Canada records second case of rare blood clot after AstraZeneca shot

blood clot

Canadian health authorities said Saturday the country has recorded a second case of rare but serious blood clotting linked to AstraZeneca’s COVID-19 vaccine, but still recommend the shot for use.

The patient, who lives in the western province of Alberta and received a version of the AstraZeneca vaccine supplied by the Serum Institute of India, “has received treatment and is recovering,” Canadian health authorities wrote on Twitter.

Canada reported its first case of blood clotting associated with low platelets on Tuesday in a Quebec woman who received the same shot.

Blood clot formations linked to the AstraZeneca vaccine “remain very rare” and Canada still believes that the vaccine’s benefits “outweigh the potential risks,” Health Canada and the Public Health Agency of Canada said.

Canada’s health authorities added that they would “continue to monitor the use of all #COVID19 vaccines closely and examine and assess any new safety concerns.”

At the end of March Canada’s National Advisory Committee on Immunization (NACI) recommended suspending the use of the AstraZeneca vaccine in people under the age of 55 while it evaluated the risks.

However Health Canada said Wednesday that according to its analysis, limiting the use of the vaccine to certain populations was not necessary for the moment.

After a slow start, Canada’s vaccine campaign is gaining momentum. To date, 23.3 percent of the Canadian population has received at least one vaccine dose according to the COVID-19 Tracker Canada website.

The country is facing a third coronavirus wave, however, that has recently forced provinces to tighten restrictions.

Ontario, which has the highest number of cases, announced Friday it would strengthen and extend lockdown measures until May 19, and also close its borders with the provinces of Quebec and Manitoba beginning Monday.

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Australia has 2nd likely AstraZeneca COVID-19 vaccine clot case

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CANBERRA, Australia – Australian authorities have identified a second case of a rare blot clot likely linked to the AstraZeneca coronavirus vaccine.

Officials said Tuesday the woman is in her 40s and is in a stable condition. A 44-year-old man developed the same condition following an AstraZeneca injection March 22.

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Australia has administered 700,000 doses of the AstraZeneca vaccine since early March. That equates to a clotting frequency of 1-in-350,000 cases. British authorities say the risk of such blood clots has been 1-in-250,000 in that country.

Australia had planned to rely on Australian-manufactured AstraZeneca for delivering at least one dose of a vaccine to all eligible adults among its population of 26 million by October. But it said last week the Pfizer vaccine is now the preferred option for people under 50 because of the potential risk from AstraZeneca.

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AstraZeneca has not reacted yet to EU letter on vaccines – Corriere

MILAN (Reuters) – AstraZeneca has yet to react to a letter sent by the European Commission to complain over below-contract supplies of COVID-19 vaccines, Italian daily Corriere della Sera said, adding the Anglo-Swedish group missed a deadline indicated by Brussels.

FILE PHOTO: Empty vials of Oxford/AstraZeneca’s COVID-19 vaccine are seen at a vaccination centre in Antwerp, Belgium March 18, 2021. REUTERS/Yves Herman/File Photo

The European Union member states and the pharmaceutical company are at odds over the delivery of the shots after the group shipped to the block less than indicated in the initial agreement.

“AstraZeneca has breached and continues to breach its contractual obligations on the production and supply of the initial 300 million doses for Europe,” EU Head of Health and Food Safety DG Sandra Gallina said in a letter sent to the company on March 19, according to Corriere.

The Italian daily said that Brussels had asked AstraZeneca to “remedy the material breaches of contract within 20 days of the letter”, but added that the deadline expired two days ago without any reaction from the company.

AstraZeneca has not replied to a request for comment from Reuters.

A spokesman for the European Commission confirmed that Brussels on March 19 sent a written message to AstraZeneca, calling it “a notice for dispute settlement”, adding this was a first step to engage in an dialogue to resolve the issue.

“At this stage we are still waiting for the necessary elements … we remain in contact with AstraZeneca to ensure timely delivery of a sufficient number of doses,” the spokesman told Reuters, without elaborating.

According the contract signed between EU and the company, which is public, if a dispute arises one of the parties shall first notify the problem with a letter. Then, after 20 days from the written notice, they “shall meet and attempt to resolve the dispute by good faith negotiations”.

Under the contract signed on COVID-19 vaccines, the European Union states had expected to receive 120 million doses by the end of March from AstraZeneca, but the company had supplied only 30.12 million doses, Corriere said.

With contagion still rising in many European countries and vaccination campaigns hitting hurdles, some governments are shown increasing irritation against the pharma group.

“Manifestly, they (AstraZeneca) did not honour their commitments and thus, in a certain way, they were mocking us Europeans,” France’s European Affairs Minister Clement Beaune said on Sunday, speaking to LCI television news channel.

Beaune said that the EU letter to the Anglo-Swedish group could even lead to a battle in court.

“We sent a formal notice in recent days, it is the beginning of a possible judicial procedure if the company doesn’t fix things,” he said, adding that putting pressure on the company to accelerate production in Europe appeared to be a better option compared with starting a legal process, which would take time.

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EMA announcement: European Medicines Agency to give safety update on AstraZeneca vaccine

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The European Medicines Agency (EMA) will hold a briefing on Wednesday which will discuss the investigation of the AstraZeneca vaccine relating to cases of thromboembolic events. Millions of people have been given the AstraZeneca Covid vaccine without experiencing severe side effects. However, in recent months there have been a small number of reports that recipients of the AstraZeneca vaccine have experienced extremely rare blood clots.

