AdvertisementContinue reading the main storySupported byContinue reading the main storyPandemic Forces F.D.A. to Sharply Curtail Drug Company InspectionsThe steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics say inspectors should be considered essential workers and do their jobs.The F.D.A. conducted more than 1,671 inspections of foreign and domestic drug manufacturing facilities in 2019. Last year, that number dropped by more than half, to 742. Credit…Ariana Lindquist/BloombergMarch 9, 2021, 5:00 a.m. ETThe Covid-19 pandemic has forced the Food and Drug Administration to postpone hundreds of drug company inspections, creating an enormous backlog that is delaying new drug approvals and leading the industry to warn of impending shortages of existing medicines.Pandemic-related travel restrictions and safety concerns have also hampered the F.D.A.’s ability to ensure the safety of the ever-increasing number of imported medicines, which make up more than 60 percent of the drugs sold in the United States.“Regardless of where drugs are manufactured, domestically or overseas, the F.D.A. has the responsibility to ensure they are effective and safe,” said Mary Denigan-Macauley, director of health care, public health and private markets for the Government Accountability Office, a congressional watchdog agency. “Any drop in inspections, or backlog, is concerning.”The numbers show a steep decline. The F.D.A. conducted 52 inspections of domestic pharmaceutical plants between March 2020, when the pandemic took hold in the U.S., and Oct. 1, compared with 400 during the same months in 2019, according to the G.A.O. Inspections of foreign manufacturing facilities have been at a virtual standstill for months.In an interview, F.D.A. officials said they sharply curtailed the inspections to protect their investigators, following guidelines from the Centers for Disease Control and Prevention, which discouraged federal employees from travel during the pandemic.But some people in both industry and public health communities say that federal drug inspections are essential, and that the agency should bypass travel restrictions by taking precautions, including wearing proper personal protective equipment.“I think they can and they should,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, a nonprofit advocacy organization. “They should be considered essential workers and they should be vaccinated as soon as possible. And they should be provided with N95s masks, gowns and gloves to ensure their own safety during travel and during the inspection.”Dr. Denigan-Macauley said that the F.D.A. has postponed more than 1,000 surveillance inspections — the routine visits that the agency conducts to check for adherence to good manufacturing practices. “Drugs that are waiting for pre-approval inspections will also have a backlog,” she said.In interviews, F.D.A. officials denied that the dramatic drop in inspections has slowed drug approvals. But a number of drug companies, including Spectrum Pharmaceuticals, Biocon Biologics and Bristol Myers Squibb, has issued statements noting deferred F.D.A. action because of the agency’s inability to conduct inspections.In October, Spectrum announced that the F.D.A. had deferred action on its application for Rolontis, a treatment for cancer patients who have a very low number of certain white blood cells, because it could not inspect the manufacturing plant the company uses in South Korea.In late December, Biocon Biologics notified shareholders that the F.D.A. deferred action on its joint application with Mylan for a proposed biosimilar to Avastin, a cancer drug.Bristol Meyers Squibb announced in November that the F.D.A. would miss its November deadline for taking action on a lymphoma treatment, lisocabtagene maraleucel because it could not inspect a third-party Texas manufacturing plant. The agency eventually did complete its inspection and approved the drug last month.In addition, Nivagen, a pharmaceutical company specializing in generic versions of injectable medications, filed an application in January 2019 for an expedited review of a generic version of a drug used in cardiac therapy and for other problems. In March 2019, the F.D.A. granted its request for what is known as a competitive generic therapy designation, for products that the F.D.A. believes should get high priority for consideration. Then the pandemic hit, and the F.D.A. pushed the company’s inspection back twice, according to Jay Shukla, Nivagen’s chief executive officer. He said he does not know when one will be scheduled.Dr. Erin Fox, who tracks drug shortages for the American Society of Health System Pharmacists, says shortages of the brand name version of the drug, which is made by only one company in its injectable form, have occurred on and off since 2006. That’s why Mr. Shukla said he decided it would be a good product for his new business.“For me, a small start-up company, our growth depends on this product for the manufacturing I want to build in the U.S.,” said Mr. Shukla. “It all depends on this approval. The review is done, it’s only pending the facility inspection. We appreciate the hard work the F.D.A. is doing, but we are suffering too.”Mr. Shukla has proposed an alternative — a virtual inspection using remote video technology to permit the F.D.A. inspector to view inside the facility. The pharmaceutical industry has been pressing the F.D.A. to adopt remote inspections, but the agency said that it is still evaluating the idea, as it has been doing for months. So far, it has conducted virtual sessions sparingly, generally more for viewing a company’s documents than for actual remote viewing of a manufacturing plant.Donald D. Ashley, director of compliance for the agency’s Center for Drug Evaluation and Research, said he was wary of relying heavily on remote viewing, especially for inspections at facilities that had had past violations.