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Moderna Coronavirus Vaccine Trial Shows Promising Early Results Moderna Coronavirus Vaccine Trial Shows Promising Early Results
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The first coronavirus vaccine to be tested in people appears to be safe and able to stimulate an immune response against the infection, the manufacturer, Moderna, announced on Monday, offering a glint of hope to a world desperate for ways to stop the pandemic.The first coronavirus vaccine to be tested in people appears to be safe and able to stimulate an immune response against the infection, the manufacturer, Moderna, announced on Monday, offering a glint of hope to a world desperate for ways to stop the pandemic.
The preliminary findings, in the first eight people who each received two doses of the experimental vaccine, must now be repeated in far larger tests in hundreds and then thousands of people, to find out if the vaccine can work in the real world. Moderna’s technology, involving genetic material from the virus called mRNA, is relatively new and has yet to produce any approved vaccine.The preliminary findings, in the first eight people who each received two doses of the experimental vaccine, must now be repeated in far larger tests in hundreds and then thousands of people, to find out if the vaccine can work in the real world. Moderna’s technology, involving genetic material from the virus called mRNA, is relatively new and has yet to produce any approved vaccine.
The promising early news sent Moderna’s stock soaring by more than 25 percent on Monday afternoon and helped drive Wall Street to its best day in six weeks. Stocks were also lifted by statements from the Federal Reserve chair, Jerome H. Powell, that the central bank would continue to support the economy and markets.The promising early news sent Moderna’s stock soaring by more than 25 percent on Monday afternoon and helped drive Wall Street to its best day in six weeks. Stocks were also lifted by statements from the Federal Reserve chair, Jerome H. Powell, that the central bank would continue to support the economy and markets.
Trading on Monday had all of the characteristics of a rally focused on prospects for a return to normal: The S&P 500 rose more than 3 percent; stock benchmarks in Europe were 4 percent to 6 percent higher; and oil prices also jumped. Among the best performers in the S&P 500 were travel-related companies, like United Airlines, Expedia Group and Marriott International.Trading on Monday had all of the characteristics of a rally focused on prospects for a return to normal: The S&P 500 rose more than 3 percent; stock benchmarks in Europe were 4 percent to 6 percent higher; and oil prices also jumped. Among the best performers in the S&P 500 were travel-related companies, like United Airlines, Expedia Group and Marriott International.
[Follow our Live Coronavirus Vaccine Tracker.][Follow our Live Coronavirus Vaccine Tracker.]
With the weather warming and state after state starting to lift lockdown restrictions, Americans are eager to regain their freedom to shop, go to the beach and enjoy bars and restaurants. Still, more than 1,000 people died most days last week in the United States.With the weather warming and state after state starting to lift lockdown restrictions, Americans are eager to regain their freedom to shop, go to the beach and enjoy bars and restaurants. Still, more than 1,000 people died most days last week in the United States.
Vaccines are now seen as the best and perhaps only hope of stopping or even slowing a disease that has sickened nearly five million people worldwide, killed 315,000 and locked down entire countries, paralyzing their economies.Vaccines are now seen as the best and perhaps only hope of stopping or even slowing a disease that has sickened nearly five million people worldwide, killed 315,000 and locked down entire countries, paralyzing their economies.
Dozens of companies and universities are rushing to create coronavirus vaccines, and human trials have already started for several manufacturers, including Pfizer and its German partner BioNTech, the Chinese company CanSino and the University of Oxford, which is working with AstraZeneca.Dozens of companies and universities are rushing to create coronavirus vaccines, and human trials have already started for several manufacturers, including Pfizer and its German partner BioNTech, the Chinese company CanSino and the University of Oxford, which is working with AstraZeneca.
Experts agree that it is essential to develop multiple vaccines, because the urgent global need for billions of doses will far outstrip the production capacity of any one manufacturer. But there is widespread concern among scientists that haste could compromise safety, resulting in a vaccine that does not work or even harms patients.Experts agree that it is essential to develop multiple vaccines, because the urgent global need for billions of doses will far outstrip the production capacity of any one manufacturer. But there is widespread concern among scientists that haste could compromise safety, resulting in a vaccine that does not work or even harms patients.
The potential strength of Moderna’s mRNA approach to vaccine making is that it uses a genetic framework that can be quickly adapted for each new viral threat. The company has said that it is proceeding on an accelerated timetable, with a second phase of tests involving 600 people to begin soon, and a third phase to begin in July involving thousands of healthy people. The Food and Drug Administration gave Moderna the go-ahead this month for the second phase.The potential strength of Moderna’s mRNA approach to vaccine making is that it uses a genetic framework that can be quickly adapted for each new viral threat. The company has said that it is proceeding on an accelerated timetable, with a second phase of tests involving 600 people to begin soon, and a third phase to begin in July involving thousands of healthy people. The Food and Drug Administration gave Moderna the go-ahead this month for the second phase.
