Moderna to seek regulatory approval for COVID-19 vaccine for very young children

GENERALLY WELL-TOLERATED

It is not clear how many US parents will vaccinate their children in the age group. Only 27 per cent of 5- to 11-year-olds in the country are fully vaccinated, and COVID-19 is generally more mild in children than adults.

There were no severe cases in Moderna’s pediatric trial for either vaccine or placebo partipicants.

Moderna said the shots, spaced four weeks apart, were generally well tolerated in the age group and the majority of side effects experienced were mild or moderate.

The dose size tested was 25 micrograms – a quarter of the dose that adults receive for each of their first two shots.

There have been some concerns about the size of the dose. By comparison, the dosage of Pfizer and BioNTech’s vaccine – which uses similar messenger RNA technology – was 10 micrograms for 5- to 11-year-olds. They are testing 3 microgram doses for children younger than 5.

“FDA did ask us to evaluate lower doses and we intend to do so,” said Moderna’s Miller. “However, we believe that the current data really support the dose selections that we have made in this age group … We are confident in the dose that we’ve chosen.”

Moderna’s vaccine is approved by the FDA for use in adults 18 and older. But it has yet to be approved for 6- to 17-year-olds in the United States despite gaining approval for that age group in Australia, Canada and the European Union. The United Kingdom and Switzerland have allowed the vaccine to be used in 12- to 17-year-olds.

US regulators have asked the company for more safety data and the FDA also said it needed additional time to evaluate the risk of a type of heart inflammation called myocarditis after vaccination in the age group, a rare side effect that has primarily affected young males.

Moderna says it plans to update its emergency use authorisation filing in 12- to 17-year-olds with more data, and has started the process for 6- to 11-year-olds.

The company also said it plans to study a booster dose for all pediatric populations, including a booster that combines a vaccine designed to tackle the Omicron variant of the virus with its original COVID-19 vaccine.