The communications of the Agency of the drug after the green light of the EMA to resume the administration: “The vaccine is safe with no age limits or contraindications and the benefits far outweigh the risks”, explained the general director, Nicola Magrini. “The link with thrombosis is not proven, but we will start further studies”. Rezza: “Risk of curbing the vaccination campaign now”
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“Aifa has lifted the ban on use for the Astrazeneca vaccine”. This was stated by the director general of Aifa, Nicola Magrini, in a press conference convened at the Ministry of Health, after the recommendation of the EMA, the European Medicines Agency, to continue vaccinations with Astrazeneca, which ruled out an association between the thrombosis cases and the product of the Anglo-Swedish company. Magrini then reiterated what the Ema said: “The main news to be emphasized is that the benefits of the Astrazeneca vaccine far outweigh the risks and therefore the vaccine is safe without age restrictions and without substantial contraindications for use. It is not associated with an increase in thrombotic risk, nor are there any problems with respect to batches “. In addition to Magrini, the general director of Prevention of the Ministry of Health, Giovanni Rezza, and the president of the Higher Health Council, Franco Locatelli (THE SPECIAL VACCINES – THE ALGORITHM THAT ESTIMATES WHEN YOU WILL BE VACCINATED).
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Magrini (Aifa): “Rare vaccine-thrombosis link not proven, we will deepen”
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“The causal link with rare thrombotic events is not proven but further studies will be initiated,” added Magrini. “The justified concern arising from the reporting of these few serious cases has led to the suspension of the vaccination campaign in the EU. But rare events can only be known better after use. There is currently no causal link”, the director of Aifa specified. Magrini recalled the figures on these rare events: “18 cases of cerebral cavernous sinus thrombosis and 7 of coagulation in 20 million vaccines” (COVID, LIVE UPDATES – THE SPECIAL).
Rezza: “Risk of curbing the vaccination campaign”
The Director General of Prevention of the Ministry of Health, Giovanni Rezza, stressed that “the lifting of the suspension is a great relief because we must give a strong acceleration to the vaccination campaign. In the face of the very rare adverse events we must instead consider that we now have a high incidence of Covid. in the country with 150 cases per 100 thousand inhabitants. To give up a strong vaccination campaign now would be extremely risky “. On the progress of the vaccination campaign, Rezza recalled: “We were at 200 thousand vaccinations a day and unfortunately we had a setback. We know that we have to double this pace. The vaccination campaign can now go live also because in mid-April a new quarter vaccine will become available “.
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Locatelli: “25 thromboses out of 20 million vaccinated. Covid more dangerous”
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The president of the Higher Health Council, Franco Locatelli, reiterated: “We have valued the principle of maximum precaution by arriving at the temporary suspension of the AstraZeneca vaccine”, he said. “It has been estimated that out of 20 million people vaccinated in the EU and GB there is no evidence that the AstraZeneca vaccine, which covers 100% for severe forms, increases the risk of thromboembolic complications”, Locatelli underlined. “In all, there are 25 thrombotic cases out of 20 million vaccinated and a causal link cannot be demonstrated and we remember that Covid infection is much more dangerous even for this type of infection”.
Magrini: “Do not use preventive drugs such as aspirin or heparin”
Magrini also explained that Aifa will express an official document in the coming days against a preventive or prophylactic use of anti-inflammatory drugs such as aspirin, tachipirin or heparin. “There is no reason to use preventive drugs or after vaccination because there is no proven link. There are no indications even for women who use the pill,” said the director general of Aifa. “The vaccinated are calm and safe and only if there are symptoms they should go to the doctor”.
Rezza: “No changes to vaccination procedures”
Rezza then specified that “we do not foresee changes in vaccination procedures but we have asked Agenas to update the part concerning informed consent, not only as regards Astrazeneca but to make it even more agile”. Ema and Aifa, added Magrini, “will go to an explicit recommendation not to have concerns about the use of the pill in relation to vaccination with Astrazeneca”.
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What the Ema said about Astrazeneca
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Yesterday the EMA, in anwaiting for press conference from the Amsterdam headquarters, he gave the green light for the resumption of vaccinations with Astrazeneca after the precautionary stop last Monday of several European countries following some suspected cases of thrombo-embolism. He reiterated that the Astrazeneca vaccine is “safe and effective” and “cannot be associated with an increase in thromboembolic events”, and that the “benefits” of undergoing the vaccination “outweigh the risks”. The EMA also specified that a link with the rare thromboembolic cases recorded in some countries cannot be excluded, but that it is only “25 cases out of about 20 million vaccine administrations”. The agency explained that “further investigations” will be carried out on these rare adverse events. He also recommended adding a warning to the Astrazeneca vaccine package insert so that this information on rare adverse events is “made known to physicians and the public”. Immediately after the pronouncement of the EMA, Prime Minister Mario Draghi explained that vaccination with AstraZeneca will resume in Italy today from 3 pm.
Aifa: “The reasons for the prohibition of use no longer exist”
After the pronouncement of the EMA, Aifa, which last Monday suspended the administration of the Astrazeneca vaccine after the stop in other countries, did it know that “after hearing the Minister of Health, the Directorate General for Prevention of the Ministry of Health and the Superior Health Council, the reasons behind the precautionary ban on the use of vaccine batches, issued on March 15, 2021, no longer exist”.
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Date last modified March 19, 2021 at 1:10 pm
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