
Johnson & Johnson on Tuesday morning asked federal regulators to authorize a booster shot for adults, becoming the third coronavirus vaccine manufacturer to do so.
The company said that a second shot of its vaccine about two months after the first significantly boosts protection, to 94 percent, against moderate to severe disease. Other coronavirus vaccines have been given in two doses, but Johnson & Johnson’s is a single dose.
The Food and Drug Administration last month authorized boosters for many recipients of Pfizer-BioNTech’s vaccine, and Moderna is seeking authorization for boosters of its inoculation. Regulators could decide on both Moderna’s and Johnson & Johnson’s applications as early as this month.
Senior federal health officials have been privately convinced for some time about the need to offer a booster shot to recipients of Johnson & Johnson’s vaccine.
A recent study by the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was 71 percent effective against hospitalization from Covid-19, compared with 88 percent for Pfizer-BioNTech’s and 93 percent for Moderna’s two-dose vaccines. Other research found that Johnson & Johnson recipients were more likely to suffer breakthrough infections or symptomatic Covid-19 than recipients of the other two vaccines.
Johnson & Johnson’s own study cited better results, finding its vaccine was 81 percent effective against hospitalization and 79 percent effective against infection. The company has said that its study also found that the protection its vaccine provides does not wane over time like protection from Pfizer-BioNTech’s vaccines.
Nearly 15 million Americans have been inoculated with Johnson & Johnson’s vaccine, compared to 102 million fully vaccinated with the Pfizer-BioNTech vaccine and nearly 69 million with Moderna’s.
It is unclear to some scientists whether it would be better to give a booster shot of Johnson & Johnson after about two months or six months. Johnson & Johnson’s submission to the F.D.A. shows that when a booster shot was given six months after the initial injection, antibody levels increased ninefold within a week and 12-fold within a month.
Some research from the National Institutes of Health also indicates that Moderna’s vaccine may work even better as a booster for Johnson & Johnson’s shot.
“We look forward to our discussions with the F.D.A. and other health authorities to support their decisions regarding boosters,” said Dr. Mathai Mammen, a key research and development leader within Johnson & Johnson. “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
The F.D.A. and the Centers for Disease Control have been grappling with whether to shore up vaccine effectiveness with booster shots for weeks. After fraught debates with experts on outside advisory panels, the agencies decided late last month to offer a booster shot to a broad swath of Pfizer-BioNTech adult recipients.
The eligible include those 65 and older and those who live in long-term care facilities, who have underlying medical conditions or who are at higher risk of exposure to the virus because of their jobs or institutional settings.
Federal officials are expected to push this month for the same eligibility categories — if not broader — for booster shots of the other two vaccines. The F.D.A.’s advisory panel is scheduled to take up the issue of a third shot of Moderna’s vaccine on Oct. 14, one day before it is to consider Johnson & Johnson’s request.
On Monday, federal regulators for the European Union went farther than U.S. regulators, authorizing booster shots for all Pfizer-BioNTech recipients 18 or older.
Dr. Francis S. Collins, the National Institutes of Health director who has led the agency for more than a decade and through three presidential administrations, said on Tuesday that he would step down from his post by the end of the year.
President Biden is expected to nominate a replacement, who will have to be confirmed in an evenly divided Senate, to manage a budget of over $40 billion.
“No single person should serve in the position too long,” Dr. Collins said in a statement. “It’s time to bring in a new scientist to lead the N.I.H. into the future.”
Dr. Collins, 71, was appointed in 2009 by President Barack Obama after more than a decade leading the National Human Genome Research Institute, which is part of the N.I.H.
Mr. Biden on Tuesday lavished praise on Dr. Collins, whom he called “one of the most important scientists of our time.”
“After I was elected president, Dr. Collins was one of the first people I asked to stay in his role with the nation facing one of the worst public health crises in our history,” Mr. Biden said. “Millions of people will never know Dr. Collins saved their lives. Countless researchers will aspire to follow in his footsteps. And I will miss the counsel, expertise and good humor of a brilliant mind and dear friend.”
