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A brand new research hints at a purpose the J.&J. and AstraZeneca vaccines could trigger blood clots in uncommon circumstances.

A new study hints at a reason the J.&J. and AstraZeneca vaccines may cause blood clots in rare cases.

An advisory group from the Centers for Disease Control and Prevention has recommended that the Johnson & Johnson Covid-19 vaccine hiatus be lifted for all adults while also putting up a warning sign about a rare but dangerous blood clot disorder. However, a central mystery remains: how could a vaccine given to nearly eight million people cause the side effect in just a few of them?

There’s no clear answer yet, but Dr. Andreas Greinacher, a researcher at the University Medical Center Greifswald in Germany, leads an attempt to find out. Speaking at a news conference on Tuesday, he said he had an agreement with Johnson & Johnson to study the components of the vaccine to see if it could interfere with normal blood clotting under certain rare conditions.

“We just agreed that we’d like to work together,” he said.

It is possible, said Dr. Greinacher that the Johnson & Johnson vaccine can cause rare side effects through the same process that he suspects is responsible for similar side effects of the AstraZeneca vaccine. The main component of both vaccines are harmless viruses called adenoviruses, which invade human cells and deliver a coronavirus gene that later triggers an immune response.

On Tuesday, Dr. Greinacher and his colleagues published a report on how the AstraZeneca vaccines can trigger the side effect. The study has not yet been published in a scientific journal.

The scientists found that components of the AstraZeneca vaccine can adhere to a protein that releases platelets when blood clots form. These lumps of molecules could be viewed by the body as foreign invaders, the scientists speculated, triggering a cascade of reactions that turn platelets into dangerous clots.

Dr. Paul A. Offit, a vaccines expert at Philadelphia Children’s Hospital who was not involved in the study, found Dr. Greinacher fascinating, but far from the final word. “It throws a lot of opportunities,” he said.

Dr. Offit said it was not clear which of the many factors the researchers looked at could explain the rare blood clots in people vaccinated with AstraZeneca’s doses. “It’s like taking a sip from a fire hose,” he said.

At a press conference on Tuesday, Dr. Greinacher said the research could reveal ways the AstraZeneca vaccine can lower the risk of blood clots or treat the side effects. However, he stressed that the small risk of these side effects was outweighed by the protection that vaccines like AstraZeneca offer against Covid-19.

“Not being vaccinated is far more dangerous than being vaccinated and at risk for this adverse drug reaction,” he said.

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Health

Vaccines Are Efficient In opposition to the New York Variant, Research Discover

Vaccines Are Effective Against the New York Variant, Studies Find

For weeks, New Yorkers have been witnessing the alarming rise of a native variant of the coronavirus that has stubbornly kept the number of cases in the city high. City officials have repeatedly warned that the variant could be more contagious and evade the immune response.

At least on this second point, they can now breathe easier: Both the Pfizer BioNTech and Moderna vaccines will be effective in preventing serious illness and death of the variant, according to two independent studies.

Antibodies stimulated by these vaccines are only slightly less effective in controlling the variant than the original form of the virus, both studies found.

“We don’t see any big differences,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York and a member of the team that published one of the studies on Thursday.

The final result? “Get vaccinated,” he said.

The results are based on laboratory experiments with blood samples from a few vaccinated people and have not yet been assessed by experts. Still, they are consistent with what is known about similar variants, several experts said, and they complement a growing body of research suggesting that the two main vaccines in the United States protect against all of the variants identified so far.

“The takeaway message is that the vaccines against the New York variant and the South African variant as well as the British variant will work,” said Nathan Landau, a virologist at NYU’s Grossman School of Medicine who led the study.

The vaccines spur the body to build an expansive immune response using thousands of types of antibodies and different types of immune cells. A subset of these immune fighters, called neutralizing antibodies, is essential to preventing infection. But even when neutralizing antibodies are in short supply or even absent, the rest of the immune system can deploy enough defenses to fight off serious illness and death.

In both new studies, neutralizing antibodies from people who were vaccinated were able to thwart the virus better than those from people who developed antibodies because they had Covid-19. A head-to-head comparison of the two sets of antibodies offered a possible explanation: Antibodies from vaccinated individuals are spread over a wider range of parts of the virus, so no single mutation has a major impact on their effectiveness – vaccines are therefore a better choice against variants than immunity from natural ones Infections.

The variant first identified in New York, known to scientists as the B.1.526, sped through the city after its first discovery in November. By April 13, it was one in four diagnosed cases, and as of April 13, almost half of the cases. Variant B.1.1.7, which brought Great Britain to a standstill, is also widespread in New York. Together, the two account for more than 70 percent of coronavirus cases in the city.

Concern for the variant identified in New York has centered on a form that contains a mutation that scientists call Eek. The Eek mutation subtly changes the shape of the virus, making it difficult for antibodies to target the virus and, as a result, underperforms vaccines.

Updated

April 23, 2021 at 12:36 AM ET

In the second study, Dr. Landau states that the Pfizer and Moderna vaccines are only marginally less protective against the variant that devastated the UK and against forms of the variant discovered in New York that do not contain the Eek mutation.

Several laboratory studies have shown that antibodies induced by the Pfizer and Moderna vaccines are slightly less effective against a third variant identified in South Africa that also contains Eek. Other vaccines fared worse. South Africa suspended use of the AstraZeneca vaccine after clinical studies showed that the vaccine did not prevent mild or moderate disease of the variant circulating there.

“It already started at a lower level in terms of the immunity it produced,” said Dr. Nut branch about the AstraZeneca vaccine. Regarding the Pfizer and Moderna recordings, he said, “We are so lucky in this country to have these vaccines compared to the rest of the world.”

Florian Krammer, an immunologist at the Icahn School of Medicine on Mount Sinai who was not involved in any of the new studies, said he was more concerned about other countries’ vaccination programs than the variants themselves.

“I’m less worried about variants than I was two months ago,” he said, but added, “I’m worried about countries that don’t have enough vaccines and that don’t have this vaccine launch.” In all honesty, I don’t worry about the US anymore. “

Dr. Landau also tested monoclonal antibodies used to treat Covid-19 against the variants. They found that the cocktail of monoclonal antibodies made by Regeneron was effective against both the variant discovered in New York and the original virus.

The studies are reassuring, but they show that the Eek mutation is being observed, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.

“This could certainly be a step towards making the virus a little more resistant to infection- and vaccine-mediated immunity,” said Dr. Bloom. “I don’t think it’s something people need to be alerted about right away, but it definitely impresses us as important.”

Dr. Bloom led the analysis comparing vaccine-induced antibodies with those produced by natural infections. He found that the strongest antibodies bind to multiple sites in a key part of the virus. Even if a mutation affected binding at one site in that region, antibodies targeting the remaining sites would still be protective.

Antibodies induced by the vaccine cover many more sites in this region than those due to natural infection – and are therefore less likely to be affected by a mutation in any one site.

The study only looked at antibodies stimulated by the Moderna vaccine, but the results for the Pfizer BioNTech vaccine are likely to be the same, he added.

“This could potentially be a good thing as the virus creates mutations,” said Dr. Bloom.

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World News

Covid-19 Dwell Updates: Vaccines, Variants and Instances

South African health care workers were given the Johnson & Johnson vaccine at a hospital in Johannesburg in March.

Here’s what you need to know:

Credit…Joao Silva/The New York Times

South Africa will resume the use of the Johnson & Johnson vaccine to inoculate health care workers next week, offering some relief to the country that has suffered a series of blows to its vaccination efforts in recent months, according to South African authorities.

The country suspended an early-access Johnson & Johnson vaccination program last week after health officials in the United States put a pause on the vaccine amid concerns of rare blood clots that emerged in a handful of people who received it.

South Africa’s decision to move forward again was the second green light this week for Johnson & Johnson. On Tuesday, the European Union drug regulator also recommended resuming the rollout of the company’s vaccine.

Now, many eyes are on Washington, where a federal advisory panel is scheduled to meet Friday to discuss whether to lift the pause in the United States.

The blood clots that led to the Johnson & Johnson suspensions were all reported in the United States. In South Africa, officials confirmed Thursday that no cases of clots have been reported among the roughly 290,000 health care workers who have received the vaccine so far.

“The temporary suspension in South Africa was in line with government’s commitment to ensure comprehensive measures are undertaken regarding vaccine rollout,” Khumbudzo Ntshavheni, a cabinet minister, told reporters on Thursday.

Health experts welcomed the resumption of the vaccine campaign in South Africa, which has recorded more coronavirus cases than any other country on the continent and has suffered serious setbacks in its attempt to combat the virus in recent months.

In February, health officials scrapped plans to use the AstraZeneca vaccine after it proved ineffective against a variant of the virus now dominant in South Africa. The decision came a week after a million doses of the vaccine arrived in the country and amid a devastating second wave of virus cases.

