Moderna’s Interim Data on Kids Age 6 to 12 Shows Strong Vaccine Effectiveness

Moderna released top line data yesterday from a pediatric study of its mRNA COVID-19 vaccine, which showed a half-dose of the vaccine to be safe and effective in kids ages six up to 12 years old.

The results came just a day before the FDA’s vaccine advisory panel meets to consider the other mRNA COVID-19 vaccine, that of Pfizer and BioNTech, which is seeking Emergency Use Authorization for its shot in children ages five to 11.

Moderna said the interim analysis from the phase 2/3 study on mRNA-1273, also known as Spikevax, showed a robust neutralizing antibody response after two doses 28 days apart at the 50 µg dose level, half the dose of the Moderna shots authorized for emergency use in adolescents and adults. The study was conducted in collaboration with the National Institutes of Health.

The vaccine was well-tolerated, the company said. The majority of adverse events were mild or moderate in severity, with the most common solicited adverse events being fatigue, headache, fever and injection-site pain.

“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children ages six to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Moderna CEO Stéphane Bancel.

The company said it plans to submit these data to the FDA, the European Medicines Agency (EMA) and other global regulators in the near term.

Moderna’s data haven’t been peer-reviewed or published.

The company is also testing its vaccine in kids ages two to six years old, and six months to two years old.

Also yesterday, the EMA‘s human medicines committee (CHMP) concluded that Moderna’s COVID-19 booster shot may be taken by people age 18 and over. Earlier this month, the expert panel made the same pronouncement for Pfizer/BioNTech’s COVID-19 booster shot.

Late last week, the U.S. Centers for Disease Control and Prevention greenlighted half-dose booster shots of Moderna for those age 65 years and older, adults at high-risk of contracting severe COVID-19 and adults at high-risk of contracting the disease based on their workplace (DID, Oct. 25).

It also gave the thumbs up to the Johnson & Johnson (J&J) COVID-19 vaccine booster for the general population, as well as the mixing and matching of booster shots from Moderna, J&J and Pfizer/BioNTech.

Earlier this month, Norway and Sweden advised men younger than age 30 and all people under 18 years old to avoid taking the Moderna COVID-19 vaccine because of its rare association with myocarditis and endocarditis, though “the numbers have been small and therefore uncertain,” said Geir Bukholm, deputy director general at the Norwegian Institute of Public Health (DID, Oct. 7). — Suz Redfearn