Pause on Johnson & Johnson’s Vaccine Fuels New Concerns
Some health officials fear a focus on rare potential side effects may increase hesitancy — and virus exposure. Here’s the latest on Covid-19.,
To federal health officials, asking states on Tuesday to suspend use of the Johnson & Johnson coronavirus vaccine until they could investigate six extremely rare but troubling cases of blood clots was an obvious and perhaps unavoidable move.
But where scientists saw prudence, public health officials saw a delicate trade-off: The blood clotting so far appears to affect just one out of every million people injected with the vaccine, and it is not yet clear if the vaccine is the cause. If highlighting the clotting heightens vaccine hesitancy and helps conspiracy theorists, the “pause” could ultimately sicken — and even kill — more people than it saves.
“It’s a messaging nightmare,” said Rachael Piltch-Loeb, an expert in health risk communications at the N.Y.U. School of Global Public Health. But officials had no other ethical option, she added. “To ignore it would be to seed the growing sentiment that public health officials are lying to the public.”
The one-dose Johnson & Johnson vaccine was just beginning to gain traction among doctors and patients after its reputation took a hit from early clinical trials suggesting its protection against the coronavirus was not as strong as that from the vaccines made by Pfizer-BioNTech and Moderna. Before Tuesday’s pause, some patients were asking for it by name.
But amid the blizzard of news and social media attention around the pause, those gains may well be lost, especially if the rare blood clotting feeds politically driven conspiracy theorists and naysayers, who seemed to be losing ground as the rate of vaccinations rose.
The problem is explaining relative risk, said Rupali J. Limaye, who studies public health messaging at the Johns Hopkins Bloomberg School of Public Health. She noted that the potential rate of blood clotting in reaction to the vaccine is much smaller than the blood clotting rate for cigarette smokers or for women who use hormonal contraception, although the types of clots differ.
And officials are not “pulling” the vaccine. They are simply asking for a timeout, in effect, to figure out how best to use it.
Vaccinators were already fielding questions from worried patients on Tuesday.
Maulik Joshi, the president and chief executive of Meritus Health in Hagerstown, Md., which has given 50,000 doses of all three vaccines without any reported major reactions, said he had a simple message to calm patients’ fears: “It’s a great thing that they have paused it, and this is science at work.”
Jennifer Steinhauer, Madeleine Ngoand Hailey Fuchs contributed reporting.
An advisory committee for the Centers for Disease Control and Prevention will meet on Wednesday afternoon to discuss whether the Johnson & Johnson Covid-19 vaccine should remain paused while a possible link to rare blood clots is investigated.
The emergency meeting follows the Food and Drug Administration’s announcement on Tuesday that it was studying six cases of rare and severe blood clots in women aged 18 to 48, one of whom died. All of the women had received the Johnson & Johnson vaccine before developing the clots, though it is unclear whether the vaccine is responsible. As of Tuesday, more than seven million people in the United States have received the shot, and another 10 million doses have been shipped out to the states, according to C.D.C. data.
Following the call from federal health agencies, all 50 states, Washington, D.C., and Puerto Rico on Tuesday quickly paused or recommended that providers pause the administration of the vaccine. The U.S. military, federally run vaccination sites, and a host of private companies, including CVS, Walgreens, Rite Aid, Walmart and Publix also paused the injections.
The Advisory Committee on Immunization Practices, or ACIP, is a panel of independent experts who advise the C.D.C. on its vaccine policies. At the meeting, the experts will be reviewing and debating the data from the six cases, and listening to comments from the public, before taking a vote on how to proceed. They could vote to recommend that the pause continues, for example, or to specify that it should apply only to a certain age or sex.
Federal officials said on Tuesday that the pause might last only a few days, though it depended on what officials learned in the investigation. They said that the pause will give officials more time to alert doctors that patients who have these rare blood clots should not be given the drug heparin, the standard treatment that doctors administer for typical clots, and also provide time to determine whether there are any more cases.
The clotting disorder of concern in the vaccine recipients is different — and much rarer — than typical blood clots, which develop in hundreds of thousands of people every year. The six women had not only clotting in the brain, but a notably low level of platelets, parts of the blood that help form normal clots.
