Moderna to seek FDA authorization for COVID-19 vaccines for children younger than 6
Positive results from a Phase 2/3 study suggest the vaccine is safe and effective in younger populations, with few adverse events reported.
Photo: Marko Geber/Getty Images
Moderna said it's planning to submit a request to the U.S. Food and Drug Administration to authorize a low-dose COVID-19 vaccine for children under 6 years old, part of a push to inoculate the 18 million American children under 5 who are not yet eligible for vaccination – the last group to await eligibility.
The biotechnology company, which along with Pfizer/BioNTech was among the first companies to have a vaccine cleared and approved for adults, recently revealed data from a Phase 2/3 KidCOVE study of its vaccine showing a "robust" neutralizing antibody response in children as young as 6 months and as old as 6 years.
Moderna said it is using these results to submit its application to the FDA, the European Medicines Agency and other global regulators "in the coming weeks."
KidCOVE is a randomized, observer-blind, placebo-controlled study to evaluate the safety and efficacy of two doses of the vaccine given to healthy children 28 days apart.
WHAT'S THE IMPACT?
According to the results of the Phase 2/3 study, the tolerability of the vaccine among children younger than 6 was consistent with that shown by older age groups, including adults. The majority of adverse events were mild or moderate and were more frequently reported after dose two and occurred at lower rates than in other age groups.
No new safety concerns arose, and there were no deaths during the trial. The recommended dosage for the younger age groups is 25 µg, compared with the 100 µg recommended for those 18 to 25.
When the study was conducted, the Omicron variant was the dominant strain of coronavirus in the U.S., and protection against this variant in children younger than 6 was consistent with observational data among adults. Vaccine efficacy in children 6 months to 2 years was 43.7% and was 37.5% in the 2 to under 6 years age group; the majority of cases were mild, and there were no instances of severe disease in either age group.
As it has with adults, Moderna is preparing to evaluate the potential of a booster dose for all pediatric patients.
In addition to the under-6 set, Moderna is also initiating a submission process with the FDA for emergency-use authorization for a two-dose vaccine series in those 6 to 12 years old. The vaccine has already been cleared for that age group by regulators in Australia, Canada and the European Union.
The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at HHS.
THE LARGER TREND
Moderna earned full FDA approval for a COVID-19 vaccine dubbed Spikevax in February. Until then, it had been approved under emergency-use authorization. Pfizer's offering has also been approved by the FDA.
Spikevax has the same formulation as the EUA Moderna COVID-19 vaccine and is administered as a primary series of two doses one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 vaccine, the FDA said.
The Moderna vaccine, as well as those from Pfizer and Johnson & Johnson, has long been in use to fight the coronavirus that has killed more than 6 million people worldwide and over 970,000 in the United States, according to the Johns Hopkins data map.
An estimated 64% of the United States population has been fully vaccinated. The federal government has both urged and mandated vaccination – in some cases unsuccessfully – as the best prevention against the virus.
ON THE RECORD
"We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age," said Moderna CEO Stéphane Bancel. "We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults. Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible.
"Additionally, after consultation with the U.S. FDA, we have initiated a submission for emergency-use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency-use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages."
Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com
