The Cambridge, Mass., company said Monday it would submit results to health regulators in the US, Europe and elsewhere seeking authorization to broaden the use of its shots to include this young age group.
The company announced the interim data in a press release, and the results have yet to be published in a peer-reviewed medical journal.
Moderna’s vaccine is currently authorized for use in the US in adults 18 years of age and older.
The company’s efforts to expand its vaccine use to include children are ahead of Pfizer Inc. and BioNTech SE, which could receive FDA authorization in days or weeks for their vaccine use in children 5 to 11.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to 12 years and are pleased that the study meets its primary immunogenicity endpoints,” said Moderna Chief Executive Stephen Bansel. Immunogenicity refers to a vaccine’s ability to trigger an immune response, although this alone is not definitive evidence that an immune response will protect someone from disease.
The company has asked the Food and Drug Administration to authorize the vaccine’s use in children ages 12 to 17, but the FDA’s decision was overturned by the agency’s assessment of the risk of heart-inflammatory conditions in young vaccine recipients. has gone.
Moderna’s new study is part of a broader push to expand the Covid-19 mass vaccination campaign, which initially focused on vaccinating adults, to include children.
Pfizer and BioNTech’s vaccine is authorized for use in adolescents 12 years of age and older, and the companies have requested authorization for that vaccine’s use in children ages 5 to 11.
The FDA’s decision on the Pfizer vaccine in children could come soon, following Tuesday’s advisory panel meeting.
The risk of severe Covid-19 in children is much lower 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 age group of 5 to 11, according to the FDA.
According to several health experts, vaccination can also help reduce the transmission of the virus in children.
Moderna previously reported that a study of its vaccine in adolescents showed that it induced an immune response that was comparable to those seen in adults.
In March, Moderna launched a separate study to test its vaccine in children under the age of 12, including children as young as six months old. US government agencies, including the National Institute of Allergy and Infectious Diseases, are helping to conduct the study.
The company on Monday released partial results of that study in children 6 to 11. This part of the study enrolled 4,753 children ages 6 to 11, each given two doses of either Moderna’s vaccine or a placebo, spaced four weeks apart.
The vaccine dose used in the study is 50 micrograms, which is half the dose of a vaccine 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 comparable to those seen in young adults enrolled in a separate study conducted last year. were in
Moderna said the vaccine’s safety and tolerability profile was in line with what was generally observed in studies of adults and adolescents. The company said the most common side effects included fatigue, headache and fever, and most were mild or moderate.
In recent months, there have been reports of heart-inflammatory conditions, including myocarditis, in some people receiving vaccines from Moderna and Pfizer. US health officials have said the risk appears to be highest in young men and male adolescents after the second dose of the vaccine.
US officials say the benefits of vaccination in people 12 years and older outweigh any risks, including myocarditis. They also say that most cases of vaccinated myocarditis have been mild and that the Covid-19 disease itself carries the risk of myocarditis as a complication.
Moderna did not say whether any cases of myocarditis were seen in the new study of children under 12 years old.
The company continues to enroll children between the ages of 6 months and 5 years in the study.
This story has been published without modification to the text from a wire agency feed
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