Astrazeneca vaccine suspended in Germany, France, Italy and Spain, here are all the news
The facts, the decisions of some national drug agencies with the precautionary suspension, the position of the EMA and the version of the pharmaceutical company Astrazeneca
Italy, Germany, France and Spain have temporarily blocked the administration of the Astrazeneca vaccine.
The alarm over the Astrazeneca vaccine is spreading in Europe.
Yesterday in Ireland, health authorities called for the drug to be stopped, Denmark suspended the administration of the vaccine and Italy had already stopped a batch of the drug after two deaths.
All without the cause-effect relationship having been confirmed. So much so that that alarm on the safety of the serum was defined, yesterday evening, March 14, "unjustified" by the Italian drug agency (Aifa).
Here are all the news with the position of the pharmaceutical company ("A careful review of all available safety data of over 17 million people vaccinated in the EU and UK with the Covid-19 vaccine AstraZeneca showed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any age group, sex, batch or in a particular country ").
WHAT GERMANY HAS DECIDED ON THE ASTRAZENECA VACCINE
Germany has announced the suspension of the administration of the AstraZeneca vaccine. The German health minister spoke of a "precautionary choice" in view of further analyzes on serious adverse events on people vaccinated with the British pharmaceutical company anti-Covid.
THE RECOMMENDATIONS OF THE FEDERAL INSTITUTE FOR VACCINES
The Federal Government, explained a spokesman for the Ministry of Health, acted following a recommendation from the Federal Institute for Vaccines Paul Ehrlich (Pei). After new reports of thrombosis cases in people who had been vaccinated in Germany and Europe, the Institute believes further investigation is needed.
THE STOP OF ITALY
Italy also blocks the administration as a precaution. The AIFA, as a precautionary and temporary way, has decided to extend the ban on the use of the vaccine throughout the country, pending the pronouncements of the EMA.
INDICATIONS FOR THOSE WHO MADE THE FIRST DOSE
The Agency also informed that it will soon provide all the information to those who have taken the first dose.
The AIFA, writes the same Agency, will make “promptly known any further information that may become available, including the further methods of completing the vaccination cycle for those who have already received the first dose”.
TWO SEQUESTRATED LOTS
The decision comes after, in the last few hours, the Public Prosecutor of Biella ordered the seizure of another Astrazeneca lot, ABV5811, following the death of a teacher from the conservatory in the Piedmontese province on which the judiciary is investigating. This would be the second batch blocked at national level after the ABV2856, withdrawn after the two deaths recorded in Sicily.
HOW THE INITIATIVE OF THE JUDICIARY IS BORN
An investigation into manslaughter and the seizure, throughout Italy, of lot ABV5811. This is the decision of the prosecutor of Biella, which has opened an investigation into the death of Sandro Tognatti, 57 years old from Cossato, clarinet teacher at the Novara conservatory. Tognatti was given a dose of the AstraZeneca anti-Covid vaccine on March 13. His death occurred on Sunday 14.
The prosecutor of Biella has ordered the seizure of the entire lot as a precautionary measure, as had already done by the prosecutor of Syracuse who is investigating the case of the non-commissioned officer of the Navy, delegating the operations at all the distribution hubs and centers to the Nas vaccination, where a total of 393,600 doses were delivered.
THE SITUATION IN VENETO
Among the areas affected by the seizure – according to the Fatto Quotidiano – there is also the Veneto, where the doses had been distributed to all the Ulss, between the '1' Dolomites and the '9' Scaligera. The Veneto batch concerns 41,300 doses, of which 20,952 were used. "The block is precautionary – underlined the president Luca Zaia – but we must be quick to clarify whether the vaccine is the cause, the contributing cause or has nothing to do with death".
WOMAN IN SERIOUS CONDITION IN NAPLES
Also in Naples, a woman is in serious condition after receiving, last week, the first dose of the Astrazeneca vaccine, batch ABV5811 (in the process of being seized in these hours). Sonia Battaglia, 54, is hospitalized in intensive care in the hospital of the sea in Naples. As told by family members, the woman had no previous pathologies and is in intensive care in very serious conditions.
HOPE: PRECAUTIONAL CHOICE, WE WAIT FOR CLARIFICATION
“The choices made and shared today by the main European countries on AstraZeneca were made exclusively as a precaution, pending the next decisive meeting of EMA. We are confident that the European Agency will be able to definitively clarify the issue in the next few hours ”, said Health Minister Roberto Speranza.
