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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.

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Michigan’s governor, confronting a surge in virus cases, calls on Biden for more vaccines.

Gov. Gretchen Whitmer of Michigan said Friday that she had urged President Biden to surge Covid-19 vaccines into her state, where a worst-in-the-nation outbreak has filled hospitals and forced some schools to close.

“I made the case for a surge strategy. At this point that’s not being deployed, but I am not giving up,” Ms. Whitmer said, describing a Thursday evening call with the president. “Today it’s Michigan and the Midwest. Tomorrow it could be another section of our country.”

Ms. Whitmer, a Democrat whom the president considered as a potential running mate, took pains to praise aspects of Mr. Biden’s coronavirus response at a Friday news conference. But Ms. Whitmer said a rapid influx of shots, particularly the one-dose Johnson & Johnson vaccine, was essential to tamping down case numbers even as she resisted additional restrictions on gatherings and businesses. Johnson & Johnson will send 86 percent fewer doses across the United States next week than are currently being allocated, according to data provided by the Centers for Disease Control and Prevention, dealing a setback to a national vaccination campaign that has just found its footing.

“The Biden administration does have a strategy and by in large it is working,” Ms. Whitmer said. “As should be expected, though, in an undertaking of this magnitude, there are shortcomings and different points of view.”

Michigan is bad and getting worse. Hospitalizations have more than tripled in the last month and cases continue to spike. About 7,200 new cases are being reported each day, a sevenfold increase since late February. And 16 of the 20 metro areas with the country’s highest recent case rates are in Michigan.

Debra Furr-Holden, an epidemiologist at Michigan State University, said before the governor’s announcement on Friday that the state should reimpose restrictions that were loosened just before the most recent surge.

“What it looks like happened is she tried to be fair and meet us in the middle,” said Dr. Furr-Holden, who was appointed last year by Ms. Whitmer to the state’s Coronavirus Task Force on Racial Disparities. “And what I think we’ve learned — and I hope other states will get the message — is that there really isn’t a lot of middle ground here. We just have to tighten up and hold tight.”

But there is also a sense — articulated by Ms. Whitmer, politicians from both parties and even some public health officials — that pandemic fatigue and partisanship have limited the effectiveness that any new state mandates might have.

“It’s been a long time,” said Mayor Pauline Repp of Port Huron, where case rates are among the highest in the country. “It’s a long time to be restrictive and you get to the point where you kind of think, ‘Will life ever go back to normal?’”

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India Suffers a Coronavirus Second Wave, With Global Impact

NEW DELHI — When the coronavirus first struck India last year, the country enforced one of the world’s strictest national lockdowns. The warning was clear: A fast spread in a population of 1.3 billion would be devastating.

Though damaging and ultimately flawed, the lockdown and other efforts appeared to work. Infections dropped and deaths remained low. Officials and the public dropped their guard. Experts warned fruitlessly that the government’s haphazard approach would bring a crisis when a new wave appeared.

Now the crisis is here.

India on Friday reported a daily record of 131,878 new infections as Covid-19 races out of control. Deaths, while still relatively low, are rising. Vaccinations, a mammoth task in such a large nation, are dangerously behind schedule. Hospital beds are running short.

Parts of the country are reinforcing lockdowns. Scientists are rushing to track new strains, including the more hazardous variants found in Britain and South Africa, that may be hastening the spread. But the authorities have declared contact tracing in some places to be simply impossible.

now behind the United States and Brazil.) The economic blowback of the resulting lockdown was devastating.

But the numbers at the time actually understated the first wave, scientists now say, and deaths in India never matched levels of the United States or Britain. Leaders began acting as if the problem had been solved.

Serum Institute of India, one of the world’s largest vaccine makers, boasted of a major stockpile of the Oxford-AstraZeneca vaccine, which makes up the bulk of the country’s drive. The government even launched a “vaccine diplomacy” campaign that sent doses to other countries.

But the initial rollout within India was slowed by complacency and plagued with public skepticism, including questions about the Oxford-AstraZeneca vaccine and lack of disclosure about an Indian-developed dose. Now the vaccination program is not matching the spread. The Serum Institute has said that practically all of its daily production of about two million doses will over the next two months go to the government, delaying commitments to other countries.

Several Indian states now worry that their vaccines stocks will run out. Mumbai, India’s largest city, had shut more than half of its vaccination centers, local media reported on Friday. The central government’s health minister lashed out at the states, reassuring that there would be no shortage and that more supplies were in the pipeline.

hit the campaign trail for state elections. Prime Minister Modi has addressed more than 20 rallies, each with thousands of often-unmasked people.

