His COVID-19 Vaccine Is Effective For Children 6 Months - 5 Years Old, Moderna Awaits Regulatory Approval

JAKARTA - Moderna Inc., said it awaits regulatory approval of a COVID-19 vaccine in children under 6 years old, based on data showing that the vaccine produces an immune response similar to that of adults in clinical trials on Wednesday.

The Omicron variant of COVID-19 was dominant during Moderna's pediatric trial, and the drugmaker said two doses were about 38 percent effective in preventing infection in children 2 to 5 years of age, and 44 percent effective for children 6 months to under 2. year.

It said these figures were consistent with the lower effectiveness against Omicron seen in adults who had received two doses of its vaccine.

The Moderna vaccine could be the first official shot for a child under the age of 5 in the United States, and many parents of young children have been waiting for the vaccine.

Meanwhile, vaccines made by Pfizer Inc., and BioNTech SE from Germany are allowed for use in children aged 5 years and over. However, their trial results for children aged 2 to 4 years showed a weaker immune response than in adults, forcing the trial to be extended to test a third dose. Results are expected in April.

"Given the need for a vaccine against COVID-19 in infants and young children, we are working with the US FDA and regulators globally to deliver this data as soon as possible," Moderna Chief Executive Stephane Bancel said in a statement.

Meanwhile, Dr. Jacqueline Miller, a top scientist at Moderna told Reuters the company was "a few weeks away" from filing authorizations for age groups in the United States, Europe and elsewhere.

It is not clear how many US parents will have their children vaccinated in that age group. Only 27 percent of children aged 5-11 years in the country are fully vaccinated. Meanwhile, COVID-19 is generally milder in children than adults.

There were no severe cases in the Moderna pediatric trial for either the vaccine or placebo participants.

Moderna says the vaccine, four weeks apart, is generally well tolerated in this age group, with most side effects being mild or moderate.

The dose size tested was 25 micrograms, a quarter of the dose adults receive for each of their first two injections. Although, there is some concern about dose size.

For comparison, the dose of Pfizer and BioNTech vaccines, which use similar messenger RNA technology, is 10 micrograms for children aged 5 to 11 years. They are testing 3 microgram doses for children under 5 years of age.

"The FDA did ask us to evaluate a lower dose and we intend to do so," said Miller of Moderna.

"However, we believe that the current data really support the dose selection we have made in this age group. We are confident in the dose we have chosen."

The Moderna vaccine is FDA-approved for use in adults 18 years of age and older. However, it has not been approved for ages 6 to 17 in the United States, although it does get approval for that age group in Australia, Canada and the European Union. Meanwhile, the UK and Switzerland have allowed the vaccine to be used in children aged 12-17 years.

Uncle Sam's State regulator has asked the company for more safety data, with the FDA also saying it needs 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 mainly affects young men.

Moderna said it plans to update its emergency use authorization applications for 12-17 year olds with more data, and has started the process for 6 to 11 year olds.

In addition, the company also said it plans to study booster doses for all pediatric populations, including boosters that combine a vaccine designed to treat the Omicron virus variant with the original COVID-19 vaccine.