“When we go back to reassess whether they have corrected their ways, we want to use our most robust tool, and that’s an on site inspection,” Mr. Ashley said.F.D.A. inspectors at a mail facility in New York in 2018. The agency cited pandemic-related restrictions and safety concerns for hampering its  ability to conduct on-site reviews of the increasing number of imported medicines.Credit…Michael J. Ermarthh/U.S. Food and Drug AdministrationDuring most drug company inspections, investigators review the company’s internal records and scrutinize the building, checking how supplies are handled, reviewing quality controls and determining whether the company complies with good manufacturing practices. The F.D.A. conducts three types of inspections: pre-approval inspections when companies have filed applications for new drugs; routine surveillance inspections, which it tries to do at least once every five years; and those following up on a problem.Proponents of remote audits say they can do the same thing virtually. Peter Miller, president of Dynamic Compliance Solutions, of New Jersey, which helps life science companies comply with F.D.A. regulations, says his remote audit kit can do a great inspection. The kit features a tiny 360-degree camera, which an on-site host carries on a tripod while the investigator watches on a computer screen.“The inspector can say, ‘I see a stack of boxes there. Can we move a little closer? I’d like to see if they have proper stickers,’ ” he said. “I believe the auditor should be in control of what they are looking at. We do a livestream, unrecorded broadcast.”Industry lawyers believe the F.D.A. is being too fussy in rejecting remote inspections, given the current backlog. Mark I. Schwartz, a former F.D.A. deputy director who had oversight of inspections conducted by the agency’s Center for Biologics Evaluation and Research, thinks wider use of remote inspections is way overdue. Mr. Schwartz believes that when done properly, remote inspections will yield similar results to in-person visits — which he said more than a dozen of his clients are desperate to have done.“The suggestion that being on-site makes a whole hell of a difference in finding things is a fallacy,” said Mr. Schwartz, now a director at Hyman, Phelps & McNamara, a law firm with a large pharmaceutical industry practice. At best, Mr. Schwartz said, investigators on-site see only about 15 percent of a company even when they are there in person.The issue has drawn congressional attention. Dr. Denigan-Macauley is scheduled to testify on Tuesday before the House appropriations subcommittee that oversees the F.D.A. Representative Sanford Bishop, a Georgia Democrat who is chairman of the panel, said, “The pressure to ensure F.D.A. is still able to assess the safety and efficacy of the drug supply grows every day. ”While public health experts are troubled by the big drop in inspections, most believe that virtual inspections would be a poor substitute for in-person reviews.“Remote inspections just aren’t going to cut it,” Dr. Carome said. “Often the F.D.A. identifies serious problems and if you aren’t on-site, those will go undetected.”“There have been examples where F.D.A. have found filthy conditions in the manufacturing facility or they found rodents or insects that could contaminate products,” Dr. Carome said. “The facility isn’t going to show you that.”The F.D.A. has increasingly relied on electronic submission of manufacturing records during the pandemic, but prefers to view them in person to confirm accuracy. Mr. Ashley of the F.D.A. recalled a 2019 inspection of an over-the-counter drug manufacturer in China, where an investigator found falsification of records that would not have been detected by simply studying them on line.“The front management presented these to our investigator, who noticed that the documents were dated a long time ago, but the ink was still wet,” Mr. Ashley said. “We asked them to recall all their drug products.”The F.D.A. was already behind on inspections before the pandemic, according to congressional investigators, particularly those overseas. The G.A.O. placed part of the blame on the lack of investigators qualified to conduct the inspections.But the watchdog also questioned the wisdom of the F.D.A.’s practice of giving foreign manufacturers up to 12 weeks notice before the inspection, potentially enabling them to fix or hide problems. The pandemic has also prompted the F.D.A. to provide domestic facilities advance notice of its visits, the G.A.O. noted. Another problem is the F.D.A.’s reliance on translators chosen by the company being inspected.Dr. Denigan-Macauley of the G.A.O. said that from March to October 2020, the F.D.A. conducted only three foreign inspections that it considered “mission critical,” compared to more than 600 during the same time period in 2019 and 2018. The G.A.O. also said that the F.D.A. was able to put 54 overseas manufacturers on what are called “import alerts” by sampling their products, rather than doing an inspection. An import alert permits the F.D.A. to block that company’s products from entering the United States.The F.D.A. confirmed that the vast majority of foreign inspections continue to be postponed.“If this continues,” Dr. Denigan-Macauley said, “they are going to be very challenged.”AdvertisementContinue reading the main story