On Wednesday, Delhi officials said that even a solo car driver would be punished for not wearing a mask properly. The same day, Amit Shah, the country’s de facto No. 2 leader, drove through a campaign crowd in the state of West Bengal, waving without a mask and throwing rose petals.

The government also gave the go ahead for a long Hindu religious festival called Kumbh Mela, which runs through the end of April. Between one million to five million people attend the festival each day in the city of Hardiwar, on the banks of the river Ganges in the state of Uttarakhand.

no one would face restrictions as “the faith in God will overcome the fear of Covid-19.” Days later, Mr. Rawat tested positive for Covid.

The positivity rate of random tests is rising at the festival, and more than 300 participants have tested positive, said Dr. Arjun Singh Senger, a health officer at the festival.

The sheer speed of new infections has surprised health officials, who wonder whether variants might be a factor. Answering that question will be difficult. India has put only about 1 percent of its cases through genome sequencing tests, according to Dr. Reddy, of the Public Health Foundation of India, but researchers require a minimum of 5 percent to determine what is circulating.

So far, the government has found variants from the U.K. and South Africa as well as a local mutation. Limited information suggests that more infectious variants are circulating in India, as well, Dr. Reddy said.

Even if the variants have not yet been a major part of the new wave of infections, they have cast a shadow over India’s crucial vaccination drive. The AstraZeneca vaccine has been rejected by South Africa ineffective against that variant.

“This time, the speed is much faster than the last time,” said Dr. Vinod K. Paul, the head of India’s Covid response task force. “The next four weeks are very, very crucial for us.”

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To Speed Vaccination, Some Call for Delaying Second Shots

The prospect of a fourth wave of the coronavirus, with new cases climbing sharply in the Upper Midwest, has reignited a debate among vaccine experts over how long to wait between the first and second doses. Extending that period would swiftly increase the number of people with the partial protection of a single shot, but some experts fear it could also give rise to dangerous new variants.

In the United States, two-dose vaccines are spaced three to four weeks apart, matching what was tested in clinical trials. But in Britain, health authorities have delayed doses by up to 12 weeks in order to reach more people more quickly. And in Canada, which has precious few vaccines to go around, a government advisory committee recommended on Wednesday that second doses be delayed even longer, up to four months.

Some health experts think the United States should follow suit. Dr. Ezekiel J. Emanuel, a co-director of the Healthcare Transformation Institute at the University of Pennsylvania, has proposed that for the next few weeks, all U.S. vaccines should go to people receiving their first dose.

“That should be enough to quell the fourth surge, especially in places like Michigan, like Minnesota,” he said in an interview. Dr. Emanuel and his colleagues published the proposal in an op-ed on Thursday in USA Today.

10 days after the first dose, researchers could see that the volunteers were getting sick less often than those who got the placebo.

In the same month, Britain experienced a surge of cases caused by a new, highly transmissible variant called B.1.1.7. Once the British government authorized two vaccines — from Pfizer-BioNTech and AstraZeneca — it decided to fight the variant by delaying the second doses of both formulations by 12 weeks.

said on Jan. 31 on NBC’s “Meet the Press.”

But the government stayed the course, arguing that it would be unwise to veer off into the unknown in the middle of a pandemic. Although the clinical trials did show some early protection from the first dose, no one knew how well that partial protection would last.

“When you’re talking about doing something that may have real harm, you need empirical data to back that,” said Dr. Céline R. Gounder, an infectious-disease specialist at Bellevue Hospital Center and a member of Mr. Biden’s coronavirus advisory board. “I don’t think you can logic your way out of this.”

But in recent weeks, proponents of delaying doses have been able to point to mounting evidence suggesting that a first dose can provide potent protection that lasts for a number of weeks.

The Centers for Disease Control and Prevention reported that two weeks after a single dose of either the Moderna or the Pfizer-BioNTech vaccine, a person’s risk of coronavirus infection dropped by 80 percent. And researchers in Britain have found that first-dose protection is persistent for at least 12 weeks.

Dr. Emanuel argued that Britain’s campaign to get first doses into more people had played a role in the 95 percent drop in cases since their peak in January. “It’s been pretty stunning,” Dr. Emanuel said.

studies that show that a single dose of Moderna or Pfizer-BioNTech does not work as well against certain variants, such as B.1.351, which was first found in South Africa.

