The German laboratory BioNTech works with the American Pfizer. REUTERS / Dado Ruvic / Illustration / File Photo
Pfizer / BioNTech has already signed several contracts, notably with the EU and the United States, and is currently discussing "with 30 countries".
The director of the German laboratory BioNTech, which is working with the American Pfizer on a vaccine against Covid-19, estimated Thursday "possible" its authorization and distribution by the end of the year in the United States or in the 'European Union. "We are working hard," Ugur Sahin told AFP in a videoconference interview, specifying that the authorization request would be filed on Friday with the US Medicines Agency (FDA).
"There is a chance that we can still obtain authorization this year in the United States or in Europe or in both regions", assures the researcher, specialist in immunology. "We may be able to deliver vaccines in December," he said.
The European Medicines Agency (EMA) is currently carrying out an ongoing assessment of the product with a view to its authorization and additional data will be sent to it "next week".
The Pfizer / BioNTech laboratory project is, along with that of the American laboratory Moderna, the most advanced in large-scale clinical trials which have shown in both cases a comparable efficacy, of 95% for that of the American-German alliance.
Hundreds of millions of doses have already been reserved around the world. But several governments have announced that the injections will initially be intended for hospital staff and the most vulnerable people. The rest of the population will have to wait several more months.
"At least one year" protection
If "all actors including governments, pharmaceutical companies and the supply chain do a good job, we can immunize 60% to 70% of the population by winter 2021," Sahin noted during This interview. "If we get there, we will be able to have a normal winter, without new + confinement +", added the scientist, co-founder of BioNTech, based in Mainz (western Germany).
Pfizer / BioNTech has already signed several contracts, notably with the EU and the United States, and is currently discussing "with 30 countries". The laboratories are also speaking with "several organizations", including the United Nations, with the objective of "making the vaccine available everywhere" and reducing its cost to make it accessible to poor countries.
Mr. Sahin, 55, and his wife Özlem Türeci, medical director and co-founder of the company, will "obviously" be vaccinated as soon as possible. Mr. Sahin says he is "very confident" in the safety of the vaccine. The question of the acceptance of a vaccine by the populations, in a context of growing mistrust, is one of the questions that will arise for the authorities. So far, "no serious side effects" have been seen in large-scale trials, Pfizer and BioNTech said on Wednesday when additional data from their tests were released.
German Chancellor Angela Merkel said Thursday that it was necessary "now to authorize these vaccines without taking any risk". The duration of the protection conferred by an injection remains one of the questions to be clarified in the studies which are continuing. "Reasonably, I would say the vaccine will protect for at least a year, if not much longer," Sahin said.
Another challenge: the distribution of this product which involves being stored at very low temperature, -70 degrees Celsius, and no more than five days at refrigerator temperature. The company considers that it is "well prepared" for a first phase of distribution according to these very cold conditions for which special packaging exists.
In parallel, BioNTech is already working on a "second generation" of vaccine that can be stored at lower temperatures. "We are in the process of identifying conditions that allow transport at -20 degrees or longer storage in the refrigerator," said Sahin.
Unknown to the general public until recently, the founders of BioNTech also attracted attention by their career as children of Turkish immigrants, trained in Germany. The couple created the company in 2008 with the aim of developing a new generation of one-on-one therapies for cancer patients.
This research continues: the innovative messenger RNA technology, on which their project against Covid-19 is based, makes it possible to consider the outcome of other vaccines or therapies, "in particular against cancer", explains the CEO .