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$1.2 Billion From U.S. to Drugmaker to Pursue Coronavirus Vaccine $1.2 Billion From U.S. to Drugmaker to Pursue Coronavirus Vaccine
(4 days later)
Expanding its pursuit of an inoculation against the coronavirus, the U.S. Department of Health and Human Services said on Thursday it would provide “up to $1.2 billion” to the drug company AstraZeneca to develop a potential vaccine from a laboratory at Oxford University.Expanding its pursuit of an inoculation against the coronavirus, the U.S. Department of Health and Human Services said on Thursday it would provide “up to $1.2 billion” to the drug company AstraZeneca to develop a potential vaccine from a laboratory at Oxford University.
The deal with AstraZeneca is the fourth and by far the largest vaccine research agreement that the department has disclosed. The money will pay for a Phase 3 clinical trial of a potential vaccine in the United States this summer with about 30,000 volunteers.The deal with AstraZeneca is the fourth and by far the largest vaccine research agreement that the department has disclosed. The money will pay for a Phase 3 clinical trial of a potential vaccine in the United States this summer with about 30,000 volunteers.
The H.H.S. statement said the agency and AstraZeneca “are collaborating to make available at least 300 million doses,” and projected that the first doses could be available as early as October.The H.H.S. statement said the agency and AstraZeneca “are collaborating to make available at least 300 million doses,” and projected that the first doses could be available as early as October.
That is a very accelerated, ambitious timetable. Most public health experts and scientists caution that a viable, mass-produced vaccine would probably not be available until sometime next year, at the earliest. Plus, billions of doses would be needed around the world.That is a very accelerated, ambitious timetable. Most public health experts and scientists caution that a viable, mass-produced vaccine would probably not be available until sometime next year, at the earliest. Plus, billions of doses would be needed around the world.
There is no proven treatment or vaccine against the virus, and infectious-disease experts also warn that many vaccine candidates take years to perfect. Some fail or cause such severe side effects that human trials are halted.There is no proven treatment or vaccine against the virus, and infectious-disease experts also warn that many vaccine candidates take years to perfect. Some fail or cause such severe side effects that human trials are halted.
But even before any are approved, governments and other organizations like the Bill & Melinda Gates Foundation are spending millions of dollars to prepare for the manufacturing of several potential vaccines to make them broadly available as soon as possible.But even before any are approved, governments and other organizations like the Bill & Melinda Gates Foundation are spending millions of dollars to prepare for the manufacturing of several potential vaccines to make them broadly available as soon as possible.
In a separate statement, AstraZeneca said it had reached agreements with several governments and other organizations to produce at least 400 million doses, had “secured manufacturing capacity for one billion doses,” and will begin its first deliveries in September.In a separate statement, AstraZeneca said it had reached agreements with several governments and other organizations to produce at least 400 million doses, had “secured manufacturing capacity for one billion doses,” and will begin its first deliveries in September.
AstraZeneca said it was also discussing deals for simultaneous production by other companies, including the giant Serum Institute of India, a major supplier of vaccines to the developing world.AstraZeneca said it was also discussing deals for simultaneous production by other companies, including the giant Serum Institute of India, a major supplier of vaccines to the developing world.
The Biomedical Advanced Research and Development Authority at H.H.S. is distributing billions of dollars to companies to develop vaccines, including the latest funding to AstraZeneca. The authority, known as Barda, has already agreed to provide up to $483 million to the biotech company Moderna and $500 million to Johnson & Johnson for their separate vaccine efforts. It has also agreed to provide $30 million to a coronavirus vaccine effort by the French company Sanofi, building on a larger contract announced last December for making flu inoculations.The Biomedical Advanced Research and Development Authority at H.H.S. is distributing billions of dollars to companies to develop vaccines, including the latest funding to AstraZeneca. The authority, known as Barda, has already agreed to provide up to $483 million to the biotech company Moderna and $500 million to Johnson & Johnson for their separate vaccine efforts. It has also agreed to provide $30 million to a coronavirus vaccine effort by the French company Sanofi, building on a larger contract announced last December for making flu inoculations.
Scores of vaccine efforts are underway around the world, and several potential vaccines are now in at least small-scale clinical trials. But the Oxford vaccine candidate, now licensed by AstraZeneca, has moved quickly into the kind of large-scale testing necessary to prove safety and effectiveness.Scores of vaccine efforts are underway around the world, and several potential vaccines are now in at least small-scale clinical trials. But the Oxford vaccine candidate, now licensed by AstraZeneca, has moved quickly into the kind of large-scale testing necessary to prove safety and effectiveness.
