Tag: Vaccine

E.U. Set to Curb Covid Vaccine Exports for six Weeks

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Post date March 24, 2021

E.U. Set to Curb Covid Vaccine Exports for 6 Weeks

BRUSSELS – The European Union completes emergency legislation that gives it extensive powers to curb exports of the block-made Covid-19 vaccines for the next six weeks. This is a marked escalation in their response to domestic supply shortages that have created a political vortex amid a rising third wave on the continent.

The bill, due to be released on Wednesday, has been reviewed by the New York Times and approved by two EU officials involved in the drafting process. The new regulations will make it harder for pharmaceutical companies that make Covid-19 vaccines in the European Union to export them, and supplies to the UK are likely to be disrupted.

The European Union has come into conflict with AstraZeneca in the first place, as it drastically reduced its supplies to the bloc and cited production problems in January. The company is the main target of the new regulations. However, legislation that could block the export of millions of doses from EU ports could also affect Pfizer and Moderna vaccines.

Britain is by far the biggest benefactor of EU exports and will lose the most to these rules. However, they could also be used to curb exports to other countries such as Canada, for example the second largest recipient of vaccines made in the EU. and Israel, which is receiving doses from the block but is very advanced in its vaccination campaign and is therefore seen as less needy.

“We are in the crisis of the century. And I’m not ruling anything out for now, because we have to make sure that Europeans are vaccinated as soon as possible, ”said Ursula von der Leyen, President of the European Commission, in comments last week that paved the way for the new rules. “Human life, civil liberties and also the prosperity of our economy depend on it, on the speed of vaccination and on further development.”

The legislation is unlikely to affect the United States, which has received fewer than one million doses from facilities in the EU.

The Biden government has announced that it has received enough doses from its three authorized manufacturers – Pfizer-BioNTech, Moderna, and Johnson & Johnson – to cover all adults in the country by the end of May. Most of this supply comes from plants in the United States. The country also exports vaccine components to the European Union, which is reluctant to risk disrupting the raw material supply chain.

The European Union allowed pharmaceutical companies to perform their contracts by authorizing them to export more than 40 million doses of vaccine to 33 countries between February and mid-March, with 10 million going to the UK and 4.3 million going to Canada. The bloc has kept about 70 million at home and distributed them to its 27 member states, but its efforts to run mass vaccination campaigns have been set back by a series of missteps.

Liberal overseas exports when domestic supply is low was a significant part of the problem, and the bloc was criticized for allowing exports at all when the United States and Britain practically closed domestic production through contracts with pharmaceutical companies .

The result was a problematic introduction of vaccines for the richest group of nations in the world. The impact of the outages is compounded by a third wave that puts health systems across the continent on emergency mode and instigates painful new lockdowns.

Updated

March 23, 2021, 8:03 p.m. ET

The European Commission, which ordered the vaccines, and individual governments in member states responsible for their national campaigns, have been banned by voters fed up of being banned and increasing the number of Covid-19 cases because of their failure , heavily criticized. Public anger and political costs have risen as the bloc has fallen behind several wealthy counterparts in the world in promoting vaccination campaigns, despite major manufacturers based here.

The bloc has seen recipients of vaccines made in its member countries as well as other rich countries drive their vaccination campaigns. Almost 60 percent of Israelis have received at least one dose of vaccine, 40 percent of British and a quarter of Americans, but only 10 percent of EU citizens have been vaccinated, according to the latest information released by Our World in Data.

The export restrictions are being enforced by the European Commission, the executive branch of the European Union, and while changes to the new rules could take place before the law is finalized, officials said they are unlikely to be substantial. They are expected to enter into force quickly.

EU officials said the rules would allow for a degree of discretion, meaning they would not result in a blanket export ban, and officials still expected many exports to continue.

“The proposed measures concern,” said Youmy Han, spokeswoman for Canada’s Minister for International Trade, Mary Ng.

“Minister Ng’s colleagues have repeatedly assured her that these measures will not affect vaccine shipments to Canada,” said Ms. Han. She added: “We will continue to work with the EU and its member states, as we have done throughout the pandemic, to ensure that our essential health and medical supply chains remain open and resilient.”

Canada depends on the European Union for almost all of its vaccine supply: all of Canada’s Moderna and Pfizer vaccines come from Europe, although the country received a small shipment of the AstraZeneca vaccine from India.

The new rules come after months of escalating tensions between the European Union and AstraZeneca in a situation that has become toxic to the bloc’s fragile relations with its recently deceased member, the UK.

The problems started in late January when AstraZeneca notified the block that it would cut its shipments by more than half in the first quarter of 2021, which turned plans to launch vaccines upside down. In response, the European Union has put in place an export authorization process whereby pharmaceutical companies must obtain permission to export vaccines and give the European Union the power to block them if they are seen as a breach of a company’s contractual obligations to the bloc.

As of February 1, the European Union has blocked just one of more than 300 exports, a small shipment of AstraZeneca vaccines to Australia, on the grounds that the country is virtually Coviden-free while the block struggles with increasing infections.

The new rules will introduce more reasons to block exports, the drafts show. They will encourage blocking shipments to countries that do not export vaccines to the European Union – a clause clearly targeting the UK – or to countries that have “a higher vaccination rate” than the European Union, “or where the current epidemiological situation is less serious “than in the block according to the Times.

In recent days, British Prime Minister Boris Johnson has tried to use a conciliatory tone to avert an EU export ban that would deal a severe blow to his country’s rapidly advancing vaccination campaign.

At a press conference on Tuesday, Mr Johnson said he was against blockades and was “encouraged by some of the things I’ve heard from the continent.” The UK news media reported that his government would be ready to have the block produce four million AstraZeneca cans in an EU factory.

Benjamin Mueller reported from London, Sharon LaFraniere from Washington and Ian Austen from Ottawa.

Tags Covid, curb, Exports, set, Vaccine, Weeks

World News

Covid-19 and Vaccine Information: Reside Updates

Post author By
Post date March 23, 2021

AstraZeneca’s Covid-19 vaccine being administered in Milan on Monday.

Here’s what you need to know:

Credit…Alessandro Grassani for The New York Times

Federal health officials said Tuesday that the encouraging results that AstraZeneca announced about its Covid-19 vaccine may have been based on outdated and incomplete information about the vaccine’s effectiveness, an extraordinary blow to the credibility of an already embattled vaccine.

