EMA Committee recommends approving the Moderna vaccine for children aged 6 to 11 years

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that the indication of the vaccine against COVID-19 of Moderna to include its use in children aged 6 to 11 years.

The dose of Moderna’s vaccine in children 6 to 11 years of age will be lower than that used in people 12 years of age and older. As in the older age group, the vaccine is given as two injections into the muscles of the upper arm, four weeks apart.

A main study in children aged 6 to 11 years showed that the immune response to the lowest dose of Moderna’s vaccine (50 ug) was comparable to that seen with the highest dose (100 ug) in children aged 18 to 25 years depending on the level of antibodies.

The most common side effects in children 6 to 11 years of age are similar to those in children over 12 years of age. These include vomiting, swollen or tender lymph nodes under the arm, fever, and muscle and joint pain. “These effects are usually mild or moderate and improve within a few days of vaccination,” clarifies the EMA.

Evidence indicates that the efficacy and safety of Moderna’s vaccine in children 6 to 11 years of age are “similar” to that in adults. Therefore, the CHMP concluded that the benefits of Moderna’s vaccine in this age group “outweigh the risks, especially in those with conditions that increase and

In any case, the European regulatory body has clarified that the safety and efficacy of the vaccine, both in children and adults, “will continue to be closely monitored as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies by the company and by authorities. European”.

The CHMP will now send this recommendation to the European Commission, which is responsible for issuing a final decision. “The CHMP recommendation to authorize the use of our vaccine in children aged 6 to 11 years in Europe is an important milestone. It reveals the it helps our children to be safe and to lead a normal school and family life. We are grateful to the CHMP for their thorough review of our submission and look forward to an authorization decision from the European Commission.”commented the CEO of Moderna, Stéphane Bancel.

On the other hand, as announced by Moderna, the EMA has also recommended updates in the use of the vaccine. Now, the 50 ug booster dose, indicated for people 18 years of age and older, is recommended at least three months after the second dose. This period has been shortened compared to the previously approved six months.

The changes also include the possibility of administering a heterologous (mixed) booster dose, after completing the primary vaccination with another licensed COVID-19 vaccine.