• Green light from Ema to Pfizer vaccine for 12-15 year olds

  • Usa, Moderna starts testing the vaccine on adolescents

  • Usa, from Thursday Pfizer vaccine also to children from 12 years old

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May 29, 2021 The green light requests for Pfizer / BioNTech's anti-Covid vaccine in

the age groups 2-5 and 5-11 years

could arrive in September on the desks of various regulatory bodies

.



The two companies announce this by commenting on the first authorization obtained in the European Union for their shield product for adolescents. Yesterday the European Medicines Agency EMA announced the green light for the 12-15 year range.       



"The pediatric study that is evaluating the safety and efficacy of Pfizer / BioNTech's Covid vaccine in children between 6 months and 11 years is ongoing," the note reads. The two companies expect to have definitive readings and, based on the data generated, to be able to "submit an application for authorization for emergency use, for example in the US, or request for a change to the conditional authorization for trade, for example in Europe, for the two cohorts 2-5 years and 5-11 in September ". While the reading of the results and the submission of a green light request for the cohort of children, between 6 months and 2 years, "is expected in the fourth quarter" of the year, therefore between October and December.



Since last March Pfizer has been administered to the first healthy children in a global phase 1/2/3 study to evaluate safety, tolerability and immunogenicity. The roadmap calls for the inoculation of two doses approximately 21 days apart in three age groups: children 5 to 11 years, 2 to 5 years and 6 months to 2 years. 



"We appreciate EMA's comprehensive and efficient review of the data from our clinical trial", added Pfizer's chief executive, "and we look forward to seeing more people across Europe immunized as a result of the official decision." This decision is based on data from a phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. The recruited boys received two doses of the vaccine and the trial results, published in the 'New England Journal of Medicine' on May 27, showed "vaccine efficacy of 100% in participants with or without prior Sars-CoV infection. 2 and robust antibody responses, "the two pharmaceutical companies recall. In the study, the vaccine was "generally well tolerated - the note reads - Participants will continue to be monitored for long-term protection and safety for another two years after the second dose. "



In the meantime, after the decision of the EMA on the administration of Pfizer-BioNTech for the age group between 12 and 15 years, eight and a half million Italian adolescents will fully enter the vaccination campaign against the Covid. The president of the Italian regulatory body Giorgio Palù announced that Aifa will receive the authorization in a couple of days. "It is an important novelty, also considering the reopening of schools in September. If we continue to be cautious, with the epidemiological picture showing encouraging signs, we can look to the future with more confidence", commented Health Minister Roberto Speranza.   



Moderna is also working in the US on the vaccine for young people and has enrolled 3,000 children between 12 and 17 years of age for testing.