The U.S. surgeon general, Dr. Vivek Murthy, reiterated on Wednesday that the pause in Johnson & Johnson vaccinations gives public health officials a chance to investigate the cases and discuss them with health care professionals. He added that pauses are common when new vaccines and drugs are rolled out.
“We’re just doing the due diligence we need to do to make sure everything is safe so we can continue with our vaccination efforts,” Dr. Murthy said on “CBS This Morning.”
The committee’s assessment will be crucial at a time when the nation is racing to vaccinate as many people as possible to curb the steady accumulation of cases, particularly as worrisome variants gain traction. Some public health experts were disappointed in the F.D.A.’s recommendation to suspend the Johnson & Johnson vaccine, arguing that preventing these extremely rare side effects was not worth the trade-off of slowing the vaccination campaign and potentially eroding the public’s trust of vaccines in general.
Madeleine Ngo contributed reporting.
— The New York Times
The European Union will receive an extra 50 million doses this month of the coronavirus vaccine developed by Pfizer and BioNTech, a lift in its effort to speed up inoculations in the face of difficulties with vaccines developed by AstraZeneca and Johnson & Johnson.
The announcement by Ursula von der Leyen, the president of the European Commission, is part of the European Union’s hard pivot to mRNA vaccines such as Pfizer’s, staking its future coronavirus response on them.
The moves come a day after Johnson & Johnson suspended the rollout of its vaccine in the European Union and as the bloc continued to suffer the fallout from restrictions on the AstraZeneca vaccine, after reports of extremely rare but serious potential side effects from both.
The 27-nation bloc has also entered negotiations with Pfizer over the supply of 1.8 billion new vaccine doses — including booster shots to prolong immunity and new vaccines to tackle emerging variants — in 2022 and 2023, Ms. von der Leyen said.
In another setback for AstraZeneca, Denmark on Wednesday became the first country to permanently stop the administration of the company’s vaccine, saying the potential side effects were significant enough to do so given that it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna.
The European Union has not canceled its existing orders of the AstraZeneca and Johnson & Johnson vaccines, but signaled it was not going to be placing more.
The European Medicines Agency, the bloc’s top drug regulator, continues to say that for most people the benefits of the AstraZeneca vaccine far outweigh the risks of a dangerous, but extremely rare, blood disorder. On Wednesday, the agency said it was expediting its investigation of “very rare cases of unusual blood clots” in recipients of the Johnson & Johnson vaccine, and expected to issue a recommendation next week.
While the evaluation is ongoing, the agency reiterated its view that the benefits of that vaccine also outweigh the risks.
The European Union’s turn away from AstraZeneca follows difficult months in which relations between the company and the bloc deteriorated over delayed shipments and unpredictable supply. And since then, concerns over the possible side effects have exacerbated vaccine skepticism that was already dangerously high in Europe.
Those problems have contributed to Europe’s falling seriously behind vaccination campaigns in the United States and Britain. The bloc is hoping the new Pfizer shipments will help it begin to catch up and to meet its goal to fully vaccinate 70 percent of its adult population by the end of the summer, some 255 million people.
Pfizer’s commitment to bring forward the delivery of the 50 million doses, which were originally slated for the end of the year, means the company will deliver a total of 250 million doses to the bloc by the end of June.
“We need to focus now on technologies that have proven their worth: mRNA vaccines are a clear case in point,” Ms. von der Leyen said.
Monika Pronczuk contributed reporting.
Organizers marked 100 days until the start of the Tokyo Olympics on Wednesday with a subdued ceremony amid tougher restrictions and growing questions over the event as Japan endures another surge of coronavirus infections.
The governor of Tokyo, Yuriko Koike, pledged that officials would do everything to deliver a “memorable tournament.” Wearing a mask and gloves, she unveiled statues of the Olympic mascots inside Tokyo government headquarters while a video link showed another group of officials unveiling a monument of the Olympic rings atop fog-shrouded Mount Takao, 30 miles west of the capital.
But parts of Tokyo and other municipalities remain under a quasi-state of emergency ordered last week to stem what officials describe as Japan’s fourth wave of infections. Japan has recorded nearly 3,200 infections a day over the last week, according to a New York Times database — few by the standards of the United States and Europe, but a worryingly high number for Asia.
The host nation is also lagging in vaccinations: Shots for those 65 and just began on Monday. So far, Japan has inoculated only frontline medical workers, who make up less than 1 percent of the population, and it will be far from fully vaccinated by July 23, when the Games are scheduled to begin.