“Relying on one dose of Moderna or Pfizer to stop variants like B.1.351 is like using a BB gun to stop a charging rhino,” said John P. Moore, a virologist at Weill Cornell Medicine.

Dr. Moore said he also worried that delaying doses could promote the spread of new variants that can better resist vaccines. As coronaviruses replicate inside the bodies of some vaccinated people, they may acquire mutations that allow them to evade the antibodies generated by the vaccine.

But Dr. Cobey, who studies the evolution of viruses, said she wasn’t worried about delayed doses breeding more variants. “I would put my money on it having the opposite effect,” she said.

Last week, she and her colleagues published a commentary in Nature Reviews Immunology in defense of delaying doses. Getting more people vaccinated — even with moderately less protection — could translate into a bigger brake on the spread of the virus in a community than if fewer people had stronger protection, they said. And that decline wouldn’t just mean more lives were saved. Variants would also have a lower chance of emerging and spreading.

“There are fewer infected people in which variants can arise,” she said.

Dr. Adam S. Lauring, a virologist at the University of Michigan who was not involved in the commentary, said he felt that Dr. Cobey and her colleagues had made a compelling case. “The arguments in that piece really resonate with me,” he said.

Although it seems unlikely that the United States will shift course, its neighbor to the north has embraced a delayed strategy to cope with a booming pandemic and a short supply of vaccines.

Dr. Catherine Hankins, a public health specialist at McGill University in Montreal and a member of Canada’s Covid-19 Immunity Task Force, endorsed that decision, based on the emerging evidence about single doses. And she said she thought that other countries facing even worse shortfalls should consider it as well.

“I will be advocating at the global level that countries take a close look at Canada’s strategy and think seriously about it,” Dr. Haskins said.

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Vaccine Passports Could Unlock World Travel and Cries of Discrimination

LONDON — For Aruba, a Caribbean idyll that has languished since the pandemic drove away its tourists, the concept of a “vaccine passport” is not just intriguing. It is a “lifeline,” said the prime minister, Evelyn Wever-Croes.

Aruba is already experimenting with a digital certificate that allows visitors from the United States who tested negative for the coronavirus to breeze through the airport and hit the beach without delay. Soon, it may be able to fast-track those who arrive with digital confirmation that they have been vaccinated.

“People don’t want to stand in line, especially with social distancing,” Ms. Wever-Croes said in an interview this week. “We need to be ready in order to make it hassle-free and seamless for the travelers.”

Vaccine passports are increasingly viewed as the key to unlocking the world after a year of pandemic-induced lockdowns — a few bytes of personal health data, encoded on a chip, that could put an end to suffocating restrictions and restore the freewheeling travel that is a hallmark of the age of globalization. From Britain to Israel, these passports are taking shape or already in use.

But they are also stirring complicated political and ethical debates about discrimination, inequality, privacy and fraud. And at a practical level, making them work seamlessly around the globe will be a formidable technical challenge.

The debate may play out differently in tourism- or trade-dependent outposts like Aruba and Singapore, which view passports primarily as a tool to reopen borders, than it will in vast economies like the United States or China, which have starkly divergent views on civil liberties and privacy.

The Biden administration said this week that it would not push for a mandatory vaccination credential or a federal vaccine database, attesting to the sensitive political and legal issues involved. In the European Union and Britain, which have taken tentative steps toward vaccine passports, leaders are running into thorny questions over their legality and technical feasibility.

And in Japan, which has lagged the United States and Britain in vaccinating its population, the debate has scarcely begun. There are grave misgivings there about whether passports would discriminate against people who cannot get a shot for medical reasons or choose not to be vaccinated.

Japan, like other Asian countries, has curbed the virus mainly through strict border controls.

“Whether or not to get vaccinated is up to the individual,” said Japan’s health minister, Norihisa Tamura. “The government should respond so that people won’t be disadvantaged by their decision.”

Still, almost everywhere, the pressure to restart international travel is forcing the debate. With tens of millions of people vaccinated, and governments desperate to reopen their economies, businesses and individuals are pushing to regain more freedom of movement. Verifying whether someone is inoculated is the simplest way to do that.

“There’s a very important distinction between international travel and domestic uses,” said Paul Meyer, the founder of the Commons Project, a nonprofit trust that is developing CommonPass, a scannable code that contains Covid testing and vaccination data for travelers. Aruba was the first government to sign up for it.

