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| Find a Vaccine. Next: Produce 300 Million Vials of It. | Find a Vaccine. Next: Produce 300 Million Vials of It. |
| (2 days later) | |
| In the midst of national shortages of testing swabs and protective gear, some medical suppliers and health policy experts are looking ahead to another extraordinary demand on manufacturing: Delivering a vaccine that could potentially end the pandemic. | In the midst of national shortages of testing swabs and protective gear, some medical suppliers and health policy experts are looking ahead to another extraordinary demand on manufacturing: Delivering a vaccine that could potentially end the pandemic. |
| Making a vaccine is not easy. More than two dozen companies have announced programs to develop a vaccine against the coronavirus, but it may still take a year or more before one passes federal safety and efficacy tests in humans and becomes available to the public. | Making a vaccine is not easy. More than two dozen companies have announced programs to develop a vaccine against the coronavirus, but it may still take a year or more before one passes federal safety and efficacy tests in humans and becomes available to the public. |
| Here in the United States, more than 300 million people may need to be inoculated. That means at least as many vials and syringes — or double that amount, if two shots are required. To meet that demand, companies will have to ramp up manufacturing; products that doctors give little thought to now could easily become obstacles to vaccine delivery in the future. | Here in the United States, more than 300 million people may need to be inoculated. That means at least as many vials and syringes — or double that amount, if two shots are required. To meet that demand, companies will have to ramp up manufacturing; products that doctors give little thought to now could easily become obstacles to vaccine delivery in the future. |
| “We’re thinking about the vaccine, but what if the vials it is stored in, or rubber stoppers in the vial or the plungers in the syringes become the constraint?” said Prashant Yadav, who studies health care supply chains at the Center for Global Development in Washington. | “We’re thinking about the vaccine, but what if the vials it is stored in, or rubber stoppers in the vial or the plungers in the syringes become the constraint?” said Prashant Yadav, who studies health care supply chains at the Center for Global Development in Washington. |
| Timing the orders of medical products like syringes and all the raw materials required to make them will be essential. Medical device manufacturers could increase inventory or find alternative supply chains for products that are running low, but everything will need to be systematically planned. Adding the capacity to make millions more syringes could take a manufacturer as long as 18 months to complete such a large order, for example. | Timing the orders of medical products like syringes and all the raw materials required to make them will be essential. Medical device manufacturers could increase inventory or find alternative supply chains for products that are running low, but everything will need to be systematically planned. Adding the capacity to make millions more syringes could take a manufacturer as long as 18 months to complete such a large order, for example. |
| “The Covid-19 pandemic is creating industrywide challenges, including expected delays in inventory replenishment for certain products,” said Lucy Bradlow, a spokeswoman for Cardinal Health, which makes vials and syringes as well as other medical supplies. | “The Covid-19 pandemic is creating industrywide challenges, including expected delays in inventory replenishment for certain products,” said Lucy Bradlow, a spokeswoman for Cardinal Health, which makes vials and syringes as well as other medical supplies. |
| Several manufacturers worry that the Trump administration may be waiting too long before ordering an ample supply of medical equipment needed to deliver a vaccine. One manufacturer said it had recently received an order for syringes, but was concerned that the Biomedical Advanced Research and Development Authority, a branch of the Health and Human Services Department built to help with pandemic preparedness, was still soliciting too few supplies for nationwide vaccine delivery. | Several manufacturers worry that the Trump administration may be waiting too long before ordering an ample supply of medical equipment needed to deliver a vaccine. One manufacturer said it had recently received an order for syringes, but was concerned that the Biomedical Advanced Research and Development Authority, a branch of the Health and Human Services Department built to help with pandemic preparedness, was still soliciting too few supplies for nationwide vaccine delivery. |
| Elleen Kane, a spokeswoman for the H.H.S., said the department had been “working daily with our manufacturers to secure those supplies and assist them with any anticipated obstacles in their supply chains.” | Elleen Kane, a spokeswoman for the H.H.S., said the department had been “working daily with our manufacturers to secure those supplies and assist them with any anticipated obstacles in their supply chains.” |