Though the Johnson & Johnson vaccine has not yet been approved for general use in South Africa, it has been used as part of a research study offering early access to the vaccine to the country’s 1.2 million health care workers.

South African health officials are gearing up to extend vaccinations to the general public starting in May. In a first step to launching a national rollout, the country last week opened its vaccine registration to people over 60 years old, who will be among the first to be inoculated.

That plan depends on tens of millions of doses of the Pfizer-BioNTech vaccine, which requires two doses and will be used in major cities. The single-shot Johnson & Johnson vaccine, which is easier to store and better for hard-to-reach populations, will be used in the country’s rural areas.

United States › United StatesOn Apr. 21 14-day change
New cases 64,853 –4%
New deaths 879 –1%
World › WorldOn Apr. 21 14-day change
New cases 952,928 +23%
New deaths 17,951 +14%

U.S. vaccinations ›

Where states are reporting vaccines given

People waiting in line to register for a vaccination in Brooklyn earlier this month.Credit…Spencer Platt/Getty Images

Federal health officials appear to be leaning toward lifting their recommended pause on the use of Johnson & Johnson’s coronavirus vaccine after finding only a limited number of additional cases of a rare blood clotting disorder among recipients.

Instead, the Food and Drug Administration is likely to attach a warning to the vaccine’s label to inform health practitioners — and the public — about the exceedingly uncommon, but dangerous possible side effect.

Federal health officials are waiting to act until they hear from a committee of outside experts who advise the C.D.C. The committee is scheduled to meet on Friday to discuss whether to recommend lifting, extending or modifying the pause that was initiated on April 13.

“We know that it’s not a good thing to leave the pause going for any longer than it absolutely has to go for,” Dr. Peter Marks, the Food and Drug Administration’s top vaccine regulator, said Thursday, adding that a protracted pause could contribute to greater vaccine hesitancy. “Once, essentially, the adequate discussion has occurred, we’re prepared to move as quickly as we possibly can.”

When top federal health officials abruptly decided early last week to recommend a temporary halt in the use of the shot, six women had been reported to have suffered from the disorder, a combination of clots in the brain that led to bleeding and low platelets, components of the blood that normally help to heal wounds.

That was fewer than one in a million recipients of Johnson & Johnson’s shot in the United States. But officials worried that more cases were hidden or could develop shortly as the new vaccine rolled out.

That fear has not materialized.

Dr. Marks and Dr. Janet Woodcock, the F.D.A.’s acting commissioner, said the clotting disorder appeared to be nearly as rare as they hoped it would be when they recommended the pause.

“We’ve now received more cases, but it isn’t an avalanche,” Dr. Woodcock said “We’re not seeing a big surge, which is a great relief.”

Even if the C.D.C.’s advisory committee decides Friday that the benefits of Johnson & Johnson’s single-dose vaccine outweigh its risks, the company will still face manufacturing hurdles at a Baltimore plant that regulators have refused so far to certify. That plant was supposed to deliver the bulk of the nearly 100 million doses the firm had promised to have ready by the end of May.

But it would mean a temporary surge of about 10 million shots that were effectively put on hold when the pause was announced.

A man who died of complications from the coronavirus was being cremated in Mumbai on Wednesday.Credit…Atul Loke for The New York Times

India’s rapidly worsening coronavirus outbreak is now expanding on a scale beyond any previously measured in more than a year of the pandemic: The health ministry reported more than 310,000 new infections on Thursday, the most recorded in any country on a single day.

India’s total eclipsed the previous one-day high of 300,669 recorded coronavirus cases, set in the United States on Jan. 8, according to a New York Times database, though differences in testing levels from country to country, and a widespread lack of tests early in the pandemic, make comparisons difficult.

Over the past two months, the outbreak in India has exploded, with reports of superspreader gatherings, oxygen shortages and ambulances lined up outside hospitals because there were no ventilators for new patients.

As cases worldwide reach weekly records, a substantial proportion of the new infections are coming in India, a sobering reminder that the pandemic is far from over, even as infections decline and vaccinations speed ahead in the United States and other wealthy parts of the world. India has surpassed 15.6 million total reported infections so far, second-most after the United States.

The death toll has also begun to climb precipitously.

On Thursday, the Indian government recorded 2,104 deaths, and an average of more than 1,600 people have died of the virus every day for the past week. That is less than the tolls at the worst points of the pandemic in the United States or Brazil, but it is a steep increase from just two months ago, when fewer than 100 people in India were dying daily.

There are signs that the country’s health system, patchy even before the pandemic, is collapsing under the strain. On Tuesday, at least 22 people died in an accident in the central city of Nashik when a leak in a hospital’s main oxygen tank cut the flow of oxygen to Covid-19 patients.

The picture is staggeringly different from early February, when India was recording an average of just 11,000 cases a day, and domestic drug companies were pumping out millions of vaccine doses. More than 132 million Indians have received at least one dose, but supplies are running low and experts warn that the country is unlikely to meet its goal of inoculating 300 million people by the summer.

Critics say Prime Minister Narendra Modi, who imposed a harsh nationwide lockdown in March 2020 in the early stages of the pandemic, failed to prepare for a second wave or to warn Indians to remain vigilant against the virus, especially as more infectious variants began to spread.

Mr. Modi’s Hindu nationalist government has also allowed a massive Hindu festival to take place, drawing millions of pilgrims to the banks of the Ganges River, and his party has held packed political rallies in several states.

“India’s rapid slide into this unprecedented crisis is a direct result of complacency and lack of preparation by the government,” Ramanan Laxminarayan, the director of the Center for Disease Dynamics, Economics and Policy in Washington, wrote in The New York Times on Tuesday.

The hardest-hit region is Maharashtra, a populous western state that includes the financial hub of Mumbai. On Wednesday, the state’s top leader ordered government offices to operate at 15 percent capacity and imposed new restrictions on weddings and private transportation to slow the spread of the virus.

This week, Britain’s prime minister, Boris Johnson, and Japan’s prime minister, Yoshihide Suga, called off plans to visit India. On Thursday, the Australian prime minister, Scott Morrison, said that direct flights from India would be reduced by about 30 percent, and that Australians would be allowed to travel to India only in “very urgent circumstances.” Canada also suspended all direct flights from India and Pakistan starting Thursday night for 30 days.

People relaxed in the Place des Vosges in central Paris on Saturday. Prime Minister Jean Castex said that France will relax many of its coronavirus restrictions in May. Credit…Dmitry Kostyukov for The New York Times

The French government outlined plans on Thursday to gradually reopen the country starting in early May, stoking hopes that life might finally return to something close to normal after more than a year of on-and-off pandemic restrictions.

Prime Minister Jean Castex said at a news conference that primary school students would be allowed to return to classrooms on Monday, followed by middle and high school students the following week. Travel restrictions will be lifted on May 3.

Depending on how things are going at that point, Mr. Castex said, retail stores, outdoor dining, and certain cultural and sporting activities could start to reopen in mid-May.

The pandemic situation appears to be improving in France, with the daily average number of new cases falling to about 32,000 from 42,000 the week before. Hospitalizations seem to have plateaued at nearly 6,000.

“The peak of the third wave seems to be behind us,” Mr. Castex said.

The government is hoping to alleviate the deep sense of pandemic fatigue that has taken root in France. When the country went into its third lockdown at the start of April, once again closing schools and “nonessential” retail stores, the move was met with anger and some pointed protests.

Hundreds of lingerie shops across France, closed under the lockdown order, have been mailing panties to Mr. Castex since the beginning of the week, as part of a campaign called “Action Culottée,” meaning “cheeky action,” which was coordinated on Facebook.

The country’s vaccination campaign, which stumbled for months, has gathered speed recently, and is now administering about 2.5 million doses a week. More than 13 million people have received at least one dose so far, and the country aims to raise the figure to 20 million — 30 percent of the population — by mid-May. Even so, France lags far behind countries like the United States, Britain and Israel in its vaccination efforts.

To limit the spread of highly transmissible virus variants, Mr. Castex said, France will tighten testing and quarantine requirements for travelers arriving from five countries — Brazil, Chile, Argentina, South Africa and India — where the variants are circulating widely.

The Atlantic City boardwalk last July.Credit…Michelle Gustafson for The New York Times

With summer on the horizon, states are beginning to rethink social-distancing measures.

In Rhode Island, Gov. Dan McKee said that starting May 7, the state will stop requiring masks outside, and social gatherings can increase to 25 people indoors and 75 people outdoors. By May 28, the state will lift capacity limits on businesses and houses of worship; the bar areas of restaurants will be able to open; and dance floors can once again be filled.

“It’s a good day for everyone here in the Ocean State,” Mr. McKee said at a news conference Thursday. “It’s a little early to put a ‘Mission Accomplished’ sign up but we’re getting ready to order that sign.”