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyPandemic Relief Bill Fulfills Biden’s Promise to Expand Obamacare, for Two YearsWith its expanded subsidies for health plans under the Affordable Care Act, the coronavirus relief bill makes insurance more affordable, and puts health care on the ballot in 2022.President Biden after delivering remarks on the Affordable Care Actin November. The changes to the health law would cover 1.3 million more Americans.Credit…Amr Alfiky/The New York TimesMarch 8, 2021Updated 8:30 p.m. ETWASHINGTON — President Biden’s $1.9 trillion coronavirus relief bill will fulfill one of his central campaign promises, to fill the holes in the Affordable Care Act and make health insurance affordable for more than a million middle-class Americans who could not afford insurance under the original law.The bill, which will most likely go to the House for a final vote on Wednesday, includes a significant, albeit temporary, expansion of subsidies for health insurance purchased under the act. Under the changes, the signature domestic achievement of the Obama administration will reach middle-income families who have been discouraged from buying health plans on the federal marketplace because they come with high premiums and little or no help from the government.The changes will last only for two years. But for some, they will be considerable: The Congressional Budget Office estimated that a 64-year-old earning $58,000 would see monthly payments decline from $1,075 under current law to $412 because the federal government would take up much of the cost. The rescue plan also includes rich new incentives to entice the few holdout states — including Texas, Georgia and Florida — to finally expand Medicaid to those with too much money to qualify for the federal health program for the poor, but too little to afford private coverage.“For people that are eligible but not buying insurance it’s a financial issue, and so upping the subsidies is going to make the price point come down,” said Ezekiel Emanuel, a health policy expert and professor at the University of Pennsylvania who advised Mr. Biden during his transition. The bill, he said, would “make a big dent in the number of the uninsured.”But because those provisions last only two years, the relief bill almost guarantees that health care will be front and center in the 2022 midterm elections, when Republicans will attack the measure as a wasteful expansion of a health law they have long hated. Meantime, some liberal Democrats may complain that the changes only prove that a patchwork approach to health care coverage will never work.“Obviously it’s an improvement, but I think that it is inadequate given the health care crisis that we’re in,” said Representative Ro Khanna, a progressive Democrat from California who favors the single-payer, government-run system called Medicare for All that has been embraced by Senator Bernie Sanders, independent of Vermont, and the Democratic left.“We’re in a national health care crisis,” Mr. Khanna said. “Fifteen million people just lost private health insurance. This would be the time for the government to say, at the very least, for those 15 million that we ought to put them on Medicare.”Mr. Biden made clear when he was running for the White House that he did not favor Medicare for All, but instead wanted to strengthen and expand the Affordable Care Act. The bill that is expected to reach his desk in time for a prime-time Oval Office address on Thursday night would do that. The changes to the health law would cover 1.3 million more Americans and cost about $34 billion, according to the Congressional Budget Office.Representative Frank Pallone Jr. of New Jersey, who helped draft the health law more than a decade ago and leads the House Energy and Commerce Committee, has called it “the biggest expansion that we’ve had since the A.C.A. was passed.”But as a candidate, Mr. Biden promised more, a “public option” — a government-run plan that Americans could choose on the health law’s online marketplaces, which now include only private insurance.“Biden promised voters a public option, and it is a promise he has to keep,” said Waleed Shahid, a spokesman for Justice Democrats, the liberal group that helped elect Representative Alexandria Ocasio-Cortez and other progressive Democrats. Of the stimulus bill, he said, “I don’t think anyone thinks this is Biden’s health care plan.”Just when Mr. Biden or Democrats would put forth such a plan remains unclear, and passage in an evenly divided Senate would be an uphill struggle. White House officials have said Mr. Biden wants to get past the coronavirus relief bill before laying out a more comprehensive domestic policy agenda.Senators Bill Hagerty and Chris Coons at the Capitol on Saturday during a series of votes on amendments to the relief bill.Credit…Anna Moneymaker for The New York TimesThe Affordable Care Act is near and dear to Mr. Biden, who memorably used an expletive to describe it as a big deal when he was vice president and President Barack Obama signed it into law in 2010. It has expanded coverage to more than 20 million Americans, cutting the uninsured rate to 10.9 percent in 2019 from 17.8 percent in 2010.The Coronavirus Outbreak

