Expert Panel to C.D.C. to Vote on Johnson & Johnson Vaccine Pause

An advisory committee for the Centers for Disease Control and Prevention is discussing the Johnson & Johnson Covid-19 vaccine pause during a meeting on Wednesday afternoon while a possible link to a small number of 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 are reviewing and debating data from the rare cases, and will later hear comments from the public, before a possible 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.

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.”

was not worth the trade-off of slowing the vaccination campaign and potentially eroding the public’s trust of vaccines in general.

At the news conference, Jeffrey D. Zients, the White House’s pandemic coordinator, said that the pause would not generally interrupt the momentum of the country’s vaccination campaign.

“In the very short term, we do expect some impact on daily averages as sites and appointments transition from Johnson & Johnson to Moderna and Pfizer vaccines,” he said. “We have more than enough Pfizer and Moderna vaccine supply to continue or even accelerate the current pace of vaccinations.”

Noah Weiland and Madeleine Ngo contributed reporting.

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Once again, South Africa finds itself halting use, at least temporarily, of a Covid-19 vaccine it had bet on.

South Africa has faced blow after blow to its pandemic-control efforts: A worrisome variant swept across the country, driving a devastating second wave of coronavirus cases. Then officials had to scramble for an alternative when the vaccine it had bet on, from AstraZeneca, proved ineffective against the variant, which can partially dodge the body’s immune system response.

Now the alternative — Johnson & Johnson’s single-dose vaccine, the only one now in use in South Africa — has run into trouble as well, over concerns of rare blood clots that emerged in a handful of people in the United States who had received the shot. It is unclear whether the vaccine is responsible.

South Africa’s health minister, Dr. Zwelini Mkhize, announced on Tuesday that the country would temporarily halt its vaccine program for medical workers, which has inoculated around 290,000 people so far. Dr. Mkhize said he expected the program — a clinical trial — to resume in a few days, after the authorities have had a chance to look into the blood clot cases in the United States.

“Science must be respected at all times, although this may mean a disruption in our plans,” Dr. Mkhize said on Tuesday.

halted use of the AstraZeneca vaccine after evidence emerged that it did not protect clinical-trial participants from becoming mildly or moderately ill from the variant, known as B.1.351, that is now dominant in the country. South African authorities then pivoted to the Johnson & Johnson vaccine, which is manufactured in the country under license and has a 64 percent efficacy rate in South Africa, according to an analysis by the U.S. Food and Drug Administration.

Health experts say that the decision on Tuesday to pause vaccinating health care workers is the kind of thing that happens often in clinical trials, and that it probably won’t have any major implications for vaccinating the general public.

“At the moment, there is nothing to indicate that this will delay the national rollout program,” said Dr. Richard Lessells, an infectious diseases specialist at the KwaZulu-Natal Research and Innovation Sequencing Platform.

Even so, if evidence emerges to implicate the Johnson & Johnson vaccine in blood clotting problem, and health officials begin to question its safety, it could be a devastating blow for South Africa, the African country hardest hit by the coronavirus, as it races to inoculate its population before an even more dangerous variant appears.

“The U.S. has access to other vaccines to fill a gap, in terms of not using the Johnson & Johnson vaccine,” said Shabir Madhi, a virologist at University of the Witwatersrand who ran the AstraZeneca vaccine trial in South Africa. “That sort of luxury doesn’t exist in other countries, including South Africa.”

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Western Warnings Tarnish Vaccines the World Badly Needs

The solution in many European countries — to stop using seemingly riskier vaccines in younger people, who are at lower risk from Covid-19 — would be unworkable in Africa, where the median age in many countries is below 20.

And any further restrictions would compound the hurdles facing Covax, among them a paucity of funding for every part of inoculation programs beyond the touchdown of doses at airports.

Mali, in western Africa, has administered 7 percent of the AstraZeneca doses that Covax has delivered. Sudan, in eastern Africa, has given 8 percent of the doses it has received.

Skittishness over the AstraZeneca and Johnson & Johnson vaccines, analysts fear, could stoke demand for Russian- and Chinese-made shots about which far less is known. As it is, some global health officials have turned their attention to the Novavax vaccine, which is not yet authorized but makes up a third of Covax’s portfolio.

