Pfizer and BioNTech are expected to submit a request to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) for their COVID-19 vaccine for children ages six months to five years old.
The request may be submitted as early as Tuesday, The Washington Post reported. If approved, the vaccine would be the only one approved for use in infants.
The Post quoted individuals who spoke on condition of anonymity as saying that the FDA urged Pfizer and BioNTech to submit their application to allow regulators to begin reviewing the data on the two-dose series.
One of those people told the Post, "We know that two doses isn’t enough, and we get that. The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in."
Data on a third dose for children ages 2-5 years is not expected to become available before late March. Children in that age group, unlike their younger peers ages six months to two years, did not generate a sufficient immune response to two doses of the baby-sized three-microgram dose.
The dose for children ages 5-11 is ten micrograms, while the adult dose is 30 micrograms.
The FDA's outside advisers are expected to meet mid-February to discuss the application, and the US Centers for Disease Control and Prevention's (CDC) outside experts are also expected to convene on the issue, the Post added.
In an email to the Post, Pfizer spokeswoman Jerica Pitts said, "At this time, we have not filed a submission and we’re continuing to collect and analyze data from both two and three doses in our younger age cohort. As part of our ongoing commitment, we will share new updates as they become available."