On Tuesday, the N.I.H. said that Dr. Collins would return to his laboratory there, which is studying the causes of and prevention for Type 2 diabetes and new therapies for Hutchinson-Gilford Progeria Syndrome, a form of premature aging.
A geneticist by training, Dr. Collins oversees 18,000 employees and a sprawling federal research program, spread across 27 institutes and centers in 75 buildings over 300 acres of land in Bethesda, Md.
During the pandemic, Dr. Collins helped found a project known as ACTIV, which enabled trials on antivirals and other treatments for Covid-19 to run at many sites at once. He has also been a regular spokesman for vaccines for both the Trump and Biden administrations.
He endorsed Mr. Biden’s decision this summer to require federal workers to be vaccinated against the coronavirus, and has said that businesses asking employees for proof of vaccination or regular testing were taking steps “in the right direction.”
An outspoken Christian who has written widely on the mingling of religion and science, Dr. Collins has been deployed by the Biden administration as a surrogate among vaccine-hesitant conservatives, speaking on Christian radio and addressing evangelical groups to make the case for getting inoculated.
He has often criticized what he views as the politicization of the pandemic. “Imagine you were an alien who landed on planet Earth,” he said in one appearance on CNN last year when asked to comment on a political rally for President Donald J. Trump at which few attendees wore masks. “You would scratch your head and think, ‘This is just not a planet that has much promise for the future.’”
Dr. Collins is known in the medical community as a folksy, colorful personality. He rides a motorcycle, and last year recorded a Covid-19-themed cover of “Puff the Magic Dragon” on a guitar ornamented with a double helix.
Lazar Hayward, a former N.B.A. player, was arrested in Hawaii last week for trying to enter the state with a fake negative Covid test, the authorities said.
Mr. Hayward, a first-round draft pick in 2010, and a woman traveling with him, Raven Randle had uploaded the fake documents onto Hawaii’s Safe Travels portal, the police on the western Hawaiian island of Kauai said in a statement on Facebook. The state requires unvaccinated travelers to quarantine for 10 days upon arrival unless they present a negative Covid test.
The pair were arrested on Sept. 28 soon after they had flown to Kauai from Los Angeles, the police said. They were immediately sent back to California.
The Safe Travels system flagged the tests, which were then investigated by the state’s Department of the Attorney General before the two were arrested, the statement said.
Mr. Hayward, 34, and Ms. Randle, 33, are to appear in court, but a date has not yet been set. Phone calls placed to a number listed as belonging to Mr. Hayward were not returned on Monday night.
Mr. Hayward, a standout player at Marquette University, was the last pick in the first round of the 2010 N.B.A. draft. He spent three seasons in the league, where he played for the Minnesota Timberwolves and the Oklahoma City Thunder before he was sent to the N.B.A.’s development league.
Mr. Hayward and Ms. Randle traveled to Hawaii despite the governor’s request in August that tourists stay away to ease the strain on hospitals.
New infections in the state on Sunday were less than a third of the amount a month ago, when the state reached a pandemic high, according to a New York Times database. Fifty-eight percent of the state’s residents who are eligible for vaccinations are fully inoculated, which is above the nationwide average of 56 percent.
AstraZeneca said on Tuesday that it had asked the Food and Drug Administration to grant emergency authorization for a long-acting antibody treatment to prevent Covid-19 in people who are at high risk of the disease. If authorized, it would become the first such preventive treatment to be available in the United States, the company said.
The company said in a statement that the treatment had reduced the risk of symptomatic Covid-19 by 77 percent in a trial in which most participants either had other medical conditions that placed them at greater risk of severe illness or were not producing sufficient antibodies after vaccination.
It said the treatment could be used in conjunction with vaccines in people with weaker immune systems. Other antibody treatments in use in the United States, including one developed by the drug maker Regeneron, have mainly been used to treat people who are already infected with the coronavirus. The AstraZeneca treatment is designed to stay in the body for much longer than the available antibody treatments for Covid, the company has said.
“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing Covid-19,” Mene Pangalos, an executive vice president at AstraZeneca, said in a statement. “With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines.”
An F.D.A. authorization would raise the fortunes of AstraZeneca, whose coronavirus vaccine, which is in use in numerous countries, has not been authorized in the United States.
