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A scientist opens an incubator containing cells that produce antibodies against coronavirus disease (COVID-19), in a university laboratory in Athens, Greece, on July 8, 2020. Photo taken on July 8, 2020. REUTERS / Alkis Konstantinidis
Nikos Sypsas, Professor of Infectious Diseases at the University of Athens, explained to SKAI TV the reasons why he considers the suspension of tests of the AstraZeneca vaccine against the coronavirus as “good news”.
“In my opinion, I would call it a good development, in the sense that it seems that all the safety rules of the clinical study work. Because you know, there are some governments that are pushing to ‘skip’ some parts (of the study) and especially security. This is not possible. For me it is good news, it reassures me that everything is done correctly, “emphasized Mr. Sypsas.
He explained that the vaccine is currently in phase 3 of the study, that is, it is administered to 30,000 people in America, Brazil and South Africa. One of the study volunteers developed a disease, it is not known what type and the question is “if the disease is accidental or if the vaccine is due / related”.
The standard procedure in this case is to stop the study so that a special monitoring body, which is irrelevant to the researchers, the university and the company, can examine the data and decide if it is a side effect of the vaccine or not. .
If these experts consider that it is indeed a side effect, the study can be discontinued. If they consider it to be a random event, the study continues. From there, the company must make those modifications to the vaccine, if they occur, so that this side effect does not reoccur.
“What I want to reassure people is that these people are, to put it bluntly, ruthless, that is, they don’t accept anything, they don’t have side effects from the vaccine. In other words, everyone must be absolutely sure that the vaccine’s safety problems are under control ”, emphasized the infectious diseases professor.
He added that this development will certainly go backwards, however, he noted that at the moment there is no vaccine with proven safety and efficacy.
“We hope this vaccine will go ahead. This development goes a bit further in any case, but we should not wait for the results of the phase 3 clinical study before October.” Then the approval procedures will follow and then we will have the vaccine available, ” Mr. Sypsas emphasized.
Regarding the production of the vaccine, which has started for the first time without obtaining approval, he said that if it has side effects, “all this production will go to the bucket, it will be thrown away” and that it is a risk that the company has taken.
“In any case, the EU has ordered some deliveries of this production and some of them will arrive in Greece in the best of cases from the beginning of the new year,” he said.
Source: ΑΠΕ-ΜΠΕ