| In March, the H.H.S. set up a public-private partnership to find drug packaging solutions based in the United States. It could be adapted for future therapeutic or vaccine delivery for the Strategic National Stockpile, a federal cache of supplies and medicines held in case of emergencies. | In March, the H.H.S. set up a public-private partnership to find drug packaging solutions based in the United States. It could be adapted for future therapeutic or vaccine delivery for the Strategic National Stockpile, a federal cache of supplies and medicines held in case of emergencies. |
| The White House is also developing a plan, called Operation Warp Speed, to accelerate vaccine production and try to get manufacturing capacity set up in advance of a vaccine approval. But some experts say that it is unclear whether the plan would apply to vaccine delivery devices like syringes, and details are still scarce about which federal agency would be responsible. | The White House is also developing a plan, called Operation Warp Speed, to accelerate vaccine production and try to get manufacturing capacity set up in advance of a vaccine approval. But some experts say that it is unclear whether the plan would apply to vaccine delivery devices like syringes, and details are still scarce about which federal agency would be responsible. |
| In April, New Hampshire’s senators, Jeanne Shaheen and Maggie Hassan, sent a letter to Vice President Mike Pence, urging him “to ensure that the federal government obtains the materials to meet the demand for a vaccine when it becomes available.” | In April, New Hampshire’s senators, Jeanne Shaheen and Maggie Hassan, sent a letter to Vice President Mike Pence, urging him “to ensure that the federal government obtains the materials to meet the demand for a vaccine when it becomes available.” |
| Of course, a lot will depend on the type of vaccine and when it is approved. A variety of RNA- and DNA-based vaccines are currently undergoing clinical trials, as well as more traditional types, which are made by placing instructions for coronavirus spike proteins inside a different dead or harmless virus. | Of course, a lot will depend on the type of vaccine and when it is approved. A variety of RNA- and DNA-based vaccines are currently undergoing clinical trials, as well as more traditional types, which are made by placing instructions for coronavirus spike proteins inside a different dead or harmless virus. |
| RNA or DNA vaccines might have different storage and refrigeration requirements because the technology has never been used for an approved vaccine before. The final vaccine might be packaged in ready-to-use glass syringes, which are commonly used in flu campaigns in Europe, or in a single-dose or multidose vials that would be administered with disposable plastic syringes, which are standard for many vaccines in the United States. | RNA or DNA vaccines might have different storage and refrigeration requirements because the technology has never been used for an approved vaccine before. The final vaccine might be packaged in ready-to-use glass syringes, which are commonly used in flu campaigns in Europe, or in a single-dose or multidose vials that would be administered with disposable plastic syringes, which are standard for many vaccines in the United States. |
| The amount of vaccine manufactured by a company could also affect the number of delivery systems needed, said Michael Gusmano, a health policy expert at the Hastings Center and Rutgers School of Public Health. It is unlikely that a pharmaceutical company will be able to match demand immediately — nationally or internationally. | The amount of vaccine manufactured by a company could also affect the number of delivery systems needed, said Michael Gusmano, a health policy expert at the Hastings Center and Rutgers School of Public Health. It is unlikely that a pharmaceutical company will be able to match demand immediately — nationally or internationally. |
| “The good news is we have time,” Dr. Gusmano said. Medical device manufacturers could slowly scale up vials and syringes as a vaccine becomes more widely available. | “The good news is we have time,” Dr. Gusmano said. Medical device manufacturers could slowly scale up vials and syringes as a vaccine becomes more widely available. |
| Early estimates of the coronavirus’s infectiousness suggest that at least 70 percent of the population would need to be immunized to reach what experts call herd immunity, when enough people are immune to a disease that they can also indirectly protect others who are not immune. | Early estimates of the coronavirus’s infectiousness suggest that at least 70 percent of the population would need to be immunized to reach what experts call herd immunity, when enough people are immune to a disease that they can also indirectly protect others who are not immune. |
| “That’s a remarkably high number, and I don’t think we’re anywhere close to that just with people who have been exposed to the virus and developed antibodies,” Dr. Gusmano said. “So you’re talking about a fairly massive vaccination campaign.” | “That’s a remarkably high number, and I don’t think we’re anywhere close to that just with people who have been exposed to the virus and developed antibodies,” Dr. Gusmano said. “So you’re talking about a fairly massive vaccination campaign.” |