Antibody treatments have gained greater attention in recent months as an alternative, if expensive, tool against Covid-19 in the United States, particularly by some who have shunned vaccines. The Biden administration has emphasized that vaccinations are the best way to prevent the spread of the coronavirus, but has urged state and local health officials to make antibody therapy — which the federal government covers at a per-dose cost of roughly $2,100 — more widely available.
The AstraZeneca treatment is one of several in a class of therapies known as monoclonal antibodies, which introduce lab-made, disease-fighting proteins into the bodies of patients, usually through an infusion.
Last month, a World Health Organization panel endorsed the use of Regeneron’s antibody treatment in high-risk Covid-19 patients, while the health agency urged the company and its partner, the Swiss manufacturer Roche, to lower the cost of the therapy and make it more widely available.
The photo caption in an earlier version of this report misidentified the pictured building. It is AstraZeneca's research and development center, not the company's U.S. headquarters, which are in Delaware.
Louisiana’s largest nonprofit health care provider is increasing its insurance fees next year for employees whose spouses or domestic partners are not vaccinated against Covid.
In a letter to its employees last month, the provider, Ochsner Health, said that it was adding the extra charge — about $200 a month — for unvaccinated spouses and domestic partners who covered by the company’s insurance plan.
The letter said the move was an effort to “protect our entire Ochsner team, which includes employees, their families and the communities we serve.”
Warner Thomas, the company’s president and chief executive, said in a statement that spouses and domestic partners would be allowed to file for medical or religious exemptions to the policy.
“This is not a mandate,” he said, noting that the spouses and domestic partners could switch insurance plans to avoid the new fee.
“The reality is the cost of treating Covid-19, particularly for patients requiring intensive inpatient care, is expensive,” he added.
Mr. Thomas said that about 90 percent of the company’s Covid patients since December had been unvaccinated. According to a New York Times analysis in August, fully vaccinated people accounted for just 1 percent of Covid hospitalizations in Louisiana. The analysis looked at 40 states and the District of Columbia, and the rate in most of them was under 2 percent.
In August, Ochsner said that its employees must be vaccinated by the end of this month. Around 70 percent of its employees were inoculated at the time the mandate was announced.
The provider’s decision to charge extra was similar to a policy implemented by Delta Air Lines, which said in August that starting on Nov. 1, it would charge any employee who remains unvaccinated an additional $200 per month to remain on the company’s health care plan.
Delta became the first large U.S. employer to embrace an idea that has been widely discussed but is mired in legal uncertainty: charging unvaccinated employees more for health insurance.
Insurance surcharges may appeal to companies that are seeking a less coercive means to increase vaccination rates, said Wade Symons, a partner at Mercer, a benefits consulting firm.
New infections in Louisiana on Sunday were less than a fifth of the amount in August, when the state reached a pandemic high, according to a New York Times database. Hospitalizations are experiencing a similar trend.
The state authorities are still struggling to vaccinate people, however. Less than half of the state’s eligible population is fully vaccinated, according to a Times database, which is below the nationwide average of 56 percent.
NEW DELHI — India’s coronavirus death toll could now amount to a government payout of hundreds of millions of dollars.
The country’s Supreme Court has ordered India’s disaster management agency to pay 50,000 rupees, about $671, to families of people who have died from Covid. The country’s official death toll from the pandemic is 449,260, although experts estimate that the true number of Covid deaths is several times higher. Even that smaller number would suggest payouts amounting to about $300 million.
The number of families applying for compensation could quickly balloon, because the government has expanded the definition of what qualifies as a Covid-19 death to anyone who died within 30 days of a positive RT-PCR test or clinical examination confirming the infection.
“This is a herculean task for the government,” said Gaurav Kumar Bansal, the lawyer who brought the litigation to India’s top court.
India’s National Disaster Management Act stipulates that government compensation of 400,000 rupees, about $5,400, should be given to families who lose relatives in typhoons, floods and other disasters.
