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Moderna Gets OK to Start Larger Trial for a Coronavirus Vaccine Moderna Gets OK to Start Larger Trial for a Coronavirus Vaccine
(14 days later)
One of the first biotech companies to begin human trials of an experimental vaccine for the coronavirus is now ready to move onto the next phase of testing.One of the first biotech companies to begin human trials of an experimental vaccine for the coronavirus is now ready to move onto the next phase of testing.
On Thursday, Moderna announced that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 600 people.On Thursday, Moderna announced that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 600 people.
“The imminent Phase 2 study start is a crucial step forward,” Stéphane Bancel, Moderna’s chief executive, said in a statement.“The imminent Phase 2 study start is a crucial step forward,” Stéphane Bancel, Moderna’s chief executive, said in a statement.
The main goal of this set of tests is to find out if the vaccine is safe and if positive results from the first few dozen volunteers in the first phase can be replicated in a much larger group. If it is successful, later studies, known as Phase 3 trials, will determine exactly how well the vaccine works.The main goal of this set of tests is to find out if the vaccine is safe and if positive results from the first few dozen volunteers in the first phase can be replicated in a much larger group. If it is successful, later studies, known as Phase 3 trials, will determine exactly how well the vaccine works.
More than a dozen companies, including known vaccine producers like Johnson & Johnson, or Sanofi, are involved in a global race to develop a vaccine to tamp down the highly infectious coronavirus that has killed more than a quarter-million people around the world.More than a dozen companies, including known vaccine producers like Johnson & Johnson, or Sanofi, are involved in a global race to develop a vaccine to tamp down the highly infectious coronavirus that has killed more than a quarter-million people around the world.
Four Chinese companies have started testing their potential vaccines on humans, including CanSino Biologics, which announced the beginning of Phase 2 trials in early April. A few others, such as Pfizer and its German partner, BioNTech, are enrolling volunteers for combined Phase 1 and 2 trials.Four Chinese companies have started testing their potential vaccines on humans, including CanSino Biologics, which announced the beginning of Phase 2 trials in early April. A few others, such as Pfizer and its German partner, BioNTech, are enrolling volunteers for combined Phase 1 and 2 trials.
Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, has suggested that it would still take 12 to 18 months for a vaccine to be widely available to the public. There is no proven treatment, and many researchers and corporations around the world are pursuing remedies in addition to vaccines.Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, has suggested that it would still take 12 to 18 months for a vaccine to be widely available to the public. There is no proven treatment, and many researchers and corporations around the world are pursuing remedies in addition to vaccines.
Moderna’s vaccine candidate, called mRNA-1273, relies on genetic material known as messenger RNA, which carries the recipe for making proteins to tiny ribosome chefs inside cells. The vaccine is written with a very specific recipe — in this case for making the spike protein of the coronavirus.Moderna’s vaccine candidate, called mRNA-1273, relies on genetic material known as messenger RNA, which carries the recipe for making proteins to tiny ribosome chefs inside cells. The vaccine is written with a very specific recipe — in this case for making the spike protein of the coronavirus.
Because the virus typically uses this protein as a key to unlock and take over lung cells, the vaccine could train a healthy immune system to produce antibodies to fight off an infection before someone gets sick.Because the virus typically uses this protein as a key to unlock and take over lung cells, the vaccine could train a healthy immune system to produce antibodies to fight off an infection before someone gets sick.
Moderna’s vaccine is one of many using this unusual technology. Its first tests in humans were conducted in 45 healthy adults in Seattle, funded by the National Institutes of Health. Since then, other companies, using different approaches, have also joined the race to find a coronavirus vaccine.Moderna’s vaccine is one of many using this unusual technology. Its first tests in humans were conducted in 45 healthy adults in Seattle, funded by the National Institutes of Health. Since then, other companies, using different approaches, have also joined the race to find a coronavirus vaccine.
Updated July 7, 2020
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.)
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 F.D.A. said its policy was not to comment on phases of any drug trial, and Moderna did not release results from the first phase.The F.D.A. said its policy was not to comment on phases of any drug trial, and Moderna did not release results from the first phase.
In its first-quarter update on Thursday, Moderna appeared to be speeding up its timeline for a coronavirus vaccine, stating that the next phase would begin “shortly.” The company is also gearing up for a Phase 3 trial in the summer, and hopes to have the final vaccine approved “as soon as 2021.”In its first-quarter update on Thursday, Moderna appeared to be speeding up its timeline for a coronavirus vaccine, stating that the next phase would begin “shortly.” The company is also gearing up for a Phase 3 trial in the summer, and hopes to have the final vaccine approved “as soon as 2021.”
Moderna’s shares soared as much as 13 percent in early Thursday trading. Excitement over a potential vaccine has led to an increase of more than 150 percent in the company’s stock since the beginning of this year.Moderna’s shares soared as much as 13 percent in early Thursday trading. Excitement over a potential vaccine has led to an increase of more than 150 percent in the company’s stock since the beginning of this year.
The biotech firm is also accelerating plans for manufacturing a vaccine so it can start building a stockpile as soon as this July. Last week, the firm announced a 10-year collaboration with the Swiss contract drugmaker Lonza to manufacture up to one billion doses per year for worldwide distribution, if the vaccine proves successful.The biotech firm is also accelerating plans for manufacturing a vaccine so it can start building a stockpile as soon as this July. Last week, the firm announced a 10-year collaboration with the Swiss contract drugmaker Lonza to manufacture up to one billion doses per year for worldwide distribution, if the vaccine proves successful.