Pfizer-BioNTech is postponing its rolling application to the Food and Drug Administration (FDA) to expand the use of its two-dose COVID-19 vaccine for children ages 6 months to 4 years, NBC News reported on Friday.
The move means that vaccines for this age group will not be available in the coming weeks.
Pfizer said on Friday that it will wait for its data on a three-dose series of the vaccine, because it believes three doses "may provide a higher level of protection in this age group." Data on the third dose is expected in early April, the company said.
Pfizer and BioNTech last week officially announced they have begun submitting data to US regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5.
Outside advisers to the FDA had been scheduled to meet on February 15 to discuss whether to recommend the regulator to authorize the vaccine.
Had the vaccine been approved, the US government had been planning to roll out of the vaccine for children under the age of 5 before the end of the month.
The FDA was expected to publish an analysis of the Pfizer data Friday, ahead of the advisory committee meeting. The FDA said Friday the meeting has been postponed.
Two people familiar with the FDA’s plans said there had already been a lot of pushback on the agency from outside experts who had concerns that Pfizer’s data wasn’t sufficient. The experts felt, one of the people said, that their concerns were “falling on deaf ears” within the agency.
On Tuesday, Pfizer CEO Albert Bourla told CNBC the chances are “very high” the FDA would authorize the vaccine for young children.
“I think that they will be pleased with the data and they will approve,” Bourla said, while noting that the regulatory process still has to play out.
(Israel National News' North American desk is keeping you updated until the start of Shabbat in New York. The time posted automatically on all Israel National News articles, however, is Israeli time.)