“Ema green light in January is not excluded”

(Photo by Rafael Henrique / SOPA Images / Sipa Usa)

Published on: 12/31/2020 5:16 PM

“It is by no means excluded that the EU green light for AstraZeneca’s Covid vaccine may arrive at the end of January.. The company yesterday presented the data to the EMA “in support of the request for conditional marketing authorization, so” if the data presented turns out to be robust, homogeneous and easy to interpret, the Agency will be able to express itself in about twenty days: from 15 to 30 business days, if, as I imagine, it has not changed its modus operandi “. Guido Rasi, Former Executive Director of the European Regulatory Body, Professor of Microbiology at the University of Rome Tor Vergata.

Regarding the brake ‘pulled’ in recent days by the deputy executive director of Ema Noel Wathion, who told the Belgian newspaper ‘Het Nieuwsblad’ that it is most likely that the Agency will not be able to approve the vaccine developed by the University of Oxford in January . and Irbm di Pomezia, and produced by AstraZeneca, Rasi believes that “it is no coincidence” that on December 29 the official made such a peremptory statement requesting new data, and the next day the company presented it. Now the information is there and “I hope that, after having examined it, the EMA will provide us with a timetable for the week. – the former number one of the Agency contributes – that is, tell us how long it will take to express himself ”.

The problem arose around the AstraZeneca vaccineRasi recalls, on the basis of what was “publicly known”, was the “lack of homogeneity” of some data related, in particular, with the dose to use for optimal efficacy (one and a half or two doses), in the “highly variable (4-12 weeks)” time interval between the first and second doses, and the “heterogeneous” epidemic situations in which the product was tested. But if the information presented yesterday exceeds these criticalities, “it is not ruled out at all” that the evaluation time is similar to that of the Pfizer / BioNTech and Moderna vaccines: “About twenty days”, reiterates the former director.

Regarding the green light already granted to the AstraZeneca vaccine by the British regulatory agency Mhra, for Rasi “it would be good if it reappeared the difference between the UK and the EU“At the regulatory level. The main one is that, while the UK must approve the production of a series of batches for a single state, the EMA must do so for all states, even those that fully delegate to central agencies. It’s another job, ”he says.

Lacceleration UKThe former head of the European Medicines Agency also observes, it was probably also based “on the ‘acute’ state of the Covid epidemic in Great Britain, where 50,000 cases were recorded daily for a couple of days.” A scenario where, even assuming the lowest percentage of efficacy demonstrated by the AstraZeneca vaccine in clinical trials (around 60% instead of around 90%), the country is probably in a rush to secure at least certain categories of population. Presumably the ‘active’ group, considering that the product in question “works very well in a relatively young population.”

In short, “instead of making strange comparisons with the UK,” according to Rasi, “Italy should use the next 2 months to calibrate a vaccination strategy“aimed at specific groups. In fact, the expert expects that” at least two other vaccines will be available by March-April, probably those from J&J and AstraZeneca. “And” if there will be 4-5 vaccines in circulation, two of which the 95% effective (an unexpected stroke of luck) and others with different characteristics, a strategic adjustment will be necessary. “We will have to” do a modeling at that point. Also for the Italian health system it will be essential not to vaccinate everyone at random, but start thinking ‘what vaccine do I give to whom’“.

However, Rasi is optimistic about the success of the tricolor vaccination campaign, even more so after today came the clarification about the number of doses available from the president of the Higher Health Council, Franco Locatelli: “To have 62 million doses” Pfizer and Moderna “in the first part of 2021 – observe – means power vaccinate 31 million people, that’s 50% of the population. And even eliminating that 7-8% share where the vaccine might not work, it still means that 23 million Italians, a third of the entire population, are protected “by Sars-CoV-2.”If it happens in March, it will feel like a dream.”, Concludes the former executive director Ema.