Modern vaccine, Ema: green light for 12-17 year olds

Green light from the European drug agency Ema to the anti-Covid Spikevax vaccine * from the American Moderna also in adolescents aged 12 to 17 years of age. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting an extension to the use of the product, initially authorized for the over 18. It is the second Covid-19 vaccine approved for the over 12, after that 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 apart. The effects of Moderna’s vaccine – explains the EU regulatory body – were evaluated in a study involving 3,732 children between the ages of 12 and 17. A trial still ongoing, conducted in accordance with Spikevax’s Pediatric Investigation Plan (Pip), which was agreed with the Ema Pediatric Committee (PDCO). In the study, the vaccine produced “in 12-17 year olds an antibody response comparable to that observed in young adults between 18 and 25 years of age, measured by the level of antibodies against Sars-CoV-2 – reports the agency – Furthermore, none of the 2,163 children who received the vaccine developed Covid-19, compared to 4 of the 1,073 who were given a placebo “. The CHMP therefore concluded that “the effectiveness of Spikevax from 12 to 17 years of age is similar to that shown in adults”. The most common side effects in the 12-17 year old age group are also “similar to those seen in people of age 18. They include pain and swelling at the injection site – lists Ema – fatigue, headache, muscle and joint pain, swollen lymph nodes, chills, nausea, vomiting and fever. These effects are usually mild or moderate, and improve within a few days of vaccination “. The CHMP states that, “due to the limited number of children and adolescents included in the study, the trial could not have detected new uncommon side effects, or estimated the risk of known side effects of” Covid-19 mRna vaccines “such as myocarditis. (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) “. However,” the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study, “so the Committee considered that” the benefits of vaccine in children between the ages of 12 and 17 are greater than the risks, particularly “in children” with conditions that increase the danger of serious Covid-19. “The safety and efficacy of the vaccine in children and adults – guarantees Ema – will continue to be closely monitored in the vaccination campaigns launched in the Member States, through the EU pharmacovigilance system, and with ongoing and adjunctive studies by the manufacturer and the European authorities.