Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
While the move was framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same. Within two hours of the announcement, Gov. Mike DeWine of Ohio, a Republican, advised all health providers in his state to temporarily stop giving Johnson & Johnson shots. In New York, the health commissioner, Dr. Howard Zucker, said the state would halt the use of the vaccine statewide while federal officials evaluate the safety risks. Appointments for Johnson & Johnson’s shot on Tuesday at state mass sites would be honored with Pfizer doses, Dr. Zucker said.
Scientists with the F.D.A. and C.D.C. will jointly examine possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to authorize use of the vaccine for all adults or limit the authorization. An emergency meeting of the C.D.C.’s outside advisory committee has been scheduled for Wednesday.
The move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy. Regulators in Europe and elsewhere are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca and Oxford University researchers. That concern has driven up some resistance to all vaccines, even though the AstraZeneca version has not been authorized for emergency use in the United States.
The vast majority of the nation’s vaccine supply comes from two other manufacturers, Pfizer–BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines. There have been no significant safety concerns about either of those vaccines.
But while shipments of the Johnson & Johnson vaccine have been much more limited, the Biden administration had still been counting on using hundreds of thousands of doses every week. In addition to requiring only a single dose, the vaccine is easier to ship and store than the other two, which must be stored at extremely low temperatures.
The development also throws a wrench into the Biden administration’s plans to deliver enough vaccine to be able to inoculate all 260 million adults in the United States by the end of May. Now federal officials expect there will only be enough to cover fewer than 230 million adults. But a certain percentage of the population is expected to refuse shots, so the supply may cover all the demand.
Federal officials are concerned that doctors may not be trained to look for the rare disorder if recipients of the vaccine develop symptoms of it. The federal health agencies said Tuesday morning that “treatment of this specific type of blood clot is different from the treatment that might typically be administered” for blood clots.
“Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” the statement said.
In a news release, Johnson & Johnson said: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.” Janssen is the name of Johnson & Johnson’s division that developed the vaccine.
In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to C.D.C. data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous sinus thrombosis, is extremely rare.
All of the women developed the condition within about two weeks of vaccination, and government experts are concerned that an immune system response triggered by the vaccine was the cause. Federal officials said there was broad agreement about the need to pause use of the vaccine while the cases are investigated.
The decision is a fresh blow to Johnson & Johnson. Late last month, the company discovered that workers at a Baltimore plant run by its subcontractor had accidentally contaminated a batch of vaccine, forcing the firm to throw out the equivalent of 13 million to 15 million doses. That plant was supposed to take over supply of the vaccine to the United States from Johnson & Johnson’s Dutch plants, which were certified by federal regulators earlier this year.
The Baltimore plant’s certification by the F.D.A. has now been delayed while inspectors investigate quality control issues, sharply reducing the supply of Johnson & Johnson vaccine. The sudden drop in available doses led to widespread complaints from governors and state health officials who had been expecting much bigger shipments of Johnson & Johnson’s vaccine this week than they got.
The virus is again surging in parts of the United States, but it’s a picture with dividing lines: ominous figures in the Northeast and Upper Midwest, but largely not in the South.
Experts are unsure what explains the split, which doesn’t correspond to vaccination levels. Some point to warmer weather in the Sun Belt, while others suspect that decreased testing is muddying the virus’s true footprint.
The contours of where the virus is resurgent can be drawn around one figure: states that are averaging about 15 new cases a day for every 100,000 people. The 23 states — including Alabama, Mississippi and Arkansas — that have averaged that or fewer over the past week seem to be keeping cases relatively low, according to a New York Times database. Nationally, the country is averaging 21 new cases per 100,000 people.
In the 27 states above that line, though, things have been trending for the worse. Michigan has the highest surge of all, reporting the most drastic increase in cases and hospitalizations in recent weeks. Illinois, Minnesota and others have also reported worrisome increases.
Nationally, reported cases in the United States are growing again after a steep fall from the post-holiday peak in January. In the past two weeks, new confirmed cases have jumped about 11 percent, even though vaccinations picked up considerably, with an average of 3.2 million doses given daily.
Some Southern states, like Alabama and Mississippi, are lagging in vaccinations. Only about 28 percent of people in each state have received at least one shot, according to a New York Times vaccine tracker. Still, case counts continue to drop in both states.
