Green light to Pfizer-Biontech's Covid vaccine for children between 5 and 11 years old. This was established by EMA, the European medicines agency during an extraordinary meeting, held in advance of the previously set date.
According to the agency, Comirnaty's benefits in children outweigh its risks, especially in those at higher risk of serious infection. For this age group, however, the dose changes: it will be reduced to one third of that used in people aged 12 and over (10 micrograms versus 30). But "as in the older age group, it will be administered with two injections into the muscles of the upper arm, three weeks apart," explained the EMA in a statement.
After the opinion of the EMA, it is up to the Technical-Scientific Commission (Cts) of the Italian Medicines Agency (AIFA), comment on the matter. The Commission has been convened for next week, from 1 to 3 December. As anticipated by Minister Speranza, the administration of the vaccine to the under 12s could start in the third week of December.
The EMA's approval came after analyzing the results of a study conducted by Pfizer on almost 2 thousand children who showed no signs of previous infection. These children were divided into two groups: one received the vaccine, the other a placebo. Comparing the results showed that the vaccine was 90,7% effective in preventing symptomatic infection. Side effects are similar to those seen in people 12 years of age and older: arm pain, tiredness, headache, muscle pain, and chills.
Italian experts consider the vaccination of the youngest to be crucial in order to stop the fourth wave of Covid 19. As for the other countries, the French should start vaccinating the 5-12 age group no earlier than 2022, while the United States they have already immunized three million children. Instead, Israel e Canada they started the vaccination campaign for under 12s earlier this week.
In the meantime, the color changes for the regions are starting in Italy. The first is the Friuli-Venezia Giulia which from Monday 28 November returns to yellow zone, moving forward by one week the tightening on no vax provided for by the new decree anti-Covid. The province of Bolzano is also traveling towards the yellow zone: the incidence has already exceeded the limit since the beginning of November, as well as intensive care (10%) and the medical area (15%).
