First hitch along the vaccine road. According to the Ministry of Health's schedule, in addition to Pfizer vials, they should also have arrived in January the first doses branded AstraZeneca (from which around 16 million vaccines were expected within the first quarter). The British pharmaceutical company, however, is behind schedule, so it is probable that the start of deliveries will be postponed at least to late February.
On Tuesday, the deputy executive director of the European Medicines Agency, Noel Wathion, defined the possibility that the EMA will authorize the vaccine produced by AstraZeneca in collaboration with the University of Oxford as "improbable": "They have not yet submitted an application – he explained – and the data we have at the moment are not sufficient to grant a conditional authorisation”.
In other words: there is a need for a plan B. The European Commission has already run for cover, buying another hundred million Pfizer doses, Of which 13,5 million will go to Italy. Furthermore, to cover the shortfall caused by AstraZeneca, our country has also asked the doubling of the doses of Moderna: another 10 million spread over nine months. Finally, it will be very convenient too the increase from five to six of the doses that the Regions have been authorized to derive from each vial of the Pfizer vaccine: a net increase of 20% which corresponds to five million and 315 thousand doses more than the expected supply. Without this unexpected green light, which came first from AIFA and then from the Ministry of Health, a similar increase in vaccines would have cost Italy another 60 million euros.
In any case, AstraZeneca assures that in a few days, at most a week, it will put together the dossier to be submitted to the EMA with data from phase three trials in Great Britain, Brazil and South Africa on 24 volunteers. Once the documentation has been received, the European Medicines Authority usually takes about twenty days to give the go-ahead.
In spite of everything, Great Britain – which has its own independent regulatory authority (MHRA) – has already approved the AstraZeneca vaccine and the administrations will begin on January 4th.
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