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyPandemic Relief Bill Fulfills Biden’s Promise to Expand Obamacare, for Two YearsWith its expanded subsidies for health plans under the Affordable Care Act, the coronavirus relief bill makes insurance more affordable, and puts health care on the ballot in 2022.President Biden after delivering remarks on the Affordable Care Actin November. The changes to the health law would cover 1.3 million more Americans.Credit…Amr Alfiky/The New York TimesMarch 8, 2021Updated 8:30 p.m. ETWASHINGTON — President Biden’s $1.9 trillion coronavirus relief bill will fulfill one of his central campaign promises, to fill the holes in the Affordable Care Act and make health insurance affordable for more than a million middle-class Americans who could not afford insurance under the original law.The bill, which will most likely go to the House for a final vote on Wednesday, includes a significant, albeit temporary, expansion of subsidies for health insurance purchased under the act. Under the changes, the signature domestic achievement of the Obama administration will reach middle-income families who have been discouraged from buying health plans on the federal marketplace because they come with high premiums and little or no help from the government.The changes will last only for two years. But for some, they will be considerable: The Congressional Budget Office estimated that a 64-year-old earning $58,000 would see monthly payments decline from $1,075 under current law to $412 because the federal government would take up much of the cost. The rescue plan also includes rich new incentives to entice the few holdout states — including Texas, Georgia and Florida — to finally expand Medicaid to those with too much money to qualify for the federal health program for the poor, but too little to afford private coverage.“For people that are eligible but not buying insurance it’s a financial issue, and so upping the subsidies is going to make the price point come down,” said Ezekiel Emanuel, a health policy expert and professor at the University of Pennsylvania who advised Mr. Biden during his transition. The bill, he said, would “make a big dent in the number of the uninsured.”But because those provisions last only two years, the relief bill almost guarantees that health care will be front and center in the 2022 midterm elections, when Republicans will attack the measure as a wasteful expansion of a health law they have long hated. Meantime, some liberal Democrats may complain that the changes only prove that a patchwork approach to health care coverage will never work.“Obviously it’s an improvement, but I think that it is inadequate given the health care crisis that we’re in,” said Representative Ro Khanna, a progressive Democrat from California who favors the single-payer, government-run system called Medicare for All that has been embraced by Senator Bernie Sanders, independent of Vermont, and the Democratic left.“We’re in a national health care crisis,” Mr. Khanna said. “Fifteen million people just lost private health insurance. This would be the time for the government to say, at the very least, for those 15 million that we ought to put them on Medicare.”Mr. Biden made clear when he was running for the White House that he did not favor Medicare for All, but instead wanted to strengthen and expand the Affordable Care Act. The bill that is expected to reach his desk in time for a prime-time Oval Office address on Thursday night would do that. The changes to the health law would cover 1.3 million more Americans and cost about $34 billion, according to the Congressional Budget Office.Representative Frank Pallone Jr. of New Jersey, who helped draft the health law more than a decade ago and leads the House Energy and Commerce Committee, has called it “the biggest expansion that we’ve had since the A.C.A. was passed.”But as a candidate, Mr. Biden promised more, a “public option” — a government-run plan that Americans could choose on the health law’s online marketplaces, which now include only private insurance.“Biden promised voters a public option, and it is a promise he has to keep,” said Waleed Shahid, a spokesman for Justice Democrats, the liberal group that helped elect Representative Alexandria Ocasio-Cortez and other progressive Democrats. Of the stimulus bill, he said, “I don’t think anyone thinks this is Biden’s health care plan.”Just when Mr. Biden or Democrats would put forth such a plan remains unclear, and passage in an evenly divided Senate would be an uphill struggle. White House officials have said Mr. Biden wants to get past the coronavirus relief bill before laying out a more comprehensive domestic policy agenda.Senators Bill Hagerty and Chris Coons at the Capitol on Saturday during a series of votes on amendments to the relief bill.Credit…Anna Moneymaker for The New York TimesThe Affordable Care Act is near and dear to Mr. Biden, who memorably used an expletive to describe it as a big deal when he was vice president and President Barack Obama signed it into law in 2010. It has expanded coverage to more than 20 million Americans, cutting the uninsured rate to 10.9 percent in 2019 from 17.8 percent in 2010.The Coronavirus Outbreak

Coronavirus lateral flow tests are free and provide a quick result within 30 minutes. But how do you do one?Secondary pupils across the UK are taking them as part of plans to reduce the risk of Covid-19 spreading in schools.All businesses in England can also request tests for their workers as part of the government’s roadmap out of the pandemic.Although the tests are quick, it’s important they’re done correctly to give accurate results.Our health reporter Laura Foster explains.

