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.

View Source

How Worried Should You Be About the J&J Vaccine and Blood Clots?

On Tuesday morning, U.S. federal health regulators recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine while they investigated six reports of blood clots in women ages 18 to 48. One has died, and a second is hospitalized in critical condition.

As of Monday, 6.8 million people in the United States had received the vaccine without any other serious adverse reactions reported.

Experts have yet to determine to what extent, if any, the vaccine is responsible for the clots. But the investigation follows actions by European regulators who concluded that a vaccine made by AstraZeneca may also be the cause of a similar, extremely rare clotting disorder.

U.S. and European public health experts have emphasized that for most people, the benefits of the Covid vaccines far outweigh the risks.

recommends that people who have received the Johnson & Johnson vaccine within the past three weeks should contact their doctors if they experience severe headaches, abdominal pain, leg pain or shortness of breath. People should not be concerned about mild headaches and flu-like symptoms in the first few days after vaccination. Those are common, harmless side effects brought on by the immune system’s production of a defense against the coronavirus.

During clinical trials and after vaccines go into wide use, experts keep track of any medical problems experienced by people who receive them. If an unusually large cluster of cases turns up, regulators may decide to pause a trial or stop the use of a vaccine to investigate further.

Pauses are common, and typically the investigations reveal that the medical problems were a matter of coincidence. If the investigation reveals that a vaccine does pose a risk, regulators may write new guidance about who should or should not receive it.

regulators have said, roughly one in 1,000 people are affected by a blood clot in a vein every year.

But the clotting disorder of concern in the vaccine recipients is much rarer and different from typical blood clots. In addition to clotting in the brain — called cerebral venous sinus thrombosis, or CVST for short — the patients all had a notably low level of platelets, which left them prone to abnormal bleeding.

said the company was aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. “In addition, we have been reviewing these cases with European health authorities,” the company said in its statement. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”

At the news conference on Tuesday, Dr. Marks of the F.D.A. said the cases were “very, very similar.”

a number of possible symptoms, including swelling in the leg, persistent abdominal pain, severe and persistent headaches or blurred vision, and tiny blood spots under the skin beyond the area where the injection was given.

But that set of symptoms was so vague that almost immediately, British emergency rooms experienced a surge in patients who were worried that they fit the description.

Nonetheless, German researchers say that such symptoms in vaccine recipients must be followed up. Blood tests can detect the antibodies.

Doctors in Germany and Norway have treated patients with blood-thinning drugs to try to stop the growth of the clots, and with intravenous immune globulin, which can help eliminate the misguided antibodies that are causing the problem.

AstraZeneca vaccines. One recipient, a physician in Florida, died from a brain hemorrhage when his platelet levels could not be restored, and others have been hospitalized. U.S. health officials have said that the cases are being investigated, but they have not reported the findings of those reviews and have yet to indicate that there is any link to the vaccines.

Benjamin Mueller contributed reporting.

View Source

After Going ‘Free of L.G.B.T.,’ a Polish Town Pays a Price

KRASNIK, Poland — When local councilors adopted a resolution two years ago declaring their small town in southeastern Poland “free of L.G.B.T.,” the mayor didn’t see much harm in what appeared to be a symbolic and legally pointless gesture.

Today, he’s scrambling to contain the damage.

What initially seemed a cost-free sop to conservatives in the rural and religiously devout Polish borderlands next to Ukraine, the May 2019 decision has become a costly embarrassment for the town of Krasnik. It has jeopardized millions of dollars in foreign funding and, Mayor Wojciech Wilk said, turned “our town into a synonym for homophobia,” which he insisted was not accurate.

A French town last year severed a partnership with Krasnik in protest. And Norway, from which the mayor had hoped to get nearly $10 million starting this year to finance development projects, said in September that it would not give grants to any Polish town that declares itself “free of L.G.B.T.”

