EMA Authorizes Pfizer Vaccine in Adolescents 12-15 Years

It seems that one of the population sectors that for the moment was not included in the vaccination plan against Covid-19, will finally be included in the whole of Europe, after the European Medicines Agency has given the go-ahead to the Pfizer vaccine in adolescents 12-15 years of age. A vaccination that could also reach Spain coinciding with the start of the 2021-2022 school year.The EMA authorizes the Pfizer vaccine in adolescents between 12 and 15 years of age The Pfizer-BioNTech anti-Covid vaccine will also be applied in Europe for the group of age between 12 and 15 years, as it has been applied in the United States for weeks. This has been announced after the green light of the European Medicines Agency (EMA) for the administration of serum for children. “It will depend on each Member State whether or not to administer it and when to use the Pfizer-BionTech vaccine for adolescents” explained Marco Cavaleri of the EMA. The recommended use for adolescents will follow the line adopted for adults, with the application of two doses to be administered at an interval of at least 3 weeks. At the moment from Spain the vaccination plan that has been applied since December is being followed, giving priority to those sectors of the population most at risk from the coronavirus. Currently and facing the month of June, vaccination will begin for the age range between 40 and 49 years, so that the vaccination for adolescents now approved would not arrive at least until the beginning of September, something that if so would be good news already that the new school year 2021-2022 could begin with a good number of vaccinated students.The Ema study In the study carried out by the EMA, the immune response to Comirnaty (the name of the vaccine from Pfizer-BioNTech) in the 12-15 year age group was shown to be comparable to the immune response in the age between 16 and 25 years. The efficacy of Comirnaty has been estimated in about 2,000 children, between 12 and 15 years old, who did not show signs of previous infection. They received the vaccine or a placebo, without knowing which one they were given. Of the 1,005 children who received the vaccine, none developed Covid, compared to 16 of 978 children who received the sham injection. This means that, in this study, the vaccine was 100% effective in preventing the virus (although the actual rate could be between 75% and 100%). The most common side effects in children 12-15 years of age are similar to those of people 16 years of age and older. They include injection site pain, fatigue, headache, muscle and joint pain, chills, and fever. These effects are usually mild or moderate and improve within a few days of vaccination. The EMA concluded that the benefits of serum in this age group outweigh the risks; however, it was noted that due to the limited number of children included in the study, the study could not have detected rare side effects. The EMA safety committee is currently evaluating very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) that have occurred after vaccination with Pfizer, mainly in people under the age of 30 years. There is currently no indication that these cases are due to the vaccine and the EMA is closely monitoring this problem.Despite this uncertainty, the EMA considered that the benefits of Pfizer serum in children 12 to 15 years old outweigh its risks, particularly in children with conditions that increase the serious risk of Covid-19. However, the safety and efficacy of the vaccine in both children and adults will be closely monitored.