A Covid-19 vaccine for children under the age of five is unlikely to be cleared for use in the US until spring after federal regulators opted to postpone a review scheduled for next week to wait for more data.
US Food and Drug Administration (FDA) advisers had been planning to consider a two-dose regimen of Pfizer Inc's formulation for children under five on Tuesday next. The delay is to allow the company and its partner BioNTech SE to gather and evaluate more information on the impact of a third dose, agency officials said on Friday in a statement.
The news is another blow to parents who were eager to get their younger children vaccinated, fuelled by concern in relation to the emergence of new, highly transmissible Covid-19 variants like Omicron.
In December a study showed two doses of the Pfizer vaccine formulation failed to meet a laboratory standard for effective immune response in two- to four-year-olds, although it did in those from six months to 24 months of age.
Data on a third dose is expected in early April, the two partner companies said.
That stands to delay US plans for a special vaccination programme for children under the age of five.
In a press call shortly after the announcement of the delay, Peter Marks, head of the FDA’s vaccine division, hinted that the data at this point was not good enough to merit authorising the vaccine for children under five, citing the agency’s standards.
“We feel if something does not meet that standard, we cannot proceed forward,” he said on the call, adding that he hoped that the delay “reassures people that the process has a standard”.
He didn’t give more details about what the FDA saw in Pfizer’s two-dose data that caused postponement of a decision until more data comes in. – Bloomberg
