Pfizer-BioNTech has paused its plan to give its two-shot Covid vaccine to children under the age of five, meaning parents will not be able to get their young children vaccinated in the coming weeks.
The company announced that it has postponed its application to the Food and Drug Administration while it waits for data on a three-dose series of the vaccine for children aged six months to four-years-old.
Pfizer says that a three-dose series of shots “may provide a higher level of protection in the age group”, and it will not have the necessary data until April.
In December the company said that in a two-shot trial of children aged two to four its vaccine, which had a dosage of 3 micrograms, did not generate a strong enough immune response to the virus.
But earlier this month the company asked the FDA to authorise the first two doses and said it would submit additional data on the impact of a third dose.
The move came as the FDA was set to publish its own analysis of the Pfizer data on Friday, with its advisory committee set to meet next week.
The FDA then announced that its 15 February meeting had been postponed as “new data have recently emerged” about Pfizer’s emergency use authorisation request.
“This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines,” the FDA said in a statement.
“We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation.”
Earlier this week, Pfizer CEO Albert Bourla said he thought there was a “very high” chance that the FDA would grant approval for the vaccine for the younger age group.
“I think that they will be pleased with the data and they will approve,” Mr Bourla told CNBC.
