AstraZeneca, Cavaleri: “Not at all stop, from Ema ok even to the calls”

The AstraZeneca vaccine “of course it is needed. And I am genuinely amazed to read in ‘La Stampa’ a message contrary to Ema and also to what I think personally. My words have been completely misrepresented”. This was explained by Marco Cavaleri, head of Vaccines and Therapeutic Products for Covid-19 of the European Medicines Agency Ema, in an interview with ‘Il Giornale’ in which he returns to what was stated in an interview with ‘La Stampa’ which had aroused the reaction of the ‘Ema on Twitter. Read also “The AstraZeneca vaccine is still needed a lot. The risk-benefit is positive. Ema’s position has not changed especially in the over 60s, the vaccine must be used with absolute tranquility because the protection is higher than 80% and the incidence of risk of thrombosis is reduced compared to young people, “he adds. But have adverse events grown? “According to the pharmacovigilance, the cases of thrombosis collected have increased in the face of massive use of the vaccine. And in England, we have heard that the incidence on the over 60s is one in 100 thousand, while in the young it is one in 60 thousand – specifies Cavaleri. – We are collecting data to have more precise estimates for age and sex. But there is a reduction in mortality due to these thrombosis thanks to treatments that seem effective. The beneficial risk is also valid in an epidemiological framework of low virus circulation, even if it gets thinner “. By now AstraZeneca scares even the over 60 who have to take the second dose. “For recalls the risk is lower than the already minimal one of the first dose – he highlights – Thrombosis after the second dose is very rare and does not cause concern at the moment. In England, adverse events can be counted on the fingertips”. Would you recommend the AstraZeneca booster to anyone who has already taken the first dose? “The second dose can be given to everyone. But countries can decide which way to go based on the availability of vaccines,” Cavaleri replies. The Italian government has decided to use Moderna or Pfizer. Do you share? “The choice of heterologous made by Italy and Germany has its own logic. Ema, however, can only formally authorize the exchange of vaccines only after the companies have submitted detailed dossiers”, he observes. So every country goes in no particular order? “Each state can decide independently how to manage the vaccines available. By the end of June, however, Ema will consider making a recommendation on heterologous after examining among others a well-designed English study on Pfizer that replaces AstraZeneca for the booster. “, replies Cavaleri. Are the studies in circulation sufficient for a prudential choice? “The preliminaries carried out in Spain and Germany are very small but show an initial safety profile and a satisfactory immune response.” Minister Speranza, only after the 18-year-old’s death, decided to limit the use of Astrazeneca. Too late? ” The cases of atypical thrombosis – continues Cavaleri – affect, even if rarely, especially young people, we have said it several times and we have provided supporting data. Each Member State is aware of Ema’s risk contextualization work. “Is Janssen also better to dedicate it only to the over 60s?” The available data are limited – remember – but based on that seen in the US, it is legitimate to consider in advance the risk in a similar way ». Speaking of risks, what is known about Pfizer-related myocarditis? “In Europe there have been about a hundred, most of the cases return on their own and are minor and concern young people up to 29 years old”, he observes. She has a thirteen year old son. Will he vaccinate him? “Yes, I will do it when in the Netherlands there is the possibility. Vaccinating adolescents is particularly useful in fragile subjects and also reduces the circulation of the virus and variants”, he remarks. Delta or Indian, how dangerous is it? “It has a good chance of spreading across Europe and we are concerned. However, based on the available data, two doses of the vaccine, not one, protect satisfactorily,” he concludes.