Japan is calling these the “Recovery Olympics” — highlighting the nation’s recovery from the devastating earthquake, tsunami and nuclear disaster in 2011, as well as the world’s recovery from the pandemic. But the Games, originally scheduled for last year, are marching on despite more than 70 percent of the Japanese public saying they should be delayed again or called off entirely.
Organizers announced last month that international spectators would be barred, although thousands of athletes from over 200 nations are expected to compete. The ceremonial torch relay has been making its way across Japan with little fanfare; its two-day leg in Osaka this week was diverted off public roads and took place in an empty park.
Denmark on Wednesday became the first country to plan to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder.
The director general of the country’s health authority, Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna.
The Danish announcement is another setback for the AstraZeneca shot, which is easy to store and relatively cheap, and was expected to be the foundation of vaccination campaigns around the world.
The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month.
The European Union’s drug regulator, the European Medicines Agency, later recommended that countries keep using the vaccine, saying its benefits far outweighed any potential risks for most people.
Last week, though, the European regulator listed blood clots as a potential very rare side effect of the vaccine.
Several countries that had paused and restarted use of the vaccine have since said they would stop using it in younger people. Britain, which has administered around 20 million AstraZeneca doses, said it would offer alternative vaccines to people under 30.
“Based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca,” Dr. Brostroem, the Danish health official, said in a statement. “We have, therefore, decided to remove the vaccine from our vaccination program.”
“If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.”
Danish health officials said that they might reintroduce the AstraZeneca vaccine “if the situation changes.”
Public health officials have warned that pausing administration of vaccines like AstraZeneca’s or Johnson & Johnson’s could do more harm than good. They note that among seven million people vaccinated with the single-dose Johnson & Johnson vaccine in the United States, six women had developed the rare blood clots — fewer than one in one million. It is not yet known whether the vaccine had anything to do with the clots, but even if it did, the risk is smaller than that of getting struck by lightning in a given year (one in 500,000).
Denmark, which has a population of 5.8 million, has managed to contain the pandemic better than its neighbor Sweden or many other European countries. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths.
Almost one million people in the country have received at least a first dose of a vaccine, 77 percent of them the one from Pfizer, according to Denmark’s Serum Institute. Around 15 percent received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 percent received the Moderna vaccine.
The country’s health authorities said that people who received a first dose of the AstraZeneca vaccine would be offered a different vaccine for their second dose.
Jasmina Nielsen contributed reporting.
Researchers in Britain investigating the effects of using one coronavirus vaccine for a first dose and another for a second have expanded their trial, they said on Wednesday, a day after the pause in the rollout of the Johnson & Johnson vaccine in the United States, the European Union and South Africa fueled uncertainties about vaccination campaigns.
Mixing doses could help countries weather vaccine supply shortages. Some governments have also recommended that some people who have received a first dose of the AstraZeneca vaccine receive a second injection of a different vaccine after a small number of recipients developed a rare blood-clotting disorder.
On Wednesday, German health authorities recommended that anyone under 60 who had received an initial inoculation with the AstraZeneca vaccine be given either the Pfizer/BioNTech or the Moderna vaccine for their second shot.
Some 2.2 million AstraZeneca doses were given to Germans younger than 60 when the authorities first began administering the vaccine, only to reverse that strategy after detecting several dozen cases of clotting.
Public health officials have emphasized that the benefits of the vaccines that have come under scrutiny still far outweigh the potential risks for most people, and some have warned that pausing their rollout could do more harm than good.
The Com-Cov study led by the University of Oxford began in February using AstraZeneca and Pfizer shots, but on Wednesday the researchers announced that they would recruit more volunteers and expand the trial to include doses of the vaccines developed by Novavax and Moderna.
“If we can show that these mixed schedules generate an immune response that is as good as the standard schedules, and without a significant increase in the vaccine reactions, this will potentially allow more people to complete their Covid-19 immunization course more rapidly,” said Dr. Matthew Snape, the lead investigator of the trial.
Researchers are expecting to publish their first findings by July, although the study will run for a year.
In other news around the world:
Reduced air pollution during the first lockdown in France may have led to “non-negligible health benefits,” the national public health agency said on Wednesday. A study by the agency estimated that the two-month lockdown last spring had avoided roughly 2,300 deaths from exposure to particulate matter pollution and another 1,200 from exposure to nitrogen dioxide, mainly related to traffic.
