Moderna Wants FDA Approval for Pediatric COVID-19 Vaccine

The company reports that for fully vaccinated study participants aged 12-17 (2 doses administered) no cases of COVID-19 were reported.

Moderna very possibly just gave Anthony Fauci, MD, the director of the CDC’s National Institute of Allergy and Infectious Diseases, some crucial assistance in Fauci’s effort to get young children and adolescents vaccinated against COVID-19. Fauci lobbied for that yesterday while appearing with President Biden in a You Tube town hall on COVID-19 vaccination.

Well, Moderna announced today its the phase 2/3 study of its mRNA-1273 COVID-19 vaccine in the pediatric population aged 12-17 reached its immunogenicity endpoint.

This news comes from their TeenCOVE study, which enrolled more than 3700 adolescents in the United States. The company reports that for fully vaccinated participants (2 doses administered) no cases of COVID-19 were reported. In the placebo group, 4 cases were observed.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,”Moderna CEO Stéphane Bancel, Moderna, said.

The mRNA-1273 vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the phase 3 COVE study in adults. No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of the vaccine were headache, fatigue, myalgia and chills.

With this new data, Moderna plans to file for authorization. “We will submit these results to the US FDA and regulators globally in early June and request authorization,” Bancel said. “We remain committed to doing our part to help end the COVID-19 pandemic.”

This article first appeared in Contagion®.