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Estimates Fall Short of F.D.A.’s Pledge for 1 Million Coronavirus Tests Estimates Fall Short of F.D.A.’s Pledge for 1 Million Coronavirus Tests
(3 days later)
Does the United States really have the capacity to escalate its efforts and produce one million coronavirus tests by the end of this week, as the head of the Food and Drug Administration promised on Monday during a White House briefing?Does the United States really have the capacity to escalate its efforts and produce one million coronavirus tests by the end of this week, as the head of the Food and Drug Administration promised on Monday during a White House briefing?
The figure includes orders for commercial tests that companies say are still weeks away from approval, and public health laboratories say their capacities don’t come close to that.The figure includes orders for commercial tests that companies say are still weeks away from approval, and public health laboratories say their capacities don’t come close to that.
At a press briefing on Monday, Dr. Stephen Hahn, the F.D.A.’s commissioner, said actions taken by the agency to allow private labs and companies to begin making their own tests would greatly expand the capacity to test.At a press briefing on Monday, Dr. Stephen Hahn, the F.D.A.’s commissioner, said actions taken by the agency to allow private labs and companies to begin making their own tests would greatly expand the capacity to test.
“With this new policy, we have heard from multiple companies and multiple academic centers, and we expect to have a substantial increase in the number of tests this week, next week, and throughout the month,” Dr. Hahn said. “There will be — the estimates we’re getting from industry right now, by the end of this week, close to a million tests will be able to be performed.”“With this new policy, we have heard from multiple companies and multiple academic centers, and we expect to have a substantial increase in the number of tests this week, next week, and throughout the month,” Dr. Hahn said. “There will be — the estimates we’re getting from industry right now, by the end of this week, close to a million tests will be able to be performed.”
A spokeswoman for the Department of Health and Human Services said Tuesday that Dr. Hahn was referring to tests being produced by an outside manufacturer, Integrated DNA Technologies, which are being sent to “a variety of academic, health care and commercial labs around the country" in addition to the public health laboratories that are also receiving them.A spokeswoman for the Department of Health and Human Services said Tuesday that Dr. Hahn was referring to tests being produced by an outside manufacturer, Integrated DNA Technologies, which are being sent to “a variety of academic, health care and commercial labs around the country" in addition to the public health laboratories that are also receiving them.
“The process of getting a test kit out and putting it into production is not something that happens literally overnight, in particular when you’re talking about a million tests,” said Eric Blank, the chief program officer at the Association of Public Health Laboratories, which represents state and local government laboratories nationwide. “It’s a nice thing to say, and it’s a simple thing to say, but the reality is we are a couple of weeks away from being able to deploy a million tests through this process.”“The process of getting a test kit out and putting it into production is not something that happens literally overnight, in particular when you’re talking about a million tests,” said Eric Blank, the chief program officer at the Association of Public Health Laboratories, which represents state and local government laboratories nationwide. “It’s a nice thing to say, and it’s a simple thing to say, but the reality is we are a couple of weeks away from being able to deploy a million tests through this process.”
Dr. Hahn repeated the estimate on Tuesday in testimony at a Senate committee hearing. He told Senator Patty Murray, Democrat of Washington, that although “this is a dynamic process,” the federal government was working with private companies to ship about 2,500 test kits to labs by the end of the week. “That should give us the capacity, in the hands of laboratories once they validate, to perform up to a million tests,” he said at the hearing.Dr. Hahn repeated the estimate on Tuesday in testimony at a Senate committee hearing. He told Senator Patty Murray, Democrat of Washington, that although “this is a dynamic process,” the federal government was working with private companies to ship about 2,500 test kits to labs by the end of the week. “That should give us the capacity, in the hands of laboratories once they validate, to perform up to a million tests,” he said at the hearing.