Millions of India’s 1.4 billion people live below the poverty line, and the Supreme Court order, issued on Monday, came in response to public interest litigation, a type of case in India that is brought on behalf of the public at large rather than by any specific plaintiff.
Prime Minister Narendra Modi’s government declared the pandemic a disaster in March 2020, a move that gave it power to impose a strict nationwide lockdown.
Mr. Bansal said the disaster declaration should also have led to compensation payments being made.
“We challenged them to pick and choose,” he said. “If it is notified as a disaster, then all provisions of the Disaster Management Act will apply.”
The government offered $671 per death. The Supreme Court, which factored in the agency’s other costs, agreed.
Anirudh Singh Rathore, 60, a garment trader in the capital, New Delhi, lost his wife to India’s ferocious second wave last spring. He has applied online for compensation through the Delhi government, but he is doubtful that the money will arrive.
“Such compensation is not easy to take from the government,” he said. “It is very easy to announce but difficult to get.”
Australia and New Zealand moved closer on Tuesday to fully reopening their economies in the coming months, with leaders in both countries outlining steps to allow people vaccinated against the coronavirus to move more freely.
Prime Minister Scott Morrison said that Australia could allow vaccinated foreign tourists to enter the country in 2022 at the earliest, even as it prioritizes travel by its own inoculated citizens and permanent residents.
Skilled migrants and students who are vaccinated would then be allowed in, he said in an interview on Channel Seven, reaffirming plans announced in recent days.
“We will get to international visitors as well — I believe next year,” Mr. Morrison said. “The priority is Australians.”
The prime minister’s comments were the firmest assurances of when the island nation may reopen to the world, having closed its borders in March 2020. Millions of Australians have since endured lengthy lockdowns and strict border policies during the course of the pandemic.
Mr. Morrison said on Friday that an international travel ban would be lifted by mid-November as national vaccination rates continue to rise. As of Tuesday, 67 percent of Australians had received a first vaccine dose and 46 percent were fully vaccinated, according to figures compiled from government sources by the Our World in Data project at the University of Oxford.
In neighboring New Zealand, Prime Minister Jacinda Ardern said on Tuesday that people would be required to use a national vaccine certificate to get into “high-risk settings” like summer music festivals.
The certificate, which is expected to be introduced in November, will be a document that people can show in a digital form or download and print out.
New Zealand’s government is still finalizing where certificates will be used beyond large-scale events, though restaurants and bars are one possibility, Ms. Ardern said at a news conference. They will not be required for shopping in supermarkets or receiving health care, she added.
Ms. Ardern urged people in the country to get vaccinated before the passes became a requirement. “It’s one of the best ways we can ensure that summer plans can go ahead uninterrupted,” she said. “It will help us to keep people safe.”
“To be fully vaccinated and fully protected and enjoy the things you love,” she added, “you need to be vaccinated — this month, not in December.”
The plan follows in the footsteps of countries like France and Israel, which have used similar passes to manage access to cafes, restaurants and other services.
New Zealand also said this week that because of an outbreak of the Delta variant in Auckland that has proved impossible to suppress, the country would move away from a zero-Covid plan that has allowed residents to live with few restrictions throughout the pandemic.
As of Monday, nearly 80 percent of people age 12 and up in New Zealand had received one Covid vaccine dose and about 48 percent had received two doses.
Southwest Airlines said on Monday that it would require all of its more than 54,000 employees to be fully vaccinated against the coronavirus by the first week in December to remain employed.
Gary Kelly, the company’s chief executive, said that the budget carrier needed to follow competitors, including United Airlines, Alaska Airlines and Jet Blue, in requiring shots for its employees. The company has contracts with the federal government, which now requires all employees at federal contractors be vaccinated.
The airline industry was hard hit during the pandemic as borders closed, tourism evaporated and remote working kept business travelers at home. In recent months, it has seen an uptick in business as more people get vaccinated and travel restrictions are relaxed around the globe.
United Airlines mandated vaccines for its 67,000 U.S.-based employees in August. American Airlines, Alaska Airlines and JetBlue have since made similar announcements.
Southwest employees must be fully vaccinated by Dec. 8 or “be approved for a religious, medical or disability accommodation,” the company said.
