Sicily suspends the AstraZeneca vaccine as a precaution under the age of 60. The decision emerges from a circular that bears the signature of the general manager of the regional department for health activities and interim epidemiological observatory of the Sicilian Region Mario La Rocca.
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The reference refers to the administration of the first doses because, writes La Rocca, «however, in the absence of contrary scientific evidence, the possibility of proceeding with the inoculation of the second dose of vaccine to those entitled to it remains firm».
Virologist Andrea Crisanti is more prudent, explaining: «The problem of boostering is now posed for children who have received the first dose of AstraZeneca vaccine. I would wait ». “As for the second dose with a different vaccine – he underlines – I keep repeating that without data you cannot vaccinate. From an immunological point of view there would be no contraindications to do the second dose with a different vaccine, but since there are no data I remain of the idea that we must have them in hand before proceeding. While I personally don’t think there would be any risk whatsoever, it’s a matter of not being a sorcerer’s apprentice. This is not the banana republic. Who takes responsibility for boostering a different vaccine without enough data? We must be consistent with the method ».
The expected opinion of the Technical Scientific Committee (CTS) on the use of the AstraZeneca (AZ) anti-Covid vaccine for young people aged 18 and over will consider the indications already given by the Ministry of Health and the Italian Medicines Agency Aifa, or that for this immunizer a preferential use is recommended for subjects over-60. In these hours there would be a convergence to “recommend” the Anglo-Swedish vaccine to this category.
A decision that reopens the debate on the possibility of administering a different dose (so-called ‘heterologous’) to those under 60 who received the first with Astrazeneca and on the evaluation of the timing of the recall. The experts are now making a summary of their opinions which – as far as has been learned – would go towards an overall reorganization of the vaccination campaign, therefore also of the administration of the different types of vaccines according to age, in light of the changed epidemiological framework. But the decisions to be taken will still be entirely up to politics. Health Minister Roberto Speranza himself anticipates the line, but in the meantime it is ‘chaos’ in the Regions, which are proceeding in no particular order, while various experts indicate to complete the vaccination cycle with AstraZeneca anyway if a first dose has already been had. .
The question arose following the open days organized by various Regions with the AZ vaccine and also open to young people from the age of 18, and after two cases of rare thrombosis occurred in young women in recent weeks. In this regard, responding to the question time in the Senate, Speranza stressed that on April 7 the ministry, with a circular, “has already recommended the preferential use of the AZ vaccine to over-60s and Aifa reiterated that the benefit profile- risk is more conducive to increasing age “. These assessments, he anticipated, “will certainly be considered in the next CTS opinion”. However, all vaccines are “safe and effective”, the minister specified.
Pending the new ruling of the CTS, some Regions have already proceeded in recent weeks to the administration of the AZ vaccine to the under-60s (for example Tuscany, Lazio, Calabria, Sicily, Abruzzo). The first dose of AZ was administered to over-18s in some Regions also by organizing open days (for example Liguria, Lazio, Campania, Basilicata, Calabria and Sicily), while others (such as Veneto) have not started any open days. To date, a planned open day has been revoked in Naples and Sicily has suspended the Anglo-Swedish vaccine as a precaution under the age of 60. Instead, the open week until next Sunday – always with the AZ vaccine – organized in Lazio remains confirmed. The problem is linked to the question of the disposal of AZ doses, however various Regions have decided to stick to the indication of Aifa and the ministry.
“We – affirmed for example the councilor for health of Emilia-Romagna, Raffaele Donini – preferably administer to 60-year-olds, then if we have to keep doses in the fridge without using them we ask ourselves how to use them, always in compliance with AIFA prescriptions. “. Piedmont is on the same line. Another theme is that of vaccinations for tourists, a hypothesis to which Veneto, ER, Lombardy and Valle d’Aosta open, as long as there are enough doses. But on the vaccination of adolescents who had the first dose with Astrazeneca now remains the crux of the booster, that is the question of which immunizer to use for the second dose in young people already vaccinated with the same vaccine.
On this point, various experts say they are in favor of completing the vaccination cycle with AZ anyway. «At this moment, whoever has taken the first dose with a vaccine should take the second dose with the same vaccine. This is because the experimental tests that led to the approval of these vaccines were carried out on the administration of two doses for the same vaccine and demonstrated adequate conditions of safety and protection », said Walter Ricciardi, consultant to the Minister of Health. On the same line the virologist Fabrizio Pregliasco and the infectious disease specialist Massimo Andreoni, according to whom the rare adverse events occurred essentially after the first dose and the risk is very low.
Confirmation comes from the 5th AIFA Pharmacovigilance Report on Covid Vaccines: the cases of intracranial and atypical venous thrombosis in subjects vaccinated with AZ are in line with what has been observed at European level, i.e. 1 case for every 100,000 first doses administered and mainly in people with less than 60 years. No cases were reported after the second dose. Overall, for all vaccines, there are 66,258 reports of adverse events out of a total of 32,429,611 doses administered (reporting rate of 204 per 100,000 doses), of which 90% for non-serious events. Most concern Pfizer’s Comirnaty (71.8%), the most used (68.7% of the doses administered).