In a statement released after midnight, the National Institute of Allergy and Infectious Diseases said that an independent panel of medical experts that has been helping to oversee AstraZeneca’s U.S. trial had “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”

The exact nature of the institute’s concerns — and the effect they might have on how effective the vaccine appears to be — was unclear. But it is highly unusual for such a dust-up about the integrity of a clinical trial, especially one as high-profile as this, to occur in public.

“This is really what you call an unforced error,” Dr. Anthony S. Fauci, the nation’s leading infectious-disease expert, said on “Good Morning America” on Tuesday morning. “Because the fact is: This is very likely a very good vaccine, and this kind of thing does, as you say, do nothing but really cast some doubt about the vaccines and maybe contributes to the hesitancy.”

AstraZeneca defended the data that it released on Monday, which showed the vaccine was 79 percent effective at preventing Covid-19. The company said in a statement on Tuesday that the interim results, which were current as of Feb. 17, appeared to be “consistent” with more recent data collected during the trial. AstraZeneca said it would immediately share its latest efficacy data with the monitoring board. The company said it would reissue fuller results within 48 hours.

The results that AstraZeneca announced on Monday seemed encouraging — especially because they came at a moment when concerns about the vaccine’s safety had led more than a dozen countries, mostly in Europe, to temporarily suspend the shot’s use over concerns about possible rare side effects.

But the statement from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, raised the prospect that the company was presenting an overly optimistic interpretation of the data.

In recent days, the independent monitoring board’s analysis was delayed several times because the board had to ask for revised reports from those handling trial data on behalf of the company, according to a person familiar with the matter who was not authorized to discuss it publicly.

Companies sponsoring drug or vaccine trials typically wait for the monitoring board to review analyses and conclude that the study has yielded an answer before they announce trial results.

Company executives do not see the results of the study until the monitoring board reports their study data back to the company. The monitoring board ultimately conveyed the results of the study to AstraZeneca in a meeting over the weekend, leading to the company’s announcement Monday morning.

The monitoring board’s slow progress fueled concerns among federal officials that AstraZeneca may have been sitting on the data or that the monitoring board had concerns about the way the data it was reviewing had been presented.

An AstraZeneca spokeswoman, whom the company declined to name, said on Friday that it was “completely incorrect” that the trial data had formatting problems or had not been submitted to the monitoring board in a clean fashion.

“As is often the case,” the spokeswoman said, monitoring boards “can request new or clarifying analyses of data from the trial. This would enable them to ensure the robustness of their determinations.”

The national institute’s statement, issued shortly after midnight, stunned experts. Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said it was “highly irregular” to see such a public display of friction between a monitoring board and a study sponsor, which are typically in close concordance.

“I’ve never seen anything like this,” he said. “It’s so, so troubling.”

AstraZeneca’s relationship with the U.S. authorities has been fraught since last year, when senior health officials believed the company was not being forthright about the design of its clinical trials, its results and safety issues. That skepticism carried over to last week, when senior officials at a number of federal health agencies grew suspicious about why AstraZeneca had not announced data from its U.S. study.

United States ›	United StatesOn March 22	14-day change
New cases	55,621	–8%
New deaths	650	–35%

World ›	WorldOn March 22	14-day change
New cases	416,353	+25%
New deaths	7,301	+3%

U.S. vaccinations ›

Credit…Laetitia Vancon for The New York Times

Chancellor Angela Merkel of Germany, warning on Tuesday that her country is facing a significantly more deadly wave of the coronavirus, announced a five-day lockdown over Easter and the extension of existing restrictions until mid-April in an effort to break a spike in coronavirus cases.

Starting April 1, and until the following Monday, Germany will effectively shut down for an extended Easter break, with private meetings limited to no more than two groups of up to five adults and almost all stores ordered shuttered (supermarkets can open on the Saturday). Churches are asked to hold services online, and people are being asked to stay home and not travel.

“We are in a very, very serious situation,” Ms. Merkel told a news conference, after hours of deliberations with the leaders of the country’s 16 states over the Easter lockdown and extension of existing restrictions through April 18.

“After we were able to sharply bring down the number of new infections in January, we are now experiencing, through the spread of the more contagious British variant, a more dangerous variation — the numbers are going up and the intensive care beds are filling up,” she said.

Germany is the latest country in Europe to tighten restrictions as more contagious virus variants spread and the continent struggles to vaccinate its citizens. Poland, Italy and parts of France have ordered that residents stay home, and many businesses have shut before the holiday.

A resurgent virus and lagging vaccinations have forced governments to renege on promises that they would slowly reopen businesses and society as spring approached. That has spurred protests across Europe.

Europe’s vaccine campaign slowed after a small number of cases of blood clots and abnormal bleeding were reported in patients who received the AstraZeneca vaccine, dampening confidence in its safety. While the European drug regulator, the European Medicines Agency, cleared the vaccine for use last week and said it was “safe and effective,” the scare further complicated vaccination efforts.

Just three weeks ago, Ms. Merkel and state officials hammered out a road map to reopening that relied on a decline in case rates. But the number of new daily cases in Germany has increased by 69 percent in the past two weeks, to levels last seen in January.

Credit…Regeneron, via Associated Press

A monoclonal antibody treatment developed by the drug maker Regeneron sharply cut the risk of hospitalization and death when given to high-risk Covid-19 patients in a large clinical trial, the company announced on Tuesday.

The results are the latest in a growing flurry of evidence that the infused drugs, meant to mimic the antibodies that the immune system generates naturally in fighting the coronavirus, can help infected patients avoid the worst outcomes if given early.

Regeneron’s treatment, a cocktail of two antibody drugs, was given last fall to President Donald J. Trump shortly after he got sick with Covid-19 and is now one of three such therapies available in the United States.

The new results come from a Phase 3 trial that enrolled more than 4,500 patients beginning in late September, around the time virus cases began to climb dangerously in the United States. The study found that patients who got the infused treatment within 10 days of developing symptoms or testing positive had a roughly 70 percent reduced risk of being hospitalized or dying compared with patients who were infused with a placebo.

“I think these are exciting data,” said Dr. Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital who was not involved in the study.

Even as vaccinations speed up, antibody treatments are expected to be helpful for high-risk people who still get sick for many months at least, and longer still if the virus can’t be wiped out. While there are signs that emerging virus variants may in some cases make antibodies less potent, Regeneron’s cocktail has not shown such vulnerability in laboratory tests.