“Even at this stage of the pandemic, we have our fingers crossed that some vaccine will work to help vaccinate developing countries, instead of ramping up production of vaccines we know work,” said Zain Rizvi, an expert on medicines access at Public Citizen, an advocacy group.

In Kenya, where enthusiasm for vaccines is high in cities but perilously low in rural areas, “the story about blood clots from Europe could not have come at a worse time,” said Catherine Kyobutungi, the director of the African Population and Health Research Center there. “Even those who were perhaps on the fence, and leaning toward getting vaccinated, all of a sudden had second thoughts,” she said.

The American pause on Johnson & Johnson shots promised a second media furor.

“When the F.D.A. suspends, it makes headlines for days,” she said. “When it lifts the suspension, it doesn’t make as many headlines.”

Mady Camara contributed reporting from Dakar, Senegal.

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Denmark says it’s permanently stopping use of the AstraZeneca vaccine.

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.

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.

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Expert Panel to CDC to Vote on Johnson & Johnson Vaccine Pause

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.

reiterated on Wednesday that the pause in Johnson & Johnson vaccinations gives public health officials a chance to investigate the cases and discuss 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.”

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.

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Highlighting a rare potential vaccine side effect has risks of its own, public health officials warn.

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.

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Some Children With Covid-Related Syndrome Develop Neurological Symptoms

Reports about the mysterious Covid-related inflammatory syndrome that afflicts some children and teenagers have mostly focused on physical symptoms: rash, abdominal pain, red eyes and, most seriously, heart problems like low blood pressure, shock and difficulty pumping.

Now, a new report shows that a significant number of young people with the syndrome also develop neurological symptoms, including hallucinations, confusion, speech impairments and problems with balance and coordination. The study of 46 children treated at one hospital in London found that just over half — 24 — experienced such neurological symptoms, which they had never had before.

Those patients were about twice as likely as those without neurological symptoms to need ventilators because they were “very unwell with systemic shock as part of their hyperinflammatory state,” said an author of the study, Dr. Omar Abdel-Mannan, a clinical research fellow at University College London’s Institute of Neurology. Patients with neurological symptoms were also about twice as likely to require medication to improve the heart’s ability to squeeze, he said.

The condition, called Multisystem Inflammatory Syndrome in Children (MIS-C), typically emerges two to six weeks after a Covid infection, often one that produces only mild symptoms or none at all. The syndrome is rare, but can be very serious. The latest data from the Centers for Disease Control and Prevention reports 3,165 cases in 48 states, Puerto Rico and the District of Columbia, including 36 deaths.

study published last month in JAMA Neurology, 126 of 616 young people with the syndrome admitted to 61 U.S. hospitals last year had neurological issues, including 20 with what the researchers described as “life-threatening” problems like strokes or “severe encephalopathy.”

The new report, presented as preliminary research on Tuesday as part of an annual conference of the American Academy of Neurology, evaluated children under 18 who were admitted to Great Ormond Street Hospital (GOSH) between April and September of last year with the syndrome (it has a different name and acronym, PIMS-TS, in Britain). The data is also included in a preprint of a larger study that has not yet been peer-reviewed.

As was the case with other studies of the syndrome, including in the United States, the researchers said a majority of those afflicted were “nonwhite,” a pattern that public health experts believe reflects the disproportionate way the pandemic has affected communities of color. Nearly two-thirds of the patients were male, and the median age was 10.

All 24 of the patients with neurological symptoms had headaches and 14 had encephalopathy, a general term that can involve confusion, problems with memory or attention and other types of altered mental function. Six of the children were experiencing hallucinations, including “describing people in the room that were not there or seeing cartoons or animals moving on the walls,” Dr. Abdel-Mannan said. He said some experienced auditory hallucinations involving “hearing voices of people not present.”

Six of the children had weakness or difficulty controlling muscles used in speech. Four had balance or coordination problems. One child had seizures and three children had peripheral nerve abnormalities including weakness in facial or shoulder muscles. One patient’s peripheral nerve damage led to a foot-drop problem that required the use of crutches and a recommendation for a nerve transplant, said Dr. Abdel-Mannan, who is also a senior resident in pediatric neurology at GOSH.

