EMA recommends approving Spikevax COVID-19 vaccine for adolescents

Spikevax, previously COVID-19 Vaccine Moderna, has been recommended for approval for use in children aged 12 to 17 years by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP). The messenger RNA (mRNA) vaccine is already authorised for use in people aged 18 and above.

The indication extension was based on the results of a study that evaluated the use of the Spikevax vaccine in 3,732 children aged 12 to 17 years, carried out in accordance with Spikevax’s paediatric investigation plan (PIP), which has been agreed by the EMA’s Paediatric Committee (PDCO).

The study found that Spikevax 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 anti-SARS-CoV-2 antibody titre). In addition, none of 2,163 children receiving the vaccine developed COVID-19 compared with four of 1,073 children given placebo. From this data, the CHMP concluded that the efficacy of Spikevax in 12- to 17-year-olds is similar to that in adults.

The most common side effects in the trial included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting and fever. These are similar to the side effects reported for adults and are usually mild or moderate, improving within a few days of vaccination.

The CHMP did note that the limited number of children and adolescents in the study means 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). However, the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study and thus the CHMP concluded that currently the benefits of Spikevax in children aged 12 to 17 outweigh the risks, in particular in those with conditions that increase the risk of severe COVID-19.

The use of the Spikevax vaccine in children from 12 to 17 years of age will be the same as in people aged 18 and above; two injections in the muscles of the upper arm given four weeks apart.

The safety and efficacy of the vaccine in both children and adults will continue to be monitored as it is used in vaccination campaigns across European Union (EU) Member States, through the EU pharmacovigilance system and ongoing and additional studies by Moderna and European authorities.