F.D.A. Cites Failures at Plant Where J.&J. Doses Were Ruined
An inspection of the Baltimore plant found failures to disinfect equipment and prevent contamination. Here’s the latest on Covid-19.,
Federal regulators on Wednesday issued highly critical findings from their inspection of a Baltimore plant that was forced to throw out up to 15 million doses of Johnson & Johnson’s coronavirus vaccine and ordered to temporarily stop all production.
The Food and Drug Administration cited a series of shortcomings at the massive plant, which is operated by Emergent BioSolutions. The inspection was triggered by reports that Emergent workers had contaminated a batch of Johnson & Johnson doses with the harmless virus that is used to deliver AstraZeneca’s vaccine, which is also manufactured at the plant.
The violations included failure to properly disinfect the factory and its equipment, as well as failure to institute and follow proper procedures designed to prevent contamination of doses and to ensure the strength and purity of the vaccine manufactured there. “There is no assurance that other batches have not been contaminated,” the inspectors wrote.
Their 12-page report cited nine violations, ranging from the design of the building to improperly trained employees. The inspection was finished on Tuesday.
In a statement, the F.D.A. noted that it has not authorized Emergent to distribute any doses of Johnson & Johnson vaccine, and that no vaccine manufactured at the plant has been released for use in the United States.
AstraZeneca’s vaccine is not yet authorized for use in the United States, and all the Johnson & Johnson doses that have been administered in the country so far were manufactured overseas. At the agency’s request, all production at the factory has been halted.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” the statement from Dr. Janet Woodcock, the F.D.A.’s acting commissioner, and Dr. Peter Marks, the agency’s top vaccine regulator, said.
The agency said it was working with Emergent to fix the problems.
Emergent is a longtime government contractor that has spent much of the last two decades cornering a lucrative market in federal spending on biodefense. The company’s Baltimore plant is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” that were supposed to be at the ready in the event of a pandemic.
The New York Times reported earlier this month that the Trump administration awarded a $628 million contract to the company about ten months ago despite a history of performance problems. The contract mainly allowed the government to reserve manufacturing space in the plant for vaccine production. On Tuesday, the House Select Subcommittee on the Coronavirus Crisis, announced that it will investigate that contract award and other issues involving Emergent, saying the firm had a track record of failing to meet contract requirements.
The inspectors castigated Emergent’s response to the discovery last month that Johnson & Johnson doses had been contaminated with the benign virus used to create AstraZeneca’s vaccine. The incident “has not been fully investigated,” they wrote.
They said Emergent did not thoroughly review whether the cross-contamination was caused by one or more workers who move between AstraZeneca’s and Johnson & Johnson’s manufacturing zones or whether it could be related to how raw materials used in the production of both vaccines are handled.
The inspectors found that workers frequently moved between the manufacturing zones without documenting that they had showered and changed their gowns as required. In one ten-day period in February, for instance, 13 employees moved from one zone to another on the same day, but only one documented having showered, they said. After the Johnson & Johnson doses were found to be contaminated, the report said, only routine cleaning was performed.
Workers also failed to properly handle manufacturing waste, creating risks of contamination in the warehouse where raw materials are stored, the inspectors found. They also cited peeling paint, crowded equipment and other issues with the building. Overall, it “is not maintained in a clean and sanitary condition,” they wrote.
Emergent said in a statement on Wednesday that “while we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.”
In its own statement, Johnson & Johnson said it had already stepped up its oversight of Emergent, its subcontractor, and that it would “ensure that all of F.D.A.’s observations are addressed promptly and comprehensively.”
One major change has already been made: AstraZeneca will no longer be manufactured at the plant, a move that federal officials insisted upon earlier this month to limit the chance of cross-contamination between two vaccines.
Dr. Jose Romero, the Arkansas health secretary and chairman of the expert panel advising the Centers for Disease Control and Prevention on the future of the Johnson & Johnson vaccine, said in an interview that he was dismayed by the F.D.A.’s findings. The panel is meeting on Friday on whether to lift, modify or retain a pause in the administration of Johnson & Johnson’s vaccine that was instituted last week for an entirely different issue: the discovery that eight U.S. residents developed a rare but dangerous blood clotting disorder after they got shots.
“I’m shocked” Dr. Romero said. “I can’t put it any other way. Inappropriate disinfection, the prevention of contamination — those are significant and serious violations, at least in my mind, and do of course need to be remedied.
“I would not have expected that, given the stringency that we have in this country for good manufacturing practices in these vaccine plants,” he said.