“There doesn’t seem to be any pushback on showing certification if I want to travel to Greece or Cyprus,” he said, pointing out that schools require students to be vaccinated against measles and many countries demand proof of yellow fever vaccinations. “From a public health perspective, it’s not fair to say, ‘You have no right to check whether I’m going to infect you.’”

CommonPass is one of multiple efforts by technology companies and others to develop reliable, efficient systems to verify the medical status of passengers — a challenge that will deepen as more people resume traveling.

At Heathrow Airport in London, which is operating at a fraction of its normal capacity, arriving passengers have had to line up for hours while immigration officials check whether they have proof of a negative test result and have purchased a mandatory kit to test themselves twice more after they enter the country.

Saudi Arabia announced this week that pilgrims visiting the mosques in Mecca and Medina during the Muslim holy month of Ramadan would have to show proof on a mobile app of being “immunized,” which officials defined as having been fully vaccinated, having gotten a single dose of a vaccine at least 14 days before arrival, or having recovered from Covid.

In neighboring United Arab Emirates, residents can show their vaccination status on a certificate through a government-developed app. So far, the certificate is not yet widely required for anything beyond entering the capital, Abu Dhabi, from abroad.

Few countries have gone farther in experimenting with vaccine passports than Israel. It is issuing a “Green Pass” that allows people who are fully vaccinated to go to bars, restaurants, concerts and sporting events. Israel has vaccinated more than half its population and the vast majority of its older people, which makes such a system useful but raises a different set of questions.

With people under 16 not yet eligible for the vaccine, the system could create a generational divide, depriving young people of access to many of the pleasures of their elders. So far, enforcement of the Green Pass has been patchy, and in any event, Israel has kept its borders closed.

So has China, which remains one of the most sealed-off countries in the world. In early March, the Chinese government announced it would begin issuing an “international travel health certificate,” which would record a user’s vaccination status, as well as the results of antibody tests. But it did not say whether the certificate would spare the user from China’s draconian quarantines.

Nor is it clear how eager other countries would be to recognize China’s certificate, given that Chinese companies have been slow in disclosing data from clinical trials of their homegrown vaccines.

Singapore has also maintained strict quarantines, even as it searches for way to restart foreign travel. Last week, it said it would begin rolling out a digital health passport, allowing passengers to use a mobile app to share their coronavirus test results before flying into the island nation.

Free movement across borders is the goal of the European Union’s “Digital Green Certificate.” The European Commission last month set out a plan for verifying vaccination status, which would allow a person to travel freely within the bloc. It left it up to its 27 member states to decide how to collect the health data.

That could avoid the pitfalls of the European Union’s vaccine rollout, which was heavily managed by Brussels and has been far slower than that in the United States or Britain. Yet analysts noted that in data collection, there is a trade-off between decentralized and centralized systems: the former tends to be better at protecting privacy but less efficient; the latter, more intrusive but potentially more effective.

“Given the very unequal access to vaccines we are witnessing in continental Europe, there is also an issue of equal opportunity and potential discrimination,” said Andrea Renda, a senior research fellow at the Center for European Policy Studies in Brussels.

For some countries, the legal and ethical implications have been a major stumbling block to domestic use of a passport. As Prime Minister Justin Trudeau of Canada put it last month, “There are questions of fairness and justice.”

And yet in Britain, which has a deeply rooted aversion to national ID cards, the government is moving gingerly in that direction. Prime Minister Boris Johnson last week outlined broad guidelines for a Covid certificate, which would record vaccination status, test results, and whether the holder had recovered from Covid, which confers a degree of natural immunity for an unknown duration.

Mr. Johnson insisted that shops, pubs and restaurants would not be required to demand the certificate, though they could opt to do so on their own. That did not stop dozens of lawmakers, from his Conservative Party and the opposition Labour Party, from opposing the plan on grounds that were legal, ethical and plainly commercial — that it could keep people out of the country’s beloved pubs.

Government officials now suggest that the plan is targeted less at pubs and restaurants and more at higher-risk settings, like nightclubs and sporting events.

“Would we rather have a system where no one can go to a sports ground or theater?” said Jonathan Sumption, a former justice on Britain’s Supreme Court, who has been an outspoken critic of the government’s strict lockdowns. “It’s better to have a vaccine passport than a blanket rule which excludes these pleasures from everybody.”

