Two top executives of Emergent BioSolutions, a previously obscure Maryland biotech firm whose Baltimore plant ruined millions of doses of coronavirus vaccine, have agreed to testify on Capitol Hill next week as part of a congressional investigation into their company, a politically connected federal contractor.
Fuad El-Hibri, the company’s founder and executive chairman, and Robert Kramer, its chief executive officer, will appear on May 19 before the House Select Subcommittee on the Coronavirus, committee officials said on Wednesday morning. The panel has opened a sprawling inquiry into Emergent’s manufacturing failures, and whether the company used its contacts with the Trump administration to land hundreds of millions of dollars in coronavirus vaccine contracts.
“Emergent’s actions wasted American taxpayer dollars and reduced the number of doses available for global vaccination efforts,” Representative Jim Clyburn, Democrat of South Carolina and the subcommittee’s chairman, said in a statement to The Times. He said that Congress “is looking for answers and they are long overdue.”
An investigation by The New York Times, published in March before the firm’s vaccine manufacturing troubles were known, examined Emergent’s aggressive lobbying tactics and lucrative relationship with the federal government.
The hearing will put an unwelcome spotlight on the company, which kept a low profile over the past two decades as it cornered the market on sales of anthrax vaccines and other bioterror-related products to the Strategic National Stockpile, the nation’s emergency medical reserve.
Emergent’s stock performed so well in 2020 that Mr. El-Hibri cashed in shares and options worth over $42 million, corporate filings show. Mr. Kramer, who has boasted to investors that “extensive relationships across multiple agencies within the federal government” helped build the company, took home a $1.2 million cash bonus and $2 million in stock awards.
In an interview with CNN on Wednesday morning, Mr. Clyburn indicated that the committee was also scrutinizing the executives’ market moves. “They all made millions in stock transactions while they seem to be hiding stuff from the public,” he said.
The Times reported last month that workers at Emergent’s Baltimore plant had accidentally conflated the ingredients of two coronavirus vaccines, one by Johnson & Johnson and the other by AstraZeneca. The error resulted in the loss of up to 15 million Johnson & Johnson doses, and a recent inspection by the Food and Drug Administration said that more doses may have been exposed to contamination.
In a statement on Wednesday, the company said that it had responded to the F.D.A.’s observations with a “comprehensive quality enhancement plan” and had “already started making improvements.”
On a recent call with investors, Mr. Kramer announced a management shake-up and took “full responsibility” for the manufacturing problems, acknowledging that the “loss of a batch for a viral contamination is extremely serious, and we treated it as such.” But he also said that Emergent had taken on a “herculean task” in a crisis.
In letters to the two Emergent executives last month, Mr. Clyburn and Representative Carolyn Maloney, Democrat of New York and chairwoman of the House Oversight and Reform Committee, demanded a slew of documents, including any correspondence between the company and Dr. Robert Kadlec, President Trump’s assistant secretary for preparedness and response, who previously consulted for the company. In interviews, Dr. Kadlec has said his consulting work, in 2013 and 2014, was limited and did not affect contracting decisions.
“Emergent has been in the news a lot lately, and that’s frankly not something we’re used to,” Mr. Kramer wrote in a commentary posted on the company’s website last month. “Until a year ago we were a little-known company that does our work behind the scenes.”
The company is trying to burnish its image with television and digital advertising, as part of a campaign it is calling “We Go.” The 30-second ads feature images of white-clad lab technicians and spotlight some of the company’s lesser-known work manufacturing cholera vaccines and medicine used to treat opioid overdoses, as well as its Covid-19 work.
Emergent’s plant in Baltimore is one of two federally designated Centers for Innovation in Advanced Development and Manufacturing, funded in part by taxpayers. In June 2020, the federal government awarded Emergent a $628 million contract, largely to reserve space for coronavirus vaccine manufacturing, despite staffing and quality concerns.
After The Biden administration responded to the potential contamination last month by putting Johnson & Johnson in charge of the Baltimore facility and moving out AstraZeneca. Doses made at the plant have not been cleared for use in the United States, and millions of shots made in Baltimore and sent overseas have also been put on hold.
A virus variant that has been spreading rapidly in India and designated a variant of concern by the World Health Organization might be more contagious than most versions of the coronavirus, the agency said in a report it published on Tuesday evening.
