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Why did Ema authorize the “old” Covid vaccines for children aged 6 months and over?

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Why did Ema authorize the

EMA's decision to authorize the 'old' Covid vaccines for children aged 6 months and up is being discussed. The reactions of Bassetti, Garattini and Crisanti

Double approval yesterday by the European Medicines Agency (Ema). Green light to the 'old' anti Covid vaccines from Pfizer / BioNTech and Moderna for children aged 6 months and also for theOmicron 4 and 5 adapted vaccine from Moderna from 12 years.

But the first decision raises doubts and perplexities.

YES TO ANTI COVID VACCINES OVER 6 MONTHS

Yesterday the EMA authorized the use of outdated vaccines – the first, containing only the original strain of the Sars-CoV-2 virus – from Pfizer / BioNTech (Comirnaty) and Moderna (Spikevax) even in very young children, children aged 6 months up.

In particular, the Committee recommended including use in children aged 6 months to 4 years for Comirnaty and 6 months to 5 years for Spikevax. Until now, the two vaccines were approved in both adults and children, starting at age 5 and 6, respectively.

HOW THEY WILL BE ADMINISTRATED

The doses will obviously be lower than those authorized for other age groups. Pfizer / BioNTech vaccine can be given as a primary vaccination consisting of three doses of 3 micrograms each. The first two are injected three weeks apart, followed by a third dose given at least 8 weeks after the second.

Spikevax, on the other hand, can be given as a primary vaccination consisting of two doses (of 25 micrograms each), four weeks apart.

THE REACTIONS OF VIROLOGISTS

Matteo Bassetti, virostar and director of the Infectious Diseases department of the San Martino hospital in Genoa, is perplexed and absolutely opposed to the decision of Ema Matteo Bassetti, who on Twitter advises against anyone:

The Ema says that Pfizer / BioNTech and Moderna's originally authorized vaccines are both effective in preventing Covid-associated serious illness, hospitalization and death, however, yesterday it authorized that of Moderna from the age of 12, updated to Omicron 4 and 5, which joins the others already available .

The comment by Silvio Garattini, president of the Mario Negri Irccs Institute for Pharmacological Research, was more moderate: "If the European Medicines Agency has approved [these two products, ed .] It means that there are studies that have documented that this vaccine also in young children it is effective and evidently well tolerated. Otherwise it would not be possible ”.

“It's about seeing how to use it – he explained -. What is important is that it is available. And if we have children with high risk factors, it may be reasonable to do so. No longer a mass campaign, therefore, and I don't think there will be. But a use aimed at the most fragile ".

And in May, Andrea Crisanti, director of the Department of Molecular Medicine of the University of Padua, speaking of the option of anti Covid vaccines also for children from 6 months, stated : "I think it would be a waste of money because they don't run particular dangers ".

FORECASTS AND SKEPTICISM

However, as Repubblica writes, great adhesion from parents is not expected given that pediatric coverage with two doses among children aged 5 and 11 is 35%. Better that among the boys of the age group 12-19, which reaches 83%.

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/perche-ema-ha-autorizzato-i-vecchi-vaccini-anti-covid-per-i-bambini-dai-6-mesi-in-su/ on Thu, 20 Oct 2022 12:59:35 +0000.