Mr. McKee attributed the reopening plans to the state’s vaccination rate — 48 percent of residents have received at least one shot and 33 percent are fully vaccinated, according to a New York Times database. But masks will still be required indoors.

Rhode Island is not alone.

On Monday, Gov. Ned Lamont of Connecticut announced that his state would phase out all pandemic restrictions, except the indoor mask mandate, by May 19. And in New Jersey, Gov. Phil Murphy said Wednesday that he would announce “a pretty significant amount of guidance” for summer activities next week.

“We don’t want to lurch, in other words go forward and then have to pull something back,” Mr. Murphy said at his weekly news conference. “And we don’t want to start that now. But we also owe people our best guesses for what it’s going to look like for graduation, summer, the beaches and what not.”

As more people get vaccinated and the outdoors become more appealing with spring weather and sunshine, one question persists: Do we still need to wear masks outside? Science shows that the risk of viral transmission outside is very low. The Times’ Well columnist, Tara Parker-Pope, suggests making sure your activity meets two out of the following three conditions: outdoors, distanced and masked.

Global Roundup

Police officers stood guard in Berlin as Germans demonstrated against coronavirus measures on Wednesday.Credit…Christian Mang/Reuters

BERLIN — State lawmakers in Germany approved a new version of a law on Thursday boosting the federal government’s power to enforce uniform coronavirus lockdown rules. New restrictions are expected in most districts soon after the president signs the bill into law, which could be as early as Thursday afternoon.

The law, which Chancellor Angela Merkel’s cabinet passed last week, is a response to a disjointed virus response by state governments, which previously had the ultimate say in carrying out restrictions. For months, experts have called for a lockdown to control Germany’s surging third wave of coronavirus infections.

Under the law passed by the federal council of states on Thursday, the rules would apply uniformly across the country but would depend on the rate of infection in each district, leading to more severe lockdowns in highly affected areas. There would be a curfew from 10 p.m. to 5 a.m. in districts with more than 100 new infections per 100,000 people in a week. Restaurants would remain closed, and nonessential stores would require an appointment and a negative test result in districts with more than 150 new infections per 100,000 people. Schools would close if 165 new infections per 100,000 were registered.

Germany is currently measuring 161 infections per 100,000 in a week, according to the health authorities, which also counted 29,518 new infections on Wednesday.

As many as 8,000 people, including right-wing extremists and coronavirus deniers, took to the streets in Berlin to protest the measures on Wednesday. Several lawsuits against it have already been announced.

Germany has recorded more than 80,000 deaths so far.

In other developments across the world:

  • Japan’s auto industry group canceled the biennial Tokyo Motor Show, scheduled for the fall, because of rising coronavirus cases, the Kyodo News agency reported. It was the first cancellation in the 67-year history of the event, which drew around 1.3 million people in 2019. Akio Toyoda, the chairman of the industry group and president of Toyota Motor Corp., said at a news conference that “it seems difficult to offer main programs in a safe environment.” The cancellation came as Japan reported 5,291 new infections, the highest daily total in three months. And it raised more questions about plans for the Tokyo Olympics, which organizers have insisted will begin in July even as officials plan to impose emergency measures in Tokyo and other municipalities.

  • The European Union will not order an extra 100 million vaccines from AstraZeneca foreseen in its contract, a European Commission spokesman said Thursday, underscoring the soured relationship between the pharmaceutical company and the bloc of 27 countries. The bloc could have added 100 million doses of vaccines to its existing order of 300 million from AstraZeneca but the time to do so has passed, Stefan de Keersmaecker, the spokesman, said. The European Union is embroiled in a dispute with the British-Swedish company over its inability to deliver expected doses, which has set the bloc’s vaccination efforts back significantly. They have been in a legal arbitration process for weeks, and the bloc is considering suing.

Megan Fairchild practicing in her parent’s home in Utah.Credit…Kim Raff for The New York Times

At the beginning of the pandemic, one of Megan Fairchild’s former dance teachers gave her some advice: Now would be a really great time to get pregnant. Ms. Fairchild, a principal at New York City Ballet, was aghast.

“I was like, that’s a ridiculous idea and the last thing on my mind right now,” she said. “This is going to last a couple months, and I don’t want to not be there when we get back.”

But when it became clear that her kind of live performance, dancing for thousands at Lincoln Center, would not be resuming anytime soon, the decision to have another child came to her in three words when she was meditating: Do it now.

For much of the pandemic year, Ms. Fairchild, 36, was pregnant with twins. On April 10, she gave birth to two girls.

She’s not the only one to have taken advantage of the theatrical shutdown. The dance world is experiencing a full-blown baby boom.

Federal regulators have found many shortcomings at a plant of Emergent BioSolutions in Baltimore.Credit…Saul Loeb/Agence France-Presse — Getty Images

WASHINGTON — Federal regulators have found serious flaws at the Baltimore plant that had to throw out up to 15 million possibly contaminated doses of Johnson & Johnson’s coronavirus vaccine, casting doubt on further production in the United States of a vaccine that the government once viewed as essential in fighting the pandemic.

The regulators for the Food and Drug Administration said that the company manufacturing the vaccine, Emergent BioSolutions, may have contaminated additional doses at the plant. They said the company failed to fully investigate the contamination, while also finding fault with the plant’s disinfection practices, size and design, handling of raw materials and training of workers.

The F.D.A. has not yet certified the plant, in Baltimore’s Bayview neighborhood, and no doses made there have gone to the public. All the Johnson & Johnson shots that have been administered in the United States have come from overseas.

The report amounted to a harsh rebuke of Emergent, which had long played down setbacks at the factory, and added to problems for Johnson & Johnson, whose vaccine had been seen as a game changer because it requires only one shot, can be produced in mass volume and is easily stored.

The inspection began after routine checks showed that Emergent workers had contaminated at least part of a batch of 13 million to 15 million doses of the Johnson & Johnson vaccine with the harmless virus that is used to make the AstraZeneca shot, which is not yet authorized in the United States.

The F.D.A. findings, based on an inspection that ended on Tuesday, underscore questions raised in reports by The New York Times about why Emergent did not fix problems earlier and why federal officials who oversee its lucrative contracts did not demand better performance.

In statements on Wednesday, the F.D.A., Emergent and Johnson & Johnson all said they were working to resolve the problems at the factory. There was no indication of how long that would take.

Nepal’s dethroned king, Gyanendra Shah, center, at Golden Temple in Amritsar, India, last year.Credit…Sameer Sehgal/Hindustan Times, via Getty Images

KATHMANDU, Nepal — At the beginning of this month, Nepal’s dethroned king, Gyanendra Shah, and his wife, Komal, traveled to northern India for the Kumbh Mela, a Hindu pilgrimage where millions seek a dip in the Ganges River to absolve themselves of their sins.

Gyanendra bathed in the river, and for 10 days, he and his aides mingled in crowds and met ascetics, Hindu leaders and other dignitaries. On April 18, he and Komal flew home to Nepal, where supporters welcomed them at the airport and formed a procession to escort them home, chanting pro-Hindu and pro-monarchy slogans along the way.

Three days later, the couple tested positive for the coronavirus. Now they are in quarantine at their residence in Kathmandu, the capital, while health officials in Nepal try to trace anyone who was in contact with them.

“Both king and queen have isolated themselves from other family members,” said Phani Raj Pathak, an aide to Gyanendra, who was dethroned when Nepal became a republic in 2008 and ended a two-century-old Hindu monarchy. The former ruler, who is in his 70s, retains support among some Hindus in Nepal as well as among critics of the elected government.

The infections have cast a harsh spotlight on the Kumbh Mela, where millions of Hindu pilgrims have gathered for weeks, shoulder to shoulder and often maskless, even as highly infectious variants of the coronavirus surge across South Asia. On Thursday, India reported more than 312,000 new infections, the highest daily total in any country since the pandemic began.

The Indian government has defended the gathering as safe, even as news media report thousands of infections among participants. Organizers say that attendees are required to wear masks and show proof of a negative coronavirus test, but they acknowledge that given the size of the event, many could have flouted the rules.

Now there are fears that the Kumbh Mela will cause the virus to explode in Nepal, which shares a porous border with India.

“The majority of people weren’t wearing face masks,” said Yogini Saritanandi, a pilgrim who returned to Nepal. She said she had seen “nothing other than a sea of humans on the bank of the Ganges.”

She said the authorities in the northern city of Haridwar, where the Kumbh Mela is being observed this year, began to slightly restrict entry after a few ascetics were reportedly infected and after India’s prime minister, Narendra Modi, urged organizers to observe social distancing. But it appeared to be too late.

“People got Covid one after another,” said Ms. Saritanandi, 43. “When I saw this, I thought of my 10-year-old son, and I cut my visit short to return to Nepal earlier.”