If those trials go well, some doses of a vaccine could become available for widespread use by the end of this year or early 2021, Dr. Tal Zaks, Moderna’s chief medical officer, said in an interview. “We’re doing our best to make it as many millions as possible.”If those trials go well, some doses of a vaccine could become available for widespread use by the end of this year or early 2021, Dr. Tal Zaks, Moderna’s chief medical officer, said in an interview. “We’re doing our best to make it as many millions as possible.”
President Trump said last week that a vaccine would be available before the end of this year. His prediction was supported by Moncef Slaoui, the newly appointed leader of Operation Warp Speed, the administration’s effort to speed vaccine development. At a briefing last week, Mr. Slaoui, a former member of Moderna’s board of directors who resigned when he took up his new government post, said he had seen preliminary research data that convinced him that a vaccine could be created by the end of the year. He did not identify the data.President Trump said last week that a vaccine would be available before the end of this year. His prediction was supported by Moncef Slaoui, the newly appointed leader of Operation Warp Speed, the administration’s effort to speed vaccine development. At a briefing last week, Mr. Slaoui, a former member of Moderna’s board of directors who resigned when he took up his new government post, said he had seen preliminary research data that convinced him that a vaccine could be created by the end of the year. He did not identify the data.
Also on Monday, Caitlin Oakley, a spokeswoman for the Department of Health and Human Services, confirmed that Mr. Slaoui would divest his Moderna stock options, valued at about $10 million, on Tuesday morning. Ms. Oakley added that Mr. Slaoui would donate to cancer research the increased value his shares had accrued from last Thursday until Tuesday’s sale. The share price closed at $80 on Monday, up from $64.56 last Thursday, adding $2.4 million to the value of his options.Also on Monday, Caitlin Oakley, a spokeswoman for the Department of Health and Human Services, confirmed that Mr. Slaoui would divest his Moderna stock options, valued at about $10 million, on Tuesday morning. Ms. Oakley added that Mr. Slaoui would donate to cancer research the increased value his shares had accrued from last Thursday until Tuesday’s sale. The share price closed at $80 on Monday, up from $64.56 last Thursday, adding $2.4 million to the value of his options.
At a round table with restaurant executives at the White House on Monday, Mr. Trump said, “This was a very big day, cure wise and vaccine wise,” and noted that the markets were lifted by drug news.At a round table with restaurant executives at the White House on Monday, Mr. Trump said, “This was a very big day, cure wise and vaccine wise,” and noted that the markets were lifted by drug news.
Moderna produced the vaccine in collaboration with the National Institute of Allergy and Infectious Diseases, the institute that is headed by Dr. Anthony Fauci and has been leading the clinical trials. Part of the National Institutes of Health, the agency is involved in research on other experimental coronavirus vaccines. Moderna and Johnson & Johnson have each received roughly half a billion dollars from the U.S. government, to speed development of a vaccine.Moderna produced the vaccine in collaboration with the National Institute of Allergy and Infectious Diseases, the institute that is headed by Dr. Anthony Fauci and has been leading the clinical trials. Part of the National Institutes of Health, the agency is involved in research on other experimental coronavirus vaccines. Moderna and Johnson & Johnson have each received roughly half a billion dollars from the U.S. government, to speed development of a vaccine.
The people vaccinated in Moderna’s Phase 1 study described on Monday were healthy volunteers ages 18 to 55. Their immune systems made antibodies that were then tested in infected cells in the lab, and were able to stop the virus from replicating — the key requirement for an effective vaccine. The levels of those so-called neutralizing antibodies matched or exceeded the levels found in patients who had recovered after contracting the virus in the community.The people vaccinated in Moderna’s Phase 1 study described on Monday were healthy volunteers ages 18 to 55. Their immune systems made antibodies that were then tested in infected cells in the lab, and were able to stop the virus from replicating — the key requirement for an effective vaccine. The levels of those so-called neutralizing antibodies matched or exceeded the levels found in patients who had recovered after contracting the virus in the community.
Dr. Mark J. Mulligan, director of the N.Y.U. Langone Vaccine Center, called the Moderna findings “very encouraging.” He added, “It’s a small number of participants, but it appears to be a really good start.” Dr. Mulligan was not involved in the early testing but expected to participate in a later phase of the Moderna vaccine research.Dr. Mark J. Mulligan, director of the N.Y.U. Langone Vaccine Center, called the Moderna findings “very encouraging.” He added, “It’s a small number of participants, but it appears to be a really good start.” Dr. Mulligan was not involved in the early testing but expected to participate in a later phase of the Moderna vaccine research.
Moderna’s early stage of testing, Phase 1, is continuing, Two more age groups — 55 to 70 and 71 and over — are now being enrolled to test the vaccine. The company did not mention plans to include children in its studies and did not respond to an inquiry about it in time for publication. But Dr. Mulligan said that tests in children were often delayed until a vaccine was shown to be safe in young adults.Moderna’s early stage of testing, Phase 1, is continuing, Two more age groups — 55 to 70 and 71 and over — are now being enrolled to test the vaccine. The company did not mention plans to include children in its studies and did not respond to an inquiry about it in time for publication. But Dr. Mulligan said that tests in children were often delayed until a vaccine was shown to be safe in young adults.