President Biden on Wednesday called on every employer in America to give employees paid time off to get vaccinated, the administration’s latest move to try to persuade the more than half of the nation’s adults who have yet to get a dose to do so.
“No working American should lose a single dollar from their paycheck because they chose to fill their patriotic duty to get vaccinated,” Mr. Biden said.
White House officials also said the administration would offer a paid leave tax credit to offset the cost for companies with fewer than 500 employees.
The announcement came during a presidential address to mark what Mr. Biden called a major milestone: 200 million shots in the arms of the American people, with a week to go before the president’s 100th day in office. As of Wednesday, more than 199 million doses had been administered across the country beginning Jan. 20, according to data as reported by the Centers for Disease Control and Prevention.
“It’s an incredible achievement for the nation,” Mr. Biden said, while also instructing Americans to continue wearing masks until everyone is vaccinated.
“We all need to mask up until the number of cases goes down, until everyone has a chance to get their shot,” he said.
But the distribution of those shots has been uneven: While New Hampshire has given at least one shot to 59 percent of its citizens (a percentage that includes children, most of whom are not yet eligible), Mississippi and Alabama are at 30 percent.
A senior administration official, who previewed the announcement on the condition of anonymity, described the initiative to involve the private sector as the next big opportunity and said employers would be especially effective in reaching out to the large percentage of working Americans who are still unvaccinated.
About 30 percent of unvaccinated employees said they were more likely to get a shot with an incentive like a gift card or paid time off, multiple officials who previewed the announcement said.
The seven-day average of vaccinations has declined slightly in recent days, to 3.02 million a day as of Wednesday, from a high point of 3.38 million last week, according to a New York Times analysis of C.D.C. data.
While many big companies have researched vaccine mandates, and the Equal Employment Opportunity Commission has told employers that they can require vaccination to protect public health, most have found that to be counterproductive and have chosen to incentivize the vaccine instead.
But with Republicans arguing that mandates amount to an intrusion on personal liberty, the White House is steering clear of the discussion, saying the decision to require vaccination or proof of it will be left to individual employers. And with the economy gearing up, managers are reluctant to demand inoculation, fearing too many employees would seek work elsewhere.
State health officials, business leaders, policymakers and politicians are struggling to figure out how to tailor their messages, and their tactics, to persuade not only the vaccine hesitant but also the indifferent. The work will be labor intensive, and much of it may fall on private employers, but the risk is clear: If it takes too long to reach “herd immunity,” the point at which the spread of the virus slows, worrisome new variants could emerge that evade the vaccine.
More new coronavirus cases were reported around the world last week than in any seven-day period since the beginning of the pandemic, according to new data published on Tuesday by the World Health Organization.
Last week’s figure — 5.24 million new cases — broke the previous record set at the beginning of 2021, when 5.04 million new cases were reported in the week ended Jan. 4.
The latest surge is being driven largely by an outbreak in India, where the authorities reported nearly 300,000 new cases on Wednesday alone. The country’s health care system is showing signs of buckling under the country’s second major wave of coronavirus infections, and an accident this week at a Covid-19 hospital in India killed more than 20 people.
India accounts for almost one-third of all new cases worldwide, according to the W.H.O. data. New cases are rising in all regions tracked by the organization except Europe, where they declined by 3 percent last week.
The rate at which new coronavirus-related deaths are being reported is also accelerating, according to the W.H.O. More than 83,000 deaths were reported last week, compared with 76,000 the week before.
By the organization’s reckoning, the overall death toll for the pandemic surpassed 3 million last week. A spokeswoman for the W.H.O., Margaret Harris, noted that it took nine months for the world to reach 1 million pandemic deaths, then four months to pass 2 million, and now three months to reach 3 million.
An unvaccinated health care worker set off a Covid-19 outbreak at a nursing home in Kentucky where the vast majority of residents had been vaccinated, leading to dozens of infections, including 22 cases among residents and employees who were already fully vaccinated, a new study reported Wednesday.
Most of those who were infected with the coronavirus despite being vaccinated did not develop symptoms or require hospitalization, but one vaccinated individual, who was a resident of the nursing home, died, according to the study released by the Centers for Disease Control and Prevention.
Altogether, 26 facility residents were infected, including 18 who had been vaccinated, and 20 health care personnel were infected, including four who had been vaccinated. Two unvaccinated residents also died.
The report underscores the importance of vaccinating both nursing home residents and health care workers who go in and out of the sites, the authors said. While 90 percent of the 83 residents at the Kentucky nursing home had been vaccinated, only half of the 116 employees had been vaccinated when the outbreak was identified in March of this year.