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyMany ‘Long Covid’ Patients Had No Symptoms From Their Initial InfectionAn analysis of electronic medical records in California found that 32 percent started with asymptomatic infections but reported troubling aftereffects weeks and months later.The study of 1,407 people who tested positive for coronavirus found more than 30 symptoms, including anxiety, low back pain, fatigue, insomnia, gastrointestinal problems and rapid heart rate.Credit…Pete Kiehart for The New York TimesMarch 8, 2021, 6:52 p.m. ETMany people who experience long-term symptoms from the coronavirus did not feel sick at all when they were initially infected, according to a new study that adds compelling information to the increasingly important issue of the lasting health impact of Covid-19.The study, one of the first to focus exclusively on people who never needed to be hospitalized when they were infected, analyzed electronic medical records of 1,407 people in California who tested positive for the coronavirus. More than 60 days after their infection, 27 percent, or 382 people, were struggling with post-Covid symptoms like shortness of breath, chest pain, cough or abdominal pain.Nearly a third of the patients with such long-term problems had not had any symptoms from their initial coronavirus infection through the 10 days after they tested positive, the researchers found.Understanding long-term Covid symptoms is an increasingly pressing priority for doctors and researchers as more and more people report debilitating or painful aftereffects that hamper their ability to work or function the way they did before. Last month, the director of the National Institutes of Health, Dr. Francis S. Collins, announced a major initiative “to identify the causes and ultimately the means of prevention and treatment of individuals who have been sickened by Covid-19, but don’t recover fully over a period of a few weeks.”David Putrino, director of rehabilitation innovation at Mount Sinai Health System in New York City, who was not involved in the new research, said that he and his colleagues at Mount Sinai’s center for post-Covid care are seeing a similar pattern.“Many people who had asymptomatic Covid can also go on to develop post-acute Covid syndrome,” said Dr. Putrino, who is a co-author of a smaller study on the topic published last year. “It doesn’t always match up with severity of acute symptoms, so you can have no symptoms but still have a very aggressive immune response.”The new study is published on the preprint site MedRxiv and has not finished undergoing peer review. Its strengths include that it is larger than many studies on long-term symptoms published so far and that the researchers used electronic records from the University of California system, allowing them to obtain health and demographic information of patients from throughout the state. The researchers also excluded from the study symptoms that patients had reported in the year before their infection, a step intended to ensure a focus on post-Covid symptoms.Among their findings: Long-term problems affect every age group, including children. “Of the 34 children in the study, 11 were long-haulers,” said one of the authors, Melissa Pinto, an associate professor of nursing at the University of California Irvine.The study found more than 30 symptoms, including anxiety, low back pain, fatigue, insomnia, gastrointestinal problems and rapid heart rate. The researchers identified five clusters of symptoms that seemed most likely to occur together, like chest pain and cough or abdominal pain and headache.Most previous studies of long-term symptoms have tended to involve people who were sick enough from their initial infection to be hospitalized. One of the largest found that more than three-quarters of about 1,700 hospitalized patients in Wuhan, China, had at least one symptom six months later.The Coronavirus Outbreak

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyVaccinated Americans, Let the Unmasked Gatherings Begin (but Start Small)The C.D.C. on Monday released long-awaited advice for immunized people, a glimpse at the next stage of the coronavirus pandemic.A socially distanced gathering in Davis, Calif., earlier this year. The C.D.C. now says that vaccinated adults can gather in small numbers without masks or distancing. Credit…Max Whittaker for The New York TimesMarch 8, 2021, 6:22 p.m. ETFederal health officials on Monday told millions of Americans now vaccinated against the coronavirus that they could again embrace a few long-denied freedoms, like gathering in small groups at home without masks or social distancing, offering a hopeful glimpse at the next phase of the pandemic.The recommendations, from the Centers for Disease Control and Prevention, arrived almost exactly a year after the virus began strangling the country and Americans were warned against gatherings for fear of spreading the new pathogen.Now the agency has good