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Coronavirus, stop in AstraZeneca-Oxford vaccine trial: “Abnormal reaction”
“Now we have to wait “
Walter Ricciardi, appointed by the Minister of Health Roberto Speranza to precisely follow the issue of vaccines against the coronavirus, explains that now “we have to wait. It is normal for things of this type to happen in the development of drugs or vaccines, that is, a serious adverse reaction is found. ” . At this point, the researchers must clarify whether the volunteer “had problems because of the vaccine or apart from this – Ricciardi continues – We do not know the nature of the reaction, we are waiting for the verification to be carried out and for that person to undergo all tests”. From the pharmaceutical company they point out that the people tested so far have been 50 thousand.
What happens when there is an adverse event in a study?
Each drug and vaccine research has an independent committee that evaluates the safety and therefore adverse reactions. If there is an unexplained anomaly in the volunteer’s previous health conditions where problems are found, the committee can stop enrollment and study, as in this case. The experts review all the medical records of the other cases evaluated, to look for signs of even mild reactions that coincide with the most serious adverse reaction. In practice, everything is checked in light of the new event. The intention is to understand if there is a cause-and-effect relationship between that reaction and the vaccine. Only after excluding any possible link to the adverse reaction can experimentation be resumed. It is not easy to say how much delay can accumulate in this case, according to observers at least a month is lost. If there is a cause-effect relationship, the next step is to study the vaccine and see if the responsibility for the problem falls on a modifiable element, which would allow the study to resume. If, on the other hand, that element of the vaccine cannot be changed, the experimentation must be abandoned. “The tests of vaccines, including those against Covid, despite the pandemic emergency, are severe, rigorous and reliable – says Piero di Lorenzo, CEO of Irbm – Proof of this was the voluntary suspension of the experimentation by AstraZeneca of the vaccine anti Covid developed by our research institute Irbm together with the University of Oxford “.
Doses for Italy
Italy was to receive between 2 and 3 million doses as its first supply in November and administer them to people at risk, such as those in delicate jobs such as healthcare workers. At this point, even if everything is resolved, it is postponed at least until December, although it is considered more likely that it will reach directly to 2021. Our country, together with Germany, France and the Netherlands, had been in charge of identifying the drugs in which to invest because the most promising trials in progress. At the end of this work, on August 14, the European Commission closed the preliminary agreement with AstraZeneca for “the purchase of a possible vaccine against Covid-19 also in order to donate it to lower-middle-income countries or redistribute it to Countries of Space. European Economic “. The Commission explained at the time “it has agreed on a contractual framework that will allow, as soon as the safety and efficacy of the vaccine is proven, the purchase by EU member states of 300 million doses, with an option of others 100 million “. The price would be around 2.5 euros per dose.
Others in the field if AstraZeneca stops
“An ugly tile,” experts say now. The AstraZeneca vaccine is in phase III trials and was considered the closest to the production phase and therefore to distribution. However, the English company is not the only one at the third level of research. There are six other vaccines in the same situation that our country and Europe are focusing on to close new agreements. They are developed by companies like Pfizer, Sanofi, Janssen, CureVac. However, contracts with some of these manufacturers were considered to make more vaccines available. If AstraZeneca does not reach the end, these are the candidates to become the first supplier of our country. Regarding the fully Italian vaccine of Reithera and Spallanzani of Rome, our country has reported it to the European Union as potentially very useful but the experimentation is still in phase I, so it is too early to be considered at the level continental.