Health experts say cases are rising in the Northeast and Upper Midwest for several reasons, including pandemic fatigue, the reopening of schools and the resumption of youth sports.
Hospitalizations tend to follow the trend line in cases by a few weeks, and have been rising in some states, most notably in Michigan.
Officials are also concerned about the spread of more contagious virus variants, especially B.1.1.7, first identified in Britain. The variant is now the leading source of new coronavirus infections in the United States, the director of the Centers for Disease Control and Prevention said last week.
Just why those factors might affect some states more than others is hard to pinpoint, experts say.
Dr. David Rubin, the director of PolicyLab at the Children’s Hospital of Philadelphia, said warmer weather in Southern states and California was probably playing a role, because it allows people to gather outdoors, with less risk of transmission.
New case reports have fallen by about 11 percent in Georgia over the past two weeks. And in Alabama, new cases are down roughly 29 percent, with a 17 percent decline in hospitalizations.
Some experts say, though, that reduced testing in some states could be obscuring the true picture. Testing in Alabama, for instance, has started to dip, but the share of tests that come back positive has remained high, at 11.1 percent, compared with a nationwide average of 5.1 percent, according to data compiled by Johns Hopkins University.
“People who are symptomatic and go to their provider are going to get a test,” said Dr. Michael Saag, the associate dean for global health at the University of Alabama at Birmingham, but “the desire for people to go get tested just because they want to know what their status is has dropped off dramatically.”
Still, Dr. Saag said, there is probably not a hidden spike in cases in Alabama right now, since hospitalizations in the state remain low.
India said on Tuesday that it would fast-track the approval of vaccines in use in other countries, a move aimed at rapidly increasing the country’s vaccine supply as it battles what is currently the world’s biggest coronavirus outbreak.
The Indian government said that it would grant emergency authorization to any foreign-made vaccine that had been approved for use by regulators in the United States, the European Union, Britain or Japan, or by the World Health Organization. The move had been recommended by a panel of Indian scientists and eliminates a requirement for drug companies to conduct local clinical trials.
“The decision will facilitate quicker access to such foreign vaccines” and encourage imports of materials that would boost India’s vaccine manufacturing capacity, the government said in a statement.
Earlier on Tuesday, India’s top drug regulator granted emergency approval to Sputnik V, the Russian-made vaccine, adding a third vaccine to the country’s arsenal on the same day that health officials recorded 161,736 new coronavirus infections in 24 hours.
It was the seventh straight day that India has added more than 100,000 cases, according to a New York Times database. Only the United States has seen a faster rise in infections during the pandemic.
India has administered about 105 million domestically produced vaccine doses for a population of 1.3 billion, but it is widely believed that the country needs to scale up inoculations rapidly because other measures have failed to control the virus. Many states have reimposed partial lockdowns and weekend curfews. In the country’s financial hub, Mumbai, health officials are racing to erect field hospitals as facilities report shortages of oxygen, ventilators and coronavirus testing kits.
And there is the risk of a superspreading event with the gathering of millions of Hindu pilgrims for the annual Kumbh Mela festival on the banks of the Ganges River, where the authorities say they are powerless to enforce social distancing.
India’s outbreak is reverberating worldwide as its pharmaceutical industry — which was supposed to manufacture and export hundreds of millions of doses of the AstraZeneca vaccine — is keeping most supplies at home. The approval of the Sputnik vaccine, whose first doses are expected to be available for use in weeks, offers hope that India could speed up its inoculation drive.
But it is unclear at this stage whether India will be able to procure significant quantities of other vaccines, including the Pfizer, Moderna and Johnson & Johnson shots in use in the United States. Major Western nations have accumulated much of the global supply of those vaccines and manufacturers are struggling to meet the surging demand.
India will import millions of Sputnik doses from Russia and then begin manufacturing the vaccine domestically, officials said. More than 850 million doses will be made, with some intended for export, Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, a sovereign wealth fund that has financed the vaccine’s development, said in an interview with India’s NDTV channel.
“India is a vaccine-manufacturing hub and our strategic partner for production of Sputnik V,” Mr. Dmitriev said.
India has more than 13.6 million confirmed coronavirus cases, the second most after the United States, and 171,058 deaths, the fourth highest toll.
