This is what emerges also, but not only, fromanalysis of the new protocol related to the phase III study published on the international site clinicaltrials.gov where all the data on clinical trials are made public.
Ema’s evaluation – According to the agency’s deputy executive director, Noël Wathion, the EMA does not have sufficient information on the vaccine. “At present, AstraZeneca has only provided data on its clinical trials to the European Medicines Agency”, and these “are not sufficient” to grant a conditional marketing authorization. “We need additional data on the quality of their vaccine,” added Wathion. Furthermore, he stressed, AstraZeneca has yet to submit a formal application, which is another necessary condition to give the green light to the vaccine.
Different doses during testing – The problem related to the lengthening of the time in the approval of the AstraZeneca / Oxford vaccine candidate by the EMA “does not seem to concern problems related to safety, but rather to the efficacy assessed with a non-linear protocol, as some data have been obtained with a dose followed by a second variable administered, or half a dose by mistake followed by a full dose “, notes the virologist Francesco Broccolo, of the University of Milan Bicocca. “In this way – he notes – not all subjects were subjected to a recall at the same time, leading to an element of difficult interpretation on the real percentage of effectiveness”.
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From the data relating to the phase III study of the AstraZeneca / Oxford candidate vaccine it would appear that the trial had started last March with a full dose and that only at a later time, in light of the data relating to immune coverage, a second was introduced. dose, inoculated at different times, making it very complex to compare the data. Moreover, it happened that by a chance error the first dose was administered, on a certain number of subjects, in half, giving better results. The serious difficulty in being able to compare the results obtained with different posologies has led to a new phase III trial, which began last August 28 and which involves the administration of two full doses of the vaccine candidate 21 days apart on 40,000 people. It is very unlikely that Ema will be able to give its approval by January as the data appears not sufficiently consistent.
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