Sanofi said Tuesday it plans to appeal to thousands of patients worldwide for trials of the experimental coronavirus vaccine that the French pharmaceutical group is developing with Britain's GlaxoSmithKline. Sanofi executives also told Reuters that the laboratory has begun talks with several countries for advance purchases.
Sanofi is currently working on two programs to develop a vaccine to fight Covid-19, the disease caused by the new coronavirus, and has announced that it is exploring several production options, including new collaborations, to ensure its capacity to respond to demand if a program were to succeed.
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Laboratories are working to develop treatments and vaccines against the highly contagious coronavirus, which has killed more than 255,000 people worldwide, infected more than 3.6 million people and devastated the world economy. Among more than 100 candidates for vaccine development, 10 have so far reached the stage of clinical trials, according to the Milken Institute, a Florida-based think tank.
Sanofi, whose commercial vaccines division Sanofi Pasteur has a proven track record in flu vaccines, partnered with British rival GSK last month in hopes of getting a vaccine ready next year. The two groups plan to use their respective technologies: a protein antigen that Sanofi has based on the platform used for its Flublok flu vaccine, and the recognized adjuvants developed by GSK which have the effect of promoting the production of antibodies in order improve immune resistance.
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Sanofi Pasteur executives told Reuters that the group hopes to start the first phase of clinical trials in September, using hundreds of patients. While "phase 1" clinical trials of a vaccine usually involve a small group of healthy volunteers to test safety, Sanofi said it has opted for more people in order to get it sooner more reliable data. "We envisioned Phase I with several hundred subjects, so it's actually a Phase I / II trial," said John Shiver, research manager for the vaccines division at Sanofi.
In addition to succeeding in developing an effective vaccine, the challenge for the laboratory lies in its capacity to produce it on a very large scale and to distribute it throughout the world. "We are going to compare different doses of the vaccine and this is essential. This will tell us about the plant's capacity and what we need to do to produce the number of doses we anticipate, ” said John Shiver. Sanofi has said in the past that it will be able to produce more than a billion doses. Its joint program with GSK has received financial support from the Advanced Medical Biology Research and Development Authority (BARDA) of the United States Department of Health.
John Shiver said the final phase of the trials, involving thousands of subjects, to compare the effects of the vaccine with a placebo, should take place at the end of the year or early 2021. He added that some of the clinical trials carried out in the past by Sanofi for its influenza vaccines had concerned up to 30,000 participants.
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Vaccine executive vice president David Loew said Sanofi has started preliminary discussions with countries on pre-order mechanisms for the vaccine, should it prove to be effective, though legal details must always be settled with GSK. "It is a little tricky when you join another company," he said, adding that discussions were taking place with American representatives as well as with certain European countries.
Due to the support provided by BARDA, it is expected that the doses that will be produced in the American Sanofi plant will go in priority to patients in the United States, a prospect that is fueling concerns in Europe. Asked if the French pharmaceutical group could consider new collaborations in order to guarantee the level of production it promised, David Loew replied "yes, if we come to the conclusion that we do not have enough of capacities ” . Sanofi is also working with the American Translate Bio on the development of another potential vaccine against the coronavirus.
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