In other news around the world:
Japan has begun vaccinating 36 million people over age 65, the first time shots have been made available to the public during the country’s slow vaccine rollout. Officials said that 1,139 people nationwide had received doses on Monday, and that doses to cover all Japanese above the age threshold would reach municipal health facilities by the end of June. Although Japan has weathered the pandemic better than most countries, the pace of its vaccination effort, which until now had only covered 1.1 million frontline medical workers, has sparked public criticism and raised questions about readiness for the Tokyo Summer Olympics in just over three months.
Scotland on Tuesday moved forward plans to loosen its coronavirus lockdown, a day after the British government eased many restrictions in England. New rules beginning Friday will permit Scots to meet outdoors in groups of up to six adults from six households. The current rules restrict travel and set the maximum group size at four, from two households. Restrictions on shops and outdoor service in pubs, now relaxed in England, are scheduled to remain in Scotland until April 26.
Austria’s health minister resigned on Tuesday, citing personal health problems that he said have been exacerbated by the grueling job of helping lead the country’s response to the pandemic. “It feels like it has not been 15 months, but 15 years,” the minister, Rudolf Anschober, said in a statement. Mr. Anschober, 60, was appointed in January last year, as a Green party minister in a Conservative-led coalition, and has been one of the main faces of Austria’s coronavirus response. “In the worst health crisis in decades, the republic needs a health minister who is 100 percent fit. That is not currently me,” he said.
The World Health Organization on Monday evening called on governments to suspend the sale of live wild mammals in food markets to help prevent the emergence of new diseases. “Traditional markets, where live animals are held, slaughtered and dressed, pose a particular risk for pathogen transmission to workers and customers alike,” the agency said in a statement. Animals are the source of more than 70 percent of emerging infectious diseases in humans, it said. Early in the pandemic, Chinese officials suggested that the coronavirus outbreak might have started at a market. But W.H.O. experts said in a report last year that the role of animal markets in the story of the pandemic was still unclear.
Britain has now offered vaccinations to everyone in the country age 50 and older, the government announced late on Monday, and is extending its program to another age group, the latest sign that the national rollout is continuing at pace.
On Tuesday, the authorities opened vaccinations to anyone 45 or older, yet the announcement came with small hiccup: the website for the country’s National Health Service crashed for a short time after the younger cohort was invited to book appointments online.
The new step in the country’s vaccine rollout comes as the authorities eased several restrictions in England on Monday after months of stringent lockdowns, with pubs and restaurants opened for drinks and dining outside, and nonessential shops once again opening their doors.
Prime Minister Boris Johnson called the moment a “hugely significant milestone” and in a statement thanked those involved with the vaccine rollout. Mr. Johnson said the country was on track to offer all adults a vaccination by the end of July. More than 32 million people across Britain have received their first dose of one of the vaccines, according to government data.
The government said it had also already offered vaccinations to every health or care worker, and to everyone with a high-risk medical condition.
England has also began rolling out the Moderna vaccine, which will be offered as an alternative alongside the Pfizer BioNTech vaccine for those under 30, instead of AstraZeneca’s, which has been the mainstay of Britain’s program so far.
There have been concerns about a possible link between the AstraZeneca vaccine and very rare blood clots, and last week British regulators said an alternative should be provided for younger people. Potential infection still poses much greater risks than any vaccine side effect for all those over 30, they said, and could do so for younger people if cases surged again.
“The Moderna rollout marks another milestone in the vaccination program,” Stephen Powis, the medical director of the National Health Service said in a statement. “We now have a third jab in our armory.”
The vaccination program, he added, “is our hope at the end of a year like no other” as he encouraged people to book their appointments.
But despite the hopeful vaccine news and the return to public life, the country is still battling new cases of the virus, and a cluster in two London neighborhoods of a worrisome variant first discovered in South Africa have prompted mass testing. Health workers have gone door to door to urge residents to get tested, even if they are not showing symptoms, as dozens of cases have emerged. Similar measures were carried out elsewhere in the city earlier this month.
Studies have shown that the variant contains a mutation that diminishes the vaccines’ effectiveness against it. Susan Hopkins, the chief medical adviser for the country’s test and trace campaign, said the cluster of cases in parts of South London was “significant.”
“It’s really important people in the local area play their part in stopping any further spread within the local community,” she said in a statement.
More than a year after the coronavirus first swept through New York, the streets of Sunset Park in southern Brooklyn reflect the pandemic’s deep and unhealed wounds intertwined with signs of a neighborhood trying to edge back to life.
