WASHINGTON — For many families with children under the age of 5, it's been a long time waiting for the U.S. Food and Drug Administration to approve a COVID-19 vaccine for the youngest people.
It appears that timeline will be extending at least another month.
The FDA on Friday released its tentative schedule for advisory committee meetings on vaccines. Three dates in June have been set aside for planned meetings to discuss approval of Modern and Pfizer's COVID-19 shots in young children.
The dates are June 8, 21 and 22.
Currently, Pfizer's shot is approved for those 5 and up, while Moderna's is limited to those 6 or older.
The FDA said once Moderna and Pfizer complete their submissions and the data is reviewed, the agency will provide more info on officially scheduling meetings to discuss each request.
"The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines," said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research. "We intend to move quickly with any authorizations that are appropriate once our work is completed.”
Currently, only children ages 5 or older can be vaccinated in the U.S. with Pfizer’s vaccine, leaving 18 million younger tots unprotected.
But even after that June 22 date, vaccines won't be made available right away: the approval then gets sent to the Centers for Disease Control (CDC), which will then determine who to exactly recommend the vaccine for.
Essentially, the CDC will decide whether vaccines should be given to all children between 6 months and 5 years old, or perhaps just those that are at risk of developing serious illness from COVID.
Recent research revealed about three-quarters of children of all ages show signs they've been infected at some point during the pandemic. While preliminary studies show that naturally acquired antibodies offer some protection against serious illness, experts still recommend that those who previously contracted COVID should get vaccinated.
Those upcoming committee meetings on vaccines will also be discussing potential authorization of the protein-based Novavax vaccine for those 18 and older.
Some people hesitant about getting an mRNA vaccine, like those developed by Pfizer and Moderna, have been holding back for a more traditional protein-based shot, similar to childhood immunizations. Clinical trials have found the Novavax inoculation to be 90% effective.