Indonesia will allow international flights to begin landing at the airport on Bali island next week as it weighs reopening the country to foreign tourists for the first time in more than 18 months.
International carriers from countries including China, Japan, New Zealand, South Korea and the United Arab Emirates could resume flights to Bali on Oct. 14, Luhut Pandjaitan, a top minister in the cabinet of President Joko Widodo, said on Monday.
Under the current rules, eligible passengers would include Indonesian citizens as well as foreigners with a work permit or business visa. They would be subject to eight days quarantine at a hotel at their own expense.
Bali is Indonesia’s most important tourist destination, and closing the island to foreign tourists has devastated the tourism industry, leading to tens of thousands of people losing their jobs. Indonesia has been the Southeast Asian nation hit hardest by Covid, with nearly 143,000 deaths. It reached a peak of nearly 57,000 cases a day in July, though the number of infections has dropped sharply since then.
Foreign tourists have been barred from entering Indonesia since April of last year, and international flights have been allowed to land only in Jakarta, the capital, and the city of Manado on Sulawesi island.
Indonesia’s tourism minister, Sandiaga Uno, told reporters that reopening Bali’s airport to overseas flights would serve as a “trial opening of Bali for foreign tourists,” though he did not provide a timetable for their return. Domestic tourists are already allowed to visit.
Earlier he said that Indonesia was studying the example of Thailand’s “Phuket Sandbox,” which allows vaccinated foreign tourists who test negative for Covid-19 to roam freely on Phuket island.
Taufan Yudhistira, a spokesman for Bali’s Ngurah Rai International Airport, said the airport had not received specific instructions for the reopening but had begun readying the international terminal and preparing health protocols.
In Germany, where one in four jobs depends on exports, the crisis gumming up the world’s supply chains is weighing heavily on the economy, which is Europe’s largest and a linchpin for global commerce.
Recent surveys and data point to a sharp slowdown of the German manufacturing powerhouse, and economists have begun to predict a “bottleneck recession.”
Almost everything that German factories need to operate is in short supply: not just computer chips, but also plywood, copper, aluminum, plastics and raw materials like cobalt, lithium, nickel and graphite, which are crucial ingredients of electric car batteries.
More than 40 percent of German companies said they had lost sales because of supply problems in an August survey by the Association of German Chambers of Industry and Commerce. Europewide, exports would have been 7 percent higher in the first six months of the year if not for supply bottlenecks, according to the European Central Bank.
While every economy in the world is suffering from shortages, Germany is particularly sensitive because of its dependence on manufacturing and trade. Nearly half of Germany’s economic output depends on exports of cars, machine tools and other goods, compared with 12 percent in the United States.
In the chic Manhattan neighborhood of SoHo, more than 40 stores have closed during the pandemic. More than a quarter of the offices, once among the most desirable and expensive in New York City, are empty, the highest vacancy rate in Manhattan. The international tourists who fueled the area’s economy vanished a year and a half ago.
As New York climbs out of the depths of an economic free-fall, it has reached some major milestones lately. In-person classes have resumed at the city’s schools, Broadway theaters have reopened and 300,000 municipal workers have returned to their offices for the first time in 18 months.
But on SoHo’s cobblestone streets, the economic scars remain, a sign of how vulnerable New York is to a contagious disease that has unraveled an urban economy built on face-to-face interactions in offices, restaurants and stores.
Just a few years ago, SoHo was one of the world’s hottest retail districts, packed with luxury brands like Chanel, Gucci, Louis Vuitton and Ralph Lauren that paid some of the highest rents in the country. Shoppers spent $3.1 billion in SoHo and neighboring NoHo in 2016, according to a report by HR & A Advisors, second only to Fifth Avenue in Midtown Manhattan in total retail revenue.
Almost overnight, the shoppers, notably those from overseas, evaporated.
COVID-19 - Latest - Google News
October 05, 2021 at 07:17PM
https://ift.tt/2ZYBEiW
Top Indian Court Orders Payments Over Pandemic Deaths - The New York Times
COVID-19 - Latest - Google News
https://ift.tt/2VQ2gy8
No comments:
Post a Comment