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| Tests for Coronavirus Vaccine Need This Ingredient: Horseshoe Crabs | Tests for Coronavirus Vaccine Need This Ingredient: Horseshoe Crabs |
| (about 13 hours later) | |
| For decades, drug companies have depended on a component in the blood of the horseshoe crab to test injectable medicines, including vaccines, for dangerous bacterial contaminants called endotoxins. | For decades, drug companies have depended on a component in the blood of the horseshoe crab to test injectable medicines, including vaccines, for dangerous bacterial contaminants called endotoxins. |
| Conservationists and some businesses have pushed for wide acceptance of an alternative test, to protect the horseshoe crabs and birds that feed on their eggs. Earlier this year, these people seemed to be on the brink of success as the nongovernmental group that issues quality standards for such tests moved toward putting the alternative test on the same footing. | Conservationists and some businesses have pushed for wide acceptance of an alternative test, to protect the horseshoe crabs and birds that feed on their eggs. Earlier this year, these people seemed to be on the brink of success as the nongovernmental group that issues quality standards for such tests moved toward putting the alternative test on the same footing. |
| But on Friday, that organization, the U.S. Pharmacopeia, announced that the alternative test known as rFC (recombinant factor C) requires significantly more study. | But on Friday, that organization, the U.S. Pharmacopeia, announced that the alternative test known as rFC (recombinant factor C) requires significantly more study. |
| Pharmacopeia representatives said they have 30 years of data on the current test and only two years on the new test so they needed more information. | Pharmacopeia representatives said they have 30 years of data on the current test and only two years on the new test so they needed more information. |
| Internationally, the European Pharmacopeia has approved widespread use of the alternative test. | Internationally, the European Pharmacopeia has approved widespread use of the alternative test. |
| The debate has been widely monitored as demand has grown for testing new vaccines against the coronavirus. Billions of vaccine doses would eventually require endotoxin testing. | The debate has been widely monitored as demand has grown for testing new vaccines against the coronavirus. Billions of vaccine doses would eventually require endotoxin testing. |
| Endotoxins are molecules in the cell walls of many common bacteria. E. coli is one, salmonella another. The toxins can cause fever and death in humans even if the bacteria that produced them have been killed. Toxic shock syndrome is caused by endotoxins. | Endotoxins are molecules in the cell walls of many common bacteria. E. coli is one, salmonella another. The toxins can cause fever and death in humans even if the bacteria that produced them have been killed. Toxic shock syndrome is caused by endotoxins. |
| Pharmaceutical companies must make sure the toxins are not present in any injectable drugs they make. Ingredients, like water, must be tested at each step of the manufacturing process, as well as in the final product. | Pharmaceutical companies must make sure the toxins are not present in any injectable drugs they make. Ingredients, like water, must be tested at each step of the manufacturing process, as well as in the final product. |
| “It is crazy making that we are going to rely on a wild animal extract during a global pandemic,” Ryan Phelan, the head of the nonprofit Revive and Restore, said before the recent decision. Her group supports technological solutions to conservation problems, including replacing the test that uses a component of horseshoe crab blood, called LAL, with a test that uses rFC. It is the synthetic equivalent of a chemical in the crab blood, produced by inserting genes for its creation into microorganisms grown in the lab. | “It is crazy making that we are going to rely on a wild animal extract during a global pandemic,” Ryan Phelan, the head of the nonprofit Revive and Restore, said before the recent decision. Her group supports technological solutions to conservation problems, including replacing the test that uses a component of horseshoe crab blood, called LAL, with a test that uses rFC. It is the synthetic equivalent of a chemical in the crab blood, produced by inserting genes for its creation into microorganisms grown in the lab. |
| The billions of doses of candidate vaccines, and many of the ingredients at many steps in the production process will all have to undergo endotoxin testing. But companies that produce LAL from horseshoe crab blood say that the supply is adequate. | The billions of doses of candidate vaccines, and many of the ingredients at many steps in the production process will all have to undergo endotoxin testing. But companies that produce LAL from horseshoe crab blood say that the supply is adequate. |
| Lonza AG, a multinational biotechnology company, sells both tests. Also, Lonza recently struck a deal with Moderna to produce a much publicized vaccine candidate for Covid-19. Lonza said in a statement that five billion doses of vaccine would require “less than a day’s combined production for all three LAL manufacturers in the United States.” The three manufacturers are Lonza, Charles River and Associates of Cape Cod. They all argue that the supply of crabs is more than adequate and current production could handle the vaccine surge without difficulty. | Lonza AG, a multinational biotechnology company, sells both tests. Also, Lonza recently struck a deal with Moderna to produce a much publicized vaccine candidate for Covid-19. Lonza said in a statement that five billion doses of vaccine would require “less than a day’s combined production for all three LAL manufacturers in the United States.” The three manufacturers are Lonza, Charles River and Associates of Cape Cod. They all argue that the supply of crabs is more than adequate and current production could handle the vaccine surge without difficulty. |
