The trial of Pfizer-BioNTech’s Covid vaccine in children between the ages of 5 and 11 has ended. The American pharmaceutical company presented the data in a press release. The vaccine, it reads, produces a robust antibody response against the coronavirus. Compared to children over 12 and adults, children only need a third of the dose: 10 micrograms instead of 30. However, two injections will remain 21 days apart.
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Side effects are mild, similar to those in other age groups. The next steps require Pfizer and BioNTech to submit trial data to regulatory authorities: the US Food and Drug Administration in late September-early October and the European Medicines Agency about a month later. The vaccine, if the test is positive, will be used starting from the end of October in the United States (experts predict for Halloween) and, presumably, from the end of November in Europe.
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The regulatory authorities will carefully look at any cases of myocarditis: in the over 12s, 60-70 have been observed for every million injections with RNA vaccines. They all healed without complications in a couple of days, but obviously there is a lot of attention on this aspect. Vaccination of children is in fact considered more useful to society – to slow the spread of the virus in delicate pockets such as schools – than to individual children, where Covid rarely produces serious symptoms, but the reopening of schools in the United States has caused a big wave in the pediatric age, with the closure of over 1,500 institutes.
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In Pfizer-BioNTech tests, approximately 4,500 children between 6 months and 11 years participated in the trial in the USA, Finland, Poland and Spain. For now, the companies have released the results between 5 and 11 years. Between November and December, the data will also arrive, divided into two tranches, on the age groups 2-5 years and then 6 months-2 years. Both received an even lower dose: 3 micrograms. Moderna will also shortly present the results of its tests on children. So far only Israel has immunized children between 5 and 11 years old outside the trial, but only if they are particularly fragile and after authorization granted on a case-by-case basis by the Ministry of Health.
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