SPAIN: ADMINISTRATIONS SUSPENDED FOR TWO WEEKS
In Spain, the administration of the vaccine will be interrupted from Tuesday 16 March for at least two weeks, writesEl Mundo. The decision, explains the Minister of Health, Salvador Illa, is taken "as a precaution" and "for prudence" until the European Medicines Agency clarifies whether there is a relationship between the numerous cases of thrombosis (one occurred in Spain) and the use of that vaccine.
THE FRENCH STOP
Even France, again as a “precaution”, has suspended the administration of the Astrazeneca vaccine, writes Le Monde . The National Agency for the Safety of Medicines and Health Products, ANSM, stressed that "thromboembolic events and coagulation disorders" are "rare" and are currently not related to vaccination. "To date – adds the agency – few cases have been reported in France, and no deaths, as data from the enhanced surveillance implemented since the beginning of vaccination".
Emmanuel Macron, announcing the stop at a press conference in Montauban, assured that vaccination will resume as soon as possible "if the opinion of the European authority allows it".
THE WORDS OF THE EMA TOPICS ABOUT THE ASTRAZENECA VACCINE
"The balance between benefits and risks" for AstraZeneca's anti-Covid vaccine "is considered positive and we see no problem in continuing vaccinations using this vaccine", underlined Marco Cavaleri, head of Ema's vaccination strategy, in the hearing to the European Parliament. "We are examining the data and lethal events reported to try to understand if there are specific clusters of cases" linked "to certain types of pathologies or to the medical status of the subjects", added Cavaleri, underlining that so far there is no evidence that " demonstrate an emerging risk that affects the benefit / risk ratio ".
Meanwhile, confirmation of the efficacy of Pfizer, Moderna and Johnson & Johnson vaccines against variants also arrives from Ema.
THE NOTE OF THE EMA
"While its investigation is ongoing, the EMA currently remains of the opinion that the benefits of the AstraZeneca vaccine in preventing COVID-19, with the associated risk of hospitalization and death, outweigh the risks of side effects," reads a note from the European Medicines Agency .
THE COMMENT OF WHO
There is no evidence that cases of thrombosis in recent weeks have been caused by the Astrazeneca vaccine, the World Health Organization (WHO) reported today, after Germany also suspended administration of the drug. In a statement, the WHO reported that it is evaluating the vaccine documents of the Anglo-Swedish multinational and that it is still important to continue with the immunization campaign.
WHAT THE BRITISH GOVERNMENT SAID ABOUT THE ASTRAZENECA VACCINE
The Covid vaccine developed at the University of Oxford and produced by the Anglo-Swedish pharmaceutical company AstraZeneca remains "safe and effective", according to data from the current administration in the United Kingdom, where over 11 million people have already received this serum (first Country in the world by size of its use), reiterated, urged by journalists on the subject in the briefing of the day, a spokesman for British Prime Minister Boris Johnson . The spokesman then added, in the wake of new assurances also given today by British health authorities and researchers from the same University of Oxford, that "there is no evidence" of an increase in thrombosis cases after vaccinations compared to ordinary statistics.
THE VERSION OF ASTRAZENECA
But what does Astrazeneca say? "A careful review of all available safety data from over 17 million people vaccinated in the EU and UK with the AstraZeneca Covid-19 vaccine showed no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any age group, sex, batch or in a particular country, ”AstraZeneca announced on the evening of March 14th. Specifying that out of 17 million vaccinated "there were 15 deep vein thrombosis events and 22 pulmonary embolism events reported among those given the vaccine, based on the number of cases the Company received as of March 8" .
A number "much lower than one would expect to occur naturally in a general population of this size and is similar for other licensed Covid-19 vaccines." In short, in clinical studies, "even if the number of thrombotic events was small, these were lower in the group of vaccinated subjects" and "there was no evidence of an increase in bleeding in the over 60 thousand enrolled participants".
And again, in terms of quality, there are no confirmed problems for the company with any batch of our vaccine used in Europe or the rest of the world. "Further tests have been and are being conducted by ourselves and independently by European health authorities and none of these new tests have shown cause for concern." The company specifies that "more than 60 quality tests are conducted by AstraZeneca, its partners and more than 20 independent testing laboratories" during the vaccine production.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-astrazeneca-tutte-le-novita/ on Mon, 15 Mar 2021 15:31:52 +0000.