Green light of the European drug agency Ema for the anti-Covid Spikevax vaccine * of the American Moderna also in adolescents aged 12 to 17 years of age. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting an extension to the use of the product, initially authorized only for the over 18s.
This is the second Covid-19 vaccine approved for over 12s, after that of Pfizer / BioNTech initially indicated for over 16s and then extended to 12-15 year olds. Spikevax – Ema recalls – is administered with 2 injections in the arm, 4 weeks (28 days) apart.
Covid vaccine from 12 years old? The doubts of the parents and the answers of the pediatrician
by Elena Bozzola
“The study – reads the Ema note – showed that Spikevax produced an antibody response comparable in young people aged between 12 and 17 years to that observed in young adults aged between 18 and 25 years (measured by the level of antibodies against Sars-CoV-2). Furthermore, none of the 2,163 children who received the vaccine developed Covid-19 compared to four of the 1,073 children who were given a sham injection. These results allowed the Committee to human medicines to conclude that the efficacy of Spikevax in subjects 12 to 17 years of age is similar to that in adults. “
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