The Association of Public Health Laboratories has said that its labs would be able to conduct about 10,000 tests a day when all of its 100 members that can conduct testing are running. Mr. Blank said that labs can run about 100 tests per day. As of Tuesday, he said 54 of those labs were able to do so, with the rest expected to be up and running by the end of the week.The Association of Public Health Laboratories has said that its labs would be able to conduct about 10,000 tests a day when all of its 100 members that can conduct testing are running. Mr. Blank said that labs can run about 100 tests per day. As of Tuesday, he said 54 of those labs were able to do so, with the rest expected to be up and running by the end of the week.
Dr. Hahn and White House officials have been trying to address the lag in testing caused by botched test kits that were rolled out by the Centers for Disease Control and Prevention early last month, and that agency’s enforcement of strict testing criteria.Dr. Hahn and White House officials have been trying to address the lag in testing caused by botched test kits that were rolled out by the Centers for Disease Control and Prevention early last month, and that agency’s enforcement of strict testing criteria.
But as the coronavirus spread in Washington State and California, and has cropped up in the Northeast and Florida, state and federal lawmakers have clamored for expedited tests and the authority to conduct their own. So far, more than 100 people in the United States have been sickened and at least nine have died.But as the coronavirus spread in Washington State and California, and has cropped up in the Northeast and Florida, state and federal lawmakers have clamored for expedited tests and the authority to conduct their own. So far, more than 100 people in the United States have been sickened and at least nine have died.
Public health experts have become concerned that the lack of adequate testing in several states has led to community transmission and warned there may be many undetected cases that could lead to further infections.Public health experts have become concerned that the lack of adequate testing in several states has led to community transmission and warned there may be many undetected cases that could lead to further infections.
New York State’s public health lab, which was one of the first to receive emergency approval for its own testing, set a goal of conducting 1,000 tests a day statewide, according to a statement by Gov. Andrew M. Cuomo.New York State’s public health lab, which was one of the first to receive emergency approval for its own testing, set a goal of conducting 1,000 tests a day statewide, according to a statement by Gov. Andrew M. Cuomo.
A handful of private companies have said they are working on a test for the virus, but none are yet available in the United States. Maurice Exner, the vice president of research and development for the diagnostics division at Hologic, said in an interview Tuesday that the company was weeks way from F.D.A. approval of a commercial test. If approved, the tests could be used in hundreds of labs around the country and each machine could process as many as 1,000 tests per day, he said.A handful of private companies have said they are working on a test for the virus, but none are yet available in the United States. Maurice Exner, the vice president of research and development for the diagnostics division at Hologic, said in an interview Tuesday that the company was weeks way from F.D.A. approval of a commercial test. If approved, the tests could be used in hundreds of labs around the country and each machine could process as many as 1,000 tests per day, he said.
Another company, Cepheid, has said it does not expect to get emergency approval from the F.D.A. for its test before April. Dr. David Persing, the company’s chief medical officer, said last week that the company still wanted to ensure its test was accurate. “We are moving aggressively,” he said.Another company, Cepheid, has said it does not expect to get emergency approval from the F.D.A. for its test before April. Dr. David Persing, the company’s chief medical officer, said last week that the company still wanted to ensure its test was accurate. “We are moving aggressively,” he said.
On Monday, Darwa Peterson, a Cepheid spokeswoman, said the F.D.A. policy to allow more labs to conduct tests hadn’t changed the company’s timeline. “We still need to optimize and validate our tests because commercial vendors are held to a high standard,” she said.On Monday, Darwa Peterson, a Cepheid spokeswoman, said the F.D.A. policy to allow more labs to conduct tests hadn’t changed the company’s timeline. “We still need to optimize and validate our tests because commercial vendors are held to a high standard,” she said.
Qiagen, another company working on testing, said Tuesday that it expected F.D.A. approval later this month, but that it was still gathering data and testing its product, noting that “this does take some time.”Qiagen, another company working on testing, said Tuesday that it expected F.D.A. approval later this month, but that it was still gathering data and testing its product, noting that “this does take some time.”
