Moderna is asking federal regulators for an emergency authorization of its mRNA covid-19 vaccine for those between 6 months and 5 years old. No vaccine has yet been approved for very young children in the U.S., which is a population of approximately 18 million people.
The emergency authorization request to the U.S. Food and Drug Administration will be completed by next week, the company said. If approved, it will be sent off to the U.S. Centers for Disease Control and Prevention for a vote and further authorization from the agency’s director.
The New York Times reported that Dr. Peter Marks, who heads the FDA’s vaccine regulation, said in a senate hearing Tuesday he might consider all vaccine doses for people under 18 years old as a whole. Hearings for this and other authorizations likely won’t happen before June, according to the Times.
In a statement on its website, Stéphane Bancel, Moderna’s CEO, said “We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against covid-19 and will be especially welcomed by parents and caregivers.”
The Massachusetts-based company’s mRNA vaccine announced back in March that its interim results from its KidsCOVE study, which included 2,400 children aged 6 months through 24 months and an additional 4,200 children aged 2 through 5 years old.
The company said results showed positive results for a two, 25-microgram dose series for children younger than 6, with results similar to those shown for the 100-microgram dose in adults in previous studies. The one-fourth dose in children “showed a robust neutralizing antibody response in the 6 month to under 6 years of age group,” according to Moderna’s release. Results were mostly done with most cases being from the Omicron variant.
Efficacy, or effectiveness of the vaccine was 51% at preventing symptoms for 6 months to two years old and 37% effective for those 2 to 6 years old. The company said that is consistent with how well the vaccine prevents Omicron symptoms in adult populations after the initial two doses.
Moderna’s Chief Medical Officer Dr. Paul Burton told CNN that the most common reactions for children in the age group were pain at the injection site and fever, with no reaction of heart inflammation that has been a very rare side effect of vaccines.
The announcement comes hot on the heels of the company asking for the FDA to authorize a fourth vaccine dose for people over the age of 18. The original Moderna vaccine was given emergency authorization back in December of 2020, and was given full official authorization by the FDA in January of 2022.
So far, only the Pfizer-BioNTech vaccine has been given authorization to sell vaccines for 5 through 11 year olds and 12 through 17 year olds. Moderna is also currently seeking approval for vaccines in those age ranges. The FDA is awaiting results of Pfizer’s results of a third dose for young children before continuing with the authorization process.
The pandemic continues to be an issue in the U.S., even despite White House chief medical advisor Anthony Fauci saying in an interview yesterday that the country is past the “pandemic phase” of the virus’ spread. Yesterday’s numbers show there were close to 100,000 new cases reported in the U.S., with over 15,000 hospitalizations and 684 new deaths.