As Indian states impose new lockdowns, tens of thousands of Nepali migrant workers have returned from India without undergoing coronavirus tests. After reporting no new infections for much of January, Nepal is now averaging more than 1,100 cases a day, according to a New York Times database.

The government has closed schools and colleges in urban areas and tried to speed up vaccinations, with more than 1.7 million people having received at least one shot. But the inoculation drive was slowed after India restricted exports of vaccines to fight the outbreak at home, leaving Nepal to rely on a donation of shots from China.

A man used a self-administered coronavirus test kit in Durham, N.C., in February.Credit…Pete Kiehart for The New York Times

The health effects of Covid-19 not only can stretch for months, but also appear to increase the risk of death and chronic medical conditions even in people who were never sick enough with Covid to be hospitalized, according to a new study published Thursday in the journal Nature.

Researchers looked at medical records of more than 73,000 people across the United States who were infected with the coronavirus between March and November 2020 and did not require hospitalization. In the period from one to six months after becoming infected, those patients were 20 percent more likely to need outpatient medical care, and 60 percent more likely to die, than people who had not contracted the coronavirus.

The Covid survivors experienced a vast array of long-term medical problems that they had never had before — not just lung issues from the respiratory effects of the virus, but symptoms that could affect virtually any organ system or part of the body, from neurological to cardiovascular to gastrointestinal. They were also at greater risk of mental health problems, including anxiety and sleep disorders.

Some of the patients’ post-Covid medical issues — like diabetes, kidney disease and some heart problems — could become chronic conditions that would require treatment for the rest of their lives.

Most of the nearly 32 million people who have contracted the coronavirus in the United States have not needed hospitalization, so the findings may have wide implications. But the study sample and the control group they were compared with may not be very representative of the general public: They were Veterans Health System patients, overwhelmingly men with a median age over 60.

A pregnant woman receiving the Pfizer vaccine in Schwenksville, Pa., in February.Credit…Hannah Beier/Reuters

In an early analysis of coronavirus vaccine safety data, researchers at the Centers for Disease Control and Prevention have found no evidence that the Pfizer-BioNTech or Moderna vaccines pose serious risks during pregnancy.

The findings are preliminary and cover just the first 11 weeks of the U.S. vaccination program. But the study, which included self-reported data on more than 35,000 people who received one of the vaccines during or shortly before pregnancy, is the largest yet on the safety of the coronavirus vaccines in pregnant people.

During the clinical trials of the vaccines, pregnant women were excluded. That left patients, doctors and experts unsure whether the shots were safe to administer during pregnancy.

“There’s a lot of anxiety about whether it’s safe and whether it would work and what to expect as far as side effects,” said Dr. Stephanie Gaw, a maternal-fetal medicine specialist at the University of California, San Francisco.

The new data, Dr. Gaw said, demonstrate that “a lot of pregnant people are getting the vaccine, there isn’t a significant increase in adverse pregnancy effects at this point, and that side effect profiles are very similar to nonpregnant people.”

“I think that’s all very reassuring,” she said, “and I think it will really help providers and public health officials more strongly recommend getting the vaccine in pregnancy.”

Covid-19 poses serious risks during pregnancy. Pregnant women who develop symptoms of the disease are more likely to become seriously ill, and more likely to die, than nonpregnant women with symptoms.

Because of those risks, the C.D.C. has recommended that coronavirus vaccines be made available to pregnant women, though it also suggests that they consult with their doctors when making a decision about vaccination.

The new study, which was published on Wednesday in The New England Journal of Medicine, is based largely on self-reported data from V-safe, the C.D.C.’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to complete regular surveys about their health, and any side effects they might be experiencing, after receiving a Covid-19 vaccine.

The researchers analyzed the side effects reported by V-safe participants who received either the Pfizer or Moderna vaccine between Dec. 14, 2020, and Feb. 28, 2021. They focused on 35,691 participants who said that they had been pregnant when they received the vaccine or became pregnant shortly thereafter.

After vaccination, pregnant participants reported the same general pattern of side effects that nonpregnant ones did, the researchers found: pain at the injection site, fatigue, headaches and muscle pain.

Women who were pregnant were slightly more likely to report injection site pain than women who were not, but less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose.

Pregnant V-safe participants were also given an opportunity to enroll in a special registry that tracked pregnancy and infant outcomes.

By the end of February, 827 of those enrolled in the pregnancy registry had completed their pregnancies, 86 percent of which resulted in a live birth. Rates of miscarriage, prematurity, low birth weight and birth defects were consistent with those reported in pregnant women before the pandemic, the researchers report.

“This study is of critical importance to pregnant individuals,” Dr. Michal Elovitz, a maternal-fetal medicine specialist at the University of Pennsylvania, said in an email. “It is very reassuring that there were no reported acute events in pregnant individuals” over the course of the study, she said.

But the report has several limitations and much more research is needed, experts said. Enrollment in the surveillance programs is voluntary and the data are self-reported.

In addition, because the study period encompassed just the first few months of the U.S. vaccination campaign, the vast majority of those enrolled in the pregnancy registry were health care workers. And there is not yet any data on pregnancy outcomes from people who were vaccinated during the first trimester of pregnancy.

“I think we can feel more confident about recommending the vaccine in pregnancy, and especially with pregnant people that are at risk of Covid,” Dr. Gaw said. “But we do need to wait for more data for complete pregnancy outcomes from vaccines early in pregnancy.”

Jackie Robinson Day at Dodger Stadium earlier this month.Credit…Kirby Lee/USA Today Sports, via Reuters

Fully vaccinated baseball fans will be granted their own section at the Los Angeles Dodgers game this weekend against the San Diego Padres.

The set-aside seats, reported by The Los Angeles Times, are part of the many incentives being offered — from doughnuts to beer — to encourage people to get vaccinated against Covid-19. The Miami Heat and the San Francisco Giants have introduced similar sections at their stadiums.

To prove they are fully vaccinated, fans will have to show government-issued I.D. and documentation like a vaccination card, according to the Dodgers’ website. Everyone 16 years and older will have to show proof that at least two weeks have passed since they were fully vaccinated. Fans younger than 16 will be required to show proof of a negative coronavirus test taken within 72 hours before admission.

Face masks will still be required, but social distancing will not. The team said spectators in the sections for the fully vaccinated will be seated directly next to each other.

The game Saturday won’t mark the first time fans have entered Dodger Stadium since the pandemic began. The team’s home opener on April 9 was attended by fans — just not all that many of them. Attendance was capped at around 11,000, about 20 percent of capacity.

In the past week, there has been an average of more than 2,300 daily coronavirus cases in the state, and Los Angeles County has seen an average of 435 daily cases — a 20 percent drop over the past two weeks, according to a New York Times database.

As of Wednesday, more than 40 percent of Californians had received at least one dose of the vaccine, and more than 20 percent had been fully vaccinated.

On April 15, Gov. Gavin Newsom loosened some restrictions in the state, permitting limited outdoor gatherings and live events, depending on a region’s Covid-19 risk level.

A 5K run organized by New York Road Runners in October.Credit…John Minchillo/Associated Press

New York Road Runners, the club that puts on the New York City Marathon, has announced the return of its first regularly scheduled race since the beginning of the pandemic.

On Thursday, the club said that it would hold the annual New York Mini 10K on June 12. The 10-kilometer, women-only race has been held annually since 1972, with the exception of last year.

“This is our first real table setting,” said Kerin Hempel, the organization’s interim chief executive. “It’s starting to feel like ‘OK, we’re back, we’re coming back.’”

This will not be the first race the club has held since the onset of the pandemic.

The organization has held a series of “return to racing” events as pilots starting last fall, allowing very small fields to run with safety protocols in place. Among other measures, the races had temperature checks, staggered starts and different corralling of runners.

Those events, Ms. Hempel said, have given N.Y.R.R. the confidence to move ahead with its first regularly scheduled race since March 2020.

The Mini 10K field will be smaller than in past years, with a cap of 1,200 runners. The race will also have safety protocols, such as requiring runners to mask up at the start and finish. (They will be strongly encouraged to wear masks during the race, too.)

It will be the first time N.Y.R.R. has welcomed elite athletes since the 2019 New York City Marathon, with 25 elite athletes expected at the starting line. The 2019 Mini 10K champion, Sara Hall, will return to defend her title.

The announcement comes as runners look ahead — with cautious optimism — to the return of major road races. Ms. Hempel anticipated the question on the minds of many: What does this mean for the New York City Marathon?

“We’ve been saying the marathon is going to happen,” she said. “It’s more about what it’s going to look like, and how many people we can accommodate on the course.”

Categories
Politics

Federal Inspectors Worry Extra Vaccines Have been Uncovered to Contamination

Federal Inspectors Fear More Vaccines Were Exposed to Contamination

WASHINGTON – Federal regulators have identified serious defects at the Baltimore plant that resulted in up to 15 million potentially contaminated doses of Johnson & Johnson’s coronavirus vaccine being spilled. This casts doubt on the continued production of a vaccine in the US that the government once considered essential in the fight against the pandemic.

