After falling behind its competitors at the start of clinical trials, French drug maker Sanofi announced plans to speed up a vaccine development timeline that could gain regulatory approval sometime next year, perhaps in the first half of 2021, the company announced Tuesday.
The company and its partner in the effort, GlaxoSmithKline, originally projected that a vaccine would be available, at the earliest, in the second half of next year.
Like other contenders in the race for a coronavirus vaccine, Sanofi is eager to move forward. Still, “such a rapid and intense scale of vaccine production is unprecedented,” and the future is unknown, said Padmini Pillai, an immunologist at MIT.
The Sanofi-GSK vaccine contains a laboratory-synthesized version of the coronavirus “spike” protein, which decorates the virus’s surface and is crucial to its ability to enter host cells. This so-called recombinant vaccine is also formulated with one of GSK’s proprietary adjuvants, compounds that can enhance the body’s immune response to a strange attack, in theory by increasing the staying power of a given vaccine.
A combined Phase I / II clinical trial for the vaccine, originally scheduled for December 2020, will now begin in September. The goal is to have the recombinant vaccine fully licensed by June 2021.
At Tuesday’s briefings, both companies expressed confidence in their collaboration and their potential to deliver a successful vaccine. Sanofi’s history with vaccine development is profound; Its production lines are responsible for hundreds of millions of doses of the flu vaccine each year.
“As all eyes are on prevention of infectious diseases through vaccines, this is a point in time when we are being asked to find innovative ways to protect public health,” Thomas Triomphe, Executive Vice President of Sanofi Pasteur, the company’s global vaccine business. unit said in a statement.
Sanofi is also developing a separate set of vaccine candidates with Translate Bio, an American therapeutics company, in a slightly less accelerated time frame. This second batch of recipes is based on mRNA technology, an approach taken by several of Sanofi’s competitors, including Moderna and a partnership between BioNTech, Pfizer and Fosun Pharma.
Such mRNA vaccines are new; to date, none have been authorized for use in humans. Still, they have been touted as a potential improvement over their predecessors, especially for their scalability and versatility, Dr. Pillai said. They are designed to induce human cells to make proteins that resemble those produced by the coronavirus, thus avoiding the need for the pathogen itself. The goal is to elicit a strong immune response that protects the body from disease if the virus tries to settle.
Saad Omer, a vaccine researcher and director of the Yale Institute of Global Health, said Sanofi, a company with remarkable “large-scale vaccine manufacturing and distribution muscle memory,” was well prepared to push forward innovative vaccine formulations, such as those containing mRNA. But “that doesn’t mean we shouldn’t be cautious when projecting timelines,” added Dr. Omer.
Sanofi-Translate Bio mRNA vaccines are currently in preclinical testing. Sanofi expects Phase I trials to begin in late 2020, and hopes to gain approval from regulatory bodies like the US Food and Drug Administration. USA Or the European Medicines Agency by the end of 2021. As part of this push, the French company has announced that it will expand its collaboration with Translate Bio, reaching an agreement in which the US group will receive $ 425 million in advance payments.
If a coronavirus vaccine mix, made by Sanofi and its partners, or by one of their competitors, meets the brand sometime next year, it will be a record. Most vaccines take many years, if not decades, to develop. The particular mRNA formulation would be the “first of its kind” if approved, said Asher Williams, a chemical engineer at Cornell University.
But there are many obstacles. The researchers are wisely searching for multiple types of vaccines, Dr. Omer said, since different recipes, each with different pieces of the coronavirus, are likely to vary in effectiveness. A multiple approach is a good way for the global community to hedge its bets to slow the spread of the disease.
“I think there are reasons to be cautiously optimistic,” said Dr. Omer. “But we must not get ahead of ourselves.”
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