In the new findings, Regeneron’s treatment worked equally well when given at half the dosing at which it was authorized. Regeneron said that it planned to request that the Food and Drug Administration allow the treatment to be given at that reduced strength.

Such a change would bring several advantages: While the cocktail is safe, getting it at a lower dose reduces the odds of side effects, such as an infusion reaction.

It would also allow Regeneron to increase the supply it can provide the United States. The company said that it had expected to supply the country with about 750,000 doses at the originally authorized higher strength by the end of June. If the lower strength is authorized, the company expects to provide about 1.25 million doses by then.

The antibody treatments from Regeneron and the drug maker Eli Lilly, which makes the other two such drugs authorized in the United States, were expected to be in high demand and to serve as a bridge in fighting the pandemic before vaccinations ramped up. Instead, they ended up sitting on refrigerator shelves in many places even during recent surges.

Many patients and their doctors did not know to ask for them or where to find them. Overwhelmed hospitals lacked the bandwidth to prioritize giving out the treatments. And some doctors were unconvinced by the relatively weak evidence available last fall supporting their use.

That picture is gradually shifting, thanks to improved logistics and more awareness. And more solid evidence, like the new data from Regeneron, also appears to be helping the drugs get used more widely. “As the data get stronger and stronger, I would expect that use will increase,” Dr. Gandhi said.

Credit…Jim Wilson/The New York Times

Positive trends in pandemic statistics in the United States are easy to distrust. After all, the country went through two false dawns last year, in the late spring and then again in the late summer, when declines in case reports prefaced even darker days. Each time, the apparent good news prompted relaxations and reopenings that helped bring on the next wave.

So it is no surprise that public health experts are wary about the latest flattening in the curve of the pandemic, from the steep decline in cases seen in late January and February to something like a plateau or slight decline more recently. With more contagious virus variants becoming prevalent, they fear the good news could be ending and a fourth wave might be building.

On Monday, Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, again warned Americans about the spread of the coronavirus, saying that with increased travel, looser pandemic restrictions and worrisome variants bearing down on the United States, another surge could erupt if Americans did not take protection efforts seriously “for just a little bit longer.”

“We are at a critical point in this pandemic, a fork in the road, where we as a country must decide which path we are going to take. We must act now,” said Dr. Walensky, who has been one of many federal officials in recent weeks to warn governors against lifting mask mandates too soon. “And I am worried that if we don’t take the right actions now, we will have another avoidable surge, just as we are seeing in Europe right now and just as we are so aggressively scaling up vaccination.”

That said, there are positive signs:

Daily death reports, which stayed stubbornly high long after the post-holidays surge, have finally come down sharply, to levels not seen since mid-November. As of Monday, the nation had averaged 1,051 newly reported virus deaths a day over the past week; the average had hovered around 3,000 for weeks over the winter.
Some recent hot spots have made major progress — notably Los Angeles, whose mayor, Eric Garcetti, said on CBS on Sunday that he had “not felt this optimism in 12 months.” The city and surrounding county, where cases in some areas leapt 450 percent over the holidays and hospitals became so swamped that some turned away ambulances, now has a test positivity rate of about 1.9 percent, and in an important shift, new case reports have fallen among people experiencing homelessness.
Vaccinations are becoming more accessible by the week, as states receive more doses and open up eligibility, in some cases to include all adult residents. The number of doses administered nationwide each day is rising, and the country surpassed President Biden’s initial goal to have administered 100 million shots on March 19, almost six weeks ahead of schedule.

The question now is which will prevail: the positive effects of trends like these or the negative effects of looser behavior and the evolution of the virus into more dangerous forms?

It’s still “a race between vaccinations and variants,” Dr. Ashish Jha, dean of the Brown University School of Public Health, said on Twitter. Like other experts, he cautioned: “Opening up too fast helps the variants.”

Noah Weiland contributed reporting.

Credit…Taylor Glascock for The New York Times

In the fall, after Samar Khan came down with a mild case of Covid-19, she expected to recover and return to her previous energetic life in Chicago. She was 25 and healthy.

But weeks later, she said, “this weird constellation of symptoms began to set in.”

She had blurred vision encircled with halos. She had ringing in her ears, and everything began to smell like cigarettes or Lysol. One leg started to tingle, and her hands would tremble while she was putting on eyeliner.

She also developed “really intense brain fog,” she said. Trying to concentrate on a call for her job in financial services, she felt as if she had come out of anesthesia.

By the end of the year, Ms. Khan was referred to a special clinic for Covid-related neurological symptoms at Northwestern Memorial Hospital in Chicago, which has been evaluating and counseling hundreds of people with similar problems.

Now, the clinic has published the first study focused on long-term neurological symptoms in people who were never physically sick enough from Covid-19 to need hospitalization, including Ms. Khan.

The study of 100 patients from 21 states, published on Tuesday in The Annals of Clinical and Translational Neurology, found that 85 percent of them experienced four or more neurological issues like brain fog, headaches, tingling, muscle pain and dizziness.

“We are seeing people who are really highly, highly functional individuals, used to multitasking all the time and being on top of their game, but, all of a sudden, it’s really a struggle for them,” said Dr. Igor J. Koralnik, the chief of neuro-infectious diseases and global neurology at Northwestern Medicine, who oversees the clinic and is the senior author of the study.

Credit…Jose A. Alvarado Jr. for The New York Times

With virus cases seeming to stabilize in New York City and vaccinations becoming more widespread, city officials intend to send a message that New York is close to returning to normal: On May 3, the city will compel its municipal office employees to begin to report to work in person, according to planning documents shared with The New York Times. Workers will return in phases over several weeks.

Mayor Bill de Blasio’s decision to bring the nation’s largest municipal work force back to the office signals a remarkable turnabout in the fortunes of a city that was the national epicenter of the pandemic, coming to symbolize the perils of living in densely packed global capitals.

The move is meant to broadcast that New York City will soon be open for business, and to encourage private companies to follow suit.

The new policy is expected to affect about 80,000 employees who have been working remotely, including caseworkers, computer specialists and clerical associates. The rest of the city’s roughly 300,000-person work force, many of them uniformed personnel including police officers, firefighters and sanitation workers, have already been reporting to work sites.

“Above all else, this is a major momentum builder,” said Reggie Thomas, a senior vice president with the Real Estate Board of New York.