Food and Drug Administration regulators said the company that makes the Emergent BioSolutions vaccine may have contaminated additional doses at the facility. They said the company had not fully investigated the contamination while raising concerns about the disinfection practices, the size and design of the facility, the handling of raw materials and the training of workers.

“There is no guarantee that other lots have not been exposed to cross-contamination,” said the FDA’s 12-page report.

The report was a harsh reprimand for Emergent, who had long downplayed setbacks at the factory, and added to the problems for Johnson & Johnson, whose vaccine was viewed as a game changer because it only takes one shot and is mass-produced can volume and is easy to store.

In the US, production is now ceasing and all vaccines made at the factory have been quarantined. Johnson & Johnson fell far short of its promises to deliver tens of millions of doses to the federal government, partly because concerns about an extremely rare but dangerous blood clotting disorder led federal officials to temporarily suspend distribution last week.

The FDA’s findings, based on an inspection that ended Tuesday, underscore questions raised in New York Times reports about why Emergent didn’t fix issues sooner and why federal officials overseeing their lucrative contracts weren’t demanding better performance .

A series of confidential audits The Times conducted last year warned of the risk of viral and bacterial contamination and a lack of adequate sanitation at the Baltimore plant. Separately, The Times reported, a leading federal manufacturing expert warned last June that Emergent must be “closely monitored.”

Some health officials were surprised by the FDA’s conclusions.

“I’m shocked – I can’t put it any other way,” said Dr. José R. Romero, chairman of a panel that advises the Centers for Disease Control and Prevention and will recommend the use of Johnson & Johnson vaccine later this week. “Inappropriate disinfection, prevention of contamination – these are significant and serious violations.”

In statements on Wednesday, the FDA, Emergent and Johnson & Johnson said they were working to resolve the issues at the factory. There was no indication of how long that would take.

Emergent said, “While we are never satisfied with defects in our manufacturing equipment or processes, they can be corrected and we will take quick action to correct them.”

The FDA has not yet certified the facility in the Bayview neighborhood of Baltimore, and no doses administered there have been released to the public. All Johnson & Johnson recordings made in the United States are from overseas.

In a statement, Dr. Janet Woodcock, Acting Commissioner of the FDA, and Dr. Peter Marks, the top vaccine regulator: “We will only allow the release of products when we are sure that they meet our quality expectations.”

Emergent is a longtime government contractor who has spent much of his time over the past two decades building a market for federal biological defense spending.

Although the Emergent government placed a $ 163 million contract in 2012 to prepare the Baltimore plant for mass production in a pandemic, the site remained largely untested and the company failed to meet the requirement to demonstrate its rapid-reaction capabilities, according to former health officials and contract documents.

Even so, the Emergent government placed a $ 628 million order in June last year, largely to reserve manufacturing space at the plant, and prompted the company to manufacture the Johnson & Johnson shot and a separate vaccine developed by AstraZeneca.

Now Emergent’s dealings with the government are being scrutinized more and more closely. On Tuesday, the House Select Coronavirus Crisis Subcommittee and House Committee on Oversight and Government Reform announced an investigation into the company’s Covid-19 vaccine deal, as well as its long-standing control over an oversized portion of the country’s emergency medicine budget to Reserve, the Strategic National Stockpile.

A Times investigation found that the company’s purchase of the company’s anthrax vaccine over the past decade accounted for nearly half of the reserve’s total annual budget, leaving less cash to spend on critical supplies like masks, which were in short supply last year.

The Bayview facility was supposed to produce most of the Johnson & Johnson vaccine, which received federal emergency approval this year, but only for doses made in the Netherlands. AstraZeneca’s vaccine is not yet approved in the US, regardless of where it is made.

The FDA inspection began after routine checks revealed that Emergent employees had contaminated at least part of a batch of 13-15 million doses of the Johnson & Johnson vaccine with the harmless virus used to make the AstraZeneca shot. Regulators determined that Emergent did not investigate this incident thoroughly and only performed a routine cleanup afterwards. A previous review by Bayview for a pharmaceutical customer found that Emergent glossed over deviations from manufacturing standards without conducting thorough reviews.

The inspectors who examined security recordings as part of their review found that Emergent was not considering whether one or more employees might have been the source of the contamination. Workers are expected to change clothes, ankle boots and showers before moving between the various manufacturing zones for Johnson & Johnson and AstraZeneca.

But regulators said the rule appeared to be routinely violated. In a period of 10 days in February, for example, 13 employees moved from one zone to another on the same day, but only one documented having showered. The inspectors also said Emergent failed to consider whether using common storage containers for raw materials might have caused the contamination. Emergent’s internal audit last July found that the flow of workers and materials through the plant was not adequately controlled “to avoid mix-ups or contamination.”

Federal officials have already insisted on a major change that they believe should significantly limit the risks. This month they instructed Emergent to stop the AstraZeneca shot at the factory and are now trying to help AstraZeneca find a new manufacturing facility.

In another result, the FDA regulators wrote that the Bayview building “is not being kept in a clean and hygienic condition”. Nor is it “of the appropriate size, design and location to facilitate cleaning, maintenance and proper operation,” they said.

They cited peeling paint, damaged walls, improperly trained staff, overcrowded equipment and poor waste disposal. A problem that, in their opinion, could lead to contamination of the warehouse in which raw materials are stored.

The results were released two days prior to the CDC’s scheduled vote to extend, lift, or change the suspension of Johnson & Johnson. Officials recommended the break to investigate eight cases of a rare coagulation disorder in vaccine recipients, one of which was fatal.

Johnson & Johnson resumed its rollout in Europe this week after regulators investigated similar concerns. They recommended putting a warning about the blood clots on the vaccine label, but said the benefits outweighed the risks.

The inspection report comes as a group of shareholders sued Emergent, alleging executives misled investors about the company’s ability to manufacture Covid-19 vaccines in Baltimore.

Emergent’s share price soared following announcements of $ 1.5 billion in deals with the federal government, Johnson & Johnson and AstraZeneca last year. Throughout 2020, its founder and chairman Fuad El-Hibri deposited over $ 42 million in shares and options, and the company’s executive director Robert Kramer recently received a cash bonus of $ 1.2 million.

The lawsuit alleges that the stock price was artificially increased because executives failed to disclose significant quality control issues at the facility. Emergent stocks have been falling in the past few weeks.

Shortly after the Trump administration’s Operation Warp Speed ​​decided to award the $ 628 million contract to Emergent, Carlo de Notaristefani, a manufacturing expert who has been overseeing vaccine production for the federal government since last May, warned the company about his To have to “strengthen” quality controls. requires “significant resources and dedication”.

Dr. Robert Kadlec, the former Trump administration official overseeing the procurement process, said in an interview Tuesday that officials “recognized that there would be inherent risks,” but the government intends “to try to manage those risks consistently.” to reduce. ” . ”

Dr. Romero, the head of the CDC advisory board who is also the Arkansas Secretary of Health, was concerned that the plant’s problems could keep people from getting vaccinated, even though doses from there have not reached the public. Andy Slavitt, a senior health advisor to President Biden, told reporters that the audit “demonstrated a process that is working as it should”.

Johnson & Johnson said it had already increased oversight of Emergent and would “ensure that all FDA observations are promptly and comprehensively addressed”.

The pharmaceutical company is expected to nearly double its supervisors at the Bayview facility to perhaps a dozen, although Emergent will continue to employ around 600 people.

Categories
Health

No Being pregnant Danger Discovered From 2 Covid-19 Vaccines, Preliminary Analysis Exhibits

No Pregnancy Risk Found From 2 Covid-19 Vaccines, Preliminary Research Shows

In an early analysis of coronavirus vaccine safety data, researchers from the Centers for Disease Control and Prevention found no evidence that the Pfizer-BioNTech or Moderna vaccines posed a serious risk during pregnancy.

The results are preliminary and only cover the first 11 weeks of the US vaccination program. The study, which included self-reported data on more than 35,000 people who received any of the vaccines during or shortly before pregnancy, is the largest to date on the safety of coronavirus vaccines in pregnant women.

Pregnant women were excluded during clinical trials with the vaccines. Patients, doctors and experts were therefore unsure whether the shots could be safely administered during pregnancy.

“There is great concern about whether it is safe and whether it would work and what to expect in terms of side effects,” said Dr. Stephanie Gaw, a Maternal-Fetal Medicine Specialist at the University of California at San Francisco.

The new data, said Dr. Gaw, show that “many pregnant people receive the vaccine, there is no significant increase in adverse pregnancy effects at this point and that the side effect profiles are not very similar to pregnant people.”