The W.H.O. emphasized in its report that it wasn’t yet clear how much the variant, known as B.1.617, had contributed to the devastating surge that has crushed India in recent weeks. It cautioned that India, like many countries, is only sequencing a tiny fraction of positive samples, and that with so little surveillance, it’s difficult to make firm conclusions about B.1.617.
The W.H.O. study comes amid growing condemnation of the Indian government’s response to its ferocious virus wave and calls for nationwide restrictions to try to limit the death toll, as hospitals are overrun and crematories burn nonstop.
India recorded more than 360,000 new cases on Wednesday and more than 4,200 deaths, the country’s highest daily death toll since the pandemic began. India has now reported more than 250,000 deaths from the virus, although experts believe that the true toll is far higher.
Experts also caution that it is not yet clear just how much of a factor B.1.617 has played in the explosion of cases in India. They point to a perfect storm of public health blunders, such as permitting enormous political rallies and religious festivals in recent months. It’s possible that the variant is being lifted up by the surge, rather than the other way around.
The W.H.O. speculated that another variant known as B.1.1.7, first identified in Britain and now dominant in the United States, might also be driving the swell in cases.
It’s not yet clear whether B.1.617 causes more severe Covid-19. Anecdotally, doctors in India are reporting higher numbers of young people and children testing positive for the virus and more patients with severe disease requiring oxygen support. But until more genetic sequencing is done, it’s impossible to know if the variant is to blame.
Stacia Wyman, a genomics scientist at the University of California, Berkeley, said that the W.H.O. had made the right decision. She pointed to the fact that the variant had already spread to at least 49 countries. “This appears to be posing the biggest threat right now in terms of transmissibility, with many countries reporting increasing trajectories of the B.1.617 variant,” she said.
B.1.617 is the fourth variant of concern recognized by the W.H.O. The others include B.1.1.7; B.1.351, which swept through South Africa; and P.1, which has devastated Brazil.
B.1.617 first came to light in October 2020. It had a number of mutations, some of which have been proved worrisome in other variants. Preliminary studies on the mutations suggest that some of them might give the coronavirus a tighter grip on cells, increasing their chances of a successful infection.
Other mutations could make it more difficult for antibodies produced by infections with other variants to stick to them. Studies on antibodies produced by vaccinated people also suggest that they work less successfully against B.1.617. Experts expect that most vaccines will remain effective against the variant.
W.H.O. researchers determined that B.1.617 is spreading fast in India, making up over 28 percent of samples from positive tests. The shift suggests that B.1.617 has a higher growth rate than other variants circulating in India, with the possible exception of B.1.1.7. And B.1.617 has been growing rapidly in Britain.
Gagandeep Kang, a pre-eminent Indian virologist, said there was not enough data to conclude whether either variant was contributing to India’s deadlier second wave.
“There is some conflicting data regarding the B.1.1.7 variant, which seems to indicate in some studies that it does cause more severe disease, in other studies not,” said Dr. Kang, the executive director of the Translational Health Science and Technology Institute in India.
Based on reports from hospitals, Dr. Kang said, it appeared that B.1.617 was causing more severe disease but that, again, there was insufficient data to draw conclusions. She said that real-time genetic information would be needed to determine whether B.1.617-infected people needed more oxygen.
Officials in India are trying to track how many fully vaccinated people have fallen ill. If an unusual number of these so-called breakthroughs are caused by a variant such as B.1.617, then that could point to the variant’s ability to evade a vaccine.
NEW DELHI — Just a few months ago, the southwestern state of Goa was welcoming tourists from across the rest of India who were drawn to its picture-perfect beaches, an ideal source of relief from coronavirus rules in other regions.
Group celebrations, many without masks, were common. Life appeared to have gone back to normal.
But it did not last.
With India in the grip of a devastating coronavirus outbreak, 26 people died at the state-run Goa Medical College and Hospital on Tuesday morning, possibly because of an oxygen shortage, one official said.
“Due to interrupted supply of oxygen, we feel that between 2 a.m. and 6 a.m. many people are dying in G.M.C.,” the health minister for Goa, Vishwajit Rane, told The Times of India. He also called for a High Court inquiry to investigate the cause of the deaths.
Goa reported 75 deaths in total on Tuesday, its highest daily toll of the pandemic, and there were over 32,800 new daily infections in the state, which has a population of about 1.5 million. Officially, India has surpassed 250,000 total reported deaths from Covid.