“We have become Europe’s laughingstock, and it’s the citizens not the local politicians who’ve suffered most,” lamented Mr. Wilk, who is now lobbying councilors to repeal the resolution that put the town’s 32,000 residents in the middle of a raucous debate over traditional and modern values. The situation also illustrates the real-life consequences of political posturing in the trenches of Europe’s culture wars.

rally its base before a presidential election in 2020, did not bar gay people from entering or threaten expulsion for those already present. Instead they vowed to keep out “L.G.B.T. ideology,” a term used by conservatives to describe ideas and lifestyles they view as threatening to Polish tradition and Christian values.

Cezary Nieradko, a 22-year-old student who describes himself as Krasnik’s “only open gay,” dismissed the term “L.G.B.T. ideology” as a smoke screen for homophobia. He recalled how, after the town adopted its resolution, his local pharmacist refused to fill his prescription for a heart drug.

will cut funding to any Polish town that violates Europe’s commitment to tolerance and equality.

The European Parliament also passed a resolution last month declaring all 27 countries in the bloc an L.G.B.T. “Freedom Zone,” although like the Polish resolutions declaring the opposite, the declaration has no legal force.

All the posturing, however, has begun to have concrete consequences.

Krasnik’s mayor said he worried that unless his town’s “free of L.G.B.T.” status is rescinded, he has little chance of securing foreign funds to finance electric buses and youth programs, which he said are particularly important because young people keep leaving.

called off the visit to Krasnik after what he described as pressure from Polish officials not to go, a claim that Poland’s foreign ministry said was untrue.

When Krasnik and other towns adopted “free of L.G.B.T.” resolutions in early 2019, few people paid attention to what was widely seen as a political stunt by a governing party that delights in offending its foes’ “political correctness.”

But that changed early last year when Bartosz Staszewski, an L.G.B.T. activist from Warsaw began visiting towns that had vowed to banish “L.G.B.T. ideology.” Mr. Staszewski, a documentary filmmaker, took with him an official-looking yellow sign on which was written in four languages: “L.G.B.T.-FREE ZONE.” He put the fake sign next to each town’s real sign, taking photographs that he posted on social media.

The action, which he called “performance art,” provoked outrage across Europe as it put a spotlight on what Mr. Staszewski described in an interview in Warsaw as a push by conservatives to “turn basic human rights into an ideology.”

Prime Minister Mateusz Morawiecki has accused Mr. Staszewski of generating a fake scandal over “no-go zones” that don’t exist. Several towns, supported by a right-wing outfit partly funded by the government, have filed defamation suits against the activist over his representation of bans on “ideology” as barring L.G.B.T. people.

But even those who support the measures often seem confused about what it is that they want excluded.

Asked on television whether the region surrounding Krasnik would become Poland’s first L.G.B.T.-free zone, Elzbieta Kruk, a prominent Law and Justice politician, said, “I think Poland is going to be the first area free of L.G.B.T.” She later reversed herself and said the target was “L.G.B.T. ideology.”

For Mr. Wilk, Krasnik’s mayor, the semantic squabbling is a sign that it is time to drop attempts to make the town “free” of anyone or anything.

But Mr. Albiniak, the initiator of the resolution, vowed to resist what he denounced as blackmail by foreigners threatening to withhold funds.

“If I vote to repeal,” he said, “I vote against myself.”

Anatol Magdziarz contributed reporting.

View Source

Blood Clots Linked to AZ Vaccine Stem From Rare Antibody Reaction

Two reports published on Friday in a leading medical journal help to explain how AstraZeneca’s Covid vaccine can, in rare cases, cause serious and sometimes fatal blood clots.

Scientific teams from Germany and Norway found that people who developed the clots after vaccination had produced antibodies that activated their platelets, a blood component involved in clotting. The new reports add extensive details to what the researchers have already stated publicly about the blood disorder.

Why the rare reaction occurred is not known. Younger people appear more susceptible than older ones, but researchers say no pre-existing health conditions are known to predispose people to the problem, so there is no way to tell if an individual is at high risk.