India has recorded a record 184,372 new coronavirus cases in 24 hours, officials said on Wednesday, as Maharashtra State, the country’s second most populous, prepared to impose a 15-day lockdown. The authorities in Maharashtra ordered its 120 million residents to remain indoors except for essential reasons beginning Wednesday evening. Hospitals there are running out of beds and essential supplies, and the state’s top official, Uddhav Thackeray, has asked the central government to mobilize the Indian Air Force to deliver oxygen cylinders. The leader of the state of Uttar Pradesh, Yogi Adityanath, said on Wednesday that he had tested positive for the coronavirus and was self-isolating.
Infections are surging in Thailand, which reported 1,335 new cases on Wednesday, its highest one-day total of the pandemic. Although the country has kept the virus largely under control for more than a year, officials are worried that the latest outbreak, centered in Bangkok, could spread nationwide as people visit relatives during the ongoing Songkran holiday, which marks the Thai New Year. With less than 1 percent of the population vaccinated, most of Thailand’s provinces have imposed entry restrictions.
Aurelien Breeden contributed reporting.
In March, a year into the pandemic, Jane Fraser, the chief executive of Citigroup, made a new workplace rule: no video calls on Fridays.
“After listening to colleagues around the world,” she wrote in a companywide blog post, “it became apparent we need to combat the ‘Zoom fatigue’ that many of us feel.”
Video calls have emerged as such a widespread pain point in this era of remote work that the term “Zoom fatigue” has entered our lexicon — a catchall phrase referring to the tiredness related to video calls on any number of platforms.
Now, research from Stanford University published on Tuesday found that women experience significantly more Zoom fatigue than men.
The research, which hasn’t been peer-reviewed, suggests that video calls amplify longstanding gender dynamics in group settings and exacerbate an already wide gender stress gap, with women consistently reporting more stress and stress-related health conditions than men, according to the American Psychological Association.
During in-person meetings, people aren’t staring into your face from nearby — some might be typing notes, some might be reading. Video calls disrupt that natural rhythm, forcing everyone logged in to stare at each other, a phenomenon known as “hyper gaze.”
“From an evolutionary standpoint, if somebody was very close to you and staring right at you, this meant you were going to mate or get in a fight,” said Jeremy Bailenson, founding director of Stanford University’s Virtual Human Interaction Lab and a co-author of the study. Constantly being on high alert, he said, creates stress.
He and other researchers created a scale to measure five types of fatigue associated with video calls: general (overall tiredness), social (wanting to be alone), emotional (being overwhelmed and “used up”), visual (symptoms of stress on one’s eyes) and motivational (lacking the drive to start new activities). In their most recent survey of over 10,000 participants, the researchers found that women of all ages scored higher on all five.
In a second survey, the researchers discovered that women reported more mirror anxiety — a psychological phenomenon where seeing oneself in a mirror can trigger heightened self-focus, which in turn creates more anxiety and depression. The self-view in video calls seems to be replicating the mirror anxiety effect, said Geraldine Fauville, a researcher who worked on the study.
As companies consider post-pandemic work culture, the solutions to Zoom fatigue aren’t going to be as simple as switching off self-view (which the researchers recommend you do anyway) or abandoning video calls, said Mollie West Duffy, co-author of “No Hard Feelings: The Secret Power of Embracing Emotions at Work.”
“I don’t think anyone has a playbook for how to do this perfectly,” Ms. Duffy said, “so we’re going to all try to do our best and then we’re going to have to be willing to have conversations two months in about how to adapt.”
With all American adults soon to be eligible for Covid-19 vaccines and businesses and international borders reopening, a fierce debate has kicked off across the United States over whether a digital health certificate (often and somewhat misleadingly called a “vaccine passport”) should be required to prove immunization status.
Currently, Americans are issued a white paper card as evidence of their Covid-19 shots. But these can easily be forged, and online scammers are already selling false and stolen vaccine cards.
While the federal government has said it will not introduce digital vaccine passports by federal mandate, a growing number of businesses say they will require proof of vaccinations for entry or services.
The drive has raised privacy and equity concerns. States such as Florida and Texas have banned businesses from requiring vaccination certificates.