Contradicting the health minister, Pramod Sawant, Goa’s chief minister, who visited the hospital, said that there was “no scarcity” and that the state had “abundant supplies of oxygen.” Mr. Rane said the chief minister might be “misguided.”
Goa has been reporting one of the highest infection rates in the country for at least a week.
Mr. Rane said in an interview with CNN last week, “Opening up of tourism without any restrictions in December has led to this situation.”
Goa has also created headlines for approving the use of ivermectin, an anti-parasite drug, in the treatment and prevention of Covid-19. The World Health Organization has said that there is not enough evidence to suggest that the drug reduces mortality in coronavirus patients.
On Monday, Mr. Rane announced on Twitter that the state government would make the drug available for everyone over 18 as a prophylactic.
Patients will be treated with ivermectin for a period of five days, Mr. Rane said, adding that the government would make the drug available at hospitals and primary health centers for people to “start the treatment immediately, irrespective of any symptoms.”
The W.H.O. has warned against the use of the drug, except in clinical trials.
“Safety and efficacy are important when using any drug for a new indication,” said Dr. Soumya Swaminathan, the W.H.O. chief scientist, in a post about ivermectin on Tuesday.
On May 4, Dr. Hina Talib, who goes by the handle @teenhealthdoc on Instagram, asked the parents among her 33,000 followers if they were hesitant to get the coronavirus vaccine for their 12- to 15-year-olds, and if so, why. Dr. Talib, a physician in the adolescent medicine division at the Children’s Hospital at Montefiore in New York, got 600 messages in response.
More often than not, Dr. Talib said, the parents had already had the Covid-19 vaccine, and would preface their message with: “I’m not an anti-vaxxer or an anti-masker. I’m just worried.”
Although trials have shown no serious safety concerns for children thus far, some recent polls show that only about 30 percent of parents nationwide say they would get their children vaccinated right away. Parents of infants and preschoolers expressed even more anxiety about the vaccine than parents of teenagers.
These parents tend to be concerned about the vaccine affecting puberty and future fertility for their children, and its possible impact on allergies and side effects. Their fears are a key hurdle for U.S. efforts to expand vaccinations to younger teens.
As hospitals in Nepal strain to cope with one of the world’s fastest-growing coronavirus outbreaks, relief groups in the Himalayan nation are asking mountain climbers to hand over their used oxygen cylinders so that they can be refilled for Covid-19 patients.
The unusual appeal reflects the strange duality in Nepal: While hundreds of foreign climbers are attempting costly expeditions to the summits of Mount Everest and other peaks, the impoverished nation down below is facing urgent shortages of hospital beds, medical oxygen, coronavirus test kits and other supplies.
Expedition operators are preparing to airlift thousands of cylinders from the Himalayas as expeditions are completed this month, the culmination of the climbing season. Kul Bahadur Gurung, general secretary of the Nepal Mountaineering Association, estimated that tour companies would be able to provide at least 4,000 cylinders by the first week of June.
“We are asking them not to leave even a single oxygen cylinder in the mountains,” Mr. Gurung said.
Climbers attempting to reach the top of Everest, the world’s tallest peak, and other mountains carry oxygen to help them breathe in the thin air. Although Nepal prohibits leaving equipment behind in the mountains, canisters are sometimes left buried in the snow by exhausted climbers or stashed by expedition companies for later use.
Cylinders used in mountaineering are smaller to those typically found in intensive-care wards, but Mahabir Pun, a prominent Nepali scientist who is helping to lead the cylinder drive, said that they could be used by patients who cannot find a hospital bed or who are being treated at home.
“I.C.U. beds are already filled with critical Covid patients, so we want to distribute these portable expedition cylinders with regulators for those patients staying in home isolation,” Mr. Pun said.
Nepal’s outbreak has surged in recent weeks, most likely fueled by the virus’s catastrophic surge in India, with which it shares a long, porous border. On May 1, Nepal reported 26 deaths from the virus. On Tuesday, the official death toll was 225.
Doctors say that a shortage of medical oxygen is a factor in many of the deaths. Many hospitals have stopped admitting new Covid-19 patients, citing a lack of oxygen. Wealthy families are airlifting their loved ones by chartered helicopter to cities where they can find intensive-care beds. Other patients are being treated in makeshift emergency facilities set up in parking lots and other open spaces.
