The American company Moderna said on Thursday that it had filed an application for authorization in the United States to be able to administer its vaccine against Covid-19 to children aged 6 months to 5 years.
This is the last age group not yet eligible for vaccination in the country, as well as in many others.
The file must now be examined by the American Medicines Agency (FDA), whose decisions are often referred to in the world.
A vaccine that protects “safely”
This vaccine “will be able to safely protect these children against SARS-CoV-2, which is so important to our ongoing battle against Covid-19, and will be especially welcomed by parents,” a statement said. Stéphane Bancel, the boss of Moderna.
Indeed, the effectiveness of the vaccine against symptomatic infections is 51% for babies from 6 months to less than 2 years old, and 37% for children from 2 to 5 years old, specified Moderna.
These results are very slightly different from the preliminary data published in March by the company, because this time they are only based on infections confirmed by a PCR test.
The dosage of this vaccine for infants and young children is reduced to 25 micrograms per injection, compared to 100 for adults. They are also expected to be given two doses.
The filing of the application will be complete next week, the company said, adding that similar applications were “in progress” with other regulatory agencies around the world.
Moderna before Pfizer
Pfizer is also due to file for approval soon for its own vaccine in children aged 6 months to under 6 years, but the timeline has been delayed by disappointing early results, which led the company to decide to test a series initial three doses and not just two.
Indeed, for these very young children, a dosage of only 3 micrograms per bite was chosen by Pfizer-BioNTech, but the immune response triggered after only two doses was then not sufficient.