The study, released in tandem with one involving Chicago nursing homes, underscored the importance of maintaining measures like use of protective gear, infection control protocols and routine testing, no matter the level of vaccination rates. The rise of virus variants also has increased concerns.
Resistance to vaccines has been steep among nursing home staffs nationwide, and the low acceptance rates of vaccination increase the likelihood of outbreaks in facilities, according to the authors, a team of investigators from the C.D.C. and Kentucky’s public health department.
“To protect skilled nursing facility residents, it is imperative that health care providers, as well as skilled nursing facility residents, be vaccinated,” the authors of the Kentucky study wrote.
The outbreak involved a variant of the virus that has multiple mutations in the spike protein, of the kind that make the vaccines less effective. Vaccinated residents and health care workers at the Kentucky facility were less likely to be infected than those who had not been vaccinated, and they were far less likely to develop symptoms. The study estimated that the vaccine, identified as Pfizer-BioNTech, showed effectiveness of 66 percent for residents and 75.9 percent for employees, and were 86 percent to 87 percent effective at protecting against symptomatic disease.
In the Kentucky outbreak, the virus variant is not on the C.D.C.’s list of those considered variants of concern or interest. But, the study authors note, the variant does have several mutations of importance: D614G, which demonstrates evidence of increased transmissibility; E484K in the receptor-binding domain of the spike protein, which is also seen in B.1.351, the variant first recognized in South Africa, and P.1. of Brazil; and W152L, which might reduce effectiveness of neutralizing antibodies.
In Chicago, meanwhile, routine screening of nursing home residents and staff members identified 627 coronavirus infections in 78 skilled nursing facilities in the city in February, but only 22 were found in individuals who were already fully vaccinated. Two-thirds of the cases in the vaccinated individuals were asymptomatic, the report found, but two residents were hospitalized, and one died.
The authors of the Chicago study said their findings demonstrate that nursing homes should continue to follow recommended infection control practices, such as isolation and quarantine, use of personal protective equipment and doing routine testing, regardless of vaccination status.
They also emphasized the importance of “maintaining high vaccination coverage among residents and staff members” in order to “reduce opportunities for transmission within facilities and exposure among persons who might not have achieved protective immunity after vaccination.”
New York City health officials estimate that nearly a quarter of adult New Yorkers were infected with the coronavirus during the catastrophic wave of last spring, and that the toll was even higher among Black and Hispanic residents.
The estimates, based on antibody test results for more than 45,000 city residents last year, suggest that Black and Hispanic New Yorkers were twice as likely as white New Yorkers to have had antibodies to the coronavirus — evidence of prior infection.
Hispanic New Yorkers had the highest rate, with about 35 percent testing positive for antibodies, according to the study, whose authors include officials and researchers at the city Health Department and the National Institute for Occupational Safety and Health. Among Black New Yorkers, 33.5 percent had antibodies. Among Asian New Yorkers, the rate was about 20 percent. For white New Yorkers, the rate was 16 percent.
Antibody surveys of segments of the population have become a useful way to gauge what percentage of people were infected and what groups were most at risk, especially since there was limited testing for the virus during the first wave.
The new paper, which has been accepted by the Journal of Infectious Diseases, has substantial limitations: Of the 45,000 New Yorkers in the study, fewer than 3,500 were Black, a major underrepresentation. And the participants were recruited partly through advertisements online, which the study’s authors acknowledge may have attracted people who believed they had been exposed to Covid-19.
But the study adds to experts’ understanding of the disproportionate toll that the pandemic has taken on Black and Latino people.
Its findings also come amid a push to vaccinate more people in the United States. A recent survey conducted by the Kaiser Family Foundation found that the number of Americans, particularly Black adults, who want to get vaccinated has continued to increase. According to an analysis last month by The New York Times, Black people were still being inoculated at half the rate of white people. The disparities are especially alarming as Black and Latino people and Native Americans have been dying at twice the rate of white people.
In New York City, about 44 percent of white adults have received at least one dose of a Covid-19 vaccine, while 26 percent of Black adults and 31 percent of Latino adults have, according to city data.
Experts and community leaders across the country say that over all, the lower vaccination rates are linked to technological and linguistic barriers and disparities in access to vaccination sites. Other factors include social media misinformation and a hesitancy to be vaccinated. Hesitancy among African-Americans, experts say, can be tied to a longstanding mistrust of medical institutions that have long mistreated Black people.
