The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given the green light to extend the authorization for the use of Comirnaty and Spikevax – the anti-Covid vaccines Pfizer and Moderna – even for children aged 6 months and over. The official EMA statement reads: “the committee recommended including use in children aged 6 months to 4 years for Comirnaty and use in children aged 6 months to 5 years for Spikevax” . The approval formula is the usual one: “the benefits outweigh the risks”. However, the clinical trials on which the approval is based are not available for consultation (“they will be presented in due course,” writes the EMA) and the pediatric vaccines in question have been tested against the original strain of SARS-CoV-2 today extinct and supplanted by the Omicron variant.
In Italy, out of a total of over 170 thousand deaths from Covid, only 39 fall into the 0-9 age group and the lethality rate, i.e. the percentage of deaths compared to the total of subjects tested positive, seems rather low for these individuals. In fact, in 2020 the lethality rate it was only 0.011%, while in the following years it decreased again, reaching the figure of 0,002%: all evidently in line with the emergence of variants, as is known less dangerous than the original strain. In addition, the percentages quoted relate to a wider age range than that of our interest and that the numbers would probably be even more derisory if only the youngest children were taken into consideration: these data, however, are difficult to extrapolate. in Italy, given that the same Higher Institute of Health refers only to the broader range of 0-9 years. According to UNICEF data, globally, children belonging to the 0-4 age group represent just 0.1% of the total number of subjects who died in concomitance with Covid positivity,
In addition to all this, it must be remembered that the green light came on the basis of two studies of which little is known. “The clinical trial data submitted by companies in their applications for the extension of the pediatric indication will be published on the Agency’s clinical data website in due course,” the agency’s website reads. What is known with certainty, however, is not only the fact that both vaccines in the new age groups will be administered with reduced doses compared to those foreseen for the others, but also that the latter involve several side effects even in younger children, including irritability, sleepiness and loss of appetite. According to the EMA, however, “for both vaccines these effects were generally mild or moderate and improved within a few days of vaccination”. Furthermore, according to the Agency, the vaccines despite the reduced doses would provide children aged 6 months and up with an immune response similar to that observed with the classic dose. However, this is a statement that one can hardly believe blindly, given the evidence that emerged in the recent past: the effectiveness of the Pfizer vaccine heralded for the age group immediately following that of our interest (5-11 years), is in fact, it was sunk by a recent study which revealed that it is much lower than previously thought.
Finally, in the light of what has been said so far, the utterances of some tele-virologists do not seem accidental, who have recently expressed themselves in reassuring tones on the Covid issue, also criticizing the new green light of the EMA. It will be enough to mention the director of the Infectious Diseases Clinic of the San Martino Polyclinic in Genoa, Matteo Bassetti, who not only has defined Covid as a “now flu-like” virus, but with regard to the Agency’s ok affirmed: «It could have been useful in 2020. Today is the wrong vaccine (it does not cover any omicron variant) at the wrong time. I would not recommend it to anyone ».
[di Raffaele De Luca]