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Astrazeneca anti Covid vaccine: facts, hitches and comments

3 years ago babelfish

Astrazeneca anti Covid vaccine: facts, hitches and comments

Experts and insiders comment and analyze the differences between the British regulatory body and the European agency Ema on the Astrazeneca anti Covid vaccine.

Experts and insiders comment and analyze the differences between the British regulatory body and the European agency Ema on the Astrazeneca anti Covid vaccine. Here are all the details.

THE COMMENT OF RASI (FORMER EMA) ON THE ASTRAZENECA ANTI COVID VACCINE

“It is absolutely not excluded that the EU green light for AstraZeneca's anti-Covid vaccine may arrive by the end of January. The company presented the data to the EMA two days ago "in support of the conditional authorization request for marketing, therefore" if the data presented will prove to be robust, homogeneous and easy to interpret, the Agency will be able to express itself within a twenty days: from 15 to 30 working days, if, as I imagine, he hasn't changed his modus operandi ”. This is what Guido Rasi, former executive director of the European regulatory body, professor of Microbiology at the University of Rome Tor Vergata, explained to Adnkronos Salute .

WHAT THE EMA SAYS ABOUT THE ASTRAZENECA ANTI COVID VACCINE

Regarding what the Deputy Executive Director of EMA Noel Wathion told the Belgian newspaper Het Nieuwsblad ( he stated that the Agency will most likely not be able to approve the vaccine developed by the University of Oxford and Irbm of Pomezia, and produced from AstraZeneca), Rasi believes it is "no coincidence" that on December 29 the official made such a peremptory statement asking for new data, and the next day the company presented them. Now the information is there and "I expect that, after having examined it, the EMA will provide us with a time schedule during the week – the former number one of the Agency provides – that will tell us how long it will take to express itself".

THE PROBLEMS OF THE ASTRAZENECA ANTI COVID VACCINE

The problem that arose around the AstraZeneca vaccine, Rasi recalls on the basis of what "publicly known", was the "inhomogeneity" of some data relating in particular to the dosage to be used to obtain optimal efficacy (one and a half or two doses), the "highly variable (4-12 weeks)" time interval between the first and second dose, and the "heterogeneous" epidemic situations in which the product was tested ( here the in-depth study by Start Magazine on the hitches of the Astrazeneca vaccine ). But if the information presented yesterday will overcome these criticalities, "it is absolutely not excluded" that the evaluation timing is similar to that of Pfizer / BioNTech and Moderna vaccines: "About twenty days", reiterates the former EMA director.

THE DIFFERENCES BETWEEN UK AND EU

On the green light already granted to the AstraZeneca vaccine by the British regulatory agency Mhra, for Rasi "it would be good if the difference between the UK and the EU would emerge again" 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 for those that completely delegate to central agencies. It's another job ”, he points out.

I WHY THE UK ACCELERATION ON THE ASTRAZENECA ANTI COVID VACCINE

The acceleration in the UK, the former head of the European Medicines Agency also notes, was probably also based "on the 'acute' state of the Covid epidemic in Great Britain, where 50,000 cases were recorded for a couple of days newspapers ". A picture in which, even taking for granted 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 hurry 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".

THE TWEETS OF PROF. GILESTRO

Here are the explanatory tweets by Giorgio Gilestro, Neurobiologist, Associate Professor, at Imperial College London:

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-astrazeneca-anti-covid-fatti-intoppi-commenti/ on Wed, 30 Dec 2020 15:50:09 +0000.