Moderna Inc.’s MRNA 7.05% Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company.
The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group.
The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal.
Moderna’s vaccine is currently authorized for use in adults 18 years and older in the U.S.
The company’s efforts to expand use of its vaccine to include children are further behind Pfizer Inc. PFE -0.02% and BioNTech SE, BNTX 5.96% which could get FDA authorization in days or weeks for use of their vaccine in children 5 to 11.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” Moderna Chief Executive Stéphane Bancel said. Immunogenicity refers to a vaccine’s ability to trigger an immune response, though it alone isn’t definitive proof that the immune response will protect someone from disease.
The company has asked the Food and Drug Administration to authorize use of the vaccine in children age 12 to 17, but the FDA’s decision has been held up by the agency’s assessment of the risk of heart-inflammation conditions in younger vaccine recipients.
Moderna’s new study is part of a broader push to expand the Covid-19 mass vaccination campaign, which initially focused on immunizing adults, to include children.
The vaccine from Pfizer and BioNTech is authorized for use in adolescents 12 years old and up, and the companies have requested authorization of that vaccine’s use in children 5 to 11 years old.
An FDA decision on the Pfizer vaccine in children could come soon, following an advisory panel meeting scheduled for Tuesday.
The risk of severe Covid-19 is much lower in children than in adults. Yet many have been hospitalized, and at least 691 children under the age of 18 have died from Covid-19, including 146 deaths in the 5- to 11-year age group, according to the FDA.
Vaccination may also help reduce children’s transmission of the virus, according to many health experts.
Moderna previously reported that a study of its vaccine in adolescents showed it induced immune responses that were comparable to those seen in adults.
In March, Moderna started a separate study testing its vaccine in children under the age of 12, including those as young as six months. U.S. government agencies including the National Institute of Allergy and Infectious Diseases are helping to run the study.
The company released partial results from that study, in children 6 to 11, on Monday. This portion of the study enrolled 4,753 children age 6 to 11, each of whom was given two doses, four weeks apart, of either Moderna’s vaccine or a placebo.
The vaccine used in the study has a dosage of 50 micrograms, half the dosage of the vaccine that is authorized for use in adults.
Researchers found that Moderna’s vaccine, code-named mRNA-1273, induced immune-system antibodies to the coronavirus in children at levels that were comparable to those seen in young adults enrolled in a separate study conducted last year.
Moderna said the vaccine’s safety and tolerability profile was generally consistent with what was seen in adults and in the study of adolescents. The most common side effects included fatigue, headache and fever, and the majority were mild or moderate, the company said.
In recent months, there have been reports of heart-inflammation conditions including myocarditis in some people receiving the vaccines from Moderna and Pfizer. U.S. health authorities have said the risk appears highest in young men and male adolescents after their second doses of the vaccines.
U.S. authorities say the benefits of vaccination in people 12 years and older continue to outweigh any risks including myocarditis. They also say that most cases of vaccine myocarditis have been mild and that the Covid-19 disease itself carries a risk of myocarditis as a complication.
Moderna didn’t say whether any cases of myocarditis were seen in the new study of children under 12 years.
The company continues to enroll children ages 6 months old to 5 years old in the study.
Write to Peter Loftus at [email protected]
Copyright ©2021 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