Some of the patients underwent brain scans, nerve conduction tests or electroencephalograms (EEGs), including 14 who showed slower electrical activity in their brains, the study reported.

Thirteen of the 24 with neurological symptoms needed to be placed on ventilators and 15 needed medication to improve their heart contractions, Dr. Abdel-Mannan said. By contrast, only three of the 22 children without neurological issues needed ventilators and seven needed such heart medication, he said. None of the children with hallucinations needed psychotropic medications.

Three children had to be hospitalized again after their initial stay, one for another episode of encephalopathy and two for infectious complications, Dr. Abdel-Mannan said, but he added that there were no deaths and “almost all children made a complete functional recovery.”

Dr. Abdel-Mannan said a team led by the study’s senior author, Dr. Yael Hacohen, will be following patients who had the syndrome — both those who had neurological symptoms and those who did not. They will conduct brain scans and cognitive assessments to see if the children experience any long-term cognitive or psychological effects.

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Several States Pausing Use of Johnson & Johnson Vaccine After CDC, FDA Advisory

“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.

Like many states, New York had already prepared for a significant drop in its supply of the Johnson & Johnson vaccine after federal officials said that supplies would be limited because of a production issue at a Baltimore manufacturing plant. On Friday, Gov. Andrew M. Cuomo said that New York expected to receive 34,900 Johnson & Johnson shots, a decrease of 88 percent from the previous week.

Dr. Zucker, New York’s health commissioner, said that the state would honor appointments made at state-run mass vaccination sites for the Johnson & Johnson vaccine by giving people the Pfizer-BioNTech vaccine instead. That vaccine requires two doses, and it was not immediately clear how the state would handle the additional strain on its supply.

New Jersey health officials said the state would work with its vaccination sites to help people get appointments for the Pfizer or Moderna vaccine instead. Mayor Bill de Blasio of New York City said that the city would do the same, rescheduling appointments at city-run vaccine sites.

“Every site has been told this morning to stop giving the J&J shots,” he said at a news conference.

The city’s health commissioner, Dr. Dave Chokshi, said that around 234,000 residents have received the Johnson & Johnson vaccine and none had reported any blood clots so far. The city had been relying on the vaccine to inoculate hard-to-reach New Yorkers, including people who are homebound.

Both Mr. Cuomo and Mr. de Blasio received the Johnson & Johnson vaccine at separate appearances last month, which they framed as an effort to boost confidence in that vaccine’s efficacy rate and 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 vaccine has not been authorized for emergency use in the United States.

Rebecca Robbins contributed reporting.

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Worry Over 2 Covid Vaccines Deals Fresh Blow to Europe’s Inoculation Push

BRUSSELS — First it was AstraZeneca. Now Johnson & Johnson.

Last week, British regulators and the European Union’s medical agency said they had established a possible link between AstraZeneca’s Covid-19 vaccine and very rare, though sometimes fatal, blood clots.

On Tuesday, Johnson & Johnson said it would pause the rollout of its vaccine in Europe and the United States over similar concerns, further compounding the continent’s one-step-forward-two-steps-back efforts to quickly get people immunized against the coronavirus.

European officials had been confident that they had secured enough alternative vaccine doses to take up the slack of the AstraZeneca problems and achieve their goal of fully inoculating 70 percent of the European Union’s adult population — about 255 million people — by the end of the summer.

On Tuesday, European officials did not immediately say whether they believed the milestone would also survive the Johnson & Johnson suspension. But the European commissioner for health, Stella Kyriakides, wrote on Twitter that “Today’s developments with the J&J vaccine in the US are under close monitoring” by the bloc’s medicines regulator.

months of short supplies and logistical problems.

There is mounting evidence that the concerns are eroding Europeans’ willingness to get the AstraZeneca vaccine in particular, and threatening to elevate already high levels of vaccine hesitancy generally.

YouGov poll published last month, 61 percent of the French, 55 percent of Germans and 52 percent of Spaniards consider the AstraZeneca vaccine “unsafe.” That is in stark contrast to the findings of a similar poll from February, when more people in those countries, with the exception of France, believed that the shot was more safe than unsafe.

