European Adolescents Eligible to Receive SpikeVax COVID-19 Vaccine

The European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously Moderna) to include use in adolescents aged 12 to 17 years.

The SpikeVax vaccine was authorized for use in people aged 18 and above in early 2021.

Spikevax works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA), which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus, which the virus needs to enter the body’s cells.

The vaccine efficacy of Spikevax has been investigated in a study involving 3,732 adolescents aged 12 to 17 years. 

The study showed that Spikevax produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years. In addition, none of 2,163 children receiving the vaccine developed COVID-19 compared with only four of 1,073 children given a placebo injection.

The CHMP noted that due to the limited number of adolescents included in the study, it 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).

The UK's Medicines and Healthcare products Regulatory Agency reported on July 14, 2021, there have been 17 reports of myocarditis, 20 reports of pericarditis following the use of COVID-19 Vaccine Moderna.

However, the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study. Therefore, the CHMP considered that the benefits of Spikevax in adolescents outweigh the risks, particularly those with conditions that increase the risk of severe COVID-19.

The safety and efficacy of this COVID-19 vaccine in both adolescents and adults will continue to be monitored across the Member States through the EU pharmacovigilance system and ongoing and additional studies by the company and by European authorities.

The European Medicines Agency is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.