Yet the move has spurred concern among some workers and union leaders who fear it is premature. New York City still has among the highest coronavirus case rates in the nation. Many workers will have to commute an hour or more on mass transit.

Facial masks will be strongly encouraged but not required: A March 18 presentation from the city’s Department of Citywide Administrative Services said agency leaders should “encourage face coverings to be worn at all times even if six-feet distancing can be maintained.” The provision allows workers to remove face coverings if they are more than six feet apart.

Vaccination will not be mandatory for those returning to the office because of legal concerns, though city officials are strongly encouraging their workers to get vaccinated and are trying to facilitate that process.

Credit…Henry Nicholls/Reuters

Residents of England who travel abroad without a valid reason will be fined 5,000 pounds, or $6,900, under coronavirus regulations that are scheduled to come into force on Monday if lawmakers approve.

Daily coronavirus deaths in Britain have dropped to their lowest level since fall, thanks in part to a vaccination program that has already reached more than half the adult population, and the country is preparing to slowly reopen its economy after months of national lockdown. A stay-at-home order is to be lifted on Monday, though many shops and other businesses will be closed until mid-April or later.

Travel abroad for leisure is banned until May 17 at the earliest, and the new regulations signal a potentially longer wait for vacationers.

If the new regulations are approved, travelers would have to provide a valid excuse for leaving the country, which would include some essential work, elite sports competitions and education. But opposition lawmakers have criticized an exemption that would allow travel “in connection with the purchase, sale, letting or rental of a residential property,” arguing that it would privilege those wealthy enough to own a second residence. Travel without an essential reason is also banned in Scotland, Wales and Northern Ireland.

The legislation, which is set to be reviewed on April 12 and expire at the end of June, would also renew a ban on indoor gatherings and limit outdoor gatherings to six people. Lawmakers on Thursday will also vote on extending a coronavirus act that gave the government emergency powers during the pandemic, which has caused friction among some members of the governing Conservative Party who have called the laws extreme.

It comes as the country marks the one year since Prime Minister Boris Johnson announced the first national lockdown. Britain has reported at least 4.3 million cases and over 126,000 deaths according to a New York Times database.

Credit…Nathan Bajar for The New York Times

Cineworld, the parent company of the U.S. movie theater chain Regal Cinemas, announced on Tuesday that it would reopen its cinemas in the United States in April and in Britain in May as those countries ease lockdown restrictions.

“We have long-awaited this moment,” said Mooky Greidinger, the chief executive of Cineworld, which is based in London. “With capacity restrictions expanding to 50 percent or more across most U.S. states, we will be able to operate profitably in our biggest markets.”

Regal Cinemas is the second largest theater chain in the United States, after AMC Theaters. The announcement by Cineworld comes six months after the movie theater chains were forced to shut down across the United States and Britain last October in an effort to curb the spread of the coronavirus. The decision affected a total of 45,000 employees in both countries and forced studios to postpone film releases.

Cineworld also announced a multiyear agreement with Warner Bros. starting in 2022 that will allow the theater chain to show the studios’ films for 45 days in the United States and 31 days in Britain. The deal shortens the typical window that theaters have to show movies before they are released to on-demand streaming services.

The reopening plans in the United States will coincide with the release of two movies from Warner Bros. Pictures, “Godzilla vs. Kong” on April 2 and “Mortal Kombat” on April 16.

“We are very happy for the agreement with Warner Bros.,” Mr. Greidinger said. “This agreement shows the studio’s commitment to the theatrical business.”

Last week, AMC Theaters announced the reopening of nearly all of its U.S. theaters.

The moves come at a time of concern that looser restrictions will lead to rise in coronavirus cases. On Monday, the director of the Centers for Disease Control and Prevention warned that relaxed pandemic restrictions could lead to another spike. “If we don’t take the right actions now,” said Dr. Rochelle Walensky, “we will have another avoidable surge.”

In September, Cineworld reported a pretax loss of $1.6 billion for the first half of 2020. In 2019, 90 percent of the company’s revenue was generated in the United States and Britain.

Credit…James Estrin/The New York Times

Most school districts in New Jersey have partly reopened, but one in four children still live in a district where public schools are closed. No state in the Northeast had more districts relying on all-virtual teaching in early March than New Jersey, according to Return to Learn, a database created by a conservative think tank, the American Enterprise Institute, and Davidson College. Nationwide, only seven states had a greater proportion of all-remote instruction.

As the distribution of vaccines has accelerated and President Biden has signaled a push for broader reopenings, frustration among parents has grown, particularly in New Jersey’s affluent suburbs, where schools with stellar reputations are a key reason families are willing to pay some of the nation’s highest taxes.

These parents have filed federal lawsuits, held protests, created online petitions and shown up at virtual board of education meetings to demand expanded in-person instruction.

The pressure to open schools more fully comes as the infection rate in New Jersey, which is small and densely populated, remains stubbornly high: With a weekly average of 45 cases for every 100,000 residents, the state leads the nation in new infections per capita, according to a New York Times database.

The drumbeat intensified after the Centers for Disease Control and Prevention announced a major policy shift on Friday, reducing its distancing recommendations to three feet from six feet for all elementary schools and for middle and high schools in areas where the virus infection rate is not high.

Anger at the pace of reopening has led some families who can afford it to enroll their children in private schools, start home-schooling them or move. If enough children leave a district in New Jersey, it could lead to cuts in state aid, scaled-back programming or potentially layoffs.

Several New Jersey cities and counties have held educator-only vaccine distribution events. But the virus’s hold on the state has left teachers and their powerful unions wary of expanded reopening.

Credit…Divyakant Solanki/EPA, via Shutterstock

Mumbai, India’s financial hub, has begun random testing for the coronavirus in malls, railway stations and other crowded places as officials attempt to tamp down on a worrying surge in cases.

Rapid antigen tests will be taken without individuals’ consent, the Municipal Corporation of Greater Mumbai said in a statement on Monday. Anyone who resists will be in violation of India’s colonial-era epidemic act, which gives the government the power to fine or imprison people who violate rules to contain an outbreak.

“We are trying to implement the existing protocol to the strictest possible level: use of face mask, regulating the number of people in one event, use of hand sanitizer, and now tests,” Suresh Kakani, a senior municipal official in Mumbai, told The New York Times.

Active Covid-19 cases in Mumbai have risen by more than 140 percent since March 1. With variants circulating and commercial activity almost back to prepandemic levels, the number of infections has also shot up in the surrounding state of Maharashtra. An entire district was forced back into lockdown last week.

