Moderna yesterday asked the US Food and Drug Administration to grant emergency use authorization for its COVID-19 vaccine in two age groups: children 6 months to under 2 years and 2 years to under 6 years of age. The biotech firm said its EUA submission would be completed next week.
FDA spokeswoman Stephanie Caccomo told The Washington Post that the agency would not be able to reach a decision without a complete filing and it's not possible to predict how long a review of the data would take. But Paul Burton, Moderna's chief medical officer, said he believes the FDA will "try and move quickly," recognizing the unmet need.
Right now, children 5 or older can be vaccinated in the US using Pfizer's COVID-19 vaccine, but that leaves 18 million younger children unprotected.
As the Associated Press points out, frustrated families have been waiting for such authorization as more people around the country drop mask usage and other precautions have been abandoned, even as mutations of the contagious coronavirus continue to spread.
Meantime, the Omicron variant has complicated analysis of how effective the vaccines are, and many health experts believe a booster will be needed, even for young children. "Let's get these kids vaccinated. Let's get started, and if they need a booster, they'll get a booster later on," Sunanda Gaur, a professor of pediatrics at Rutgers Robert Wood Johnson Medical School, told The Washington Post.
According to the CDC, around 475 children younger than age 5 have died from COVID-19 since the pandemic started. The agency said earlier this week that as of February 2022, approximately 75 percent of children and adolescents displayed serologic evidence of previous infection with SARS-CoV-2, with approximately one third becoming newly seropositive since December 2021.