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The biotech company Moderna Inc. announced that it will soon begin testing on teenagers one candidate vaccine (MRNA-1273) against SARS-CoV-2 coronavirus. Specifically, they will participate in the study, which brings together Phase 2 and Phase 3 – Three thousand young people between 12 and 17 years old, all in good health. It will be an investigation aimed primarily at determining the safety and the reactogenicity of the drug, or the appearance of any Adverse reactions and the severity of it. At Clinical studies Conducted to date in the healthy adult population (mainly in the age group 18 to 55 years), no serious adverse reactions have been reported, but mild and moderate side effects similar to those of other common vaccines (fatiguepain at the injection site temperature and so). However, according to some experts in an editorial in Science, these common symptoms would be more “intense” than those of a municipality flu shot, without representing a danger to the health of patients.
Moderna Inc.’s new vaccine study will be especially valuable in dating data on effects on children / adolescents vaccinations anti COVID they are scarce. It is no coincidence that the Joint Committee on Vaccination and Immunization (JCVI), the British Joint Vaccination and Immunization Committee, has decided not to recommend vaccination in children and adolescents under 16 years of age with the preparation “BNT162b2“This is the vaccine developed by the American pharmaceutical giant. Pfizer in collaboration with the German biotechnology company BioNTech, the first to be approved (in emergency use) in West. The lack of data has led the JCVI to also advise against vaccination for pregnant women. It is also likely that other vaccines in the process of being approved by regulatory authorities (including that of Moderna Inc.) will not be recommended for these population groups, of course, until there are data on efficacy and safety for all.
Moderna Inc. has not yet begun recruiting youth for vaccination, as the New York Times reported, but it will begin shortly. The three thousand will be subject to a double injection, with the second taking place one month after the first. The study will be randomized with placebo (a saline solution) and in double-blind, the “gold standard” of scientific research. The mRNA-1273 vaccine, developed with experts from the NIAID, from studies it has shown an efficacy of 95 percent, and it is believed that even in young people the same level of protection can be determined, but it will be essential to verify its safety. As specified in the New York Times by Dr. William Schaffner, an infectious disease specialist at Vanderbilt University and a vaccine consultant for the Centers for Disease Control and Prevention (Centers for Disease Control and Prevention), children and adolescents have immune system more reactive, which can trigger more intense reactions than in adults. According to some experts, Moderna and Pfizer vaccines can cause more intense effects due to nanoparticles on which they are based, within which is the genetic information (Messenger RNA) that pushes our body to produce viral proteins of SARS-CoV-2 and, therefore, to stimulate the immune response. Therefore, checking for reactogenicity in children is essential before proceeding with mass vaccinations. The details of the research “A study to evaluate the safety, reactogenicity and efficacy of the mRNA-1273 vaccine in adolescents aged 12 to <18 years to prevent COVID-19 (TeenCove)" have been published on the official platform ClinicalTrial.
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