Mr. Kakani said officials are determined to avert another lockdown in Mumbai, the city of 20 million that is home to Bollywood, India’s film industry, as well as the country’s largest stock exchange.

Another lockdown would be economically disastrous for India, which is just starting to recover from a lockdown last year that triggered a humanitarian crisis, as millions of migrant workers fled cities for their home villages, and a recession.

Tags Covid19, Live, News, Updates, Vaccine

Business

U.S. Well being Officers Query AstraZeneca Vaccine Trial Outcomes

Post author By
Post date March 23, 2021

U.S. Health Officials Question AstraZeneca Vaccine Trial Results

This US trial, which was attended by more than 32,000 participants, was the largest test of its kind for the shot. The results, AstraZeneca released on Monday, came from an interim look at the data after 141 Covid-19 cases occurred in volunteers.

The company had only announced on Tuesday how up-to-date this data was. This information is important because sometimes a more up-to-date look at clinical trial results may reveal different efficacy and safety.

If the analysis was done on data from a month or two ago, it is possible that a more recent look may give a different picture of the vaccine’s effectiveness and safety. The company has announced that it will provide the FDA with a more comprehensive and up-to-date dataset than it released on Monday. Although no clinical study is large enough to rule out extremely rare side effects, AstraZeneca reported that its study did not identify any serious safety issues.

The new data may have arrived too late to make a big difference in the United States, where the vaccine has not yet been approved and is not expected to be available until May. By then, federal officials say, there will be enough vaccine doses for all adults in the country from the three already approved vaccines: Pfizer-BioNTech, Moderna, and Johnson & Johnson.

Even so, the better-than-expected results have been seen as an encouraging turn for AstraZeneca’s shot, whose low cost and simple storage requirements have made it an important part of the quest to vaccinate the world.

The results were also believed to allay concerns about the AstraZeneca vaccine in Europe. Regulators there said the shot was “safe and effective” last week after conducting a review after a small number of people who had recently been vaccinated developed blood clots and abnormal bleeding. The US study found no evidence of such problems, although some real-world safety issues can only be identified when a drug or vaccine is widely used.

Millions of people have received the AstraZeneca shot worldwide, including more than 17 million in the UK and the European Union, almost all without serious side effects. To increase public confidence, many European political leaders have received the injections in the past few days. The AstraZeneca vaccine was also given to executives in South Korea, Taiwan and Thailand last week.

Tags AstraZeneca, health, Officials, question, results, trial, Vaccine

Business

Unfair to accuse EU of vaccine nationalism, Dombrovskis says

Post author By
Post date March 23, 2021

An employee in Schwaz, Austria, creates a syringe and container with the BioNTech / Pfizer vaccine.

JOHANN GRODER | AFP | Getty Images

LONDON – The European Union “is facing a serious situation” with the introduction of Covid-19 shots, but it is “highly unfair” to accuse the bloc of vaccine nationalism, the region’s commercial chief told CNBC on Tuesday .

The EU has faced a number of problems since the start of its vaccination program Criticism, among other things, for being too slow to approve vaccines and for blocking the export of Covid-19 shots.

At the same time, delivery issues with the AstraZeneca vaccine in the first quarter hampered the use of gunshots, and there are concerns in Brussels about whether contractual commitments will be fully met over the next three months.

“We are clearly facing a serious situation with the introduction of vaccines. We need to speed up vaccination, we need to speed up both vaccine production and vaccine supply,” Valdis Dombrovskis, EU chief of commerce, told CNBC’s Squawk Box Europe.

The European Commission, the EU’s executive branch, has worked with various pharmaceutical companies to increase vaccine production in the Member States. The facility wants 70% of Europe’s adult population to be vaccinated by the end of the summer.

Achieving this goal, however, depends on companies delivering the amount of vaccines expected by the bloc and on member states being able to distribute the shots among their populations.

AstraZeneca already has cut its delivery numbers twice for the first quarter and said it will distribute less than half of its original target for the second quarter as well.

We consider it extremely unfair to accuse the EU, which is one of the largest vaccine exporters, of vaccine nationalism.

Valdis Dombrovskis

Executive Vice President of the European Commission

Given the importance of the AstraZeneca shot to the EU’s vaccination program, European officials are considering imposing stricter export restrictions. For example, you could prevent shots made in the EU from being sent elsewhere, particularly to the UK, where the vaccination rate is significant higher than among the 27 countries.

That triggered Allegations that the EU practices vaccination nationalism.

“We consider it extremely unfair to accuse the EU, which is one of the largest vaccine exporters, of vaccine nationalism,” said Dombrovskis.

The EU reported last week that it had exported 41 million cans of Covid-19 shots to 33 countries, with the UK being the largest recipient. At the same time, the EU has stated that it does not see the same level of reciprocity with other parts of the world.

However, the EU also stopped shipping AstraZeneca vaccines to Australia earlier this month due to delivery problems with the pharmaceutical company.

The legislation that allowed the EU to stop this broadcast expires at the end of the month. As a result, EU officials are considering whether to expand and tighten these laws in the future.

“What is important right now is that companies actually honor their contracts, as the problem we face, especially with a company that fails to honor the contract, is that vaccine shipments are falling far short of what was agreed “said Dombrovskis.

Over the next three months, the European Union expects 55 million doses of the Johnson & Johnson shot, 200 million doses of the Pfizer BioNTech vaccine, 35 million doses from Moderna and another 70 million doses from AstraZeneca.

Tags Accuse, Dombrovskis, nationalism, Unfair, Vaccine

Health

Putin to get coronavirus vaccine; Russia’s vaccine technique in focus

Post author By
Post date March 23, 2021

Putin to get coronavirus vaccine; Russia's vaccine strategy in focus

Russian President Vladimir Putin will chair a meeting on May 13, 2020 to focus on assisting the aviation industry and aviation at his land residence in Novo-Ogaryovo, outside Moscow.

Alexey Nikolsky | AFP | Getty Images

Russian President Vladimir Putin is expected to receive a coronavirus shot on Tuesday as the country’s vaccination strategy takes center stage.

Putin’s vaccination is due one day after commending multimillion-dollar international sales of Russian vaccine Sputnik V Covid. However, the country’s adoption appears to be slow and in stark contrast to the large number of vaccines destined for the international market.