Governments, technology companies, airlines and other businesses are testing different versions of the digital health passes and are trying to come up with common standards so that there is compatibility between each system and health records can be retrieved securely.
Here’s what we know.
For the moment, only if you live in New York. Last month, it became the first state in the United States to launch a digital health certificate called the Excelsior Pass, which verifies a person’s negative coronavirus test result and if they are fully vaccinated.
Some airlines including Lufthansa, Virgin Atlantic and Jet Blue have started to use the digital health app, Common Pass, to verify passenger Covid-19 test results before they board flights.
It depends on state regulations. The Biden administration has said there will be no federal vaccination system or mandate. Individual states hold primary public health powers in the United States and have the authority to require vaccines.
All states except New Hampshire have their own immunization registries and some cities, like New York, have their own.
Currently states are required to share their registries with the Centers for Disease Control and Prevention, but the data is not public and could be withheld.
“There are a whole lot of valid concerns about how privacy and technology would work with these systems, especially as Silicon Valley does not have a great history delivering technologies that are privacy enhancing,” said Brian Behlendorf, executive director of Linux Foundation Public Health, an open-source, technology-focused organization.
Some argue that such a credential would intrude on personal freedoms and private health choices.
Others worry that an exclusively digital system would leave some communities behind, especially those who do not have access to smartphones or the internet.
The World Health Organization says it does not yet support requiring vaccination passports for travel because of the uncertainty over whether inoculation prevents transmission of the virus, as well as equity concerns.
New York City officials said Wednesday that the vast majority of people who were supposed to receive Johnson & Johnson’s coronavirus vaccine would keep their scheduled appointments but instead receive either the Pfizer-BioNTech or Moderna vaccine.
The change came after federal health authorities called for a pause in Johnson & Johnson vaccinations on Tuesday as they investigated a rare blood-clotting disorder that emerged in six recipients. States, including New York, followed suit in halting the injections.
About 4,000 people who were supposed to receive Johnson & Johnson shot had to reschedule their appointments on Tuesday, a relatively small number of the tens of thousands of people who are vaccinated daily, city officials said at a news conference.
The city had been relying on the vaccine to inoculate hard-to-reach New Yorkers, including people who are homebound. That homebound program will be suspended through Sunday, though the city is helping to arrange transport to a nearby vaccine site where that’s possible, said the city health commissioner, Dr. Dave Chokshi.
“We were thrown a curveball” on Tuesday by news of the disorder, Mayor Bill de Blasio said, “and our job is to hit that ball out of the park anyway.”
The six cases of rare and severe blood clots appeared in women aged 18 to 48, one of whom died. All of the women had received the Johnson & Johnson vaccine before developing the clots, though it is unclear whether the vaccine is responsible. As of Tuesday, more than seven million people in the United States have received the shot, and another 10 million doses have been shipped out to the states, according to C.D.C. data. Other countries will also delay using the vaccine out of an abundance of caution.
Some public health experts are concerned that the pause could sour the public on the shot and contribute to conspiracy theories and hesitancy to be vaccinated.
Dr. Chokshi said that “vaccines usually carry a very small risk of side effects, but it’s also important to keep in mind the other side of the equation, to remember that authorized vaccines protect us from diseases that threaten us so much more.”
He added that “to put a new twist on an old idiom, we may have more to fear from fear itself.”
The Johnson & Johnson vaccine pause comes as coronavirus cases in the city remain stubbornly high, even as more than five million vaccine doses have been administered overall.
Worrisome variants of the virus are a likely reason for the continued spread in the city, public health officials have said. A recent analysis shows that such variants could account for more than 75 percent of new cases genetically analyzed in the city. Sequencing capabilities remain limited in the city, only providing a glimpse of the full picture of how the variants are impacting each community.
The two main variants drawing concern from city officials are B.1.526, which was first discovered in the city, and B.1.1.7, which was first detected in Britain, spread around the globe, became the dominant version in the United States and now makes up nearly 30 percent of cases sequenced in the city.
Even though both variants have become increasingly prevalent in the city, hospitalizations seem to be on a slight decline, according to city data.
“We’ve got to keep our guard up, but the strategy remains the same,” Mr. de Blasio said. “Vaccination works, that part is clear, and that’s where we just have to put all of our efforts to once and for all beat them back.”