“I think this is all very comforting,” she said, “and I think it will really help public health providers and officials recommend the vaccine more strongly during pregnancy.”

Covid-19 carries serious risks during pregnancy. Pregnant women who develop symptoms of the disease are more likely to become seriously ill and die more often than non-pregnant women with symptoms.

Because of these risks, the CDC has recommended providing coronavirus vaccines to pregnant women, but also suggests that they consult their doctor when deciding whether to vaccinate.

The new study, published Wednesday in the New England Journal of Medicine, is largely based on self-reported data from V-safe, the CDC’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to regularly conduct surveys about their health and possible side effects after receiving a Covid-19 vaccine.

The researchers analyzed the side effects of V-Safe participants who received either the Pfizer or Moderna vaccine between December 14, 2020 and February 28, 2021. They focused on 35,691 participants who said they were pregnant when they received the vaccine or became pregnant shortly afterwards.

After vaccination, pregnant participants reported the same general pattern of side effects as non-pregnant women, the researchers noted: injection site pain, fatigue, headache, and muscle pain.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of being vaccinated.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily stopped using the vaccine or recommended providers are suspending use of the vaccine. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.
    • The hiatus could complicate the country’s vaccination efforts at a time when many states are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson had also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots. However, the company later decided to continue its campaign after the European Union Medicines Agency announced the addition of a warning. South Africa, devastated by a contagious variant of the virus, stopped using the vaccine and Australia announced it would not buy doses.

Pregnant women were slightly more likely to report injection site pain than women who did not, but were less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose.

Pregnant V-safe participants also had the option of enrolling in a special register that recorded pregnancy and infant results.

By the end of February, 827 of the people on the pregnancy register had completed their pregnancies, of which 86 percent resulted in a live birth. The incidence of miscarriages, premature births, low birth weight, and birth defects were consistent with those reported in pregnant women prior to the pandemic, the researchers report.

“This study is critical for pregnant people,” said Dr. Michal Elovitz, a maternal-fetal medicine specialist at the University of Pennsylvania, in an email. “It’s very comforting that no acute events have been reported in pregnant people,” she said as the study progressed.

However, the report has several caveats, and experts say a lot more research is needed. Participation in the monitoring programs is voluntary and the data is reported by yourself.

Since the study period only spanned the first few months of the US vaccination campaign, the vast majority of those on the pregnancy registry were healthcare workers. And there is still no data on pregnancy outcomes for people vaccinated in the first trimester of pregnancy.

“I think we can feel more secure if we recommend the vaccine during pregnancy, especially in pregnant people who are at risk of Covid,” said Dr. Gaw. “But we do I will have to wait for more data to get full pregnancy results from early pregnancy vaccines. “

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Health

FDA asks Emergent plant to pause manufacturing throughout probe of botched Covid vaccines

FDA asks Emergent plant to pause manufacturing during probe of botched Covid vaccines

The Emergent BioSolutions facility, a manufacturing partner for Johnson & Johnson’s Covid-19 vaccine, on April 9, 2021 in Baltimore, Maryland.

Saul Loeb | AFP | Getty Images

The Food and Drug Administration has asked Emergent BioSolutions to temporarily suspend production of materials for Covid-19 vaccines while U.S. regulators investigate their Baltimore plant, responsible for the destruction of millions of Johnson & Johnson shots, shared Emergent in a registration application filed on Monday.

The FDA initiated an inspection of the facility on April 12, asking the company to stop production four days later until the review and remediation was complete. In a filing with the Securities and Exchange Commission, the company also said it had quarantined all material produced at the facility.

Emergent stocks were down more than 9% on the news.

In a statement to CNBC, J&J said it would work with Emergent and the FDA “to clarify any results after the FDA inspection is complete”.

“Our goal remains to ensure that all drug substances for our COVID-19 vaccine meet our high quality standards and receive emergency use approval for drug substances manufactured in Emergent Bayview,” the company said. “At this point it is premature to speculate about the potential impact this may have on the timing of our vaccine shipments.”

Earlier this month, the Biden administration hired J&J to run the Baltimore facility after US officials learned that Emergent, a contract manufacturer that made vaccines for J&J and AstraZeneca, mixed the ingredients for the two shots would have. Officials also stopped production of the AstraZeneca vaccine.

The government’s move to let the facility manufacture only the J&J single-dose vaccine is intended to avoid future confusion, the New York Times reported, citing two senior federal health officials.

The production hiatus for new materials is the most recent setback for J & J. Last week, the Food and Drug Administration and Centers for Disease Control and Prevention advised states to temporarily “cease” use of J & J’s vaccine, after six women developed a rare but potentially life-threatening bleeding disorder in which one died and one was in critical condition.

The women developed the condition known as cerebral sinus thrombosis within about two weeks of receiving the shot, an official said. CVST is a rare form of stroke that occurs when a blood clot forms in the venous sinuses of the brain. It can eventually leak blood into the brain tissue and cause bleeding.

J.& J has privately asked Covid-19 vaccine rivals Pfizer and Moderna to participate in a study examining the risk of blood clots. The companies refused, however, the Wall Street Journal reported on Friday, citing people familiar with the matter.

–Reuter contributed to this report.

Categories
Health

Vaccines Received’t Defend Thousands and thousands of Sufferers With Weakened Immune Programs

Vaccines Won’t Protect Millions of Patients With Crippled Immune Systems

Dr. Andrew Wollowitz has been at the monastery for the most part at his Mamaroneck, NY home for more than a year

As medical director for emergency medicine at Montefiore Medical Center in the Bronx, 63-year-old Dr. Wollowitz eager to treat patients when the coronavirus raged in town last spring. However, cancer treatment in 2019 had wiped out his immune cells, leaving him defenseless against the virus. Instead, he arranged for his employees to be managed through Zoom.

A year later, people return to Dr. Wollowitz’s life returned to a semblance of normalcy. His wife, dancer and choreographer, is preparing to work for the Austrian National Ballet Company. His vaccinated friends meet, but he only sees them when the weather is nice enough to sit in his back yard. “I spend very little time in public areas,” he said.

Like his friends, Dr. Wollowitz vaccinated in January. But he wasn’t producing antibodies in response – and he hadn’t expected it either. He is one of millions of Americans with weakened immune systems whose bodies cannot learn to use immune fighters against the virus.

Some immunocompromised people were born with missing or faulty immune systems, while others, like Dr. Wollowitz, have illnesses or have received therapies that wipe out their immune defenses. Many of them make little to no antibodies in response to a vaccine or infection, which makes them susceptible to the virus. If infected, they can suffer from prolonged illness, with a death rate of up to 55 percent.

Most people who have lived with immunodeficiency for a long time are probably aware of their vulnerability. However, others have no idea that drugs could put them at risk.

“They’ll be walking around outside thinking they’re protected – but maybe not,” said Dr. Lee Greenberger, scientific director of the Leukemia Lymphoma Society, which funds research into blood cancer.

The only recourse for these patients – other than housing until the virus is withdrawn – may be to regularly infuse monoclonal antibodies, which are mass-produced copies of antibodies obtained from people who have contracted Covid-19 have recovered. The Food and Drug Administration has approved several monoclonal antibody treatments for Covid-19, but some are now also being tested to prevent infection.

Convalescent plasma or gamma globulin – antibodies distilled from the blood of healthy donors – can also help immunocompromised people, although a version of the latter that contains antibodies to the coronavirus is still months away from being available.

“It is a clear area where the need cannot be met,” said Hala Mirza, a spokeswoman for Regeneron, who made their monoclonal antibody cocktail available to a handful of immunocompromised patients through a compassionate application program. (Regeneron released experimental results this week showing the cocktail reduced symptomatic infections by 81 percent in people with normal immune systems.)

It is unclear how many immunocompromised people do not respond to coronavirus vaccines. But the list seems to include at least blood cancer survivors, organ transplant recipients, and anyone taking the widely available drug Rituxan or the cancer drugs Gazyva or Imbruvica – all of which kill or block B cells, the immune cells that develop antibodies – or Remicade, a popular one Drug used to treat inflammatory bowel disease. It can also include some people over the age of 80 whose immune responses have stalled with age.

“We are extremely concerned and interested in finding out how we can help these particular patients,” said Dr. Elad Sharon, an immunotherapy expert at the National Cancer Institute.

As the pandemic spread, doctors who specialized in treating blood cancer or caring for immunocompromised people expected at least some of their patients to encounter difficulties. Dr. Charlotte Cunningham-Rundles, an immunologist at the Icahn School of Medicine on Mount Sinai in New York, has about 600 patients who rely almost exclusively on regular doses of gamma globulin to protect against pathogens.

Nevertheless, 44 of their patients became infected with the coronavirus; four died and another four or five had long-term illnesses. (Chronic infections can give the virus the opportunity to develop into dangerous variants.)

