That’s why Astrazeneca has suspended the tests on the anti Covid vaccine (the one bought from Brussels)
Astrazeneca suspended all clinical trials of the coronavirus vaccine after one of the participants experienced an adverse reaction (transverse myelitis?). What will happen now to the vaccine purchase contract already signed by the EU Commission?
Astrazeneca suspends all clinical trials on the coronavirus vaccine it is developing with the University of Oxford after one of the participants accused an adverse reaction. According to an anonymous source quoted by the New York Times , the volunteer was participating in the UK in phase 2/3 of the vaccine trial and found transverse myelitis. Here are all the details.
WHAT HAPPENS THE ASTRAZENECA ANTI COVID VACCINE
Pharmaceutical company Astrazeneca suspended testing its Coronavirus vaccine for the second time after one of the volunteers developed an unexpected and deemed serious adverse reaction, according to the Stat News website .
THE MYELITE CASE ACCORDING TO THE NYT
In addition, an anonymous source quoted by the New York Times revealed that the volunteer was participating in the UK in phases 2/3 of the vaccine trial developed with an Oxford team, when he encountered transverse myelitis, an inflammation affecting the bone marrow. spinal and would often be triggered by viral infections. There is no confirmation for the moment that the inflammation is directly linked to the vaccine, the American newspaper added.
WHAT IS THE CROSS MYELITE
"Acute transverse myelitis can develop in people with certain diseases such as multiple sclerosis, optic neuromyelitis, Lyme disease or lupus, or in people taking certain medications," wrote Michael Rubin, MDCM, Weill Cornell Medical College .
THE OPINION OF PREGLIASCO
“It is an inflammation of the spinal cord,” virologist Fabrizio Pregliasco, from the University of Milan, told HuffPost . "Not a trivial thing – he points out – can also have quite heavy consequences". Paresis, for example, "which could also be temporary," said Pregliasco. Now, however, it must be understood whether this reaction is related to the vaccine that AstraZeneca is experimenting with. "It is not said, we need to investigate to understand whether or not there is a correlation," the virologist specified. As for the stop, "it should not be seen as a negative and worrying aspect that will inevitably mark the failure of this project, but the demonstration that there is great attention to all the steps of the research, even in this situation in which we want to speed up and obtain results as soon as possible to get the vaccine against the Sars Cov2 virus – the virologist goes on – Little has been said about phase 4, after the three to which we usually refer and in which doctors must say everything that happens during the 'taking a drug and, even in that phase, it is necessary to examine whether or not there is a real correlation between the event encountered and to be reported and the administration of the vaccine preparation ”.
WHAT ASTRAZENECA SAYS
"Our standard test review process triggered a pause," said an Astrazeneca spokesperson. "This is a routine action that occurs whenever there is a potential unexplained reaction in one of the tests" which allows time to "investigate and ensure at the same time that the integrity of the test process is maintained", added the British-Swiss company. “In broader tests, reactions can happen by chance but must be carefully evaluated independently”, adds the pharmaceutical giant, which with the announcement of the suspension drops by 6% on Wall Street in after hours trading.
THE TEST PROCEDURE
Even if the Astrazeneca vaccine is ultimately approved, this setback could result in fears about its use. Initial test data looked very promising, with the vaccine being able to produce a robust immune response and only weak side effects, Ansa wrote .
THE CONTRACT SIGNED BY THE EUROPEAN COMMISSION WITH ASTRAZENECA
At the end of August, the European Commission signed the first advance purchase contract for anti-Covid vaccines on behalf of EU member states with the Swedish-British company Astrazeneca. The Irbm company of Pomezia (Lazio) collaborates with the vaccine.
UP TO 400 MILLION DOSES
The agreement signed in these hours confirms what has already been decided between the parties: the States will be able to purchase 300 million doses of the vaccine known as Oxford, which the Italian Irbm also collaborated in, to be distributed in proportion to the population. There is also an option to reserve another 100 million doses.
ITALY AND INCLUSIVE VACCINE ALLIANCE INCLUDED
Among the countries that will have to divide the doses is also Italy, already interested in the Oxford vaccine and member of the " Inclusive Vaccine Alliance ", together with Germany, France and the Netherlands. The alliance had begun negotiations with AstraZeneca in recent months, before a public intervention by the Commission, and then took over the agreement.
WHAT HAPPENS IN THE EVENT OF DAMAGE?
The vaccine, in the third phase of testing, should arrive on the market in the coming months, but the rapid times cannot exclude damage or ineffectiveness after administration. If something should happen, the EU "will not change the rules on liability" on the safety of medicines, Member States will be able to indemnify the manufacturer for the responsibilities incurred, but, as per Brussels indications, the responsibility for the safety of the drug remains in place. head to the companies.
NOT ONLY ASTRAZENECA. THE EU STRATEGY
The one with AstraZenca should be the first in a series of contracts. The EU, in fact, is moving on several fronts and has already held talks with Sanofi-GSK (31 July), Johnson & Johnson (13 August), CureVac (18 August) and Moderna (24 August).
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PRESS RELEASE OF THE MINISTRY OF HEALTH DATED 26 AUGUST 2020
Press release n. 252
Release date 26 August 2020
Vaccine: June 12 signed agreement with Astrazeneca and August 14 ok Commission
In relation to some press news regarding the Astrazeneca vaccine, it is specified that on 12 June 2020 the agreement was signed by the 4 promoter states (Italy, France, Holland, Germany) with the company for the development and production of 400 million doses of Covid vaccine intended for the entire European population. It is an important result for our country which has been in the European lead group in the vaccine challenge.
As is known, the viral vector of the Oxford vaccine has seen the primary involvement of the IRBM of Pomezia and the filling will take place at the Catalent of Anagni.
The European Commission fully shared the initiative of the 4 countries of the “Vaccine Alliance” and on 14 August publicly announced that it had formally followed up the agreement with Astrazeneca.
All member countries have joined the initiative.
Press office
Ministry of Health
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/economia/ecco-perche-astrazeneca-ha-sospeso-i-test-sul-vaccino-anti-covid-quello-comprato-da-bruxelles/ on Wed, 09 Sep 2020 14:00:29 +0000.