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Trial of Coronavirus Vaccine Made by Moderna Begins in Seattle | Trial of Coronavirus Vaccine Made by Moderna Begins in Seattle |
(about 1 hour later) | |
The first testing in humans of an experimental vaccine for the new coronavirus began on Monday, the National Institute of Allergy and Infectious Diseases announced. | The first testing in humans of an experimental vaccine for the new coronavirus began on Monday, the National Institute of Allergy and Infectious Diseases announced. |
The main goal of this first set of tests is to find out if the vaccine is safe. If it is, later studies will determine how well it works. | The main goal of this first set of tests is to find out if the vaccine is safe. If it is, later studies will determine how well it works. |
The trial was “launched in record speed,” Dr. Anthony Fauci, the institute’s director, said in a statement. | The trial was “launched in record speed,” Dr. Anthony Fauci, the institute’s director, said in a statement. |
Such rapid development of a potential vaccine is unprecedented, and it was possible because researchers were able to use what they already knew about related coronaviruses that had caused other diseases outbreaks, SARS and MERS. | Such rapid development of a potential vaccine is unprecedented, and it was possible because researchers were able to use what they already knew about related coronaviruses that had caused other diseases outbreaks, SARS and MERS. |
Despite the rapid progress, even if the vaccine is proved safe and effective against the virus, it will not be available for at least a year. | Despite the rapid progress, even if the vaccine is proved safe and effective against the virus, it will not be available for at least a year. |
The tests, which are being conducted at Kaiser Permanente Washington Health Research Institute in Seattle, use a vaccine made by Moderna Inc. | The tests, which are being conducted at Kaiser Permanente Washington Health Research Institute in Seattle, use a vaccine made by Moderna Inc. |
Seattle was chosen as a test site before the United States had any known coronavirus cases, not because of the outbreak that erupted there. Washington State has been hard hit by the virus, with more than 670 cases to date. | Seattle was chosen as a test site before the United States had any known coronavirus cases, not because of the outbreak that erupted there. Washington State has been hard hit by the virus, with more than 670 cases to date. |
Moderna uses genetic material — messenger RNA — to make vaccines, and the company has nine others in various stages of development, including several for viruses that cause respiratory illnesses. But no vaccine made with this technology has yet reached the market. | Moderna uses genetic material — messenger RNA — to make vaccines, and the company has nine others in various stages of development, including several for viruses that cause respiratory illnesses. But no vaccine made with this technology has yet reached the market. |
The infectious disease institute has been working with Moderna because the RNA approach can produce vaccine very quickly, said Dr. Barney Graham, the deputy director of the institute’s Vaccine Research Center. | The infectious disease institute has been working with Moderna because the RNA approach can produce vaccine very quickly, said Dr. Barney Graham, the deputy director of the institute’s Vaccine Research Center. |
He said the researchers at the vaccine center were focused on pandemic preparedness. | He said the researchers at the vaccine center were focused on pandemic preparedness. |
“The goal here is to be ready for all the virus families that can infect humans,” he said. | “The goal here is to be ready for all the virus families that can infect humans,” he said. |
As bad as this epidemic is, Dr. Graham said, in one way it is lucky that a coronavirus caused it, because the researchers were at least partly ready for it. If another type of virus had caused the outbreak, it could have taken months longer to create a potential vaccine. | As bad as this epidemic is, Dr. Graham said, in one way it is lucky that a coronavirus caused it, because the researchers were at least partly ready for it. If another type of virus had caused the outbreak, it could have taken months longer to create a potential vaccine. |
Other companies, using different approaches, are also trying to manufacture coronavirus vaccines. Moderna is the first to reach a clinical trial. | Other companies, using different approaches, are also trying to manufacture coronavirus vaccines. Moderna is the first to reach a clinical trial. |
The trial will enroll 45 healthy adults ages 18 to 55. Each will receive two shots, 28 days apart. Moderna calls the vaccine mRNA-1273. | The trial will enroll 45 healthy adults ages 18 to 55. Each will receive two shots, 28 days apart. Moderna calls the vaccine mRNA-1273. |
Three different doses will be tested — each in 15 people — and the participants will be studied to determine whether the vaccine is safe and whether it stimulates the immune system to make antibodies that can stop the virus from replicating and prevent the illness it causes. | Three different doses will be tested — each in 15 people — and the participants will be studied to determine whether the vaccine is safe and whether it stimulates the immune system to make antibodies that can stop the virus from replicating and prevent the illness it causes. |
