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"The priority was speed, but without compromising safety." This is how Stéphane Bancel, CEO of the modern biotechnology company, has defined the development of the Covid-19 vaccine that this company prepares and that has started phase 3 of its clinical trial this Monday.

In a joint press conference with representatives of the National Institute of Health (NIH) of the United States Government, the company announced that its objective is to optimize its production processes to "be able to manufacture hundreds of thousands of vials of vaccine in no time . "

As Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases (NIAID), who directs the development of this phase of the clinical trial, explained, "We hope to have the first data on the effectiveness and safety of vaccine in late summer, and definitive results around November, perhaps earlier. "

In this way, as long as the results are positive, the production of the vaccine could be started before the end of the year, although the bulk of manufacturing will take place during 2021.

Record speed

This phase 3 of the clinical trial begins "just six months after the virus was sequenced in China in late January. We are breaking a world record for speed in developing a vaccine, " Fauci said.

This speed, according to those responsible for the project, has relegated the publication in scientific journals of the results of the previous phase of the trial, something that has been done by the most direct competitors in the development of a vaccine against Covid-19, United Kingdom and China, which published their results in The Lancet .

As for the development of the trial, Fauci hopes that in a few weeks, at least half of the volunteers can be recruited to test the vaccine, about 15,000.

In fact, the number of people who will participate, some 30,000 in total from all the states of the United States , make this phase 3 much more ambitious than originally planned, which has led Moderna to modify its agreement with the regulatory agency of American medicines, the FDA, and the public body BARDA, which had initially contributed 483 million to the company for the development of the mRNA-1273 vaccine and which will practically double its contribution after announcing today an expansion of $ 472 million.

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