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ROME – Green light also from the Italian drug agency for the AstraZeneca vaccine: “The Aifa committee ratified and the Agency recently revoked the ban on the use of the AstraZeneca vaccine,” said CEO Nicola Magrini, during the press conference organized by the Ministry of Health. after Ema’s pronouncement on the Astrazeneca vaccine. “The benefits of the AstraZeneca vaccine far outweigh the risks and that the vaccine is safe and effective for any age group. It is not associated with an increased thromboembolic risk and there are no problems with certain batches.” Speaking of the rare cases of thrombosis recorded after the administration of AstraZeneca (25 of 20 million doses), Magrini said: “The causal link is unproven, but attention remains high.” The vaccine will continue to be recommended “without substantial contraindications to its use.”
The Italian decision goes against other European countries: Spain will resume vaccinations on Wednesday, Sweden and Norway await clearer information. France started the administration today, but with a very important precaution: “The AstraZeneca vaccine will only be administered to people over 55 years of age.” The decision was announced by the French health authority. Cases of the rare form of thrombosis associated with a drop in platelets – the famous 25 cases that alerted Europe – were in fact concentrated among women under 55 years of age.
“Faced with a very rare risk of adverse events, we have a rapidly circulating epidemic, with approximately 150 cases per 100,000 inhabitants,” added Gianni Rezza, director general of Prevention at the Ministry of Health. It would have been counterproductive to maintain the suspension of the vaccination campaign ”. Before the suspension, he added, “vaccinations progressed rapidly, with about 200,000 daily administrations. Now we should double this rate if possible. “
Magrini added: “The AIFA will publish in the next official document against any prophylactic use of anticoagulant drugs. There is no reason to do preventive or post-vaccination treatments to prevent events that are very rare and not yet related to the vaccine, in Sin category of patients. There will be no special warnings for pregnancy or breastfeeding, or for those who take birth control pills or have genetic factors that predispose to blood clotting. Those who are vaccinated or have been vaccinated should rest assured. Your doctor. ” The system, however, Magrini admitted, “has suffered a serious shake.”
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The alarm in Italy was born after the three suspected cases occurred in succession, on which the Syracuse prosecutor had opened an investigation, Magrini explained. “The Biella prosecutor followed up with another initiative. Health authorities are examining another case of cerebral thrombosis on which there is no investigation. Meanwhile, another 4 reports have arrived from Norway and 7 from Germany ”.
Speaking of birth control pills, Magrini explained: “These drugs have a low risk of causing thrombosis, about one case in every 10,000: therefore, higher than the possible risk that we are talking about today with the vaccine. This risk is considered acceptable and the contraceptive pill is used by 100 million women on the planet today. We do not consider it appropriate to foresee a population screening or to include the drug among the risk factors. “For Magrini it is not even necessary to worry” if you are a carrier of any of the genetic mutations that predispose you to the risk of blood clotting, such as factor 5 from Leiden or other rarer ones. “
Following the green light from the EMA in Astrazeneca, vaccinations are resumed throughout Italy. Yesterday, the Medicines Health Regulatory Authority (Mhra), the British Medicines Agency and the European Medicines Agency (EMA) reaffirmed that the benefits of the AstraZeneca Covid-19 vaccine continue to far outweigh the risks. The EMA Pharmacovigilance Risk Assessment Committee (Prac) concluded that there was no increase in the overall risk of blood clots (thromboembolic events) with the AstraZeneca vaccine. “However, the PRAC also concluded that, for very rare cases of serious thromboembolic events with thrombocytopenia, a causal link with the vaccine has not been proven, but is possible and warrants further analysis. Furthermore, there was no evidence of a related problem. with specific batches of the vaccine or at particular production sites. “
Now Italy must recover the lost vaccines. After 95 hours of suspension and almost 300,000 canceled vaccines (estimate in the average of the period), Italy will now try to recover the ground lost due to the stop in Astrazeneca and finally take the step to the massive administration campaign that should take off in April . They leave today at 3 p.m. after the update of the triptych and the press conference at 12.
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The Regions, some of which in the meantime are ready to use monoclonal antibodies for the treatment of Covid, are heating up the engines of the machine that has remained stationary, especially those like the Lazio where the campaign was progressing at a good pace. And they call again with sms that the reserved ones put in stand-by. “Now don’t waste any more time,” says Health Councilor Alessio D’Amato, who would have liked to resume administration tomorrow morning. In Piedmont Private health establishments also take to the field, which according to Governor Alberto Cirio “will allow at least 3,500 more vaccines per day. And we intend to reach 20,000 per day”, also involving general practitioners. “I am going to vaccinate with AstraZeneca”, announces the governor of Liguria, Giovanni Toti.
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In SardiniaOn the other hand, the only white area and that should take advantage of the calm to vaccinate on the carpet – while instead it is among the last – President Christian Solinas says that he is willing “to invest the funds of the Region to buy vaccines and immunize to all Sardinians “before the summer.” The governor, “as long as the commissioner follows the purchasing procedures” in the emergency, tells Francesco Figliuolo “leave us the doses and we will be able to provide everything necessary to vaccinate.”
The vials for the next few days should not be missing. Substantial cargo expected from Pfizer, if you are alone Campania he will receive 120,000 on Monday, he announced, compared to an average of 49,000 a week in the last month. As for AstraZeneca, there are already at least 200 thousand doses in refrigerators throughout Italy and the emergency commission estimates that it will be able to recover the backlog accumulated in almost 4 days of shutdown in two weeks. “At the end of April 16 million doses will arrive, at the end of June 52 million, at the end of September 84 million doses.”
So Andrea Costa, Undersecretary of Health, also on Radio, on the ‘roadmap’ that the government provides for vaccines. “The supply problem – he stressed – has been addressed, there are agreements and we will monitor that these agreements are respected.” Regarding the fact that each Region is on its own, he added: “There is a need for a national course and we are doing this, so it is clear that the implementation of the plan is declined by the Regions. Certainly, ‘he insisted. there is a need for homogeneity because otherwise we would contribute to stoking the confusion ”.
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To try to fill the ‘gap’ it will also be vaccinated with evening shifts and on Saturdays and Sundays even in regions that did not. Pharmacists will take a course to train in vaccination: in the Sostegni decree there should be a rule that allows administration in pharmacies.
5,174 professionals are already qualified, another 2,800 are completing the training. In Italy there are around 5 million vaccinated with at least one dose, of which more than 2.2 million also with a booster, 3.5% of the population. Yesterday 152,500 vaccinations were carried out, which added to the approximately 70,000 failures of AstraZeneca would give a figure -220,000- not so far from the 270,000 per day of departure that marks the vaccination plan, to reach 500,000 daily in April. “Now we need a communication campaign,” says Minister Mariastella Gelmini.