Four participants were vaccinated on Monday, and four more are to get shots on Tuesday. Then there will be a pause to monitor them, before more participants receive injections, Dr. Graham said. | Four participants were vaccinated on Monday, and four more are to get shots on Tuesday. Then there will be a pause to monitor them, before more participants receive injections, Dr. Graham said. |
The participants will be followed for a year, but Stéphane Bancel, the chief executive of Moderna, said in an interview that safety data would be available a few weeks after the injections were given. If the vaccine then appears safe, he said, Moderna will ask the Food and Drug Administration for permission to move ahead to the next phase of testing even before the first stage is finished. | The participants will be followed for a year, but Stéphane Bancel, the chief executive of Moderna, said in an interview that safety data would be available a few weeks after the injections were given. If the vaccine then appears safe, he said, Moderna will ask the Food and Drug Administration for permission to move ahead to the next phase of testing even before the first stage is finished. |
Updated June 24, 2020 | |
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. | 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 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. | 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. | 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. | 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. | 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. |
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. | 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. |
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. | 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. |
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 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. | 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 second round of testing, to measure efficacy as well as to verify safety, will include many more participants. | The second round of testing, to measure efficacy as well as to verify safety, will include many more participants. |
Moderna, with headquarters in Cambridge, Mass., and a manufacturing plant in nearby Norwood, is already buying new equipment so that it will able to produce millions of doses. Mr. Bancel acknowledged that the company was taking a risk, because neither safety nor efficacy has been proved yet. | Moderna, with headquarters in Cambridge, Mass., and a manufacturing plant in nearby Norwood, is already buying new equipment so that it will able to produce millions of doses. Mr. Bancel acknowledged that the company was taking a risk, because neither safety nor efficacy has been proved yet. |
“Humans are suffering and time is of the essence,” he said. “Every day matters. We have taken these decisions to take the risk, because we believe it is the right thing to do.” | “Humans are suffering and time is of the essence,” he said. “Every day matters. We have taken these decisions to take the risk, because we believe it is the right thing to do.” |
The company’s stock price jumped in February in response to news reports about the vaccine. And on Monday, Moderna’s stock rose more than 24 percent, rising $5.19 to close at $26.49. | The company’s stock price jumped in February in response to news reports about the vaccine. And on Monday, Moderna’s stock rose more than 24 percent, rising $5.19 to close at $26.49. |
Work on the vaccine started in January, as soon as Chinese scientists posted the genetic sequence of the new coronavirus on the internet. Researchers at Moderna and the National Institute of Allergy and Infectious Diseases identified part of the sequence that codes for a spike-like protein on the surface of the virus that attaches to human cells, helping the virus to invade them. | Work on the vaccine started in January, as soon as Chinese scientists posted the genetic sequence of the new coronavirus on the internet. Researchers at Moderna and the National Institute of Allergy and Infectious Diseases identified part of the sequence that codes for a spike-like protein on the surface of the virus that attaches to human cells, helping the virus to invade them. |
A nonprofit group, the Coalition for Epidemic Preparedness Innovations, helped pay to manufacture the vaccine for the trial. | A nonprofit group, the Coalition for Epidemic Preparedness Innovations, helped pay to manufacture the vaccine for the trial. |
That spike sequence is the basis for the vaccine. Moderna does not need the virus itself to produce its vaccine: The company synthesizes the stretch of RNA required for the vaccine and embeds it in a lipid nanoparticle. | That spike sequence is the basis for the vaccine. Moderna does not need the virus itself to produce its vaccine: The company synthesizes the stretch of RNA required for the vaccine and embeds it in a lipid nanoparticle. |
By Feb. 24, Moderna had a batch of vaccine ready to ship to the infectious diseases institute, for use in the trial. On March 4, the Food and Drug Administration gave permission for the trial to begin. | By Feb. 24, Moderna had a batch of vaccine ready to ship to the infectious diseases institute, for use in the trial. On March 4, the Food and Drug Administration gave permission for the trial to begin. |
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