“Still 3 steps for approval, but we are on time”

Published on: 09/11/2020 18:37

In the light of the promising preliminary data released today, when will the first doses of the Pfizer-BionTech vaccine be available for Europe (and Italy)? And when will the large-scale vaccine be available? “Given the crucial public health considerations and the importance of transparency, we have clarified the timing of development of Pfizer and our partner BionTech’s Covid-19 vaccine and the three key areas in which, as with all vaccines, we have to prove we are successful in getting approved for public use. And we stay in line with our US deadlines. ” Pfizer communicates it to Adnkronos Health. The two companies in fact aim to submit the request for emergency authorization to the FDA, the US Medicines Agency, after the third week of November.

But what are these three key areas? “First, the vaccine has to prove effective, which means it can help prevent Covid-19 in at least the majority of vaccinated patients. Second, just as importantly, the vaccine has to prove safe, with data from reliable safety generated by thousands of patients. Finally – Pfizer recalls – we must demonstrate that the vaccine can consistently be produced with the highest quality standards. We remain in line with our expected deadlines. And as already revealed, we have started a progressive review ” and accelerated with the EMA (European Medicines Agency) “at the beginning of October”.

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