The recent data from New York “show how frontline workers bore the brunt of the first wave of the pandemic,” said Dr. Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia Mailman School of Public Health, who was not involved in the study. She noted that many jobs with higher levels of exposure — like grocery store employees, child-care providers and transit workers — have comparatively fewer white workers.
“These were the people who did not have the luxury of being able to work virtually,” she said.
Dr. Kitaw Demissie, who is dean of the School of Public Health at SUNY Downstate Medical Center in Brooklyn and was not involved in the study, noted that household crowding may have also contributed to differing infection rates. Some predominately Latino neighborhoods which were particularly hard hit in the first wave had high rates of household crowding.
More than 32,000 people in New York City have died from Covid-19 in total, according to a New York Times database.
India’s health care system shows signs of buckling under the strain of a second wave of coronavirus infections, as the authorities reported nearly 300,000 new cases on Wednesday and an accident at a Covid-19 hospital killed more than 20 people.
The accident happened at a hospital in the western state of Maharashtra after a leak in the hospital’s main oxygen tank stopped the flow of oxygen to dozens of critically ill people. Televised images showed family members wailing in the wards and nurses frantically pounding on the chests of some patients.
India is now home to the world’s fastest-growing Covid-19 crisis, reporting 294,000 new infections on Wednesday and more than 2,000 deaths. Criticism of the government is building, particularly as some large rallies and festivals in the country have been allowed to continue, while supplies of hospital beds, oxygen and vaccines run low amid an increasingly urgent health care crisis.
In some hospitals, officials even said they were just a few hours from running out of oxygen supplies. “Nobody imagined this would happen,” said Subhash Salunke, a medical adviser to the Maharashtra government.
Doctors have confirmed the first coronavirus cases among climbers trying to scale Mount Everest, a troubling sign for Nepal’s effort to reopen its lucrative high-altitude tourism industry.
Multiple climbers tested positive at CIWEC Hospital in Kathmandu, Nepal’s capital, after being flown there in recent days from Everest Base Camp, the hospital’s medical director said on Wednesday.
The medical director, Prativa Pandey, declined to offer additional information about the cases, saying only that officials at Everest Base Camp, the starting point for expeditions on the world’s tallest peak, were trying to ensure that groups of climbers were not mingling with one another.
“We are taking it up with the health ministry to see what we can do for the safety of climbers and staff up there,” Dr. Pandey said.
Nepal has reopened Everest and seven other peaks of 26,200 feet and above to small numbers of mountaineers in the hopes of restarting its tourism sector. It suspended all commercial climbing expeditions last year — a risky move for the small, tourism-dependent Himalayan country, which has been battling a resurgence of the coronavirus along with the rest of South Asia.
The government has issued 371 climbing permits to Everest hopefuls, and tourism officials say the number could increase. Journeys to the summit, 5.5 miles above sea level, begin at Everest Base Camp, where climbers stay for roughly two months to acclimate to the altitude.
To guard against an outbreak, Nepal’s government established a temporary high-altitude health care unit at the base camp, at an elevation of 17,600 feet, and expedition operators regularly test climbers for the coronavirus. Officials have mandated masks and social distancing, and said that climbers who were suspected of being infected would be flown out for testing.
A government doctor at the base camp said that three foreign climbers from his clinic were flown to Kathmandu this month after complaining of Covid-like symptoms. At least one, he later learned, tested positive. The doctor said that other climbers had developed similar symptoms and were also flown to Kathmandu for testing. He had no information on their cases.
Mingma Sherpa, the chairman of Seven Summit Treks, Nepal’s largest expedition operator, said that attempts to scale Everest would continue even if some climbers were infected with the virus.
“Expeditions won’t be canceled,” he said. “There’s no point of returning or giving up climbing after reaching base camp.”
In other news from around the world:
Prime Minister Kyriakos Mitsotakis of Greece said on Wednesday that cafes and restaurants in the country, shuttered for six months, could reopen for outdoor service on May 3, and that the country’s tourism industry would reopen on May 15. Primary and secondary schools will resume in-person instruction on May 10, he said, and church services will be allowed with limits on Orthodox Easter, May 2 — but domestic travel will remain restricted for the holiday, to minimize the chance that urbanites visiting rural relatives would seed outbreaks in ill-equipped places. Mr. Mitsotakis’ government has come under fire for opening up the country to foreign tourists while keeping restrictions in place for Greeks.
