CAMBRIDGE, Mass. — Moderna announced Monday that its COVID-19 vaccine has proven to be effective when administered to children ages 6 to 11, citing a new study.
The company says an interim analysis of data showed a robust neutralizing antibody response after two 50 microgram doses of its vaccine were administered to kids in this age group.
The study evaluated the safety, tolerability, reactogenicity and effectiveness of two doses of the Moderna vaccine given to healthy children 28 days apart.
Moderna says its vaccine was well tolerated with a safety and tolerability profile generally consistent with its study of adolescents and adults.
The majority of adverse events were mild or moderate in severity, with the most common being fatigue, headache, fever, and injection site pain, according to the company.
Moderna now plans to submit the data from the study to the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other global regulators.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
Meanwhile, Pfizer has already asked federal regulators to authorize the emergency use of its coronavirus vaccine for children ages 5 to 11. An advisory panel for the FDA will consider that company's application on Tuesday.
Top health officials, like Dr. Anthony Fauci, have said they believe the vaccine will be approved for emergency use in kids and the U.S. could start seeing the age group being vaccinated in early November.
“So if all goes well, and we get the regulatory approval, and the recommendations from the CDC, it's entirely possible, if not, very likely that vaccines will be available for children from 5 to 11 within the first week or two of November,” said Fauci told CNN on Sunday.