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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 8 hours 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.
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.
Updated June 12, 2020Updated June 12, 2020
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.
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.
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.
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.
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.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.
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.)
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
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.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
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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