The actual data from the preliminary tests has not been published or shared publicly, but has been submitted to the Food and Drug Administration, which does not comment on trials still in progress. The company said it hoped to make data publicly available this summer.The actual data from the preliminary tests has not been published or shared publicly, but has been submitted to the Food and Drug Administration, which does not comment on trials still in progress. The company said it hoped to make data publicly available this summer.
Two shots, four weeks apart, are likely to be needed, meaning that however many doses are produced, only half that number of people can be vaccinated.
Moderna said that additional tests in mice that were vaccinated and then infected found that the vaccine could prevent the virus from replicating in their lungs, and that the animals had levels of neutralizing antibodies comparable to those in the people who had received the vaccine.
Updated June 22, 2020Updated June 22, 2020
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.
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.)
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.
Two shots, four weeks apart, are likely to be needed, meaning that however many doses are produced, only half that number of people can be vaccinated.
Moderna said that additional tests in mice that were vaccinated and then infected found that the vaccine could prevent the virus from replicating in their lungs, and that the animals had levels of neutralizing antibodies comparable to those in the people who had received the vaccine.
Three doses of the vaccine were tested: low, medium and high. These initial results are based on tests of the low and medium doses. The only adverse effects at those doses were redness and soreness in one patient’s arm where the shot was given.Three doses of the vaccine were tested: low, medium and high. These initial results are based on tests of the low and medium doses. The only adverse effects at those doses were redness and soreness in one patient’s arm where the shot was given.
But at the highest dose, three patients had fever, muscle pains and headaches, Dr. Zaks said, adding that the symptoms went away after a day.But at the highest dose, three patients had fever, muscle pains and headaches, Dr. Zaks said, adding that the symptoms went away after a day.
But the high dose is being eliminated from future studies, not so much because of the side effects, but because the lower doses appear to work so well that the high dose is not needed.But the high dose is being eliminated from future studies, not so much because of the side effects, but because the lower doses appear to work so well that the high dose is not needed.
“The lower the dose, the more vaccine we’ll be able to make,” Dr. Zaks said.“The lower the dose, the more vaccine we’ll be able to make,” Dr. Zaks said.
He added, “Demand is going to far outstrip supply so I think there is an ethical obligation to go with the lowest dose you can so you can make as much vaccine as possible.”He added, “Demand is going to far outstrip supply so I think there is an ethical obligation to go with the lowest dose you can so you can make as much vaccine as possible.”
The company, based in Cambridge, Mass., has a vaccine-making facility nearby in Norwood, and recently announced a 10-year collaboration with the Swiss contract drugmaker Lonza to manufacture up to one billion doses a year for worldwide distribution, if the vaccine proves successful. Dr. Zaks said Moderna was also working with other vaccine makers in the United States to scale up production.The company, based in Cambridge, Mass., has a vaccine-making facility nearby in Norwood, and recently announced a 10-year collaboration with the Swiss contract drugmaker Lonza to manufacture up to one billion doses a year for worldwide distribution, if the vaccine proves successful. Dr. Zaks said Moderna was also working with other vaccine makers in the United States to scale up production.
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.
Work on the new coronavirus started in January, as soon as Chinese scientists posted its genetic sequence on the internet. Researchers at Moderna and the National Institute of Allergy and Infectious Diseases identified part of the sequence that codes for a spikelike protein on the surface of the virus that attaches to human cells, helping the virus to invade them.Work on the new coronavirus started in January, as soon as Chinese scientists posted its genetic sequence on the internet. Researchers at Moderna and the National Institute of Allergy and Infectious Diseases identified part of the sequence that codes for a spikelike protein on the surface of the virus that attaches to human cells, helping the virus to invade them.
The idea behind Moderna’s vaccine is to inject the mRNA for part of the spike protein and have it slip into the cells of a healthy person, which then follow its instruction and crank out the viral protein. That protein should act as a red flag for the immune system, stimulating it to produce antibodies that will prevent infection by blocking the action of the spike if the person is exposed to the virus.The idea behind Moderna’s vaccine is to inject the mRNA for part of the spike protein and have it slip into the cells of a healthy person, which then follow its instruction and crank out the viral protein. That protein should act as a red flag for the immune system, stimulating it to produce antibodies that will prevent infection by blocking the action of the spike if the person is exposed to the virus.
“The new technologies for genetic immunization are rapid and produce a product that is highly potent at producing immune responses,” Dr. Mulligan said. “Today’s RNA results confirm that there is great potential.”“The new technologies for genetic immunization are rapid and produce a product that is highly potent at producing immune responses,” Dr. Mulligan said. “Today’s RNA results confirm that there is great potential.”
Annie Karni and Sheila Kaplan contributed reporting from Washington.Annie Karni and Sheila Kaplan contributed reporting from Washington.