The green light for the administration of the single-dose Janssen vaccine by the EMA, the European Medicines Agency, engaged in recent weeks in examining the rare cases of thrombosis that occurred in the USA in some subjects a few days after vaccination with the drug developed by the American Johnson & Johnson.
A scenario that is repeated in an almost identical way to the one that saw the vaccine produced AstraZeneca as protagonist, whose administration was first blocked as a precaution after reports of rare cases of blood clots and subsequently resumed in most European countries, reserving it, in the specific case of Italy, for the population over 60 years of age.
Also for the J&J vaccine, the EMA has recognized the possible link with some rare thrombotic events reported in the USA, as already happened for the AstraZeneca vaccine, in fact. All rare events of cerebral thrombosis “have occurred in people under the age of 60 within three weeks of vaccination“Performed with Johnson & Johnson serum,” the majority in women. Based on the evidence currently available, the specific risk factors have not been confirmed “, reads the note released by the European Medicines Agency, which specifies, however, that the benefits outweigh the risks.
Received the suggestions of the European body, Aifa, the Italian Medicines Agency, could therefore have, as of today, the administration of the Johnson & Johnson vaccine only over the age of 60, as already established for the AstraZeneca vaccine, in order to further avert the risk of episodes of blood clots, which have occurred to date in very rare cases in subjects of less age. “The Janssen vaccine, approved for use from 18 years of age, it must preferentially be administered to people over the age of 60, or to those who, having a high risk of serious and fatal disease, need to be protected as a priority“, Reads a note – as reported by AdnKronos – issued after the verdict of the European Medicines Agency and signed by Franco Locatelli, president of the Superior Health Council, Nicola Magrini, general manager of Aifa, and Gianni Rezza, general manager of the Prevention of the Ministry of Health.
The European Medicines Agency Safety Committee further pointed out that to the product package insert information for Johnson & Johnson’s Janssen vaccine, “a warning about unusual blood clots with low platelets should be added. Additionally, events should be listed as very rare side effects of the vaccine“.
In Italy, the administration of the 184 thousand doses of the Janssen vaccine present in the area and previously blocked in Pratica di Mare could restart as early as April 21, pending the verdict of the EMA.
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