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This is what also arises, but not only, fromanalysis of the new protocol related to the phase III study published on the international site Clinicaltrials.gov where all data from clinical trials are made public.
Ema Assessment – According to the agency’s deputy executive director, Noël Wathion, the EMA does not have enough information about the vaccine. Currently, AstraZeneca has only provided data from its clinical studies to the European Medicines Agency, and these are “not sufficient” to grant a conditional marketing authorization. “We need additional data on the quality of your vaccine,” added Wathion. Furthermore, he emphasized, AstraZeneca has yet to submit a formal application, which is another necessary condition for giving the vaccine the green light.
Different doses during the test – The problem related to the lengthening of the time in the approval of the candidate AstraZeneca / Oxford by the EMA “does not seem to refer to problems related to safety, but rather to the efficacy evaluated with a non-linear protocol, since some data have been obtained with a dose followed by a second variable administered, or half a dose by mistake followed by a complete dose “, points out the virologist Francesco Broccolo, from the University of Milan Bicocca. to a retirement at the same time, which generated an element of difficult interpretation on the real percentage of effectiveness ”.
From the data related to the phase III study of the AstraZeneca / Oxford vaccine candidate, it would appear that the trial had started last March with a full dose and that only later, in light of the data related to immune coverage , a second was introduced. dose, inoculated at different times, which makes it very complex to compare the data. In addition, it happened that due to a fortuitous error, the first dose was administered to a certain number of subjects in half, giving better results. The serious difficulty in being able to compare the results obtained with different dosages has led to a new phase III trial, which began on August 28 and which involves the administration of two full doses of the candidate vaccine 21 days apart in 40,000 people. It is very difficult for Ema to be able to give her approval before January, as the data does not appear to be consistent enough.
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