Reports of the clots have already led a number of countries to limit AstraZeneca’s vaccine to older people, or to stop using it entirely. The cases have dealt a crushing blow to global efforts to halt the pandemic, because the AstraZeneca shot — easy to store and relatively cheap — has been a mainstay of vaccination programs in more than 100 countries.

statement on its website, AstraZeneca said it was “actively collaborating with the regulators to implement these changes to the product information and is already working to understand the individual cases, epidemiology and possible mechanisms that could explain these extremely rare events.”

The two new reports were published by The New England Journal of Medicine. One from Germany describes 11 patients, including nine women ages 22 to 49. Five to 16 days after vaccination, they were found to have one or more clots. Nine had cerebral venous thrombosis, a clot blocking a vein that drains blood from the brain. Some had clots in their lungs, abdomen or other areas. Six of the 11 died, one from a brain hemorrhage.

One patient had pre-existing conditions that affected clotting, but during a news briefing on Friday, Dr. Andreas Greinacher, an author of the report, said those conditions most likely played only a minor role in the disorder that occurred after vaccination.

second report, from Norway, described five patients, one male and four female health care workers ages 32 to 54, who had clots and bleeding from seven to 10 days after receiving the AstraZeneca vaccine. Four had severe clots in the brain, and three died. Severe headaches were among their early symptoms. Like the German patients, all had high levels of antibodies that could activate platelets.

The team from Norway also recommended treatment with intravenous immune globulin. The researchers said the disorder was rare, but “a new phenomenon with devastating effects for otherwise healthy young adults,” and they suggested that it may be more common than previous studies of the AstraZeneca vaccine had indicated.

On Friday, European regulators also said they were reviewing reports of a few blood clot cases that occurred in people who had received the Johnson and Johnson vaccine. In the United States, federal agencies are investigating reports of a different type of unusual blood disorder involving a precipitous drop in platelets that emerged in a few people who had received either the Pfizer-BioNTech or Moderna vaccines.

Benjamin Mueller and Melissa Eddy contributed.

View Source

AstraZeneca Vaccine Faces New Setbacks in U.K. and European Union

LONDON — Britain said on Wednesday that it would curb the use of AstraZeneca’s vaccine in adults under 30 because of the risk of rare blood clots, a blow to the efforts of scores of countries reliant on the vaccine to stamp out the coronavirus pandemic amid a global surge in cases.

Adding to the unease, the European Medicines Agency outlined a “possible link” between the vaccine and rare clots, even as it said that Covid-19 remained the far greater threat, leaving decisions about how to use the vaccine in the hands of the 27 member states of the European Union.

Taken together, the decisions represented a considerable setback for the AstraZeneca shot, which has been seen as the principal weapon in the battle to reduce deaths in the vaccine-starved global south.

The world’s most widely administered coronavirus vaccine, it is far less expensive and easier to store than some of the alternatives, spurring its use in at least 111 countries, rich and poor. AstraZeneca, based in Britain, has promised to deliver three billion doses this year, enough to inoculate nearly one in five people worldwide.

Cameroon and the Democratic Republic of Congo have already delayed injections of AstraZeneca’s vaccine amid mounting concerns in Europe. Any further hesitation, scientists said, could cost lives.

“In developing countries, the dynamic is to either use the vaccine you have, or you have nothing,” said Penny Ward, a visiting professor in pharmaceutical medicine at King’s College London. “In which case, carnage ensues.”

For the vast majority of people, British and European regulators said on Wednesday, the benefits of AstraZeneca’s shot far outweigh the risks. The clotting problems were appearing at a rate of roughly one in 100,000 recipients across Europe. Meanwhile, in Britain, the vaccine has driven down hospitalizations from Covid-19 — which can, itself, cause serious clotting problems — and saved thousands of lives, regulators said.

most people doubted the vaccine’s safety.

Over all, use of the shot has suffered: Across Europe, 64 percent of delivered doses of AstraZeneca’s vaccine have been injected into people’s arms, markedly lower than the rates for other shots.

“One hoped there would have been collaboration, and more discussion, between regulators, instead of lots of different countries going off in all sorts of directions,” Professor Ward said. “That aspect has really been the most unhelpful.”

watch 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.

As of March 22, regulators had carried out detailed review of 86 cases, 18 of which were fatal, they said.