news for long-separated families and individuals struggling with pandemic isolation: Vaccinated grandparents may once again visit adult children and grandchildren under certain circumstances, even if they remain unvaccinated. Vaccinated adults may begin to plan mask-free dinners with vaccinated friends.As cases and deaths decline nationwide, some state officials are rushing to reopen businesses and schools; governors in Texas and Mississippi have lifted statewide mask mandates. Federal health officials have repeatedly warned against loosening restrictions too quickly, fearing that the moves may set the stage for a fourth surge of infections and deaths.The new recommendations are intended to nudge Americans onto a more cautious path with clear boundaries for safe behavior, while acknowledging that most of the country remains vulnerable and many scientific questions remain unanswered.“As more Americans are vaccinated, a growing body of evidence now tells us that there are some activities that fully vaccinated people can resume at low risk to themselves,” Dr. Rochelle P. Walensky, the director of the C.D.C., said at a White House news conference on Monday.On Thursday, President Biden will make his first prime-time television address, noting the first anniversary of the pandemic’s onset and highlighting “the role that Americans will play” in getting the country “back to normal,” Jen Psaki, the White House press secretary, told reporters on Monday.As of Monday, 60 million Americans had received at least one dose of a Covid-19 vaccine, and about 31.3 million had been fully vaccinated, according to a database maintained by The New York Times. Providers are administering about 2.17 million doses per day on average.Mr. Biden has promised that there will be enough doses for every American adult by the end of May. C.D.C. officials on Monday encouraged people to be inoculated with the first vaccine available to them, emphasizing that the vaccines are highly effective at preventing “serious Covid-19 illness, hospitalization and death.”Despite the rapidly accelerating pace of vaccination, the pandemic will not recede overnight, said experts who praised the detail and scientific grounding of the C.D.C. recommendations.“This is not turning a switch on and off,” said Dr. Carlos del Rio, vice president of the Infectious Diseases Society of America. “This is more like turning a faucet — you slowly start turning the faucet off.”Even so, “it’s welcome news,” he added. “It’s the first time they are saying you can do something, as opposed to saying everything you can’t do. It’s huge.”The new guidelines provide much-needed advice to individuals who are still reluctant to resume in-person, face-to-face interactions even after being vaccinated, said Vaile Wright, senior director for health care innovation at the American Psychological Association.About half of all adults are anxious about re-entering normal life, including 44 percent of those who have been fully vaccinated, Dr. Wright said, citing soon-to-be published research from the American Psychological Association. “What drives that discomfort is the level of uncertainty,” she said.The Coronavirus Outbreak

#masthead-section-label, #masthead-bar-one { display: none }The Future of TravelA Year Without TravelThe Impact on the EnvironmentReimagining Tourism in HawaiiAdvertisementContinue reading the main storySupported byContinue reading the main storyA Year Without TravelHow Bad Was 2020 for Tourism? Look at the Numbers.The dramatic effects of the coronavirus pandemic on the travel industry and beyond are made clear in six charts.Idle planes stored at an airport in the Netherlands in November.Credit…Siese Veenstra/Agence France-Presse — Getty ImagesStephen Hiltner and March 8, 2021, 4:30 p.m. ETNumbers alone cannot capture the scope of the losses that have mounted in the wake of the coronavirus pandemic. Data sets are crude tools for plumbing the depth of human suffering, or the immensity of our collective grief.But numbers can help us comprehend the scale of certain losses — particularly in the travel industry, which in 2020 experienced a staggering collapse.Around the world, international arrivals are estimated to have dropped to 381 million in 2020, down from 1.461 billion in 2019 — a 74 percent decline. In countries whose economies are heavily reliant on tourism, the precipitous drop in visitors was, and remains, devastating.According to recent figures from the United Nations World Tourism Organization, the decline in international travel in 2020 resulted in an estimated loss of $1.3 trillion in global export revenues. As the agency notes, this figure is more than 11 times the loss that occurred in 2009 as a result of the global economic crisis.The following charts — which address changes in international arrivals, emissions, air travel, the cruise industry and car travel — offer a broad overview of the effects of the coronavirus pandemic within the travel industry and beyond.

