The Technical Scientific Commission (Cts) of AIFA has approved the extension of indication of use of the Spikevax (Moderna) vaccine for the age group between 12 and 17 years, fully accepting the opinion expressed by the European Medicines Agency (EMA ). According to the CTS, in fact, the available data demonstrate the efficacy and safety of the vaccine even for subjects included in this age group. Spikevax – Ema recalls – is administered with 2 injections in the arm, 4 weeks (28 days) apart.
Only a few days ago the EMA (European Medicines Agency) gave the green light to the vaccine of the Modern American even in adolescents aged 12 to 17 years of age. The Ema Committee for Medicinal Products for Human Use (CHMP) has recommended granting an extension to the use of the product, initially authorized only for the over 18. It is the second Covid-19 vaccine approved by the EMA for the over 18s. 12, after that of Pfizer / BioNTech initially indicated for over 16s and then extended to 12-15 year olds. According to ‘Ema, Spikevax produced an antibody response comparable in young adults aged 12-17 years to that seen in young adults aged 18-25 (measured by the level of antibodies against Sars-CoV-2).
The most common side effects in the age group 12-17 are also “similar to those seen in people aged 18 and over. They include pain and swelling at the injection site – lists Ema – fatigue, headache, aches muscle and joint, swollen lymph nodes, chills, nausea, vomiting and fever. These effects are usually mild or moderate, and improve within a few days of vaccination. “
.