"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 with 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.
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.”
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. 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.
The Coronavirus Outbreak ›Frequently Asked Questions Updated July 16, 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.
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.
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 are 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.”"