#masthead-section-label, #masthead-bar-one { display: none }The Future of TravelA Year Without TravelThe Impact on the EnvironmentReimagining Tourism in HawaiiAdvertisementContinue reading the main storySupported byContinue reading the main storyA Year Without TravelHow Bad Was 2020 for Tourism? Look at the Numbers.The dramatic effects of the coronavirus pandemic on the travel industry and beyond are made clear in six charts.Idle planes stored at an airport in the Netherlands in November.Credit…Siese Veenstra/Agence France-Presse — Getty ImagesStephen Hiltner and March 8, 2021, 4:30 p.m. ETNumbers alone cannot capture the scope of the losses that have mounted in the wake of the coronavirus pandemic. Data sets are crude tools for plumbing the depth of human suffering, or the immensity of our collective grief.But numbers can help us comprehend the scale of certain losses — particularly in the travel industry, which in 2020 experienced a staggering collapse.Around the world, international arrivals are estimated to have dropped to 381 million in 2020, down from 1.461 billion in 2019 — a 74 percent decline. In countries whose economies are heavily reliant on tourism, the precipitous drop in visitors was, and remains, devastating.According to recent figures from the United Nations World Tourism Organization, the decline in international travel in 2020 resulted in an estimated loss of $1.3 trillion in global export revenues. As the agency notes, this figure is more than 11 times the loss that occurred in 2009 as a result of the global economic crisis.The following charts — which address changes in international arrivals, emissions, air travel, the cruise industry and car travel — offer a broad overview of the effects of the coronavirus pandemic within the travel industry and beyond.

#masthead-section-label, #masthead-bar-one { display: none }The Coronavirus OutbreakliveLatest UpdatesMaps and CasesRisk Near YouVaccine RolloutNew Variants TrackerAdvertisementContinue reading the main storySupported byContinue reading the main storyBiden Cancels Visit to Vaccine Maker After Times Report on Its TacticsThe White House scrapped a trip to a vaccine plant in Baltimore run by Emergent BioSolutions after a New York Times investigation into the company.Emergent BioSolutions has more than $600 million in contracts with the federal government to manufacture coronavirus vaccines and to expand its “fill-and-finish” capacity for completing the process of manufacturing vaccines and therapeutics.Credit…Samuel Corum for The New York TimesSheryl Gay Stolberg and March 8, 2021, 3:51 p.m. ETWASHINGTON — President Biden on Monday canceled a visit to a coronavirus vaccine plant run by Emergent BioSolutions after The New York Times published a lengthy investigation into how the company gained outsize influence over the nation’s emergency medical reserve.Instead of visiting Emergent’s facility in Baltimore on Wednesday, the president will convene a meeting at the White House with executives of the pharmaceutical giants Merck & Co. and Johnson & Johnson, who were also to attend the session in Baltimore, White House officials said. Merck and Emergent are each separately partnering with Johnson & Johnson to manufacture that company’s coronavirus vaccine.“We just felt it was a more appropriate place to have the meeting,” Jen Psaki, the White House press secretary, told reporters.Emergent has more than $600 million in contracts with the federal government to manufacture coronavirus vaccines and to expand its “fill-and-finish” capacity for completing the process of manufacturing vaccines and therapeutics. A senior administration official said only executives from Merck and Johnson & Johnson would attend the White House session on Wednesday.An Emergent spokeswoman did not immediately respond on Monday to questions about the cancellation. The spokeswoman, Nina DeLorenzo, had previously defended the company’s business with the government in written responses to questions, saying, “When almost no one else would invest in preparing to protect the American public from grave threats, Emergent did, and the country is better prepared today because of it.”The Times investigation focused on the emergency reserve, the Strategic National Stockpile, which became infamous during the coronavirus pandemic for its lack of critical supplies such as N95 masks and other personal protective equipment.Decisions about how to spend the repository’s limited budget are supposed to be based on careful assessments by government officials of how best to save lives, but The Times found that they were largely driven by the demands and financial interests of a handful of biotech companies that have specialized in products that address terrorist threats rather than infectious disease.The Coronavirus Outbreak