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At the Anagni plant of the multinational, the 300 million doses destined for Europe will be produced, distribution from mid-2021. Always close to Rome, the filling of the Astrazeneca-Oxford vaccine will take place, while Reithera works in the totally made in Italy
by Marzio Bartoloni
The 300 million doses destined for Europe will be produced at the Anagni plant of the multinational, distribution from mid-2021. Also near Rome the filling of the Astrazeneca-Oxford vaccine will be carried out, while Reithera works in the all made in Italy
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The war against Covid has one of the most important outposts in Italy in Anagni, 70 kilometers from Rome, where the multinational Sanofi has decided that it will start its production of the vaccine it is developing together with the other pharmaceutical giant Gsk immediately after the end of experimentation. The indication comes directly from above: “Here is a center of excellence with great experience”, warns the CEO and president of Sanofi Italia, Marcello Cattani. “We plan to enter Phase Three in December,” adds Sanofi Pasteur’s Global Executive Vice President Thomas Triomphe, who aims, if all goes well in human testing, to produce 1 billion doses by 2021. 300 million are destined for Europe and a large part will be produced for Anagni. Distribution of the drug after approval by the EU Agency could start in mid-2021.
Tradition of excellence
Italy is thus confirmed as a leading country in the race for the most coveted vaccine, being able to count on a solid tradition of pharmaceutical manufacturing that, as expected, makes it the first drug producing country in Europe. Also because the filling of 400 million doses of the AstraZeneca and Oxford vaccine at the biotech company Catalent could begin in Anagni in the coming weeks. This small town of 20,000 that gave birth to four Popes will also deliver millions of doses of two of the most promising vaccine candidates. While in the north of Rome, in Castel Romano, the biotechnology company Reitehera together with Spallanzani are working on a completely Made in Italy vaccine that has reached its first tests in humans.
1 billion doses in 2021
The Sanofi announcement will be announced on Thursday, October 1, by the pharmaceutical giant at its plant near Rome where the presence of the Minister of Health, Roberto Speranza, is also expected. “This plant has been part of the Sanofi Group for 47 years and is a European center of excellence for the production of sterile injectable pharmaceutical products”, Cattani warns. Who remembers how here “there is a long experience in the production of vaccines and also in the regulatory field” and also for that in Covid we will use “a technology based on recombinant protein that is already used successfully for the production of some of our influenza vaccines : This choice, together with the use of an adjuvant from our partner GSK, allows us to target global production at all of our production sites of 1 billion doses by 2021 ». An operation in which Anagni will play” a key role alongside with two other sites in Europe. “
Phase III for December
The Sanofi vaccine is currently in phase 1 and 2 of experimentation: which provides, in addition to safety tests, also the first efficacy tests in large groups of volunteers. But she is preparing to enter the heart of the largest experimentation, the last one before the final ok: “We plan to move to Phase III in December this year,” warns Triomphe, vice president of Sanofi Pasteur. “We have high hopes because our preclinical data showed a good efficacy and immunogenicity profile.” If all goes well, the EMA authorization “could be given – he concludes – in May-June 2021 and immediately afterwards the doses will be available to European countries.
