The FDA was supposed to meet Tuesday to discuss the matter. But Friday, the agency postponed that meeting. It said new data has recently emerged on Pfizer’s emergency use authorization request for its vaccine for children in that age group.
The company had originally provided information on a two-dose series. Now, Pfizer said it expects to have three-dose data by early April.
“The delays here reflect the fact that they decreased the dose for these younger kids in order to ensure that it was safe,” said Brown University Academic Dean of Public Health Dr. Megan Ranney. “Unfortunately, it looks like that decreased dose, decreased the effectiveness of the vaccine a little bit, which is why they need the three shots instead of just two.”
Pfizer said it will extend its rolling submission as it continues to collect and submit more information. The company has not pulled its EUA application.
In a statement, the heads of the FDA said, “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.”
Dr. Ranney said, “I know how incredibly frustrating and disappointing this is for parents of those under five kids. The process works. These vaccines will not be approved until we are sure that they are both safe and effective.”
The FDA said once the new data is in, it will be evaluated as quickly as possible.
Until the FDA has time to make a decision on vaccines for this age group, health officials said the best way to protect the youngest Americans is by making sure those around them are vaccinated and using masks.
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