The sidewalks are filling with shoppers and vendors. More businesses are welcoming customers. But owners still struggle to pay rent and keep their enterprises afloat, while many workers laid off after the city locked down last year remain without jobs.
And while the rate of vaccination in New York has increased significantly, the coronavirus still percolates through this densely packed neighborhood. The ZIP code that includes Sunset Park had the highest rate of positive cases in Brooklyn in early April, nearly double the citywide rate. Some residents have expressed skepticism about the vaccines, spooked by false information circulated over TikTok and other social media.
Adding to the stress is a spate of hate crimes and violence against people of Asian descent in New York and around the country, fed in some cases by racist claims that Asian-Americans are responsible for spreading the virus.
About a third of the residents in Sunset Park have received at least one dose of the vaccine, roughly the same level as the city overall, according to the city health data. But local leaders say they want to push that number much higher.
Kuan Neng, 49, the Buddhist monk who founded Xi Fang Temple on Eighth Avenue, said that people had come to him in recent weeks to express concerns over vaccines.
“Why do I need to do that?” is a common refrain, according to Mr. Kuan, followed by: “I’m healthy now. The hard times are over, more or less.”
“Many people want to delay and see,” Mr. Kuan said, himself included.
ArcLight Cinemas, a beloved chain of movie theaters based in Los Angeles, including the Cinerama Dome in Hollywood, will permanently close all its locations, Pacific Theaters announced on Monday, after the pandemic decimated the cinema business.
ArcLight’s locations in and around Hollywood have played host to many a movie premiere, in addition to being favorite spots for moviegoers seeking out blockbusters and prestige titles. They are operated by Pacific Theaters, which also manages a handful of theaters under the Pacific name, and are owned by Decurion.
“After shutting our doors more than a year ago, today we must share the difficult and sad news that Pacific will not be reopening its ArcLight Cinemas and Pacific Theaters locations,” the company said in a statement.
“This was not the outcome anyone wanted,” it added, “but despite a huge effort that exhausted all potential options, the company does not have a viable way forward.”
Between the Pacific and ArcLight brands, the company owned 16 theaters and more than 300 screens.
The movie theater business has been hit particularly hard by the pandemic. But in recent weeks, the majority of the country’s largest theater chains, including AMC and Regal Cinemas, have reopened in anticipation of the slate of Hollywood films that have been put back on the calendar, many after repeated delays because of pandemic restrictions. A touch of optimism is even in the air as a result of the Warner Bros. movie “Godzilla vs. Kong,” which has generated some $70 million in box office receipts since opening over Easter weekend.
Still, the industry’s trade organization, the National Association of Theater Owners, has long warned that the punishing closures were most likely to affect smaller regional players like ArcLight and Pacific. In March, the Alamo Drafthouse Cinema chain, which operates about 40 locations across the country, announced that it had filed for Chapter 11 bankruptcy protection but would keep most of its locations operational while it restructured.
That does not seem to be the case for Pacific Theaters, which, according to two people with knowledge of the matter, fired its entire staff on Monday.
The reaction to ArcLight’s closing around Hollywood has been emotional, including an outpouring on Twitter.
Devastating. Too many losses to process. It’s just too much… At some point when I’m less upset, I’ll tell you guys a funny story about my first time meeting Quentin Tarantino in the lobby of Hollywood Arclight. https://t.co/cFypJxEk4L
— Lulu Wang (@thumbelulu) April 13, 2021
Three people infected with the coronavirus died at a hospital in Bucharest on Monday evening after the oxygen supply stopped functioning, according to the authorities, the latest incident involving oxygen failure, which in many countries has driven up the virus death toll.
It was also another fatal setback for Romania’s ageing and overwhelmed health care system, which has suffered two fires in Covid-19 wards in recent months, killing at least 15 people.
Ventilators shut down at a mobile intensive care unit set up at the Victor Babes hospital in Bucharest after oxygen pressure reached too high a level, the country’s health authorities said in a statement, depriving patients of a vital supply. In addition to the three patients who died, five others were evacuated and moved to other facilities in the city.
Romania has recorded its highest rate of Covid-19 patients in intensive care units since the pandemic began, and on Sunday Prime Minister Florin Citu said that there were just six intensive care beds available across Romania, out of nearly 1,600 beds.
