The Food and Drug Administration is expected to give emergency authorization by midwinter for children under 12 to receive their COVID-19 vaccines, an agency official said on Thursday.
COVID-19 vaccines are available for people ages 12 and up on an emergency-use basis. The FDA is also hoping to give all three vaccine makers their full approval in an effort to help ease the concerns of those who are unsure if they want to get their shots because of the “emergency” label.
In March, Moderna and Pfizer-BioNTech began trials for their COVID-19 vaccines for kids under 12. The results are expected to be made public in the fall and sent to the FDA.
The agency is seeking four to six months of follow-up data from these trials, according to an FDA official. In comparison, only two months of follow-up data were asked for the adult version of the vaccine.
Pfizer anticipates that they will receive results from their clinical trials conducted with kids ages 5 to 11 in September. They are expected to apply for emergency use authorization soon thereafter.
“Data for kids 2 and under 5 could arrive soon after that,” the pharmaceutical company said, adding that results on toddlers ages 6 months to 2 years will likely not come until October or November.
Researchers at Moderna are expecting the same timeline as Pfizer-BioNTech.
“I can’t imagine, except maybe for the 6- to 11-year-olds, that we’re going to have too much data before the late fall,” said Dr. Buddy Creech, a primary researcher for the Moderna KidCOVE trials, to NBC News.
The need for a vaccine for children has become even more pressing due to the rapid spread of the Delta variant among unvaccinated individuals. While current data has not suggested that the COVID-19 variants negatively affect children, they remain highly contagious.
Since July 8, more than 4 million kids have been diagnosed with COVID-19, making up 14.2% of all cases. The fatality rate remains low among younger demographics with 335 children aged 17 and younger having died from COVID-19, according to the Centers for Disease Control and Prevention.