The First Coronavirus Vaccine Tested in Humans Shows Early Promise - The New York Times

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An experimental coronavirus vaccine made by the biotech company Moderna provoked a promising immune response against the virus and appeared safe in the first 45 people who received it, researchers reported on Tuesday in The New England Journal of Medicine.

Moderna’s vaccine, developed by researchers at the National Institute of Allergy and Infectious Diseases, was the first coronavirus vaccine to be tested in humans, and the company announced on Tuesday that large Phase 3 tests of it would begin on July 27, involving 30,000 people. Half of the participants will be a control group who will receive placebos.

This large clinical trial is expected to be completed by late October. But it’s not clear whether it will be possible to prove the vaccine is safe and effective by then. The trial will need to show that those who were vaccinated were significantly less likely to contract the virus than those who got a placebo. The fastest way to get results is to test the vaccine in a “hot spot” with many cases, and the study is looking for people at high risk because of their locations or circumstances.

Vaccines and improved treatments are the only hope of returning lives back to anything close to normal, and dozens of companies are racing to develop vaccines. Experts agree that more than one vaccine will be needed, because no single company could produce the billions of doses needed.

“None of us are safe unless all of us are safe,” said Dr. Angela Rasmussen, a virologist at Columbia University in New York. “It’s not just us. It’s everybody in the world.”

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The Moderna vaccine uses genetic material from the virus, called mRNA, to prompt the immune system to fight the coronavirus.

The report on Tuesday confirmed and provided details on findings the company announced on May 18 in a news release that was criticized for lacking data. Moderna defended itself at the time, saying that as a publicly traded company it had a legal obligation to disclose results that could affect its share price, and that the actual data would be published later.

The results are from an early Phase 1 study that was designed to test low, medium and high doses of the vaccine and to gauge their safety and ability to create immunity to the virus. The participants were 45 healthy adults, ages 18 to 55, who received two vaccinations 28 days apart.

After the second shot, all of the participants developed so-called neutralizing antibodies, which can inactivate the virus in lab tests. The levels of those antibodies were similar to those in the upper range in patients who had recovered from coronavirus infections. The vaccine also produced a favorable response involving T-cells, another part of the immune system.

“It exceeds all expectations,” said Dr. Kizzmekia S. Corbett, a viral immunologist and leader of a team that developed the vaccine at the infectious disease institute.

More than half of the participants had side effects, including fatigue, chills, headaches, muscle aches and pain at the injection site. Some had fever. One person who received the low dose developed hives and was withdrawn from the study. None of the side effects were considered serious.

The Coronavirus Outbreak

• Frequently Asked Questions

  Updated July 7, 2020

  • Is the coronavirus airborne?

    The coronavirus can stay aloft for hours in tiny droplets in stagnant air, infecting people as they inhale, mounting scientific evidence suggests. This risk is highest in crowded indoor spaces with poor ventilation, and may help explain super-spreading events reported in meatpacking plants, churches and restaurants. It’s unclear how often the virus is spread via these tiny droplets, or aerosols, compared with larger droplets that are expelled when a sick person coughs or sneezes, or transmitted through contact with contaminated surfaces, said Linsey Marr, an aerosol expert at Virginia Tech. Aerosols are released even when a person without symptoms exhales, talks or sings, according to Dr. Marr and more than 200 other experts, who have outlined the evidence in an open letter to the World Health Organization.

  • 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.

  • What’s the best material for a mask?

    Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.)

  • 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.

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Experts not involved with the study said the results were encouraging, but early. “Just because you have antibodies doesn’t mean you’re completely immune,” Dr. Rasmussen said.

It is possible, she said, that a vaccine might not totally prevent infection, but that it might make the illness less severe. “If it’s a choice between a bad cold and being on a ventilator, I’ll take the bad cold,” she said.

Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania and Children’s Hospital of Philadelphia, said that the neutralizing antibodies and other immune responses were a good sign, but that it was not known yet whether they would actually protect people against the virus, or how long they would last. The side effects were a “small price to pay” for protection against a potentially severe disease, he said, though fever may be a cause for concern once the vaccine is given to large numbers of people.

“You always worry that fever, especially high fever, could lead to other things,” Dr. Offit said, adding that only a large controlled study can determine whether the vaccine is truly safe and effective.

Otherwise, “it’s reading the tea leaves,” he said. “You just don’t know anything until you do a Phase 3 trial.”

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