AstraZeneca vaccine, ok for January. “That is the reason for the delay” – Chronicle



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Professor Rasi, where are we with the AstraZeneca-Oxford vaccine? Has Ema received the documentation? “The pharmaceutical company delivered the dossier at the end of the year – answers Guido Rasi, microbiologist, former number one of the European regulatory body for medicines – I hope that the EMA can dictate the schedule during the week. It is not bureaucrats who are holding hands. However, it takes at least twenty days to validate a vaccine that requires robust and homogeneous studies. I hope the green light comes to the end of the month. “UK authorities approved it in …

Professor Rasi, where are we with the AstraZeneca-Oxford vaccineHas the EMA received the documentation?

“The pharmaceutical company delivered the file at the end of the year – responds Guido Rasi, microbiologist, former number one of the European regulatory body for medicines. I hope the EMA can dictate the schedule during the week. They are not inactive bureaucrats. However, it takes at least twenty days to validate a vaccine that requires robust and homogeneous studies. I hope the green light arrives at the end of the month. “

The UK authorities approved it in no time.

“The trend of the Covid-19 epidemic in Great Britain could have weighed on the times, galloping at the rate of 50 thousand infections a day, understandably the need to ensure certain categories of the population. The EMA, however, must verify the requirements for a product that will be distributed in 27 different states. “

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Italy had opted for this vaccine. Now we are late, why are the postponements?

“The problem is known, the uncertainties surrounding the AstraZeneca-Oxford vaccine refer to the lack of homogeneity of some data related to the dose to be used to obtain optimal efficacy (one and a half or two doses), the time interval (4-12 weeks) between the first and the second administration, the age groups in which it is particularly effective “.

Could there be political consequences related to London’s exit from the European Union?

“I exclude it, the verification is purely technical.”

When do you think the EMA will give the green light to the third European vaccine?

If the information presented exceeds the criticalities found, at the end of the month we can reach an evaluation similar to that of the Pfizer-BioNTech and Moderna vaccines ”.

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Is it true that the vaccine seems to cover young adults well and the elderly less?

“Even taking the lowest percentage of efficacy shown in clinical studies (around 60%) true, it is documented that the vaccine works very well in an average young population, while the numbers over 55 years are different.”

What remains to be done?

“Italy should calibrate the strategy, considering that at least two other vaccines will be available in March-April, probably those from Janssen and AstraZeneca. I mean having 4-5 different products, two of which are 95% effective, will be It is essential to give the right vaccine to the right person. And in any case, having 62 million doses of Pfizer and Moderna in the first part of 2021, in light of the recent clarification of the president of the Superior Council of Health, already means being able to vaccinate 31 million people against the Sars-CoV-2 virus. If it happened in March it would be a dream, we can think of achieving herd immunity in twelve months, if not sooner. “

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