Posted on Oct 25, 2021 4:45 PM
It is an encouraging sign. Moderna announced on Monday positive results for its vaccine against Covid-19 in children aged 6 to 11. This data will now have to be submitted by the company to various regulators around the world. The laboratory plans to do so “in the short term” with a view to authorization.
Phase 2/3 clinical trials involving 4,753 participants “demonstrate a strong immune response in this group of children one month after the second dose,” with “robust” antibody levels detected, Moderna said in a statement. The vaccine also has a “favorable safety profile” and was “generally well tolerated”, adds the company. The most common side effects were fatigue, headache, fever, and pain at the injection site.
A dose divided by two
“We are eager to submit the data to global regulatory agencies,” said Moderna boss Stéphane Bancel, quoted in the press release. The dose for children has been adjusted to 50 micrograms, compared to 100 micrograms for injections for older age groups. This halved dosage is also the one chosen for the booster dose in adults, which has just been authorized in the United States.
These results mean that two vaccines may be available for young children in the near future. 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.
The competing laboratory announced on September 20 that its Comirnaty vaccine was “safe” and “well tolerated” by children aged 5 to 11. The immune response was “robust” and “comparable” to that seen in 16 to 25 year olds who received a higher dose vaccine.
Moderna specifies that the participants in its clinical study will remain under surveillance for the next twelve months, and that the data communicated is subject to change. The laboratory also conducts parallel clinical trials on even younger children, between 6 months and 5 years old.