It was reported that Russia’s own manufacturing capacity is low, and Putin appeared to be nodding at it on Monday. He said Russia needs to ramp up domestic vaccine production and that household supplies are a priority, according to Reuters.

He found that 4.3 million people in the country had already received two doses of the vaccine. This is much higher than in the UK, for example, where around 2.3 million people have given both doses to date. However, Russia was the first country in the world to approve a coronavirus vaccine (Sputnik V) as early as August 2020, first shot in early December.

However, the Kremlin has not confirmed whether Putin will receive Sputnik V. There are three Russian vaccines and Putin’s spokesman said Monday that the president would be vaccinated with one of them. “All of them are good and reliable,” the spokesman said, according to the AP.

logistics

Russia faces a number of logistical challenges when introducing a vaccine. It is the largest country in the world and has around 144 million inhabitants in an area that stretches across Europe and northern Asia.

In early March, Putin found that all but nine Russian regions had started using the vaccine, with delays related to “problems with logistics, distribution (and) locations,” the Moscow Times reported.

Global data on vaccination programs shows that Russia is lagging behind many other countries in its own domestic rollout, with the number of single doses administered in Russia just above the number of doses administered in Bangladesh, according to Our World in Data.

Vaccination dates are highlighted as Russia was hit so hard by the pandemic: it has recorded the fourth highest number of cases in the world (over 4.4 million) and over 94,000 people have died of Covid in the country, according to Covid at Johns Hopkins University.

Vaccination skepticism

Another major problem hindering Russia’s adoption is citizens’ reluctance to adopt vaccines. Daragh McDowell, head of Europe and senior Russian analyst at Verisk Maplecroft, told CNBC that the country’s lower vaccination rates “are likely due to public unwillingness to be skeptical about the vaccine rather than lack of supply.”

He noted that the latest data from the Levada Center, an independent pollster in Russia, suggests that only 30% of Russians are “ready to get vaccinated, a number that has actually decreased since last year”.

“This is mainly due to concerns about side effects and the inadequate testing of the vaccine. In other words, while the Kremlin received a boost in propaganda by bringing the vaccine out first, it came at the expense of doubts about its safety.” McDowell noticed.

A woman receives the second component of the Gam-COVID-Vac (Sputnik V) COVID-19 vaccine.

Valentin Sprinchak | TASS | Getty Images

Sputnik V was originally only approved in Russia for those ages 18 to 60, which means that 68-year-old Putin was too old to receive it. However, further studies in seniors found that the vaccine was safe in people 60 and older, and that the age group can now get the shot.

“The fact that Putin waited so long to be vaccinated himself is not going to go unnoticed and has contributed to these doubts,” added McDowell.

“The president’s vaccination will convince some Russians of the vaccine’s effectiveness and safety (but) high levels of social distrust and conspiratorial thinking will mitigate its effects.”

He stressed that the same survey data that showed that 30% of Russians were willing to be vaccinated also showed that nearly two-thirds believed Covid was artificially developed as a biological weapon.

International sales agreements

Another aspect of the Russian vaccine program that has attracted attention is the high number of international sales of its vaccine. On Monday, Putin confirmed that Russia had signed international sales agreements for Sputnik V cans for 700 million people.

RDIF, Russia’s sovereign wealth fund that backed the development and deployment of Sputnik V, announced Tuesday that Sputnik V has now been approved in 56 countries, with Vietnam being last on the list. Several Eastern European countries such as Hungary and Slovakia have also ordered Sputnik V cans.

In the meantime, the European Medicines Agency launched an ongoing review of Sputnik V earlier this month.

Verisk Maplecroft’s McDowell pointed out that while exporting 700 million cans is “an extremely ambitious figure,” it is likely that licensed products also made overseas, for example in India and South Korea.

Data processing

Russian vaccine Sputnik V was approved by the Russian health authority in August last year before clinical trials were completed, leading to skepticism among experts that it may not meet strict safety and efficacy standards. Some experts argued that the Kremlin is keen to win the race to develop a Covid vaccine, an indictment it has brought against other countries. Russia has repeatedly stated that its vaccine is the target of anti-Russian sentiment.

Russia appeared to be confirmed in early February As an interim analysis of the 20,000-participant Phase 3 clinical trials of the shot was published in the peer-reviewed medical journal The Lancet. The vaccine was found to be 91.6% effective against symptomatic Covid-19 infections.

In an accompanying article in the Lancet, Ian Jones, Professor of Virology at the University of Reading, England noted that “the development of the Sputnik V vaccine has been criticized for undue urgency. However, the result reported here is clear and scientific. The principle of vaccination is demonstrated which means another vaccine can now join the fight to reduce the incidence of Covid-19. “

Tags coronavirus, Focus, Putin, Russias, Strategy, Vaccine

World News

U.S. well being company casts doubt over AstraZeneca vaccine knowledge

Post author By
Post date March 23, 2021

U.S. health agency casts doubt over AstraZeneca vaccine data

A nurse makes syringes with the preparation of Astrazeneca in Axel Stelzner’s family doctor’s practice.

Hendrik Schmidt | Image alliance via Getty Images

LONDON – A US health agency on Tuesday expressed concern that AstraZeneca may have included out of date information from a clinical trial of its Covid-19 vaccine, which may cast doubt on the published efficacy results.

The Data Safety Monitoring Board “was concerned that AstraZeneca may have included out of date information from this study that may provide an incomplete view of the efficacy data,” the US National Institute of Allergy and Infectious Diseases said in a statement.

“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible.”

The NIAID is led by the White House Chief Medical Officer, Dr. Anthony Fauci, directs and is part of the National Institutes of Health.

AstraZeneca did not immediately respond to a CNBC request for comment.

The statement comes just a day after the results of a large U.S. study showed that the coronavirus vaccine developed by AstraZeneca and Oxford University is 79% effective against symptomatic illness and 100% effective against serious illness and hospitalization.

Data from the late-stage human study was based on more than 32,000 volunteers at 88 trial centers in the United States, Peru, and Chile.

The results were welcomed as “surprisingly positive” and “good news for the global community”.

AstraZeneca said it plans to prepare the primary analysis, which will be submitted to the U.S. Food and Drug Administration for emergency approval before mid-April.

The Oxford AstraZeneca vaccine had been temporarily suspended in several countries after blood clots were reported in some people who had been vaccinated. However, AstraZeneca said Monday that the independent DSMB had not found an increased risk of blood clots.

Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, told CNBC’s “Squawk Box” Monday that it was “very gratifying to see that the Data Safety Monitoring Board, even with a magnifying glass, is not an imbalance between the vaccinated group and the vaccinated group the placebo group. “

“That gives us a lot of confidence,” he added.

Tags Agency, AstraZeneca, casts, Data, doubt, health, Vaccine

Business

AstraZeneca’s Covid-19 Vaccine Is Discovered to Be 79% Efficient in U.S. Research

Post author By
Post date March 22, 2021

AstraZeneca’s Covid-19 Vaccine Is Found to Be 79% Effective in U.S. Study

However, the rate at which several nations discontinued use of the vaccine reflected a reluctance about its safety and effectiveness that contrasts sharply with the confidence shown in other vaccines. Confidence in the vaccine has fallen in Germany, France, Italy, Spain and, to a lesser extent, the UK, according to surveys.

Participants who received the vaccine in the study did not have an increased risk of blood clots or related diseases. And a specific search did not find any cases of cerebral venous sinus thrombosis – blood clots in the brain that can cause dangerous bleeding – which raise some of the most serious concerns in Europe.

Michael Head, Senior Research Fellow on Global Health at the University of Southampton in the UK, said the results could allay concerns not only in Europe but around the world. He said he had received messages in the past few days from colleagues in Ghana resenting how he could explain safety concerns to people who had just celebrated the arrival of the vaccine weeks earlier.

“Given the light raids the AstraZeneca vaccine has suffered in the past few weeks – and particularly in the last week or two in Europe – there is new data to show that it is safe and effective, if you excuse the phrase , a good shot of the arm, ”he said. “The publication of these results is actually quite well timed as the vaccine may be hesitant.”

The US study also found no cases of serious neurological problems. This was a cause for concern last summer after two volunteers at AstraZeneca’s trial in the UK became ill with neurological problems. Although these cases forced a seven-week suspension of the clinical trial in the US, the researchers ultimately concluded that the diseases could not be linked to the vaccine. Still, the delay has been a key factor in why AstraZeneca has so far lagged behind three other vaccine manufacturers that have received emergency clearance in the United States.

According to AstraZeneca, the vaccine worked well across all races and ages. The vaccine was 80 percent effective in approximately 6,000 subjects over 65 years of age – results that likely allay concerns about insufficient clinical trial data on how well the vaccine works in the elderly. Some countries temporarily limited vaccinations with the shot to younger people before reversing course to allow use in all age groups after data from the vaccine’s launch in the UK showed the vaccine offered strong protection in the elderly.

Even if the vaccine is not used in the US, obtaining emergency clearance from the FDA – whose rigorous review process is considered the global gold standard – would be a major milestone for AstraZeneca. Some countries that have not yet approved the vaccine may try to follow the FDA’s lead.

Tags AstraZenecas, Covid19, effective, Study, Vaccine

Health

European nations resume utilizing AstraZeneca Covid vaccine after regulator OK

Post author By
Post date March 21, 2021

European nations resume using AstraZeneca Covid vaccine after regulator OK

A dose of the Oxford / AstraZeneca coronavirus vaccine is being made by a member of the Hampshire Fire and Rescue Service of the Basingstoke Fire Station, which has been set up as a vaccination center and where crews are still answering 999 calls on February 4, 2021 in Basingstoke, England.

WPA pool | Getty Images

LONDON – The European Medicines Agency has decided that the AstraZeneca coronavirus vaccine is safe and effective, despite some concerns about possible side effects.

Thursday’s announcement comes after more than a dozen EU countries stopped using the AstraZeneca shot developed with Oxford University after around 30 cases of blood clots. Some other countries have stopped using individual batches of the vaccine.

France, Germany, Italy, the Netherlands, Portugal, Spain and several other European nations are now planning to resume the use of the shot after the regulatory authority’s OK.

The EMA said Thursday that the vaccine’s benefits outweighed the risks. No batch or quality problems with the vaccine were found, although an association with the blood clot incidents could not be definitively ruled out.

“This is a safe and effective vaccine,” said Emer Cooke, EMA Executive Director, at a news conference Thursday.

“The benefits of protecting people from Covid-19, with the associated risks of death and hospitalization, outweigh the potential risks. The committee also concluded that the vaccine was not associated with an increase in the overall risk of thromboembolic events or blood clots. … We still cannot rule out a definitive link between these cases and the vaccine. “

The regulator said it will continue to investigate possible links between rare blood clots and the vaccine. It will also update its guidelines for the vaccine to clarify the potential risks.

Suspensions

The suspensions were not uniform across the 27 member states of the European Union and a number of nations continued to use the AstraZeneca shot in their vaccination campaigns.

Austria became the first country to stop using a certain batch of AstraZeneca shots last week after a 49-year-old woman who received the vaccine died.

Reports of blood clots elsewhere followed, albeit in a very small number of people, causing other leaders to suspend use and await a reassessment by the region’s health authority.

The EMA said in its review that the vaccine may be associated with very rare cases of thrombocytopenia-related blood clots, which are low platelet levels, including rare cases of blood clots in the vessels that drain blood from the brain known as CVST.

“These are rare cases – around 20 million people in the UK and EEA (European Economic Area) had received the vaccine by March 16, and the EMA had only looked at 7 cases of multiple blood clots and 18 cases of CVST. One cause A link to the vaccine has not been established but it is possible and deserves further analysis, “added the EMA in a statement.

AstraZeneca’s vaccine is widely used in the UK but has not yet been approved by the US authorities.

The benefits outweigh the risks.

The World Health Organization said Wednesday that “vaccination against Covid-19 will not reduce disease or death for other reasons. Thromboembolic events are known to be common.”

In addition, WHO said the response from some EU countries had shown that “the surveillance system is working and that there are effective controls in place”. Nonetheless, the institution reiterated its belief that “the benefits of the AstraZeneca vaccine outweigh the risks and recommends that vaccinations be continued”.

The UK Medicines Agency also said Thursday that people should continue to receive the AstraZeneca shot.

Some health professionals have raised major concerns about discontinuing use of this vaccine. Earlier this week, Cooke, of the EMA, said the institution was concerned the suspensions could affect people’s confidence in vaccines.

Recent concerns about the side effects stem from the uncertainty of some EU countries about an alleged lack of data on the effectiveness of the AstraZeneca vaccine in the elderly. However, these countries later decided to use the shot for vaccination.

