Green light from the European drug agency Ema to the anti-Covid protein vaccine Nuvaxovid from the American Novavax also in adolescents aged 12 to 17 years. The product is already approved in the EU for the over 18s, and now EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending its indication to include 12-17 year olds. For this age group the vaccine will be the same as that used in adults, which involves two intramuscular injections 3 weeks apart. The main study, conducted on over 2,200 teenagers aged 12 to 17 – explains the European regulatory body – shows that the immune response induced by Nuvaxovid in adolescents, measured as the level of antibodies against Sars-CoV-2, is comparable to that obtained in young adults between 18 and 25 years old. The trial was carried out when it dominated the Delta variant of the pandemic coronavirus, and indicated that the vaccine was nearly 80% effective in preventing infection. The most common side effects in adolescents, for the Novavax vaccine, are mostly similar to those seen in over 18. They include pain, redness and swelling at the injection site – Ema lists – headache, muscle and joint pain , fatigue, general malaise, vomiting and fever. Fever is more common in adolescents than in adults. These are usually mild or moderate symptoms, which improve within a few days of the injection. The CHMP considered that “the benefits of Nuvaxovid in adolescents aged 12-17 outweigh the risks”.
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