COVID Vaccine Delayed For Kids Under 5 In NJ: What We Know

NEW JERSEY — Despite hitting a setback when federal regulators paused Pfizer-BioNTech's emergency application to expand access to its COVID-19 vaccine for young children under 5, New Jersey Governor Phil Murphy still has hope.

"The Governor continues to encourage parents of children age five and up to vaccinate their children against COVID-19 and hopes that a safe and effective vaccine for children under five will soon be available," said Murphy's Press Secretary Alyana Alfaro.

The Food and Drug Administration postponed a meeting planned for this 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.

This decision will not impact Murphy's announcement last week to drop New Jersey's school mask mandate, effective March 7. Read More: NJ To Drop School Mask Mandate Next Month

"With the rapid decline in cases and the progress made in vaccination among the 5-11 population since they became eligible three months ago, the Governor believes that we are at a place where we can begin to give our kids a sense of normalcy and give school districts and childcare centers the ability to tailor masking and other COVID-19 mitigation policies to the unique circumstances in each community and needs of staff and students," said Alfaro.

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.

The Associated Press contributed reporting.

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