With almost half of Nepal’s coronavirus tests coming back positive, health experts warn that the worst is yet to come.
China has pledged to provide Nepal with 20,000 oxygen cylinders and 100 ventilators, the first batch of which arrived on Tuesday.
Expedition companies are stepping in with smaller donations. Mr. Gurung’s group said that he was sending five dozen cylinders, along with a few more from a local mountaineering museum, to hospitals treating coronavirus patients.
Mingma Sherpa, chairman of Seven Summit Treks, Nepal’s largest expeditions operator, said that he planned to ship as many as 500 cylinders used in expeditions to Everest and other peaks soon after climbers descended to base camps.
“My only condition is that those cylinders should be used for poor and helpless people rather than V.I.P.s,” he said, adding: “It’s our responsibility to help the government during these trying times. We will do it happily.”
As a resurgent coronavirus threatens countries across Southeast Asia, the health authorities in Thailand are working to contain an outbreak that is ripping through the tight-knit community of gemstone traders in the southeastern reaches of the country near the border with Cambodia.
The town of Chanthaburi — which has a long history as a center of the country’s business in rubies, sapphires and other stones — is at the heart of the outbreak, which has infected at least 166 in the community of traders from Africa who work in the country. At least 103 Thais in the town have also tested positive as a result of the latest outbreak, officials reported.
The cluster of cases comes as Thailand battles its worst outbreak since the pandemic began. For nearly three weeks, the country has averaged about 2,000 new cases a day — more than double its worst peak in January. The largest outbreak has been reported in Bangkok, which is under a partial lockdown.
On Wednesday, the government reported 34 deaths, a record, and 1,983 cases. One of those who died was from Finland.
Thailand was among the most effective countries last year in controlling the virus, but it has been slow to contain outbreaks this year and has lagged behind other countries in procuring vaccines.
Now, with the latest surge in cases, it is scrambling to obtain shots and to develop a mass inoculation program.
Some officials have declared that foreigners will not be vaccinated despite earlier outbreaks among migrant workers from Myanmar and now among the African gemstone traders. Other officials have said that Thailand will inoculate foreigners but have not provided specifics.
Thailand, which has a population of about 70 million, is home to more than two million foreigners who live in the country legally. More than two million more are believed to live in the country illegally.
Over the years, the gem business has attracted traders from several predominantly Muslim countries in Africa, including Gambia, Guinea and Mali. Many of them have settled in Thailand, married Thai wives and import gemstones from Africa.
Sankung Kongeh, a trader from Gambia, said members of the African community gathered daily at their offices and at the market, where they work, talk and eat together. During Ramadan, which began April 12, many also have prayed together, he said.
It is precisely that kind of close social contact that has fueled outbreaks around the world, but Mr. Kongeh discounted the group prayers as a significant risk.
“The possibility of the Covid spread has nothing to do with praying together,” said Mr. Kongeh, who recently tested negative. “It’s during the time hanging out at the office where we have the AC on, the door closed, and we chat with each other, drinking hot tea. There could be 10 or 12 of us sitting together. We don’t talk to each other during prayer.”
The next time the world faces an outbreak of a fast-spreading and deadly new pathogen, governments must act swiftly and be ready to restrict travel or mandate masks even before anyone knows the extent of the threat, according to a pair of new reports delivered to the World Health Organization.
The studies are intended to address missteps over the past year that led to more than 3.25 million deaths, some $10 trillion in economic losses and more than 100 million people pushed into extreme poverty.
“Current institutions, public and private, failed to protect people from a devastating pandemic,” concluded one of the reports, released on Wednesday, which called the Covid-19 pandemic “the 21st century’s Chernobyl moment.”
“Without change,” it said, these institutions “will not prevent a future one.”
The reviews, released in advance of this month’s meeting of the W.H.O.’s governing assembly, were written by appointees who donated countless hours in the midst of their own countries’ pandemic fights to interview hundreds of experts, comb through thousands of documents, gather data and seek counsel from public and private institutions around the world.
Pandemics, the authors concluded, are an existential threat on the order of a chemical or nuclear weapon, and preparing for them must be the responsibility of the highest levels of political leadership rather than only health departments, which are often among the least powerful of government agencies.