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Dr. Hahn was not the only Trump administration official to promise radically expanded testing. Over the weekend, Vice President Mike Pence made similar claims, appearing on television to say that more than 15,000 test kits — which contain materials to test between 700 to 800 samples — were being shipped to labs.Dr. Hahn was not the only Trump administration official to promise radically expanded testing. Over the weekend, Vice President Mike Pence made similar claims, appearing on television to say that more than 15,000 test kits — which contain materials to test between 700 to 800 samples — were being shipped to labs.
In fact, the C.D.C. said Sunday that it had shipped about 47 such kits.In fact, the C.D.C. said Sunday that it had shipped about 47 such kits.
The H.H.S. spokeswoman said Tuesday that the 15,000 test kits cited by Mr. Pence referred to the number of people who could be tested by kits that were being shipped, and that by later this week, enough tests would be sent to public health labs to test about 75,000 people.The H.H.S. spokeswoman said Tuesday that the 15,000 test kits cited by Mr. Pence referred to the number of people who could be tested by kits that were being shipped, and that by later this week, enough tests would be sent to public health labs to test about 75,000 people.
Updated June 5, 2020 Updated 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.
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.
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.
About 3,300 patient specimens had been tested by the C.D.C. since the start of the outbreak, she said. More than 1,200 people had been tested as of Tuesday, the spokeswoman said. On Monday, as the testing controversy continued, the C.D.C. removed its data on how many people had been tested from its website. The numbers were removed, the C.D.C. said, because states are reporting results quickly, and the information reported by the agency would not be representative of testing being done around the country.About 3,300 patient specimens had been tested by the C.D.C. since the start of the outbreak, she said. More than 1,200 people had been tested as of Tuesday, the spokeswoman said. On Monday, as the testing controversy continued, the C.D.C. removed its data on how many people had been tested from its website. The numbers were removed, the C.D.C. said, because states are reporting results quickly, and the information reported by the agency would not be representative of testing being done around the country.
Other countries, like South Korea, are testing thousands of citizens per week, but in the United States testing has been more limited. The C.D.C. began shipping test kits to labs around the country in early February, but a manufacturing problem led the agency to tell most states not to use the kits, severely limiting the country’s testing capacity for weeks.Other countries, like South Korea, are testing thousands of citizens per week, but in the United States testing has been more limited. The C.D.C. began shipping test kits to labs around the country in early February, but a manufacturing problem led the agency to tell most states not to use the kits, severely limiting the country’s testing capacity for weeks.
Stringent testing criteria also tied the hands of infectious disease doctors around the country, who have said they were frustrated that they were not allowed to test a broader group of patients who displayed potential symptoms of the new virus. Last week, the C.D.C. loosened its criteria and began shipping new test kits to labs around the country.Stringent testing criteria also tied the hands of infectious disease doctors around the country, who have said they were frustrated that they were not allowed to test a broader group of patients who displayed potential symptoms of the new virus. Last week, the C.D.C. loosened its criteria and began shipping new test kits to labs around the country.
Mr. Pence said on Tuesday that the C.D.C. would issue new guidance removing restrictions on who could be tested, as long as a doctor has given an order.Mr. Pence said on Tuesday that the C.D.C. would issue new guidance removing restrictions on who could be tested, as long as a doctor has given an order.
During a C.D.C. news briefing on Saturday, Dr. Jeff Duchin, public health officer of the Seattle and King County Public Health agency, which has been dealing with Washington State’s outbreak, said the death of a man in his 50s who had coronavirus was only identified because the Washington State public health lab had just recently acquired test kits.During a C.D.C. news briefing on Saturday, Dr. Jeff Duchin, public health officer of the Seattle and King County Public Health agency, which has been dealing with Washington State’s outbreak, said the death of a man in his 50s who had coronavirus was only identified because the Washington State public health lab had just recently acquired test kits.
“If we had the ability to test earlier, I’m sure we would have identified patients earlier in the community,” he said.“If we had the ability to test earlier, I’m sure we would have identified patients earlier in the community,” he said.
Sheila Kaplan contributed reporting.Sheila Kaplan contributed reporting.