Steven Lotito, 56, one of Dr. Cunningham-Rundles, was diagnosed with a condition known as common variable immunodeficiency when he was 13 years old. Before the pandemic, he had an active lifestyle, exercised, and ate well. “I’ve always known that I take special care of my body,” he said. This included infusions of gamma globulin every three weeks.

Despite careful precautionary measures, Mr Lotito caught the virus from his daughter in mid-October. He had a fever for almost a month and spent a week in the hospital. Convalescent plasma and remdesivir, an antiviral drug, provided relief for a few weeks, but his fever returned. After another infusion of gamma globulin that sweated through four shirts, he finally felt better.

Updated

April 18, 2021, 11:00 p.m. ET

Nevertheless, after almost seven weeks of illness, Mr. Lotito no longer had any antibodies to show. “I still have to take the same precautions that I took a year ago,” he said. “It’s a little daunting.”

People like Lotito-san rely on those around them to get vaccinated to keep the virus at bay, said Dr. Cunningham-Rundles.

“They hope that all of your family members and all of your close co-workers will go out and get a shot, and they will protect you with herd immunity,” she said. “You have to start with that.”

Dr. Cunningham-Rundles has tested their patients for antibodies and has registered some for Regeneron’s monoclonal antibody cocktail. However, many other people with these conditions are unaware of their risks or treatment options.

The Leukemia Lymphoma Society has set up a registry to provide information and antibody tests to people with blood cancer. Several studies are looking at the response to coronavirus vaccines in people with cancer, autoimmune diseases like lupus or rheumatoid arthritis, or in patients taking drugs that suppress the immune response.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of being vaccinated.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily stopped using the vaccine or recommended providers are suspending use of the vaccine. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.
    • The hiatus could complicate the country’s vaccination efforts at a time when many states are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson has also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots, which is taking another blow to the vaccine surge in Europe. South Africa, devastated by a contagious variant of the virus found there, also stopped using the vaccine. Australia announced that it would not buy cans.

In one such study, British researchers tracked nearly 7,000 people with Crohn’s disease or ulcerative colitis from 90 hospitals across the country. They found that less than half of the patients who took Remicade had an immune response after contracting coronavirus infection.

In a follow-up, the scientists found that 34 percent of people who took the drug were protected after a single dose of the Pfizer vaccine and only 27 percent after a single dose of the AstraZeneca vaccine. (In the UK, the current practice is to delay second doses to increase vaccine availability.)

Likewise, another study published last month showed that fewer than 15 percent of patients with blood or immune cancer and fewer than 40 percent of patients with solid tumors produced antibodies after receiving a single dose of the Pfizer BioNTech vaccine.

And a study published last month in the journal JAMA reported that only 17 percent of the 436 transplant recipients who received a dose of the Pfizer BioNTech or Moderna vaccine had detectable antibodies three weeks later.

Despite the small likelihood, immunocompromised people should receive the vaccines because they may produce some immune cells that protect, even antibodies in a subset of patients.

“These patients should likely be prioritized for optimally balanced two doses,” said Dr. Tariq Ahmad, gastroenterologist with the Royal Devon and Exeter NHS Foundation Trust who was involved in the infliximab studies.

He suggested that doctors routinely measure antibody responses in immunocompromised people even after two doses of vaccine to identify those who may also need monoclonal antibodies to prevent infection or a third dose of the vaccines.

Wendy Halperin, 54, was diagnosed with a condition known as common variable immunodeficiency when she was 28 years old. She was hospitalized with Covid-19 in January and stayed there for 15 days. However, the coronavirus caused unusual symptoms.

“I had trouble walking,” she recalled. “I just lost control of my limbs like I couldn’t walk down the street.”

Since she was being treated for convalescence plasma for Covid-19, Ms. Halperin had to wait three months for the immunization and has made an appointment for April 26th. However, despite her condition, her body managed to produce some antibodies against the initial infection.

“The takeaway message is that everyone should try to get the vaccine,” said Dr. Amit Verma, oncologist at Montefiore Medical Center.

Gambling has settled in Dr. Wollowitz’s case not paid off. With no antibodies in his system to protect him, he still works from home – a privilege he is grateful for. He was an avid mountain biker and advanced skier both at risk of injury, but he is playing it safe with the coronavirus.

In anticipation of a return to his normal lifestyle, Dr. Wollowitz his bicycles. But he said he had foreseen he would live like this until enough other people are vaccinated and the number of infections in the city drops.

“I’m not exactly sure what that date is,” he said. “I’m really waiting to get out again.”

Categories
Business

Vaccines Gained’t Shield Hundreds of thousands of Sufferers With Crippled Immune Methods

Vaccines Won’t Protect Millions of Patients With Crippled Immune Systems

Dr. Howard Wollowitz has been at the monastery for the most part at his Mamaroneck, NY home for more than a year

As chief of emergency medicine at Montefiore Medical Center in the Bronx, 63-year-old Dr. Wollowitz eager to treat patients when the coronavirus raged in town last spring. However, cancer treatment in 2019 had wiped out his immune cells, leaving him defenseless against the virus. Instead, he arranged for his employees to be managed through Zoom.

A year later, people return to Dr. Wollowitz’s life returned to a semblance of normalcy. His wife, dancer and choreographer, is preparing to work for the Austrian National Ballet Company. His vaccinated friends meet, but he only sees them when the weather is nice enough to sit in his back yard. “I spend very little time in public areas,” he said.

Dr. Wollowitz, like his friends, was vaccinated in January. But he wasn’t producing antibodies in response – and he hadn’t expected it either. He is one of millions of Americans with weakened immune systems whose bodies cannot learn to use immune fighters against the virus.

Some immunocompromised people were born with missing or faulty immune systems, while others, like Dr. Wollowitz, have illnesses or have received therapies that wipe out their immune defenses. Many of them make little to no antibodies in response to a vaccine or infection, which makes them susceptible to the virus. If infected, they can suffer from prolonged illness, with a death rate of up to 55 percent.

Most people who have lived with immunodeficiency for a long time are probably aware of their vulnerability. However, others have no idea that drugs could put them at risk.

“They’ll be walking around outside thinking they’re protected – but maybe not,” said Dr. Lee Greenberger, scientific director of the Leukemia Lymphoma Society, which funds research into blood cancer.

The only recourse for these patients – other than housing until the virus is withdrawn – may be to regularly infuse monoclonal antibodies, which are mass-produced copies of antibodies obtained from people who have contracted Covid-19 have recovered. The Food and Drug Administration has approved several monoclonal antibody treatments for Covid-19, but some are now also being tested to prevent infection.

Convalescent plasma or gamma globulin – antibodies distilled from the blood of healthy donors – can also help immunocompromised people, although a version of the latter that contains antibodies to the coronavirus is still months away from being available.

“It is a clear area where the need cannot be met,” said Hala Mirza, a spokeswoman for Regeneron, who made their monoclonal antibody cocktail available to a handful of immunocompromised patients through a compassionate application program. (Regeneron released experimental results this week showing the cocktail reduced symptomatic infections by 81 percent in people with normal immune systems.)

It is unclear how many immunocompromised people do not respond to coronavirus vaccines. But the list seems to include at least blood cancer survivors, organ transplant recipients, and anyone taking the widely available drug Rituxan or the cancer drugs Gazyva or Imbruvica – all of which kill or block B cells, the immune cells that develop antibodies – or Remicade, a popular one Drug used to treat irritable bowel disease. It can also include some people over the age of 80 whose immune responses have stalled with age.

“We are extremely concerned and interested in finding out how we can help these particular patients,” said Dr. Elad Sharon, an immunotherapy expert at the National Cancer Institute.

As the pandemic spread, doctors who specialized in treating blood cancer or caring for immunocompromised people expected at least some of their patients to encounter difficulties. Dr. Charlotte Cunningham-Rundles, an immunologist at the Icahn School of Medicine on Mount Sinai in New York, has about 600 patients who rely almost exclusively on regular doses of gamma globulin to protect against pathogens.

Nevertheless, 44 of their patients became infected with the coronavirus; four died and another four or five had long-term illnesses. (Chronic infections can give the virus the opportunity to develop into dangerous variants.)

Steven Lotito, 56, one of Dr. Cunningham-Rundles, was diagnosed with a condition known as common variable immunodeficiency when he was 13 years old. Before the pandemic, he had an active lifestyle, exercised, and ate well. “I’ve always known that I take special care of my body,” he said. This included infusions of gamma globulin every three weeks.

Despite careful precautionary measures, Mr Lotito caught the virus from his daughter in mid-October. He had a fever for almost a month and spent a week in the hospital. Convalescent plasma and remdesivir, an antiviral drug, provided relief for a few weeks, but his fever returned. After another infusion of gamma globulin that sweated through four shirts, he finally felt better.

