The process to authorize COVID-19 vaccines for kids younger than 5 had been put on hold.
Pfizer and BioNTech on Friday said in a news release they want to wait until they get additional data on a third vaccine dose for kids ages 6 months to 4 years old before moving forward with the emergency use authorization process with the FDA.
The companies believe they'll have data on how well three doses of the vaccine protect kids against COVID by early April, the release says.
Pfizer had been submitting data to the FDA related to the safety and effectiveness of the vaccine on a rolling basis, per the request of the FDA. But now it seems Pfizer won't be seeking authorization until April.
Early results from the vaccine trial for kids 6 months to 4 years old showed that two doses were effective in the youngest children but not as effective in kids aged 2-4. Pfizer previously said a third dose would likely be needed to protect kids 2-4, USA Today reports.
Pfizer has been testing doses of 3 micrograms for under 5s, which is much smaller than the 30mg given to adults and teens, and 10 mg given to kids aged 5-11.
The FDA's advisory committee had a meeting scheduled for Feb. 15 to consider emergency use authorization of the two-dose vaccine for young childen, but that has now been canceled, the FDA said Friday. A new date for the meeting hasn't been announced.
"Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," the FDA said in a news release.
The FDA says it will provide an update on timing for the advisory committee meeting once it has received additional data on a third dose for the age group from Pfizer.
Pfizer plans to extend its rolling submission to the FDA as it continues to study a low-dose version of the vaccine.
"The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion," Pfizer said.