The outbreak in India has prompted neighboring Sri Lanka to postpone plans for a two-way air travel bubble, The Hindu newspaper reported. Less than two weeks ago, India’s government said it had finalized an agreement with Sri Lanka, a small island nation whose economy is heavily dependent on tourism, to allow special commercial flights between the two countries. Indian tourists accounted for nearly one-fifth of Sri Lanka’s foreign visitors in January 2020. Infections in Sri Lanka, which reported 367 new cases on Wednesday, have declined sharply since mid-February, but officials warned this week that a new variant was spreading in the country for the first time.
France said on Wednesday that travelers arriving from India would be subjected to a mandatory 10-day quarantine, adding to a growing list of countries that the French authorities have restricted travel from to prevent the arrival of worrisome virus variants. Gabriel Attal, a spokesman for the French government, also said that the country expected to lift domestic travel restrictions on May 3 and to authorize outdoor cafe and restaurant seating that month. He said that there were encouraging signs that the current lockdown was yielding results but that pressure on hospitals remained “extremely high.”
Maine marked a milestone this week: It has now vaccinated at least half of its residents against the coronavirus with at least one shot, one of the first states in the nation to do so. But an old mill and college town in central Maine is reporting a fast rise in cases, dampening the celebration and raising fresh concerns about the virus’s staying power.
Daily confirmed cases in the Lewiston-Auburn metro area, home of Bates College and a vibrant immigrant community, are rising at a faster rate per person than in any other U.S. community with more than 50,000 people, according to a New York Times database.
“The virus has a mind of its own,” said Dale Doughty, deputy city administrator in Lewiston, who has helped coordinate the local coronavirus response. He said that local officials had been working to stop the spread, including with vaccine clinics, but that the pause of the Johnson & Johnson shot had been a setback.
The spike is part of a broader trend in the Northeast, where cases have been rising faster than in other U.S. regions. Delaware, Maine, Pennsylvania and Rhode Island have had among the highest case loads per 100,000 people over the past week. Michigan, which has outbreaks across its metro regions, remains at the top of the list.
Maine has administered more than 1.1 million vaccine doses, and 34 percent of its population is now fully immunized, according to Times data as of Tuesday. All Maine residents age 16 and up have been eligible since April 7.
Nirav Shah, the director of the Maine Center of Disease Control and Prevention, said on Tuesday that he suspected that virus variants, some highly contagious, had been driving the surge.
A spike in cases at Bates College prompted lockdowns that kept students in their rooms nearly around the clock for 12 days. Last week, the college lifted an “in-room” restriction and resumed in-person classes. The college said the outbreak had begun with social gatherings on a weekend in late March.
“The events we have all endured should serve as a powerful reminder that poor choices by a small group of people can have a powerful negative impact on the campus as a whole,” Joshua McIntosh, the vice president for campus life, wrote in a letter announcing the end of the restrictions.
William Wallace, a lecturer at the college who co-chairs a local board that advises Lewiston’s City Council on health matters, said the community had been fairly compliant with masking and social-distancing measures, and that the state had been diligent about testing, which could be uncovering more cases.
“But I think some people are just tired of all these guidelines and let down their guard,” he said. “Now that the weather has come around, people are gathering again. That’s part of it.”
Iraq surpassed one million total coronavirus cases on Wednesday and set a daily record with 8,696 new cases, as government officials urged wary Iraqis to get vaccinated.
Public health officials believe that coronavirus infections in Iraq are significantly underreported, because many people who contract the virus do not seek treatment in the country’s overstretched health care system.
The health ministry reported 38 additional Covid 19-related deaths on Wednesday. More than 15,000 deaths have been recorded since the start of the pandemic.
Iraq did not get its vaccination program started until the end of March. So far it has received about 650,000 doses of various vaccines through Covax, an international initiative to help low- and middle-income countries obtain vaccines, and through a donation from China.
About 275,000 Iraqis — less than one percent of the country’s population of 40 million — have been vaccinated to date.
The health ministry issued a statement Wednesday emphasizing that vaccinations were voluntary and denying that it was forcing citizens to be vaccinated. It called for people who work in restaurants, shopping malls and hospitals to get vaccinated.
Iraq is regarded as one of the most corrupt countries in the world, and its health care system, ravaged by years of conflict and, before 2003, more than a decade of devastating American-led international sanctions, has not been spared. Despite the country’s oil wealth, most hospitals in Baghdad, the capital, rely on patients’ relatives to procure medicine and oxygen the patients need.
Public health officials who administer even the routine vaccination programs for childhood diseases frequently encounter resistance from parents who don’t trust the health ministry.
The government spokesman and culture minister, Hassan Nazim, urged on Tuesday that all Iraqis get vaccinated. He said the government was directing the security and education ministries to encourage the nation’s teachers and security forces to take the vaccines.