Updated

April 15, 2021, 2:02 p.m. ET

Nevertheless, after almost seven weeks of illness, Mr. Lotito no longer had any antibodies to show. “I still have to take the same precautions that I took a year ago,” he said. “It’s a little daunting.”

People like Lotito-san rely on those around them to get vaccinated to keep the virus at bay, said Dr. Cunningham-Rundles.

“They hope that all of your family members and all of your close co-workers will go out and get a shot, and they will protect you with herd immunity,” she said. “You have to start with that.”

Dr. Cunningham-Rundles has tested their patients for antibodies and has registered some for Regeneron’s monoclonal antibody cocktail. However, many other people with these conditions are unaware of their risks or treatment options.

The Leukemia Lymphoma Society has set up a registry to provide information and antibody tests to people with blood cancer. Several studies are looking at the response to coronavirus vaccines in people with cancer, autoimmune diseases like lupus or rheumatoid arthritis, or in patients taking drugs that suppress the immune response.

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

    • On April 13, 2021, U.S. health officials called for an immediate halt to use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the U.S. developed a rare blood clot disorder within one to three weeks of vaccination.
    • All 50 states, Washington, DC, and Puerto Rico have temporarily suspended use of the vaccine or suspended from recommended vendors. The U.S. military, government-run vaccination centers, and a variety of private companies, including CVS, Walgreens, Rite Aid, Walmart, and Publix, also paused the injections.
    • Fewer than one in a million Johnson & Johnson vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.
    • The hiatus could complicate the country’s vaccination efforts at a time when many states are facing spikes in new cases and are trying to address vaccine hesitation.
    • Johnson & Johnson has also decided to delay the launch of its vaccine in Europe amid concerns about rare blood clots, which is taking another blow to the vaccine surge in Europe. South Africa, devastated by a contagious variant of the virus found there, also stopped using the vaccine. Australia announced that it would not buy cans.

In one such study, British researchers tracked nearly 7,000 people with Crohn’s disease or ulcerative colitis from 90 hospitals across the country. They found that less than half of the patients who took Remicade had an immune response after contracting coronavirus infection.

In a follow-up, the scientists found that 34 percent of people who took the drug were protected after a single dose of the Pfizer vaccine and only 27 percent after a single dose of the AstraZeneca vaccine. (In the UK, the current practice is to delay second doses to increase vaccine availability.)

Likewise, another study published last month showed that fewer than 15 percent of patients with blood or immune cancer and fewer than 40 percent of patients with solid tumors produced antibodies after receiving a single dose of the Pfizer BioNTech vaccine.

And a study published last month in the journal JAMA reported that only 17 percent of the 436 transplant recipients who received a dose of the Pfizer BioNTech or Moderna vaccine had detectable antibodies three weeks later.

Despite the small likelihood, immunocompromised people should receive the vaccines because they may produce some immune cells that protect, even antibodies in a subset of patients.

“These patients should likely be prioritized for optimally balanced two doses,” said Dr. Tariq Ahmad, gastroenterologist with the Royal Devon and Exeter NHS Foundation Trust who was involved in the infliximab studies.

He suggested that doctors routinely measure antibody responses in immunocompromised people even after two doses of vaccine to identify those who may also need monoclonal antibodies to prevent infection or a third dose of the vaccines.

Wendy Halperin, 54, was diagnosed with a condition known as common variable immunodeficiency when she was 28 years old. She was hospitalized with Covid-19 in January and stayed there for 15 days. However, the coronavirus caused unusual symptoms.

“I had trouble walking,” she recalled. “I just lost control of my limbs like I couldn’t walk down the street.”

Since she was being treated for convalescence plasma for Covid-19, Ms. Halperin had to wait three months for the immunization and has made an appointment for April 26th. However, despite her condition, her body managed to produce some antibodies against the initial infection.

“The takeaway message is that everyone should try to get the vaccine,” said Dr. Amit Verma, oncologist at Montefiore Medical Center.

Gambling has settled in Dr. Wollowitz’s case not paid off. With no antibodies in his system to protect him, he still works from home – a privilege he is grateful for. He was an avid mountain biker and advanced skier, both of which were at risk of injury, but he is playing it safe with the coronavirus.

In anticipation of a return to his normal lifestyle, Dr. Wollowitz his bicycles. But he said he had foreseen he would live like this until enough other people are vaccinated and the number of infections in the city drops.

“I’m not exactly sure what that date is,” he said. “I’m really waiting to get out again.”

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Health

Western Warnings Tarnish Vaccines the World Badly Wants

Western Warnings Tarnish Vaccines the World Badly Needs

South Africa immediately copied the American break in Johnson & Johnson vaccinations and enraged doctors who still call for gunshots, especially in remote parts of the country. In February, health officials dropped the AstraZeneca vaccine there because of its limited effectiveness against a dangerous variant.

To date, only half of 1 percent of the population is vaccinated and only 10,000 shots are fired a day. At this rate, it could be weeks, if not longer, for a single rare case of blood clotting to occur, said Jeremy Nel, an infectious disease doctor in Johannesburg. He was dismayed by the decision to pause the shooting, given the risk of building confidence in vaccines in a country where two-fifths of the population say they don’t intend to vaccinate.

“The slower you go, the more that failure is measured in terms of death,” said Dr. Nel. “Even if you are late by a week, there is a non-trivial chance that will cost your life.”

The solution in many European countries – stop using apparently riskier vaccines in younger people who are less at risk of Covid-19 – would not be practical in Africa, where the average age in many countries is under 20.

Further restrictions would tighten the hurdles for Covax, including a lack of funding for any part of vaccination programs beyond doses at airports.

Mali, in West Africa, has administered 7 percent of the AstraZeneca doses administered by Covax. Sudan in East Africa has given 8 percent of the doses it has received.

Analysts fear that dissatisfaction with AstraZeneca and Johnson & Johnson vaccines could fuel demand for recordings made in Russia and China, which are far less well known. Some global health officials have turned their attention to the Novavax vaccine, which is not yet approved but makes up a third of the Covax portfolio.

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Business

Maldives to supply holidaymakers vaccines on arrival

Maldives to offer holidaymakers vaccines on arrival

The Maldives will soon be offering vaccinations to visitors upon arrival. This is part of their tripartite initiative to revitalize the country’s hard-hit travel sector, said the tourism minister.

The “3V” strategy, which encourages tourists to “visit the country, vaccinate and vacation,” will provide a “more convenient” way to visit the country, Abdulla Mausoom told CNBC on Wednesday.

Currently, visitors to the Maldives must present a negative polymerase chain reaction (PCR) test and proof of hotel booking to gain entry. Mausoom said the country’s health protection agency will “very soon – maybe even this week” make an announcement of unrestricted entry to vaccinated arrivals.

The Maldives, an archipelago state in South Asia known for its tropical beaches and pristine waters, is heavily dependent on its tourism industry. Around 67% of the gross domestic product (GDP) comes directly and indirectly from the sector.

The Minister of Tourism would not be pressured into a timetable for introducing visitor vaccination. He noted that the government’s priority is to ensure that all resident populations get their first and second shots first.

However, once that process is complete, the country will be ready to vaccinate arrivals, he said.

I don’t think the supply in the Maldives is a problem because our population is relatively small.

Abdulla Mausoom

Minister of Tourism, Maldives

To date, according to Reuters’ vaccination tracker, around 53% of the approximately 530,000 inhabitants of the island state have received their first dose. Around 90% of frontline tourism workers have received their first dose, Mausoom said.

Mausoom didn’t say whether the comers are expected to pay for their shots, but he said supplies would not be an issue.

He said the country has received vaccine donations from India, China and the World Health Organization’s Covax program, which is designed to ensure vaccines are distributed fairly and equitably. The Maldives have also ordered additional supplies from Singapore, he said.

“I don’t think the supply in the Maldives is a problem because our population is relatively small,” said Mausoom. “The quota that we receive from the various organizations and friendly nations will also help.”

White sand and clear water in the Maldives.

Image Alliance | Getty Images

Mausoom said the tourism campaign is a necessary strategy to help the country meet its goal of 1.5 million tourist arrivals and 10 million overnight stays this year.

“If we achieve this year’s goal, we will still be short of the country’s needs,” he said. “Still, that’s a lot better than we expected at the end of 2020.”

Work – Working in the Maldives has become very trendy. You see very rich executives, executives of companies who come here and are based here.

Abdulla Mausoom

Minister of Tourism, Maldives

As early as this year, the Maldives received 350,000 arrivals as vacationers – mostly from nearby India – take advantage of the country’s limited entry regulations.

In the meantime, guests are booking longer stays, with many using the islands as a destination for so-called “workations” – or a working vacation. Mausoom said he was confident it would stay that way as tourists stay to receive both their first and second doses.

“Work – work is getting very trendy in the Maldives,” he said. “You see very rich executives, executives of companies, who come here and are based here.”