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On October 1, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) launched the authorization process for the first vaccine against Covid-19. The news is sensational in itself, but the circumstances make it even more so.
The European Medicines Agency has modified the normal authorization process
for the earlier approval of a vaccine developed jointly by AstraZeneca and the University of Oxford. In the basic case, all the necessary data, i.e. the preclinical test (on animals) and the data from the three phases of clinical trials in humans, are jointly reviewed by the EU Medicines Authority. In the present case, however, the method called “continuous review” will be used. In practice, this means that the manufacturer does not have to wait for all the data to be available, but can also start submitting it before the end of clinical phase 3, continuously as the different phases are completed. The goal is to speed up the review and authorization itself, as the authority’s experts do not have to review the thousands of pages of test reports at once, but can continue with them once a phase has been completed and the finalized data. This is only possible in a public health emergency; otherwise, all studies must be completed and data must be submitted at the same time. The announcement is also interesting and extraordinary because the Russian authorities (too) have received a lot of criticism from Europe for not waiting for the results of the third clinical trial in thousands of people to authorize the Russian Covid-19 vaccine. This is not exactly the case here, of course the EU will not approve the vaccine until all phases of the clinical trial have been completed and the data processed, all that will happen is that the manufacturer starts shipping the results of the phases already. closed continuously as they are carried out. AstraZeneca recently announced the start of a third clinical phase involving tens of thousands of people (followed by a suspension due to an unexpected serious side effect and then a resumption a few days later), but currently only intends to send study data preclinical. to start the procedure.
THE EXPECTED PERIOD OF FINAL AUTHORIZATION AND COMMERCIALIZATION OF COURSE IS NOT YET KNOWN,
the authority also called special attention to avoid speculation in this regard. As far as we know, there has been no example of this type of authorization procedure for vaccines in the history of the EU Medicines Agency, but in terms of medicine: the American antiviral drug Remdesivir, also used to fight Covid-19 , has been authorized in the EU under such an accelerated method. AstraZeneca is also part of Operation Warp Speed, a Covid vaccine development program started by the US government and backed by taxpayer money.
(Cover image: Dadu Ruvic / Reuters)
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