The Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has recommended granting an extension for the vaccine against COVID-19 Spikevax (formerly known as COVID- 19 Vaccine Moderna) to include use in young people aged 12-17 years . The vaccine was already authorized in people over 18 years of age.
The use of the Spikevax vaccine in this age group will be the same as in those over 18 years of age with the administration of two injections in the muscles of the upper part of the barzo, with four weeks of difference between both doses .
The effects of Spikevax have been investigated in a study involving 3,732 children between the ages of 12 and 17 . The study is ongoing and is being developed in accordance with the Spikevax Pediatric Investigation Plan (PIP), agreed to by the EMA Pediatric Committee (PDCO).
The data from the study reveal that the vaccine has produced a comparable antibody response in young people between 12 and 17 years of age to that generated in adults between the ages of 18 and 25. None of the 2,163 children who received the vaccine developed COVID-19 , compared with four of the 1,073 who received placebo. These results have allowed the CHMP to conclude that the efficacy of serum in young people between 12 and 17 years of age is similar to that reported by adults.
The most common side effects in these young people are similar to those reported by people over 18 years of age. These include pain and swelling at the injection site , headache , muscle and joint pain , enlarged lymph nodes , chills , nausea , vomiting, and fever . These effects are usually mild or moderate and improve within a few days of vaccination.
The CHMP has noted that due to the limited number of children and adolescents included in the study, the trial could not have detected new rare side effects or estimated the risk of side effects such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart muscle). the membrane that surrounds the heart).
However, the overall safety profile of Spikevax determined in adults was confirmed by the study of adolescents. Therefore, the CHMP considered that the benefits of the vaccine in the 12-17 year age group outweigh the risks , particularly in those with conditions that increase the risk of severe COVID-19.
The safety and efficacy of the vaccine will continue to be monitored in both children and adults using data from Member State vaccination campaigns through the European Union pharmacovigilance system, ongoing studies and European authorities.