Magrini: «91% of vaccinated children do not develop symptoms. But we need close supervision “

from Margherita De Bac

The Director General of the Aifa Agency: «Mild and short side effects».

«Safe and effective. We have carefully examined all the documentation delivered by the European agency Ema. There are no elements of uncertainty ». Nicola Magrini general manager of the Italian drug agency Aifa Wednesday afternoon, with the technical-scientific committee of the institution, he went through the screening the dossier on Comirnaty, the vaccine for 5-11 years. It was not an authorization issued automatically.

What did you read in the dossier?

«In the 5-11 year old population, vaccination showed 91% efficacy in reducing symptomatic Sars CoV-2 infections compared to placebo. A similar immunological response compared to 16-25 year olds. In analogy to what happens for adults, it is likely that the level of protection from hospitalization and death could be even higher».

What about the serious effects?

“No serious adverse events emerged. In 3100 children who received the vaccine were not observed, at least in follow up now available, vaccine-related serious adverse events nor episodes of myocarditis or pericarditis, heart inflammation. The list of adverse events is reassuring: they are minor and pass quickly ».

Is the number of children enrolled in the studies presented by the Pfizer company sufficient to prove the safety of a drug?

«Evidence of efficacy refers to 1518 vaccinated and 750 who received placebo. The safety study, on the other hand, involved a further 1591 immunized with Comirnaty, the other 788 with placebo. So Pfizer’s compound was tested with positive results on 3,100 small volunteers (read here about children and tests

No reservations?

«Extremely rare events, in the order of 1 every 10 thousand or 50 thousand, are obviously not evaluable in clinical studies but only in contexts of worldwide use, of millions of doses administered. Here because pharmacovigilance activity is fundamental»

Are males and females equally represented in the study?

“There is an equal distribution between the two genders: 52% boys, 48% girls”

What do the data collected in the field in the US and Israel add?

«Israel started vaccinating babies last week and we don’t have the results yet. In the US they started a month ago, 3.3 million children have already injected predominantly with one dose. No warning signals so far ».

What is expected for the healed children?

“There are no specific indications. 10% of the children included in the study had had the infection, the antibody response was equally good. No particular safety problems compared to peers who had not had the infection “

Is there no need to perform serological tests before the vaccine?

«It can be confirmed that no antibody test is required. It is reassuring given that the infection may have had an asymptomatic course and not been diagnosed “

Will the healed have to receive one or two doses?

«The EMA technicians have not expressed themselves on this. According to the American scientific body CDC, the complete vaccination schedule can be easily predicted ”.

Will only pediatricians be vaccinating children?

«The pediatricians but also the operators of the vaccination centers where it would be advisable to organize suitable courses for the age of 5-11, let’s say orange paths, identified by the cap of this color that distinguishes the pediatric dose

, reduced by three times compared to that for adults»

December 2, 2021 (change December 2, 2021 | 23:09)

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Magrini: «91% of vaccinated children do not develop symptoms. But we need close supervision ”