Concerns about the shot became acute enough in Britain this week that the University of Oxford, which developed the vaccine with AstraZeneca, stopped giving doses as part of a two-month-old trial in children.

“Safety has been our priority throughout the development of the vaccine,” Andrew Pollard, the Oxford researcher in charge of the trials, said on Wednesday. The identification of the clots, he added, “shows that the safety system works.”

In the United States, AstraZeneca is preparing to apply for emergency use authorization from the Food and Drug Administration. If and when they take up the application, that agency’s regulators are expected to scrutinize the clotting cases.

The United States, flush with vaccines from three other makers, may not ultimately need AstraZeneca’s shot. But any ruling by the F.D.A. is expected to hold considerable weight in some of the poorer nations that are relying on the shot.

The World Health Organization said a vaccine safety subcommittee had met on Wednesday and noted that “rare adverse events following immunizations should be assessed against the risk of deaths from Covid-19 disease and the potential of the vaccines to prevent infections.” It said that a link with the clotting problems, while “plausible,” had not been confirmed.

For Britain, the AstraZeneca vaccine has become a huge source of national pride, and the backbone of the country’s speedy inoculation program.

Even if younger people are at lower risk from severe Covid-19, scientists have said, inoculating them remains essential to creating enough protection in the population to end the pandemic.

Emma Bubola, Monika Pronczuk and Rebecca Robbins contributed reporting.

View Source

AstraZeneca Vaccine Faces Setbacks in U.K. and European Union

LONDON — Britain said on Wednesday that it would curb the use of AstraZeneca’s vaccine in adults under 30 because of the risk of rare blood clots, a blow to the efforts of scores of countries reliant on the vaccine to stamp out the coronavirus pandemic amid a global surge in cases.

Adding to the unease, the European Medicines Agency outlined a “possible link” between the vaccine and rare clots, even as it said that Covid-19 remained the far greater threat, leaving decisions about how to use the vaccine in the hands of the 27 member states of the European Union.

Taken together, the decisions represented a considerable setback for the AstraZeneca shot, which has been seen as the principal weapon in the battle to reduce deaths in the vaccine-starved global south.

The world’s most widely administered coronavirus vaccine, it is far less expensive and easier to store than some of the alternatives, spurring its use in at least 111 countries, rich and poor. AstraZeneca, based in Britain, has promised to deliver three billion doses this year, enough to inoculate nearly one in five people worldwide.

Cameroon and the Democratic Republic of Congo have already delayed injections of AstraZeneca’s vaccine amid mounting concerns in Europe. Any further hesitation, scientists said, could cost lives.

“In developing countries, the dynamic is to either use the vaccine you have, or you have nothing,” said Penny Ward, a visiting professor in pharmaceutical medicine at King’s College London. “In which case, carnage ensues.”

For the vast majority of people, British and European regulators said on Wednesday, the benefits of AstraZeneca’s shot far outweigh the risks. The clotting problems were appearing at a rate of roughly one in 100,000 recipients across Europe. Meanwhile, in Britain, the vaccine has driven down hospitalizations from Covid-19 — which can, itself, cause serious clotting problems — and saved thousands of lives, regulators said.

most people doubted the vaccine’s safety.

Over all, use of the shot has suffered: Across Europe, 64 percent of delivered doses of AstraZeneca’s vaccine have been injected into people’s arms, markedly lower than the rates for other shots.

“One hoped there would have been collaboration, and more discussion, between regulators, instead of lots of different countries going off in all sorts of directions,” Professor Ward said. “That aspect has really been the most unhelpful.”

watch 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.

As of March 22, regulators had carried out detailed review of 86 cases, 18 of which were fatal, they said.

Concerns about the shot became acute enough in Britain this week that the University of Oxford, which developed the vaccine with AstraZeneca, stopped giving doses as part of a two-month-old trial in children.

“Safety has been our priority throughout the development of the vaccine,” Andrew Pollard, the Oxford researcher in charge of the trials, said on Wednesday. The identification of the clots, he added, “shows that the safety system works.”