Epidemiologists in the United States are starting to hug again, running errands, gathering outdoors with friends and getting haircuts.
In a new informal survey this month by The New York Times, 723 epidemiologists responded to questions about how they were navigating this in-between phase of the pandemic, when vaccines have become widespread and cases are declining but herd immunity is not assured and Covid-19 remains a threat.
More than at any time in the past year, most are feeling hopeful that Covid-19 will eventually become just another risk in daily life, but not one that paralyzes us.
Nevertheless, their advice was to hold on to most precautions just a bit longer.
“There is a strong likelihood that we will experience unexpected problems due to moving about as if the Covid pandemic was no longer a threat,” said Jana Mossey, an epidemiologist who retired from Drexel University.
“It is not ‘one size fits all,’” said Alicia Riley, a sociologist and epidemiologist at the University of California, San Francisco, expressing a version of the profession’s unofficial motto: It depends. “How safe it is depends on the local levels of community transmission.”
Parents in South Carolina will be able to opt their children out of mask requirements in public schools, effectively ending mask mandates for schools throughout the state, according to an executive order signed by the governor that defies Centers for Disease Control and Protection guidance.
The order signed on Tuesday by Gov. Henry McMaster, a Republican, also prevented South Carolina’s local governments from using previously issued orders or states of emergency to enforce mask mandates and barred the use of “vaccine passports” in the state. South Carolina was one of several states that never had a statewide mask mandate, though several counties and cities imposed their own.
At least one school district said its legal counsel was reviewing the order. Doing away with masks in schools conflicts with C.D.C. guidance, which recommends universal masking combined with at least three feet of social distancing.
“Everybody knows what we need to do to stay safe — including wearing a mask if you’re at risk of exposing others — but we must move past the time of governments dictating when and where South Carolinians are required to wear a mask,” Mr. McMaster said in a statement, noting the availability of vaccines and falling coronavirus cases. “Maintaining the status quo ignores all of the great progress we’ve made.”
Mr. McHenry’s announcement comes as leaders in other states and cities have announced a rollback of restrictions and vaccines have become available to any adult. Mayor Muriel Bowser of Washington said on Monday that most of the city’s restrictions, including capacity limits, time restrictions and limits on types of activities would be lifted on May 21. Capacity limits on bars, nightclubs, and large sports and entertainment venues would be lifted June 11.
Mayor Jim Kenney of Philadelphia announced on Tuesday that all restrictions except the mask mandate would be lifted on June 11. The announcement came a week after Governor Tom Wolfe of Pennsylvania said that all restrictions related to gatherings, businesses and restaurants would be lifted on May 31 and that the statewide mask mandate would be lifted when 70 percent of adults in the state had been vaccinated. But the announcement came with the caveat that municipalities and school districts could continue or implement stricter mitigation efforts, despite the state’s easing restrictions.
The governor directed the Department of Health and Environmental Control and the Department of Education to develop a standardized form for opting out, the statement said.
Growing concerns in Taiwan about a small but worsening coronavirus outbreak drove a sharp intraday plunge in its stock market on Wednesday, as investors worried about new government restrictions on businesses in a place that has largely escaped the pandemic.
On Wednesday morning, Taiwan’s health minister, Chen Shih-chung, said that the island’s new outbreak has reached a “very severe stage” and that restrictions could be upgraded in “the coming days.” He spoke after the government reported 16 new cases of local infection on Wednesday and seven on Tuesday.
The Taiwan Stock Exchange weighted index slumped as much as 8.6 percent intraday following the news, a nearly 13 percent loss from its April peak. The market regained some ground later in the day and finished down 4.1 percent.
Taiwan has been a rare success story in a pandemic-stricken world. The island democracy threw up its borders when the pandemic first began to spread from mainland China and has heavily limited travel. It has recorded only 1,210 total cases, according to a tally by The New York Times.
But the authorities haven’t been able to trace the handful of cases that have popped up in recent days, raising questions about whether the government will limit the number of people who can gather within restaurants or other businesses.
Taiwan instituted some Covid-related restrictions on Tuesday, the first in a long time. It suspended large events, limiting outdoor gatherings to 500 people and indoor gatherings to 100 people. On Wednesday morning, the health minister said that the restrictions might be stiffened within days.
Source : Nytimes