Reporting was contributed by Stephen Castle in London, Motoko Rich in Tokyo, Shashank Bengali in Singapore, Vivian Wang in Hong Kong, Vivian Yee in Cairo, Asmaa al-Omar in Beirut, and Ian Austen in Ottawa.

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As U.S. Prospects Brighten, Fed’s Powell Sees Risk in Global Vaccination Pace

Jerome H. Powell, the Federal Reserve chair, stressed on Thursday that even as economic prospects look brighter in the United States, getting the world vaccinated and controlling the coronavirus pandemic remain critical to the global outlook.

“Viruses are no respecters of borders,” Mr. Powell said while speaking on an International Monetary Fund panel. “Until the world, really, is vaccinated, we’re all going to be at risk of new mutations and we won’t be able to really resume activity with confidence all around the world.”

While some advanced economies, including the United States, are moving quickly toward widespread vaccination, many emerging market countries lag far behind: Some have administered as little as one dose per 1,000 residents.

Mr. Powell joined a chorus of global policy officials in emphasizing how important it is that all nations — not just the richest ones — are able to widely protect against the coronavirus. Kristalina Georgieva, the managing director of the International Monetary Fund, said policymakers needed to remain focused on public health as the key policy priority.

fresh data showed that state jobless claims climbed last week. Mr. Powell pointed out that the burden is falling heavily on those least able to bear it: Lower-income service workers, who are heavily minorities and women, have been hit hard by the job losses.

raising corporate taxes.

“For quite some time, we have been in favor of more investment in infrastructure. It helps to boost productivity here in the United States,” Ms. Georgieva said, calling climate-focused and “social infrastructure” provisions positive. She said they had not had a chance to fully assess the plan, but “broadly speaking, yes, we do support it.”

But the White House’s plan has already run into resistance from Republicans and some moderate Democrats, who are wary of raising taxes or engaging in another big spending package after several large stimulus bills.

Some commentators have warned that besides expanding the nation’s debt load, the government’s virus spending — particularly the recent $1.9 trillion stimulus package — could cause the economy to overheat. Fed officials have been less worried.

“There’s a difference between essentially a one-time increase in prices and persistent inflation,” Mr. Powell said on Thursday. “The nature of a bottleneck is that it will be resolved.”

If price gains and inflation expectations moved up “materially,” he said, the Fed would react.

“We don’t think that’s the most likely outcome,” he said.

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Slovakia Claims a Bait-and-Switch With the Russian Vaccines it Ordered

The European Union’s regulator, the European Medicines Agency, has so far declined to approve the Russian vaccine for use and only two members of the bloc, Hungary and Slovakia, have placed orders for Sputnik V. Serbia, which is not a member of the bloc, has also ordered Sputnik V and begun using it in a mass inoculation program that has been far more successful than the stumbling efforts of most European Union states.

Even Germany, a stickler for procedure, has expressed growing interest in Sputnik V. Health Minister Jens Spahn told the public broadcaster WDR on Thursday that he would like to start bilateral talks with Russia over a potential purchase of the vaccine, which would go through only if it is approved by the European Medicines Agency.

The previous day, Markus Söder, the governor of Bavaria, said his government had signed a preliminary agreement to buy 2.5 million doses of the vaccine, which are to be produced at a Russian-owned plant in the southern state. That deal, too, is contingent on E.M.A. approval.

Sputnik V is manufactured at seven locations in Russia, and also at plants in India and South Korea. A number of other countries have signed manufacturing contracts, including Brazil, Turkey and Serbia. Russia has consistently delivered fewer doses of the vaccine than initially promised, suggesting glitches in manufacturing. Producing vaccines at scale is a difficult process and ramping up production has presented problems for Western vaccines, too.

Noting that about 40 countries are using or scheduled to use the Russian vaccine, the Slovak regulatory agency asserted that “these vaccines are only associated by the name.” That raised questions about deviations from the formula reviewed in The Lancet.

“The comparability and consistency of different batches produced at different locations has not been demonstrated,” the Slovak regulator said. “In several cases, they appear to be vaccines with different properties (lyophilisate versus solution, single-dose ampoules versus multi-dose vials, different storage conditions, composition and method of manufacture).”

The Slovak statement could damage Russia’s efforts to establish Sputnik V as a reliable brand. It could also exacerbate lingering doubts left by the vaccine’s highly politicized rollout in Russia, where President Vladimir V. Putin announced that the drug was ready for use in August, before clinical trials had finished.

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