In the United States, AstraZeneca is preparing to apply for emergency use authorization from the Food and Drug Administration. If and when they take up the application, that agency’s regulators are expected to scrutinize the clotting cases.

The United States, flush with vaccines from three other makers, may not ultimately need AstraZeneca’s shot. But any ruling by the F.D.A. is expected to hold considerable weight in some of the poorer nations that are relying on the shot.

The World Health Organization said a vaccine safety subcommittee had met on Wednesday and noted that “rare adverse events following immunizations should be assessed against the risk of deaths from Covid-19 disease and the potential of the vaccines to prevent infections.” It said that a link with the clotting problems, while “plausible,” had not been confirmed.

For Britain, the AstraZeneca vaccine has become a huge source of national pride, and the backbone of the country’s speedy inoculation program.

Even if younger people are at lower risk from severe Covid-19, scientists have said, inoculating them remains essential to creating enough protection in the population to end the pandemic.

Emma Bubola, Monika Pronczuk and Rebecca Robbins contributed reporting.

View Source

Possible Side Effects of AstraZeneca Vaccine Come Into Sharper Focus

LONDON — For months, European countries have seesawed between craving and rebuffing AstraZeneca’s vaccine, with the shot’s fortunes rising and falling on spats over supply and on questions over the efficacy of the vaccine itself.

But few concerns have proved as disruptive to the rollout of the world’s workhorse vaccine in Europe as reports of very rare blood clots in some recipients. Many countries responded by halting the shot’s use, only to start giving it again after an all-clear from regulators at the European Medicines Agency, and then stopped inoculations a second time in certain age groups after doctors became more concerned about the clots.

On Tuesday, those concerns were reinforced yet again when a top vaccines official at the European Medicines Agency said that the vaccine was linked to extremely rare, though sometimes fatal, blood clots in a small number of recipients. It was the first indication from an international regulatory body that the clots may be a real, if very unusual, side effect of the shot.

Regulators now appear to be considering issuing their first formal warnings about the potential side effects — not only in continental Europe, which has long been wary of the shot for political and scientific reasons, but also in Britain, the birthplace of the AstraZeneca vaccine and long its biggest champion, where new data have sown concerns as well.

speedy inoculation program, have also insisted that the vaccine’s benefits far outweighed the risks. They and the company cited a lack of evidence in Britain that the clotting events were any more common than would be expected among people who had never been given AstraZeneca’s vaccine.

But the evidence changed last week when Britain reported 30 cases of the rare blood clots, 25 more than previously. This week, a prominent scientific adviser to the British government said there was “increasing evidence” of the clots being associated with the vaccine.

regulators reported 30 cases of the rare blood clots combined with low platelets among 18 million people given the AstraZeneca vaccine. That translated to roughly one case in 600,000 recipients of the vaccine.

European countries’ divergent approaches to the vaccine stem from a number of factors, including the supply of vaccines and severity of the pandemic. Marco Cavaleri, the official at the European Medicines Agency who spoke about the link between the vaccine and blood clots, said on Tuesday that those factors would likely continue to dictate how countries used the shot.

Beyond those factors, countries also took very different approaches to managing risk, scientists said. Countries that have continued using the shot were more focused on securing the overall health of their citizens. Others were more preoccupied with minimizing the risk to any single person.

“The attitude here is more, ‘Get me out of the pandemic,’” said Penny Ward, a visiting professor in pharmaceutical medicine at King’s College London, referring to the British approach. In continental Europe, she said, “There seems to be a much higher emphasis on individual safety in the population.”

Adriano Mannino, a philosopher at the University of Munich and director of the Solon Center for Policy Innovation in Germany, said that the collective benefits of the vaccine dominated thinking in Britain, while Germans were more concerned with the risk of an injection going wrong in individual cases. That reflected, partly, Germany’s history with the Nazis, who conducted lethal experiments on people.

“In many areas where law has to regulate ethically delicate and potentially dangerous things,” he said, “the German state has tended to go for tough restrictions.”