| Updated June 5, 2020 | |
| 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. |
| Preliminary surveys in California and New York suggest that between 4 to 21 percent of people have developed antibodies to the coronavirus. But the accuracy of many antibody tests has been called into question. And it is still unclear whether having some of these antibodies provides effective and long-lasting immunity against the coronavirus. Plus, most vaccination campaigns aim to immunize a high proportion of the population — around 90 percent — to successfully prevent transmission of disease. | Preliminary surveys in California and New York suggest that between 4 to 21 percent of people have developed antibodies to the coronavirus. But the accuracy of many antibody tests has been called into question. And it is still unclear whether having some of these antibodies provides effective and long-lasting immunity against the coronavirus. Plus, most vaccination campaigns aim to immunize a high proportion of the population — around 90 percent — to successfully prevent transmission of disease. |
| To produce the number of vials and syringes needed for a coronavirus vaccine, medical suppliers will need to increase manufacturing shifts and overtime for their employees, as well as collaborate with American and foreign trade authorities to expedite shipments and shorten lead times. | To produce the number of vials and syringes needed for a coronavirus vaccine, medical suppliers will need to increase manufacturing shifts and overtime for their employees, as well as collaborate with American and foreign trade authorities to expedite shipments and shorten lead times. |
| A handful of manufacturers are based in the United States, but many still have to import the glass tubing for vials, polypropylene for syringes and rubber or silicone for small parts like the stoppers and plungers in these devices. Becton Dickinson & Company, one of the world’s largest manufacturers of needles and syringes, said it made nearly all components of its needles and syringes in-house in the United States. Other companies may source from their factories and partners located largely in China and India, where lockdowns and export bans have already decreased production and exports. | A handful of manufacturers are based in the United States, but many still have to import the glass tubing for vials, polypropylene for syringes and rubber or silicone for small parts like the stoppers and plungers in these devices. Becton Dickinson & Company, one of the world’s largest manufacturers of needles and syringes, said it made nearly all components of its needles and syringes in-house in the United States. Other companies may source from their factories and partners located largely in China and India, where lockdowns and export bans have already decreased production and exports. |
| Although syringe manufacturing is mostly automated, with parts like the barrel and plunger made from a mold and put together on an assembly line, Dr. Yadav said manufacturers in India had told him fewer employees were able to work than needed for full capacity. | Although syringe manufacturing is mostly automated, with parts like the barrel and plunger made from a mold and put together on an assembly line, Dr. Yadav said manufacturers in India had told him fewer employees were able to work than needed for full capacity. |
| At least 69 countries have also banned or restricted the export of medical devices, medicines and protective equipment, according to the Global Trade Alert project at the University of St. Gallen in Switzerland, because of their own needs during the pandemic. Manufacturers of medical syringes may have to find new supply channels, including partnerships with glass and plastic manufacturers that operate outside of the health care industry. | At least 69 countries have also banned or restricted the export of medical devices, medicines and protective equipment, according to the Global Trade Alert project at the University of St. Gallen in Switzerland, because of their own needs during the pandemic. Manufacturers of medical syringes may have to find new supply channels, including partnerships with glass and plastic manufacturers that operate outside of the health care industry. |
| Some lawmakers are concerned that without more federal coordination, individual companies will not have the capacity to match vaccine delivery to the overwhelming demand. | Some lawmakers are concerned that without more federal coordination, individual companies will not have the capacity to match vaccine delivery to the overwhelming demand. |
| “The Trump administration needs to prepare our domestic supply chain now for the delivery of an eventual vaccine that will need to be delivered to the entire country,” Senator Shaheen said. “It’s vital that federal agencies exercise better foresight so that we don’t see supply shortages like we continue to experience for testing and protective equipment.” | “The Trump administration needs to prepare our domestic supply chain now for the delivery of an eventual vaccine that will need to be delivered to the entire country,” Senator Shaheen said. “It’s vital that federal agencies exercise better foresight so that we don’t see supply shortages like we continue to experience for testing and protective equipment.” |