After lagging behind its competitors in starting clinical trials, the French drugmaker Sanofi has announced plans to speed a vaccine development timeline that could yield approval from regulatory authorities sometime next year, perhaps in the first half of 2021, the company announced on Tuesday.
The company and its partner in the endeavor, GlaxoSmithKline, originally projected that a vaccine would be available, at the earliest, in the latter half of next year.
Like other contenders in the race for a coronavirus vaccine, Sanofi is eager to push forward. Still, “such fast-tracking and intense scale of vaccine production is totally unprecedented,” and the future unknown, said Padmini Pillai, an immunologist at M.I.T.
The Sanofi-GSK vaccine contains a laboratory-synthesized version of the coronavirus’s “spike” protein, which decorates the surface of the virus 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 foreign onslaught, in theory boosting 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.
In news briefings on Tuesday, both companies expressed confidence in their collaboration and its potential to deliver a successful vaccine. Sanofi’s history with vaccine development runs deep; 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 disease through vaccines, this is a pointed moment in time where we are called upon to seek innovative ways to protect public health,” Thomas Triomphe, executive vice president of Sanofi Pasteur, the company’s vaccines global business unit, said in a statement.
Sanofi is also developing a separate set of vaccine candidates with Translate Bio, an American therapeutics company, on a slightly less expedited timeline. This second batch of recipes is based on mRNA technology, an approach being 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 cleared for use in humans. Still, they have been touted as a potential improvement on their predecessors, especially for their scalability and versatility, Dr. Pillai said. They are engineered to coax human cells into manufacturing proteins that resemble those made by the coronavirus, thus avoiding the need for the pathogen itself. The aim is to elicit a strong immune response that would protect the body from disease should the actual virus try to settle in.
Saad Omer, a vaccine researcher and director of the Yale Institute for Global Health, said that Sanofi, a company with notable “muscle memory of manufacturing and distributing vaccines at a large scale,” was well poised to push forward innovative vaccine formulations, like those containing mRNA. But “that doesn’t mean we shouldn’t be cautious about projecting timelines,” Dr. Omer added.
The Sanofi-Translate Bio mRNA vaccines are currently in preclinical testing. Sanofi expects Phase I trials to begin by the end of 2020, and hopes to seek approval with regulatory bodies like the U.S. Food and Drug Administration or the European Medicines Agency by the close of 2021. As a part of this push, the French company has announced that it will expand its collaboration with Translate Bio, striking a deal in which the American group will receive $425 million in upfront payments.
If a coronavirus vaccine concoction — made by Sanofi and its partners, or by one of their competitors — meets the mark sometime next year, it will be a record. Most vaccines take many years, if not decades, to develop. The mRNA formulation in particular would be the “first of its kind” if approved, said Asher Williams, a chemical engineer at Cornell University.
But there are plenty of hurdles. Researchers are wisely pursuing multiple types of vaccines, Dr. Omer said, since the various recipes, each employing different bits of the coronavirus, are likely to range in their efficacy. A multipronged approach is a good way for the global community to hedge its bets on curbing the spread of disease.
“I think there’s reason to be cautiously optimistic,” Dr. Omer said. “But we shouldn’t get ahead of ourselves.”