Green light from the European medicines agency Ema to the use of Pfizer-BioNtech's Covid vaccine in children between the ages of 5 and 11.
The vaccine is already approved for use in adults and children 12 years of age and older.
Now the ruling of the Italian Medicines Agency (Aifa), already convened according to what is learned from 1 to 3 December, will follow closely, and vaccinations will be able to start after the delivery of pediatric doses, reduced compared to those of adults, from part of the company in the third decade of December.
Health Minister Roberto Speranza, who invited families to trust doctors and pediatricians yesterday, indicated the stages of the extension of the vaccination campaign to children.
The government is also ready "for a communication campaign - explained Speranza - and the indication we will give will be to listen to pediatricians and doctors".
For the little ones, however, the Undersecretary of Health Pieropalo Sileri specified, "there is no green pass or obligation".
The issue of compulsory vaccination for children, however, remains open and the president of AIFA, Giorgio Palù, notes that "when we talk about the anti-Covid vaccination obligation for children, the risk-benefit ratio must be weighed and I would consider it carefully, as the obligation of vaccination for other categories. So if the obligation must be generalized it is a careful risk-benefit assessment but this is in keeping with the trend of the epidemic. It is an assessment that will be made progressively ". The clarification, however, is that "the risk of infection is becoming much higher than the risk of the vaccine".
Currently, ten compulsory vaccinations are already foreseen in Italy for the 0-16 year-olds, as established by the decree law of 7 June 2017.
Long Covid disorders are currently detected in about 10-20% of pediatric cases of SarsCoV2 virus infection.
The Italian Society of Pediatrics has repeatedly reiterated the opportunity and benefits of anti-Covid vaccination also for the age group 5-11.
DOSES AND ADMINISTRATIONS - In children between the ages of 5 and 11 - the Ema explains today - the dose of Comirnaty, the vaccine from Pfizer-BioNtech, will be lower than that used in people aged 12 years or older (10 µg compared to 30 µg). But as in the older age group, it will be given as two injections into the muscles of the upper arm, three weeks apart.
EFFECTIVENESS - The efficacy of Comirnaty has been calculated in nearly 2,000 children aged between 5 and 11 who did not show signs of previous infection. These children received the vaccine or a placebo (a dummy injection). Of the 1,305 children who received the vaccine, three developed Covid compared to 16 of the 663 children who received the placebo. This means that, in this study, the vaccine was found to be 90.7% effective in preventing symptomatic Covid.
UNDESIRABLE EFFECTS - The most common side effects in children aged 5 to 11 years are similar to those in people aged 12 years and older. They include pain at the injection site, fatigue, headache, redness and swelling at the injection site, muscle pain, and chills. These effects are usually mild or moderate and improve within a few days of vaccination.
The EMA therefore concluded that the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid.
The safety and efficacy of the vaccine in both children and adults will continue to be closely monitored. The EMA will now send its recommendation to the European Commission, which will issue a final decision.
(Unioneonline / vl)
