A precautionary choice, that of the pharmaceutical company that produces the vaccine Johnson & Johnson (J&J), but that could delay the vaccination campaign Italian and also European. More than the very rare side effects, this is the real concern. The United States announced yesterday that it has temporarily suspended the vaccine against the coronavirus, after the manifestation of some very rare cases of cerebral thrombosis. J&J was eagerly awaited because single-dose, and this would have allowed a faster administration among the population. The European Union was expected to receive 55 million doses in the second quarter of 2021. While in Italy 7.3 million doses should have arrived between mid-April and June, with the inoculation also carried out in pharmacies.
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The Food and Drug Administration, the US federal agency that deals with drugs, advised the suspension. The choice came despite the fact that the vaccine was administered to almost 7 million people, with 6 cases of thrombosis recorded, all in women aged 18 to 48. Circulatory problems that have occurred are extremely rare and are of the same type as those recently detected for the vaccine AstraZeneca.
The position of Italy
“We had a meeting with our scientists and Aifa and we are in connection with the EMA – said the Minister of Health, Roberto Speranza yesterday -: we will evaluate in the coming days, as soon as Ema and the USA will give us more definitive news which will be the best way to go. The US choice is precautionary – he added -. Our hope is to be able to untie these knots as soon as possible, and also use this vaccine, because it manages to immunize with a single dose instead of two. It is clear that with respect to the choice made by the US, the company has chosen not to immediately put it on the European market and to first check the American data ».
It is clear, however, that the block, although temporary, could cause a stop to the vaccination campaign, even if in Italy, fortunately not incisively. At the moment only 184 thousand doses of J&J have arrived in our country. But the situation still needs to be clarified quickly because, entro the end of June, the contract with the American company foresees a supply of 7 million doses, and this would certainly be a more serious problem if they did not arrive. Meanwhile, the hypothesis among experts is to limit it to those over 60, as was decided for AstraZeneca. But at that point it will be mandatory to review the distribution to ensure that each age group has the right vaccine available, preventing this new hitch from further lengthening the campaign time.
After yesterday’s meeting between Speranza and the experts, Italy has decided not to issue any directives. “As soon as the EMA and the United States will give us definitive news – Speranza clarified -, we will take the best path, but I think that this vaccine will also have to be used because it is important”. The real fear is that the slowdown in the distribution of doses does not allow to reach 500 thousand vaccinations per day, as foreseen by the government and by the commissioner of General Figliuolo. According to Nicola Magrini, director of the Aifa drug agency, the temporary stop of j & j con will change nothing. «It is a necessary pause wanted by the American drug agency Fda to verify the origin of the six very rare and particular cases of thrombosis reported in the US on 7 million vaccinated people – he declared -. The suspicion is that they are similar to those observed in Europe on 35 million vaccinated. These episodes are so infrequent that they are on the verge of evaluability. I hope they give us the green light soon. The FDA has used the utmost caution, perhaps excessive but which is part of the best management of an emergency ».
Creating alarmism about the J&J vaccine is «totally unjustified – he added Giuseppe Ippolito, scientific director of the Spallanzani Hospital – This is less than one case per million vaccinated, a very low risk compared to the expected benefit».