EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in adolescents aged 12 to 17 years. The vaccine, developed by Novavax CZ, a.s., is already approved for use in adults aged 18 and above.

The use of the vaccine in adolescents is the same as in adults, with two injections given in a muscle, three weeks apart.

A main study including over 2,200 children aged 12 to 17 years is being carried out in accordance with the paediatric investigation plan (PIP) for the vaccine, which was agreed by EMA's Paediatric Committee (PDCO).

This trial showed that the immune response to Nuvaxovid in adolescents, which was measured as the level of antibodies against SARS-CoV-2, was comparable to the response in young adults aged 18 to 25 years (who were part of the main study used to assess effectiveness of the vaccine in adults). The trial was carried out when the SARS-CoV-2 Delta variant was dominant and showed that the vaccine was almost 80% effective at preventing COVID-19; six out of the 1,205 adolescents who received Nuvaxovid developed COVID-19 compared to 14 out of 594 who received placebo (dummy injections). The CHMP considered that these results are in line with those seen in adults.

The most common side effects in adolescents are mostly similar to those in people aged 18 and above. They include tenderness, pain, redness and swelling at the injection site, headache, muscle and joint pain, tiredness, generally feeling unwell, feeling sick or vomiting and fever. Fever is seen more frequently in adolescents than in adults. These effects are usually mild or moderate and improve within a few days of vaccination.

CHMP therefore considered that the benefits of Nuvaxovid in adolescents aged 12 to 17 outweigh its risks.
The safety and effectiveness of the vaccine in both adolescents and adults will continue to be monitored closely as the vaccine is used in vaccination campaigns across the Member States, through the EU pharmacovigilance system and ongoing and additional studies by the company and by European authorities.