Nevertheless, Germans over 60 — the age group still being given AstraZeneca’s vaccine — flooded hotlines to book appointments and stood in line for hours in recent days as eligibility restrictions for their age group were relaxed.

In the northeastern city of Wismar, several hundred people waited for up to five hours on Tuesday in a driving wind and mix of rain and snow to receive the shot.

“I wish there had been better weather,” Kerstin Weiss, the head of the district authority in the northeastern region, told public broadcaster NDR. “But honestly, this is a sign that people are willing to be vaccinated with AstraZeneca.”

Benjamin Mueller reported from London and Melissa Eddy from Berlin. Monika Pronczuk and Emma Bubola contributed reporting.

View Source

AstraZeneca Vaccine Under More Scrutiny After Denmark Death

Denmark on Saturday reported that two people had experienced brain hemorrhages after receiving the AstraZeneca Covid vaccine, one of whom died. The Danish Medicines Agency said it was looking into whether the condition was a potential side effect.

A spokesperson for the Capital Region of Denmark confirmed the death, and the Danish Ritzau news agency reported that the other person, a female civil servant in her 30s, was critically ill.

Millions of people in dozens of countries have received the AstraZeneca Covid vaccine with few reports of ill effects. After several countries recently paused the use of the vaccine, the European Medicines Agency reviewed and said that it considered the vaccine safe, although it would continue to watch for any connections to blood disorders. The agency noted that any threat would be very small, and that the shots will prevent vastly more deaths than they might cause.

Recent blood clots and abnormal bleeding in a small number of vaccine recipients in European countries raised questions about its safety, and prompted the suspensions. That created a disruptive pause in vaccination campaigns this week, even as some European countries were entering a third wave of infections.

said in a tweet on Saturday. “We are in the process of dealing with the two specific cases.”

This is the second death in Denmark after a person was given the AstraZeneca vaccine. Norway is examining the deaths of two people who received the vaccine.

Denmark has suspended the use of AstraZeneca until Thursday, despite the European Medicines Agency’s reassurances. Other Scandinavian countries and Finland have made similar decisions. But some European countries, including France and Germany, have resumed using the shots.

Some of the continuing caution has been driven by preliminary findings from medical experts in Norway and in Germany that suggested a possible link between the vaccine and the extremely rare blood disorders. The German experts said the sinus or cerebral vein thrombosis suffered by 13 Germans days after receiving the vaccine was caused by an immune system reaction they believe could be tied to the shot. They did not release detailed data, but planned to submit their findings to The Lancet.

AstraZeneca did not immediately comment on the assertions Friday.

Dr. James Bussel, an expert on platelet disorders and a professor emeritus at Weill Cornell Medicine, said the occurrence of abnormal clotting and low platelets in people under 50 is uncommon. He noted that researchers in Europe had identified antibodies produced by the immune system — possibly in a highly unusual response to the vaccine — that may have activated the platelets and started a cascade of abnormal clotting and bleeding.

Researchers in both Germany and Norway will continue investigating and in Germany, where the vaccine is again being administered, doctors are now warning anyone receiving an AstraZeneca shot to see a doctor immediately if they have headaches, dizziness or blurred vision more than three days afterward. They said the problems could very likely be treated if caught in time.

View Source

Scientists Say They Found Cause of Rare Blood Clotting Linked to AstraZeneca Vaccine

BERLIN—Scientists in Europe said they had identified a mechanism that could lead the AstraZeneca PLC vaccine to cause potentially deadly blood clots in rare instances as well as a possible treatment for it.

Two teams of medical researchers in Norway and Germany have independently found that the vaccine could trigger an autoimmune reaction causing blood to clot in the brain, which would offer an explanation for isolated incidents across Europe in recent weeks.

Several European countries briefly halted their rollouts of the vaccine this week after more than 30 recipients were diagnosed with the condition known as cerebral venous sinus thrombosis or CVST. Most of the people affected were women under the age of 55.

The issue affected a tiny portion of those who had received the shot however, and after investigating, the European drugs regulator ruled that the benefits outweighed the potential risks of the vaccine, and recommended vaccinations resume.

