Moderna to seek regulatory approval for COVID shot for very young children

Moderna Inc MRNA.O said on Wednesday it will ask regulators to authorize its COVID-19 vaccine for children younger than 6 years old based on data showing it generated a similar immune response in young children as for adults in its clinical trial.

The Omicron variant of the coronavirus was predominant during Moderna's pediatric trial, and the drugmaker said two doses were around 38% effective in preventing infections in 2- to 5-year-olds and 44% effective for children ages 6 months to 2 years.

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

"People are automatically recalling the 95% (vaccine efficacy) from Pfizer or Moderna early on, and I don't think those are fair comparisons because Omicron is an immune evasive variant," said Dr. Amesh Adalja, infectious disease expert at the Johns Hopkins Center for Health Security. Adalja said the vaccine would be especially valuable to children at high risk of severe disease.

Moderna's vaccine could become the first authorized shot for children under the age of 5 in the United States.

The COVID vaccine from Pfizer Inc PFE.N and Germany's BioNTech SE 22UAy.DE is authorized for use in children 5 and older. Their trial results for 2- to 4-year-olds showed a weaker immune response than in adults, forcing the trial to be extended to test a third dose. Results are expected in April. Read full story

Moderna Chief Executive Stephane Bancel said in a statement that the company is "working with the U.S. FDA and regulators globally to submit these data as soon as possible."

Dr. Jacqueline Miller, a top scientist at Moderna, told Reuters the company was "a couple of weeks away" from filing for authorization for the age group.

GENERALLY WELL TOLERATED

It is not clear how many U.S. parents will vaccinate their children in the age group. Only 27% in the 5 to 11 age group 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 those who received the vaccine or a placebo.

Moderna said the shots, spaced four weeks apart, were generally well tolerated in the age group and most side effects were mild or moderate. Around a sixth of the vaccine recipients in the age group had fevers of at least 38°C (100.2°F), which Moderna said was consistent with other pediatric vaccines.

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 Pfizer/BioNTech's vaccine, which uses similar messenger RNA technology, was 10 micrograms for ages 5 to 11. 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."

Moderna's vaccine is approved by the FDA for use in adults 18 and older. 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 for ages 12 to 17.

U.S. 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 authorization filing for ages 12 to 17 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.

 

 

 

 

 

REUTERS