Yellow on the Astrazeneca / Irbm anti Covid vaccine: Conte’s securities, US doubts
Astrazeneca anti Covid vaccine: Conte's announcement, the words of Di Lorenzo (Irbm) and the US stalemate (the Food and Drug Administration has asked for further investigations to resume the experimentation after the stop)
The first doses of Astrazeneca vaccine should arrive, according to Prime Minister Giuseppe Conte, as early as the beginning of December. Calculations that can be defined plausible according to Piero Di Lorenzo, CEO and president of Irbm, the Italian company that collaborated in the development of the vaccine for Astrazeneca .
But the truth is that in the US, the vaccine trial is still stopped after a volunteer in the British trial trial presented a serious adverse reaction.
THE WORDS OF GIUSEPPE CONTE
Let's start with Conte's hypotheses. "If the last stages of preparation of the Oxford-Pomezia vaccine (produced by Astrazeneca, ed ) are completed in the coming weeks, the first doses will be available in early December", said the prime minister , interviewed for the latest book. by Bruno Vespa.
“Already at the beginning we will have the first two or three million doses – Conte specified – other millions will arrive soon after. The European Commission has commissioned Astrazeneca and other companies for several hundred million doses. I think that in order to completely contain the pandemic we will have to wait until next spring anyway ”.
THE WORDS OF DI LORENZO
Conte's calculations are not so strange, according to Piero Di Lorenzo, CEO and president of Irbm, a company that has collaborated with the Jenner Institute of the University of Oxford to develop the vaccine that will be produced by Astrazeneca.
“If no sudden problems arise, it is reasonable to think that the clinical trial phase can be completed by the end of November or early December”, Di Lorenzo said, in an interview with Financialounge.com , not denying Conte's words.
"I am certainly not the one who must validate a declaration by the Prime Minister, what he says is pure gold for me – said Di Lorenzo – but as far as I'm concerned I repeat that if sudden problems do not arise it is reasonable to think that the clinical phase of experimentation can be completed by the end of November or early December ".
BALL AT THE EMA
Once the vaccine phase is over, it will be up to EMA, the European drug agency, "the eventual validation", said Di Lorenzo. Once the approval of the EMA has been obtained, the vaccine will obviously be produced and distributed on a large scale.
"Global distribution is not prohibitive because a player like AstraZeneca has the capacity to produce 2 billion doses by June 2021 and has already started manufacturing doses for a couple of months," Di Lorenzo said.
THE DOSES TO BE ADDRESSED TO THE EU
Doing a couple of calculations, therefore, in Europe 15-20 million doses could arrive by the end of the year and in Italy, which will need about 70 million doses, 2-3 million could arrive.
“Since January we have been working belly to earth, we are fortunate to have female researchers who, in addition to being particularly good, are very willing. Our secret? To work hard and also have a little luck, because without one of the two you can't go anywhere. Having said that, I am proud that an Italian company is at the forefront of this project, even though I am convinced that science is not Italian, British or American but is a global asset, ”Di Lorenzo said.
THE USA AND THE STOP (AGAIN) TO THE EXPERIMENTATION
But if it is true that science has no flag, it is also true that America has not yet resumed the experimentation of Astrazeneca, which in the US involves 30,000 volunteers. The trial, after the stop on September 6, due to an adverse reaction from a woman from the British trial , resumed after a few weeks in the rest of the world, but the Food and Drug Administration has asked for further investigations.
The review by the US authority should have been completed and testing should resume this week.
ROBERTA VILLA: FDA WANTS TO SEE US CLEAR
And of the stop to the experimentation of the Astrazeneca vaccine, also mentioned the scientific popularizer Roberta Villa, who spoke at Omnibus , a program led by Alessandra Sardoni.
“The Astrazeneca vaccine, which was booked in a large number of doses from Italy, had a hiccup. And I don't know why in Italy it is not said that the trial in the US has not resumed, because the Food and Drug Administration is not convinced that the incident has been clarified, ”said Villa.
VILLA: WE CANNOT KNOW ACTUAL EFFECTIVENESS
"We cannot yet know the effectiveness of the vaccine," adds Roberta Villa.
“What is being measured right now is the ability of vaccines to reduce the number of severe cases. Not to block the transmission of the virus. Vaccines will not allow to reduce or eliminate the measures to be implemented ", explains Villa, saying that" We are assuming that the best possible vaccine will arrive or in any case an excellent vaccine ", but that" the studies have not yet been completed. phase 3, those that demonstrate the efficacy of the drug ".
"In December, nothing will be administered", the expert is convinced, who hopes that "the regulatory agencies are free to rely only on data" and receive "no pressure".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/giallo-sul-vaccino-astrazeneca-irbm-anti-covid-le-sicurezze-di-conte-i-dubbi-usa/ on Wed, 21 Oct 2020 14:54:21 +0000.