Latest Vaccine Developments

Some countries, such as Germany, France and Italy, resumed vaccination with AstraZeneca’s shot on Friday, with an added warning that it could be linked to blood clotting. The French healthcare authority, which recorded three cases of CVST connected to the vaccine, advised the government on Friday to only administer the shot to people older than 55.

Others, including Norway, Sweden and Denmark, said they needed more research before restarting their rollouts. Norway registered three cases of CVST, one of them fatal. The country vaccinated around 120,000 people with the shot. Finland suspended the use of AstraZeneca on Friday, after recording two cases of what the authorities called unusual blood clotting.

Pål André Holme, a professor of hematology and chief physician of the Oslo University Hospital who headed an investigation into the Norwegian cases, said his team had identified an antibody created by the vaccine that was triggering the adverse reaction.

​Europe’s top drug regulator endorsed AstraZeneca’s vaccine after it was suspended in several countries over blood-clot concerns. WSJ explains what’s at stake for a shot that’s been widely used around the world and may soon be considered for emergency use in the U.S. Photo: Mykola Tys/SOPA Images

“Nothing but the vaccine can explain why these individuals had this immune response,” Prof. Holme said.

Norway’s health authority cited the findings when announcing that it would not resume the vaccination.

A team of German researchers around Andreas Greinacher, professor of transfusion medicine at the Greifswald University Clinic, said they had independently come to the same conclusion as Prof. Holme in a statement and a press conference on Friday.

In Germany, 13 cases of CVST were detected among around 1.6 million people who received the AstraZeneca vaccine. Twelve patients were women and three died.

The German researchers, who coordinated with colleagues in Austria, Ireland and Britain, said in a statement that patients who show symptoms four days after vaccination, such as headaches, dizziness or impaired vision, could be quickly diagnosed with a blood test. Prof. Greinacher said the news meant that people should not fear the vaccine.

“Very, very few people will develop this complication,” Prof. Greinacher said in a press conference Friday. “But if it happens we now know how to treat the patients.”

Pål André Holme’s team at Oslo University Hospital identified an antibody created by the AstraZeneca vaccine that was triggering the adverse reaction.

Photo: Terje Pedersen/Associated Press

He said that, after a swift diagnosis, the condition could be treated in any mid-sized hospital.

The German government said it was examining the findings, but stuck to its decision to resume use of the AstraZeneca vaccine.

AstraZeneca didn’t immediately react to a request for comment. Neither did the medicines regulators in Britain, Germany, Austria and The Netherlands, where vaccinations using the AstraZeneca vaccine have either resumed or weren’t suspended this week.

The European Medicines Agency, or EMA, which regulates medicines for most European countries, said that it had assessed the cases from Germany and Norway and discussed them with the relevant national authorities.

A spokeswoman for EMA said that the vaccine may be associated with very rare cases of blood clots, including CVST, but that the benefits of the vaccine outweigh that risk.

“A causal link with the vaccine is not proven, but is possible and deserves further analysis,” the spokeswoman said in a statement.

Neither the German nor the Norwegian findings were published or peer reviewed. Prof. Greinacher said he had submitted his findings for publication to the British medical journal The Lancet.

The German Society for Thrombosis and Hemostasis Research reviewed Prof. Greinacher’s work and issued a statement Friday advising physicians how to diagnose and treat the condition should it arise in vaccine recipients.

Dr. Robert Klamroth, deputy-chairman of the Society for Thrombosis and Hemostasis Research, said the rare autoimmune reaction occurred more frequently in Germany because the country initially only authorized the vaccine for people younger than 64. Britain, which had fewer incidents but vaccinated many more people, was predominantly giving the shot to older recipients.

Once diagnosed, the condition should be treated with blood thinning medication and immunoglobulin, which targets the antibody that causes the problem.

“We believe the most likely hypothesis is that this particular vaccine is causing a rare autoimmune reaction that triggers antibodies, which then interact with the platelets, but we don’t know why this is happening,” Dr. Klamroth said.

Covid-19 Vaccines

Write to Bojan Pancevski at bojan.pancevski@wsj.com

Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

View Source