Intensive care units in Hungary and Poland have also been at risk of being overwhelmed, as much of Eastern Europe has struggled to cope with a third wave of infections across the continent. Some Hungarian hospitals have sought medical students and volunteers to assist in Covid-19 wards, giving training to those without previous medical experience.
The mobile unit struck by the oxygen problem on Monday had only been in operation since Saturday, and it has epitomized long-running concerns over the country’s fragile health care system. In January, five patients died and a further 102 were evacuated from a different hospital in Bucharest after a fire broke out. In November, 10 patients hospitalized with the coronavirus died after a fire broke out in a hospital in the northeastern city of Piatra Neamt.
Romania’s spending on health care is among the lowest in the European Union, with just over five percent of gross domestic product allocated toward it, compared with 10 percent on average among other countries of the bloc.
More than 25,000 people who tested positive for the virus have died in Romania, and the authorities have closed schools and kindergartens throughout April as part of an extended Easter holiday.
The authorities have so far administered more than 3.5 million vaccine doses, in a population of about 19 million.
Studies have found that women in academia have published fewer papers, led fewer clinical trials and received less recognition for their expertise during the pandemic.
Add to that the emotional upheaval of the pandemic, the protests over structural racism, worry about children’s mental health and education, and the lack of time to think or work, and an already unsustainable situation becomes unbearable.
Michelle Cardel, an obesity researcher at the University of Florida, worries that this confluence of factors could push some women to leave the sciences.
“My big fear is that we are going to have a secondary epidemic of loss, particularly of early career women in STEM,” she said.
Female scientists were struggling even before the pandemic. It was not unusual for them to hear that women were not as smart as men, or that a woman who was successful must have received a handout along the way, said Daniela Witten, a biostatistician at the University of Washington in Seattle.
Women in academia often have little recourse when confronted with discrimination. Their institutions sometimes lack the human resources structures common in the business world.
Compounding the frustration are outdated notions about how to help women in science. But social media has allowed women to share some of those concerns and find allies to organize and call out injustice when they see it, said Jessica Hamerman, an immunologist at the Benaroya Research Institute in Seattle.
In November, for example, a study on female scientists was published in the influential journal Nature Communications suggesting that having female mentors would hinder the career of young scientists and recommending that young women seek out male help.
The response was intense and unforgiving: Nearly 7,600 scientists signed a petition calling on the journal to retract the paper — which it did on Dec. 21.
The study arrived at a time when many female scientists were already worried about the pandemic’s effect on their careers, and already on edge and angry with a system that offered them little support.
Alisa Stephens found working from home to be a series of wearying challenges. Dr. Stephens is a biostatistician at the University of Pennsylvania, and carving out the time and mental space for that work with two young children at home was impossible.
Things eased once the family could safely bring in a nanny, but there was still little time for the deep thought Dr. Stephens had relied on each morning for her work.
Over time, she has adjusted her expectations of herself. “Maybe I’m at 80 percent as opposed to 100 percent,” she said, “but I can get things done at 80 percent to some extent.”
The authorities in Ohio, New York, Connecticut and Virginia said on Tuesday that they would follow the call from federal health agencies to pause the administration of Johnson & Johnson’s vaccine after six women in the United States developed a rare disorder involving blood clots within about two weeks of vaccination.
Gov. Mike DeWine of Ohio and the state’s chief health official said they were advising all state vaccine providers to temporarily halt use of the single-dose vaccine.
New York’s health commissioner, Dr. Howard Zucker, said the state would stop using the Johnson & Johnson vaccine, while the Food and Drug Administration and the Centers for Disease Control and Prevention evaluate the safety risks. Appointments for Johnson & Johnson’s shot on Tuesday at state mass sites would be honored with Pfizer doses, Dr. Zucker said.
Connecticut health officials said they told vaccine providers to delay planned appointments and give an alternative option if they had the supply.
The C.D.C.’s outside advisory committee has scheduled an emergency meeting for Wednesday. If federal health officials decide to limit the authorization for the Johnson & Johnson vaccine, it could significantly complicate the nation’s vaccine rollout, which has accelerated in recent weeks as a rise in new virus cases threatens a fourth possible surge. And any questions about the safety of the shots could bolster vaccine hesitancy.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the C.D.C. The six women who developed blood clots were between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition.
“Right now, these adverse events appear to be extremely rare,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement on Tuesday.
“People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider.”