Washington (AFP)

Clinical trials conducted by Moderna on more than 4,700 participants aged 6 to 11 "demonstrate a strong immune response in this group of children one month after the second dose," with "robust" antibody levels detected, said the company in a press release.

The vaccine further exhibits a "favorable safety profile" and was "generally well tolerated", she added.

The most common side effects were fatigue, headache, fever, and pain from the injection.

"We look forward to submitting the data to global regulatory agencies," Moderna boss Stéphane Bancel said in the statement.

This should be done "in the short term," according to the company.

The dose for children has been adjusted to 50 micrograms, compared to 100 micrograms for older age groups.

This 50 microgram dosage is also the one chosen for the booster dose of Moderna in adults, which has just been authorized in the United States.

Moderna is running parallel clinical trials on even younger children, between 6 months and 5 years old, but is still recruiting participants for this age group.

For the moment in the United States, Moderna's vaccine is only authorized from the age of 18, even if the company filed a request for authorization for adolescents months ago.

Injections in early November

The results announced on Monday mean that two vaccines may be available for young children in the near future.

An advisory committee of the American Medicines Agency (FDA) is due to meet on Tuesday to study the application for authorization of Pfizer's vaccine in children aged 5 to 11.

This represents 28 million children in the United States.

The American laboratory announced last week that its vaccine was 90.7% effective in preventing symptomatic forms of the disease in this age group.

Ahead of its committee meeting, the FDA released its own interpretation of the data, which appears to indicate the agency is in favor of authorizing the remedy.

The FDA was particularly concerned that the vaccine could cause a significant number of cases of myocarditis, an inflammation of the heart muscle in children.

But the analysis carried out "predicts that the number of clinically significant outcomes avoided linked to Covid-19 would clearly counterbalance the excess cases of myocarditis associated with the vaccine", wrote the American regulator.

If the FDA gives the green light, the Centers for Disease Prevention and Control (CDC) will also have to approve the vaccine and publish their specific recommendations for healthcare professionals administering the doses.

The White House has indicated that the vaccinations of young children could then begin in the following days.

"If all goes well (...) it is entirely possible, if not even very likely, that vaccines will be available for children aged 5 to 11 during the first or second week of November," said White House adviser on the health crisis, Anthony Fauci, on ABC Sunday.

© 2021 AFP

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