaccine, at one-third of the adult dose, has been approved for the estimated 119,000 children in that age group in the state.

Pfizer aims to give children age 6 months to 4 years shots with one-tenth of the adult dose — two doses three weeks apart followed by a third at least two months later.

Parents understandably will have more questions and be more cautious about vaccinating those under age 5, said DOH spokesman Brooks Baehr, and it will be challenging to match the vaccination rate for those ages 5-11. An estimated 88,800 children in the state are under 5 years old.

He said DOH respects the FDA’s decision to postpone its decision.

“It is important data on the vaccines are thoroughly reviewed,” Baehr said. “We will need to be able to reference credible data on vaccine safety when talking to parents about whether or not to vaccinate their children.”

A Kaiser Family Foundation poll last month found just 3 in 10 parents of children under 5 said they would get their child vaccinated as soon as shots were authorized, while about a quarter said they definitely would not.

As the omicron variant drove a surge in late December, close to record numbers of infected children were ending up in hospitals across the U.S., according to reports.

Fortunately, that has not happened in Hawaii, according to Dr. Melinda Ashton, executive vice president and chief quality officer of Hawaii Pacific Health.

“We were quite concerned hearing stories from the mainland about children’s hospitals being very busy with COVID patients,” she said during a Jan. 24 appearance on the Honolulu Star-Advertiser’s “Spotlight Hawaii” livestream program. “That has not been the case here.”

Among the handful of children hospitalized with the coronavirus, many are fragile, and a viral infection can tip them over the edge, she said.

“We’re not seeing children who are otherwise healthy end up in the ICU because of a COVID infection — at least, that would be a really rare event for us,” she said.

On Friday, DOH said 75.3% of the state had completed a primary vaccine series, with 36.1% boosted.

Hospitalizations of patients with COVID-19 in Hawaii also continue to fall, with 184 new hospitalizations reported Friday, a 35% drop from 283 on Feb. 4.

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The Associated Press contributed to this report.