Italy and Britain suggest age limits for AstraZeneca vaccine, but still recommend it By Reuters

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© Reuters. FILE PHOTO: This illustration shows a vial labeled “AstraZeneca Coronavirus Disease Vaccine (COVID-19)” affixed to the EU flag shown

By Kate Kelland, Gavin Jones and Francesco Guarascio LONDON (Reuters) – Italy recommended on Wednesday that AstraZeneca’s (NASDAQ 🙂 COVID-19 injection should only be used in people over 60 and Britain that people under 30 should have an alternative, due to possible links between the vaccine and very rare cases of blood clots. More than a dozen countries have at some point discontinued use of the vaccine, which has been administered to tens of millions in Europe. But most have returned, and some, including France, the Netherlands and Germany, recommend a minimum age. The European Union’s health ministers failed to agree on a common guide on the use of the injection, despite requests for coordination among member states to combat public doubt about a set of vaccines as a key component of many vaccination programs. . Italy’s health authority recommended that the injection only be used in people over the age of 60, but said those under the age of 60 who have received a first injection of AstraZeneca can also take a second. An official in Britain said the new advice from a government advisory group that other vaccines should be chosen for those under 30 when possible was “really out of the utmost precaution, rather than because we have serious safety concerns.” European regulators reiterated that they had found possible links between the vaccine and very rare cases of blood clots, but reaffirmed its importance in protecting people against COVID-19. Rising infections caused by more infectious variants threaten to overwhelm hospitals in many EU countries, where the pace of vaccinations lags far behind Britain and the United States, forcing France and other countries to reimpose closures. . The European Medicines Agency (EMA) received reports of 169 cases of the rare cerebral blood clot in early April, after 34 million doses were administered in the European Economic Area (EEA), according to Sabine Straus, chair of the committee for EMA security. The EEA comprises the 27 EU countries plus Iceland, Norway and Liechtenstein. By comparison, four women out of 10,000 would suffer a blood clot from taking oral contraceptives. In its statement, the EMA said it was reminding healthcare professionals and recipients to be aware of “the possibility of very rare cases of blood clots combined with low blood platelet levels occurring within 2 weeks after vaccination “. NO NEW GUIDELINES “So far, the majority of reported cases have occurred in women under the age of 60 within 2 weeks of vaccination,” he added. It did not issue any new guidance, saying that European countries should make their own decisions on how to manage risk. AstraZeneca injection is sold at cost, for a few dollars a dose. It is by far the cheapest and highest volume released so far, and it has none of the extreme refrigeration requirements of some other COVID-19 vaccines, making it likely the mainstay of many vaccination programs in the developing world. In Germany, which recommended last week that people under the age of 60 who received an AstraZeneca injection receive a second dose of another vaccine, an official said that cases of the rare clotting condition were 20 times higher in those who received the injection. But experts say that even if a causal link is shown, the risks of getting a severe clot are extremely small compared to the risks of a possible COVID-19 infection, which can cause similar clots along with other serious symptoms. “The risk of mortality from COVID is much greater than the risk of mortality from these rare side effects,” said EMA Executive Director Emer Cooke. THE BENEFITS OUTWARD THE RISKS However, AstraZeneca shares fell 1.2% to a two-week low. The injection has faced questions since late last year, when the drugmaker and the University of Oxford published test data with two different efficacy readings as a result of a dosing error. The head of Britain’s drug regulator June Raine said the benefits outweighed the risks for the vast majority, but were more balanced for younger people, for whom the risks of coronavirus infection are, on average, lower. Wei Shen Lim, COVID-19 chair of Britain’s Joint Vaccines and Immunization Advisory Committee, said it was preferable that another vaccine be offered to adults under the age of 30 with no underlying health conditions. AstraZeneca said it was working with British and European regulators to list possible blood clots in the brain as “an extremely rare potential side effect.” Possible causes of the rare cerebral sinuous vein clots being investigated include the vaccine triggering an unusual antibody in rare cases or a possible link to birth control pills. But there is no definitive evidence. Andreas Greinacher, a scientist at Germany’s Greifswald University, said his work indicates that neither birth control nor the clotting factor mutation play a role. Many experts say it is unclear if, or why, the AstraZeneca vaccine would cause a problem not shared by other vaccines that target a similar part of the virus.