Aifa approves the Moderna vaccine for adolescents aged 12 to 17

Aifa approves the Moderna vaccine for adolescents aged 12 to 17

It will be given in two doses, spaced 28 days apart, as for adults. Moderna is the second vaccine to receive the ok for adolescents after Pfizer-BioNTech

Photo: CDC / Unsplash After the recent positive opinion expressed by the European Medicines Agency (Ema), it also comes from the Italian Agency of the drug (Aifa), the approval to extend the indication of use of the Spikevax vaccine, from the Moderna biotechnology company, for the age group between 12 and 17 years: it will be administered, as in adults, in two doses, to 28 days apart from each other. Already used for people over the age of 18, according to the Technical Scientific Committee of Aifa, the available data demonstrate the efficacy and safety of the vaccine even for subjects included in the younger age group. Before Spikevax, the only vaccine approved in Italy for adolescents was that of BionNtech / Pfizer.

mRna vaccines for adolescents

Before the approval of Spikevax, among vaccines authorized in Italy, therefore, only Comirnaty, the BionNtech / Pfizer vaccine, could be administered from 12 years of age. On May 31, AIFA extended the use of Comirnaty for the age group between 12 and 15, already approved for adults and adolescents from 16 years of age. Another vaccine is now available for children, which uses the same technology as that of BionNtech / Pfizer.

Moderna's vaccine, in fact, is an mRna vaccine, just like Comirnaty. Inside there is a molecule of messenger Rna that offers instructions to the cells of the organism into which it is injected to build the Sars-Cov-2 spike protein. Spike represents the connection through which the coronavirus can penetrate inside human cells. Once produced, the protein will be recognized by the immune system of the person who received the vaccine, in order to prepare them for possible Sars-Cov-2 infection.

The effects of Spikevax in boys

The approval comes following the evaluation of the available data by the Technical Scientific Committee of Aifa, which concluded that it is a safe and effective vaccine also for children. In particular, the EMA reports a study, agreed by the pediatric committee of the regulatory agency, which involved 3,732 children between the ages of 12 and 17. The data shows that Spikevax produced, in the age group analyzed, an antibody response comparable to that observed in young adults aged between 18 and 25 years. 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 the placebo. found in people 18 years of age and older, including pain and swelling at the injection site, fatigue, headache, muscle and joint pain, swollen lymph nodes, chills, nausea, vomiting and fever. These effects are generally mild or moderate and improve within a few days of vaccination.

Constant monitoring

Also regarding the safety profile, the Committee for Medicinal Products for Human Use ( Chmp) of the EMA agreed that Spikevax's determined in adults is confirmed in the adolescent study. Although in the study, due to the relatively small number of participants, it was not possible to estimate the risk of known but very rare side effects, such as myocarditis and pericarditis, "the CHMP considered that the benefits of Spikevax in children aged 12 and 17 years are greater than the risks, especially in those with conditions that increase the risk of serious Covid-19 ", reads the press release of the European regulatory agency.

We recall, in fact, that children and adolescents can develop a serious inflammatory disease, called Mis-C, which can cause vasculitis and organ inflammation following Sars-Cov-2 infection. However, the safety and efficacy of the vaccine (as with all medicines on the market) will continue to be closely monitored, in both children and adults, through the European Union pharmacovigilance system, and through other studies by the European Union. manufacturer and European authorities.

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