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.
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Updated June 22, 2020
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Is it harder to exercise while wearing a mask?
A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.
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I’ve heard about a treatment called dexamethasone. Does it work?
The steroid, dexamethasone, is the first treatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
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What is pandemic paid leave?
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
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Does asymptomatic transmission of Covid-19 happen?
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
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What’s the risk of catching coronavirus from a surface?
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
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How does blood type influence coronavirus?
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
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How many people have lost their jobs due to coronavirus in the U.S.?
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
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My state is reopening. Is it safe to go out?
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
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What are the symptoms of coronavirus?
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
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How can I protect myself while flying?
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
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What should I do if I feel sick?
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
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.”
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