Building on efforts to develop a vaccine against a similar disease, the Middle East Respiratory Syndrome, the Oxford scientists last month began a Phase I trial of their potential vaccine against Covid-19 in Britain involving 1,100 participants. A combined Phase II and Phase III trial involving 5,000 participants is set to begin in Britain by the end of this month.Building on efforts to develop a vaccine against a similar disease, the Middle East Respiratory Syndrome, the Oxford scientists last month began a Phase I trial of their potential vaccine against Covid-19 in Britain involving 1,100 participants. A combined Phase II and Phase III trial involving 5,000 participants is set to begin in Britain by the end of this month.
The researchers have said that if the vaccine is proven effective, they hope to have an approval for emergency use, worldwide, by September. But a steep decline in the rate of new infections in Britain may make it difficult to prove effectiveness. Ethics rules generally preclude deliberately infecting test participants. That means unless enough test participants who are given a placebo become infected with the virus in the community, the researchers cannot show that the potential vaccine does its job.The researchers have said that if the vaccine is proven effective, they hope to have an approval for emergency use, worldwide, by September. But a steep decline in the rate of new infections in Britain may make it difficult to prove effectiveness. Ethics rules generally preclude deliberately infecting test participants. That means unless enough test participants who are given a placebo become infected with the virus in the community, the researchers cannot show that the potential vaccine does its job.
The large-scale tests in the United States this summer may provide another opportunity.The large-scale tests in the United States this summer may provide another opportunity.
On Monday, Moderna announced partial data of its first-phase trial, saying its vaccine candidate had proven safe and that it had provoked an immune response in 45 people, including eight who had extensive tests that found they had produced antibodies that could prevent the virus from infecting cells. It is also working on an accelerated timetable with partners at the National Institute of Allergy and Infectious Diseases and the Swiss company Lonza. Moderna received approval to move to a second phase involving 600 people and said it would also begin a third stage in July with thousands of healthy people.On Monday, Moderna announced partial data of its first-phase trial, saying its vaccine candidate had proven safe and that it had provoked an immune response in 45 people, including eight who had extensive tests that found they had produced antibodies that could prevent the virus from infecting cells. It is also working on an accelerated timetable with partners at the National Institute of Allergy and Infectious Diseases and the Swiss company Lonza. Moderna received approval to move to a second phase involving 600 people and said it would also begin a third stage in July with thousands of healthy people.
Updated June 5, 2020Updated June 5, 2020
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.
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.
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.
The Trump administration’s efforts to stanch the pandemic have been troubled by a series of agency fumbles, starting with defective C.D.C. tests that stalled detection of the virus’s spread for weeks and limited diagnoses for patients at hospitals and clinics.The Trump administration’s efforts to stanch the pandemic have been troubled by a series of agency fumbles, starting with defective C.D.C. tests that stalled detection of the virus’s spread for weeks and limited diagnoses for patients at hospitals and clinics.
Recently, President Trump reorganized vaccine and treatment efforts after he dismissed last month the head of Barda, Rick Bright, who then filed a whistle-blower complaint contending he had been pressured to seek approval for certain treatments for Covid-19. Just last week, Mr. Trump named Moncef Slaoui, a venture capitalist who was a longtime vaccine executive at GlaxoSmithKline and most recently a board member for Moderna, to help oversee “Operation Warp Speed,” the federal drive to accelerate ways to combat the virus.Recently, President Trump reorganized vaccine and treatment efforts after he dismissed last month the head of Barda, Rick Bright, who then filed a whistle-blower complaint contending he had been pressured to seek approval for certain treatments for Covid-19. Just last week, Mr. Trump named Moncef Slaoui, a venture capitalist who was a longtime vaccine executive at GlaxoSmithKline and most recently a board member for Moderna, to help oversee “Operation Warp Speed,” the federal drive to accelerate ways to combat the virus.
As lead scientist of the effort, Dr. Slaoui’s myriad financial and drug company ties have come under scrutiny from watchdog groups. He is working as a contract employee and therefore exempt from conflict-of-interest and disclosure rules that pertain to many executive and federal employees. He did sell his stock in Moderna and donated some of his gains to cancer research, he said in an interview this week.As lead scientist of the effort, Dr. Slaoui’s myriad financial and drug company ties have come under scrutiny from watchdog groups. He is working as a contract employee and therefore exempt from conflict-of-interest and disclosure rules that pertain to many executive and federal employees. He did sell his stock in Moderna and donated some of his gains to cancer research, he said in an interview this week.
On Thursday, as Mr. Trump traveled to Michigan, he was asked about the $1 billion grant to AstraZeneca. While saying he was encouraged by recent vaccine developments, he also suggested — as he had earlier — that there would be “big, big announcements” within the next few weeks or so about treatment or therapeutic developments. But he offered no specifics.On Thursday, as Mr. Trump traveled to Michigan, he was asked about the $1 billion grant to AstraZeneca. While saying he was encouraged by recent vaccine developments, he also suggested — as he had earlier — that there would be “big, big announcements” within the next few weeks or so about treatment or therapeutic developments. But he offered no specifics.