Situation in Europe “worsening”

The distribution of vaccines is vital in Europe from both a health and an economic perspective.

The President of the European Commission, Ursula von der Leyen, said on Wednesday: “The epidemiological situation is deteriorating.”

“We are seeing a third wave forming in Member States and we know we need to speed up vaccination rates,” she added.

The EU aims to vaccinate 70% of its adult population by the end of summer.

The data presented on Wednesday suggests that the bloc is on track to achieve this goal, provided that drug companies honor their supply contracts over the next three months and member states use them successfully.

– CNBC’s Sara Salinas contributed to this report.

Tags AstraZeneca, Covid, European, nations, regulator, resume, Vaccine

Health

Moderna Begins Testing Its Covid Vaccine in Infants and Younger Kids

Post author By
Post date March 21, 2021

Moderna Starts Testing Its Covid Vaccine in Babies and Young Children

The pharmaceutical company Moderna has started a study testing its Covid vaccine in children under the age of 12, including babies as young as six months, the company said Tuesday.

The study is expected to enroll 6,750 healthy children in the United States and Canada. According to a spokeswoman, Colleen Hussey, Moderna declined to say how many had signed up or received their first recordings.

“There is a great demand for information about vaccination in children and how it works,” said Dr. David Wohl, the medical director of the University of North Carolina Vaccination Clinic, who is not involved in the study.

In a separate study, Moderna is testing its vaccine in 3,000 children ages 12-17 and could have results for that age group by summer. The vaccine would then have to be approved for use in children so that it would not be immediately available.

Many parents want protection for their children, and vaccinating children should help create the herd immunity that is believed to be critical to ending the pandemic. The American Academy of Pediatrics has called for vaccine studies to be expanded to include children.

Vaccine side effects like fever, sore arms, fatigue, and sore joints and muscles can be more intense in children than adults, and doctors say it’s important that parents know what to expect after their children are vaccinated.

Every child in Moderna’s study receives two recordings 28 days apart. The study will consist of two parts. In the first case, children aged 2 to under 12 can receive two doses of 50 or 100 micrograms each. People under the age of 2 may receive two exposures of 25, 50, or 100 micrograms.

Updated

March 21, 2021, 2:25 p.m. ET

In each group, the first children to be vaccinated are given the lowest doses and monitored for reactions before later participants are given higher doses.

Researchers then do an interim analysis to determine which dose is safest and most likely protective for each age group.

Children in Part 2 of the study receive the doses or placebo shots selected by the analysis, which consist of salt water.

Moderna developed its vaccine in collaboration with the National Institute for Allergies and Infectious Diseases. The company and the institute are working together with the Federal Agency for Biomedical Research and Development on the study.

The children will be followed for a year to look for side effects and measure antibody levels, which will allow researchers to determine whether the vaccine appears to offer protection. Antibody levels will be the main indicator, but researchers will also look for coronavirus infections with or without symptoms.

Dr. Wohl said the study was well designed and likely efficient, but asked why the children should only be observed for one year when adults in Moderna’s study were observed for two years. He also said he was a bit surprised that the vaccine was being tested in children so young so soon.

“Should we first learn what happens to the older children before we go to the really young children?” Asked Dr. Well. Most young children don’t get very sick from Covid, although some develop severe inflammatory syndrome that can be life-threatening.

Johnson & Johnson has also announced that it will test its coronavirus vaccine in babies and toddlers after first testing it in older children.

Pfizer-BioNTech is testing its vaccine in children ages 12-15 and plans to switch to younger groups. The product is already approved for use in the USA from the age of 16.

Last month, AstraZeneca began testing its vaccine in the UK in children 6 years and older.

Tags Babies, Children, Covid, Moderna, starts, Testing, Vaccine, young

World News

AstraZeneca Vaccine Beneath Extra Scrutiny After Denmark Demise

Post author By
Post date March 21, 2021

AstraZeneca Vaccine Under More Scrutiny After Denmark Death

Denmark reported on Saturday that after receiving the AstraZeneca Covid-19 vaccine, two people suffered cerebral haemorrhage, one of whom died. The Danish Medicines Agency said it was looking to see if the disease was a possible side effect.

A spokesman for the capital region of Denmark confirmed the death, and the Danish news agency Ritzau reported that the other person, a civil servant in her thirties, was seriously ill.

Millions of people in dozens of countries have received the AstraZeneca Covid-19 vaccine with few reports of side effects. However, the European Medicines Agency, the continent’s top medicines agency, carried out a review after several countries stopped using the vaccine. On Thursday, the agency said it thought the vaccine was safe, although it would continue to look out for links to blood disorders. It was determined that any threat would be very minor and that the gunfire would prevent far more deaths than they could cause.

Recent blood clots and abnormal bleeding in a small number of vaccine recipients in European countries raised safety issues and resulted in suspensions. This resulted in a disruptive pause in vaccination campaigns this week, although some European countries entered a third wave of infections.

“At the moment we are investigating whether this is exactly the same clinical picture with multiple blood clots, low platelet counts and bleeding,” said Tanja Erichsen, director of the Danish Medicines Agency, in a radio interview with the Danish national broadcaster DR.

“We prioritize reports of suspected serious side effects like these and investigate them thoroughly to determine whether there is a possible link to the vaccine,” Ms. Erichsen said on Twitter on Saturday. “We are in the process of dealing with the two specific cases.”

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

Denmark has suspended the use of AstraZeneca until Thursday, despite assurances from the European Medicines Agency. Other Scandinavian countries and Finland have made similar decisions. However, some European countries, including France and Germany, have resumed recording.

Part of the continued caution is due to preliminary results from medical experts in Norway and Germany, which suggest a possible link between the vaccine and the extremely rare blood disorders. The German experts said the sinus or cerebral vein thrombosis, which Germans suffered 13 days after receiving the vaccine, was caused by an immune system reaction they believe may be related to the shot. They did not publish detailed data, but planned to present their results to The Lancet.

AstraZeneca didn’t immediately comment on the claims on Friday.

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

Researchers in Germany and Norway will continue their research. In Germany, where the vaccine is being re-administered, doctors are now warning anyone who receives an AstraZeneca shot to see a doctor immediately if they have a headache, dizziness, or blurred vision more than three days later. They said the problems could very likely be addressed if identified in time.

Tags AstraZeneca, Death, Denmark, Scrutiny, Vaccine