| Ms. Phelan said this calculation “boggles the mind” because, “for every dose going out the door — each manufacturer will use 10 times the amount of LAL to test every step along the way in the process.” That includes vials, stoppers and other ingredients in the vaccines. In addition, Ms. Phelan said there are likely to be numerous companies producing vaccines in the test phase and along the way. | Ms. Phelan said this calculation “boggles the mind” because, “for every dose going out the door — each manufacturer will use 10 times the amount of LAL to test every step along the way in the process.” That includes vials, stoppers and other ingredients in the vaccines. In addition, Ms. Phelan said there are likely to be numerous companies producing vaccines in the test phase and along the way. |
| The rFC test is allowed by the Food and Drug Administration, which is the governmental agency that rules on the safety of drugs, but companies must do more work for their F.D.A. submissions than if they were to use the standard test. | The rFC test is allowed by the Food and Drug Administration, which is the governmental agency that rules on the safety of drugs, but companies must do more work for their F.D.A. submissions than if they were to use the standard test. |
| The F.D.A. relies both on work done by manufacturers and on the standards set by the U. S. Pharmacopeia. If a company uses rFC, it must demonstrate to the F.D.A. that, for each new drug, rFC is as effective as the standard LAL test. | The F.D.A. relies both on work done by manufacturers and on the standards set by the U. S. Pharmacopeia. If a company uses rFC, it must demonstrate to the F.D.A. that, for each new drug, rFC is as effective as the standard LAL test. |
| The U.S. Pharmacopeia also announced that it would provide some additional information for any vaccine makers to assist them in doing the tests to validate rFC. Revive and Restore had been asking for some form of emergency authorization for use of rFC, given the stress of potential vaccine production. | The U.S. Pharmacopeia also announced that it would provide some additional information for any vaccine makers to assist them in doing the tests to validate rFC. Revive and Restore had been asking for some form of emergency authorization for use of rFC, given the stress of potential vaccine production. |
| One company that is turning to the new test in a big way is Eli Lilly, which also pushed for broader approval of the new test. | One company that is turning to the new test in a big way is Eli Lilly, which also pushed for broader approval of the new test. |
| Jay Bolden, a biologist with Eli Lilly, said the company had been looking at rFC testing since 2015 for several reasons, including a consistent quality of a lab product, a supply that doesn’t depend on an animal population, a company commitment to replace animal use when possible and a reduction in costs. | Jay Bolden, a biologist with Eli Lilly, said the company had been looking at rFC testing since 2015 for several reasons, including a consistent quality of a lab product, a supply that doesn’t depend on an animal population, a company commitment to replace animal use when possible and a reduction in costs. |
| Updated June 22, 2020 | Updated 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. |
| “In 2016,” he said, “we kind of drew a line in the sand.” The company decided to use rFC for new injectable products even if additional work is required. It has since had one new product, a migraine medicine, approved in the United States by the F.D.A. | |
| On Monday, Mr. Bolden expressed disappointment with the Pharmacopeia decision. “It probably looks like a three-to-four year delay with no guarantee,” he said, that rFC would be considered equivalent to the LAL test. | |
| Rob Anderson, the vice president of global communications at the U. S. Pharmacopeia, said that more evidence is needed to show the equivalence between the two tests because of the many years of data on LAL and a lack of data on rFC. | |
| Fouad Atouf, the vice president of global biologics for the rFC, said the reason for caution was that “we are dealing with a safety test.” And more evidence was needed on rFC. | Fouad Atouf, the vice president of global biologics for the rFC, said the reason for caution was that “we are dealing with a safety test.” And more evidence was needed on rFC. |
| “We’re working to build that evidence base and data,” Mr. Anderson said, “But we can’t put a time on that.” | “We’re working to build that evidence base and data,” Mr. Anderson said, “But we can’t put a time on that.” |
| Dr. Bolden, at Eli Lilly, said that given the delays his company will continue using rFC but follow a different path in submissions to the F.D.A. | Dr. Bolden, at Eli Lilly, said that given the delays his company will continue using rFC but follow a different path in submissions to the F.D.A. |
| “We’ll just start using the European test chapter,” he said, referring to the European pharmacopeia’s inclusion of rFC, which “goes live July 1.” He said the company had reason to believe the F.D.A. would accept the information from the European group, which would, essentially, put the alternative test and the traditional one “on an even playing field.” | “We’ll just start using the European test chapter,” he said, referring to the European pharmacopeia’s inclusion of rFC, which “goes live July 1.” He said the company had reason to believe the F.D.A. would accept the information from the European group, which would, essentially, put the alternative test and the traditional one “on an even playing field.” |