Regulators have asked vaccine recipients and doctors to be on the lookout for certain symptoms, including severe and persistent headaches and tiny blood spots under the skin. Doctors’ groups have circulated guidance about how to treat the disorder.

In Poland, where the vaccination campaign relies to a large extent on AstraZeneca and where its use has not been restricted, a recent poll showed that given a choice, fewer than 5 percent of Poles would choose the AstraZeneca shot.

Almost everywhere across the European Union, it seems, many are eager for alternatives, as the new types of vaccines that include the Moderna and Pfizer, which utilize science known as “mRNA,” have not been associated with similar side effects.

Data from the 27 E.U. member states by the European Center for Disease Prevention and Control shows that over all, 80 percent of vaccine doses distributed to the bloc have already been administered. That share drops to 65 percent for AstraZeneca, however, suggesting that many of its doses are sitting unused.

Yet it is hard to predict how serious a blow the latest twist in the AstraZeneca saga — and the new Johnson & Johnson concerns — will be to E.U. vaccination efforts, as officials in Brussels have made big if belated efforts to turbocharge the second-quarter supply of doses.

The European Union is poised to receive at least 300 million doses of various vaccines, three times what it got in the first quarter. Two hundred million are slated to come from Pfizer/BioNTech. Moderna is expected to deliver 35 million doses. Another 55 million doses are due of the Johnson & Johnson jab, and 70 million from AstraZeneca.

In the rosiest scenario, the European Union could get up to 360 million doses by June.

On Thursday, after Spain’s government changed the age threshold for the AstraZeneca shot, two-thirds of people called up for vaccination in Madrid did not show up, Antonio Zapatero, the regional health minister, told a news conference on Friday.

He attributed the no-show by 18,200 people to “confusion” generated by Spain’s central government, which said on Wednesday that the AstraZeneca vaccine should be given only to people over 60. Before this change, Mr. Zapatero said, the rate of abstention was 2 percent.

In Belgium, where the use of the AstraZeneca vaccine has also been limited, the authorities said they did not expect major delays in the overall rollout, but they are still concerned about the confusion that the rare blood clotting issue is causing.

Yves Van Laethem, a top epidemiologist who is the country’s Covid task force spokesman, said he expected a two-week delay that would mostly affect younger age groups in late summer. He said the E.U. regulator guidance had only partly helped in clarifying the situation.

The European Medicines Agency’s opinion “wasn’t very clear, and it is also part of the problem,” Dr. Van Laethem said in an interview. “When you say, ‘We don’t apply limitations, but we just say there are serious side effects,’ there is part science and part diplomacy in that.”

He said the limited effect that the new AstraZeneca issues would have on Belgian’s rollout was in large part because the country had ordered big shares of other vaccines.

Although all E.U. countries have been offered a chunk of each vaccine approved in the bloc so far — AstraZeneca, Johnson & Johnson, Moderna and Pfizer — many opted to forgo parts of their share of more expensive or cumbersome vaccines like Pfizer and Moderna early on, instead favoring the AstraZeneca jab.

“In Britain or Eastern Europe, a big part of the campaigns are based on AstraZeneca,” Dr. Van Laethem said.

Wealthier bloc members like Denmark, France, Germany and the Netherlands can better compensate for the loss of confidence in AstraZeneca, because they acquired extra doses of other vaccines — especially Pfizer — through a secondary market after poorer E.U. nations gave theirs up.

Those countries — including Bulgaria, Croatia, Latvia and Slovakia — are likely to be less able to quickly offer alternatives.

Dr. Van Laethem, the Belgian immunologist, said that the national and European authorities needed to better communicate the costs and benefits of taking the AstraZeneca dose versus and the other authorized vaccines.

Experts worry that even limited concerns over one vaccine’s unlikely side effects can affect people’s overall willingness to be immunized.

“The main thing is to make people understand that the problem is the virus,” he said. “We have to vaccinate people — the risk linked to the virus is higher than those rare side effects.”

Raphael Minder contributed reporting from Madrid and Constant Méheut from Paris.

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