EMA Authorizes the Use of Moderna’s COVID Vaccine in Children 12+

July 26, 2021

This past Friday, the European Medicines Agency (EMA) authorized the use of Moderna’s COVID-19 vaccine in children 12+ years of age. This will be the second vaccine manufacturer to be authorized for use in those 12+, alongside Pfizer. Children will be given two shots, four weeks apart, which is the same dosing schedule for adults.

The European Commission will take the next steps to approve if and when the vaccine will be used in each of the E.U.’s countries. As of now, more than a dozen E.U. countries have been vaccinating children between the ages of 12 and 17 with the Pfizer vaccine.

The EMA’s decision was influenced by an ongoing pediatric study involving 3,732 children (2,163 of which received the vaccine and 1,569 receiving a placebo) showing that the Moderna vaccine “produced a comparable antibody response in 12 to 17-year-olds to that seen in young adults aged 18 to 25 years (as measured by the level of antibodies against SARS-CoV-2).” None of the 2,163 children who received the COVID-19 vaccine contracted the virus.

The Committee for Medicinal Products for Human Use (CHMP) noted that, at this time, “due to the limited number of children and adolescents included in the study, the trial could not have detected new uncommon side effects or estimated the risk of known side effects such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart).”