Some countries have suspended the use of the vaccine as a precaution, while other countries have set age limits on the AstraZeneca jab.

A senior official for the European Medicines Agency (EMA) said in an interview published on Tuesday there was a link between the vaccine and rare blood clots in the brain but the possible causes were still unknown.

The EMA later said in a statement that its review of the vaccine was ongoing and that it would give an update on its investigation on Wednesday afternoon.

When is the EMA AstraZeneca vaccine briefing?

The European Medicines Agency (EMA) briefing will be held on Wednesday at 3pm. 

Speakers at the EMA briefing will include EMA executive director Emer Cooke and EMA safety committee chairwoman Dr Sabine Straus.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunisation (JCVI) will also be giving a televised briefing at 3pm on Wednesday.

The briefing will be led by Deputy Chief Medical Officer for England Professor Jonathan Van-Tam.

Professor Van-Tam will be joined by MHRA chief executive Dr June Raine, chair of the Committee of Human Medicines Sir Munir Pirmohamed and chair of the JCVI Professor Wei Shen.

The briefing is also expected to address whether the AstraZeneca vaccine is directly causing rare brain blood clots.

Both the EMA and the MHRA have carried out reviews into reports of rare brain clots in people who have had the AstraZeneca vaccine.

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The updates from both the EMA and the MHRA have been widely anticipated, with vaccine rollout uncertain in many countries due to the reports.

Some European countries have restricted the vaccine use in younger people following reports of low platelet counts and cerebral venous sinus thrombosis (CVST), a specific type of clot that prevents blood from draining from the brain.

However in the UK, experts this week have urged people to take the AstraZeneca vaccine if they are offered it, stressing vaccine rollout should continue to help protect people against COVID-19.

Former MHRA chief Professor Sir Kent Woods also told LBC radio: “Covid itself – the infection itself – is known to be associated with a substantial increased risk of blood clots of various kinds.

“At a time when the population has got lots of Covid going around, it’s very difficult to know what the actual background rate of these clotting events is without the vaccine.

“We can say, I think, that if there is a connection, it’s a very, very rare one.”

Ravi Gupta, professor of clinical microbiology at the Cambridge Institute of Therapeutic Immunology and Infectious Diseases, also urged people to keep their vaccine appointments.

He told Sky News: “I think that’s on balance at the moment – there’s still transmission of Covid, and there is a risk to all of us of being infected, particularly as the economy is being opened up and society’s opening up, we are at risk of getting severe infection.

“So I would certainly be going forward for that vaccine in the current situation.”

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Should you have the AstraZeneca vaccine if you’re on blood thinners?

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The AstraZeneca vaccine has caused a small number of reports to emerge of people experiencing blood clots in the days and weeks following the vaccination. The European Medicines Agency (EMA) reported one person in Austria was diagnosed with blood clots and died 10 days after vaccination, but the agency stressed there is “currently no indication that vaccination has caused these conditions”. Another person was admitted to hospital in Austria with pulmonary embolism (blockage in arteries in the lungs) after being vaccinated, while one death involving a blood clot was reported in Denmark.

A 50-year-old man is also thought to have died in Italy from deep vein thrombosis (DVT), while there are unofficial reports of another death in Italy.

Ireland’s decision to withdraw the vaccine temporarily followed reports of serous clotting in Norwegian adults which left four people in the hospital.

Bulgaria’s Prime Minister, Boyko Borissov, said its suspension would last until the EMA issued a written confirmation that the vaccine is safe.

Italy has followed Austria, Estonia, Latvia, Luxembourg and Lithuania in banning vaccines from particular batch of a million AstraZeneca vaccines sent to 17 countries, following reports of a death.

Should you have the AstraZeneca vaccine if you’re on blood thinners?

In general, yes, it’s understood that the AstraZeneca vaccine is safe for people on blood thinners.

The British Heart Foundation (BHF) states that all in all, it’s safe to get the vaccine but “you should let the person giving you the vaccine know” that you’re taking blood thinners.

As with any injection in any other circumstance, there is a risk of bleeding after having the vaccine.

The BHF writes on its website: “Like most vaccines, the coronavirus vaccine is injected into the muscle of your upper arm.

“Injections into your muscle may bleed a little more than injections that are given under the skin, but less than those that are given into a vein.

“If you are taking a blood thinner such as warfarin, or a new anticoagulant, the bleeding may take a little longer to stop and you may get more bruising on your upper arm.

“Public Health England (PHE) and the Department of Health have said that you can have the vaccine if your anticoagulant treatment is stable.

“That generally means that you will have been taking the same dose for a while and that if you are on warfarin, that your INR checks are up to date and your latest INR level was in the right range.”

When contacted for comment, the MHRA said: “As with other intramuscular injections, COVID-19 Vaccine AstraZeneca should be given with caution to individuals with thrombocytopenia, any coagulation disorder or to persons on anticoagulation therapy, because bleeding or bruising may occur following an intramuscular administration in these individuals.” 

The MHRA, like BHF, advises recipients to tell their doctor, pharmacist or nurse before being vaccinated if they have a problem with bleeding or bruising, or if they are taking blood-thinning medicine. 

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For people taking blood thinners like clopidogrel or other anti-platelet drugs, the vaccine is also safe, although again, you may experience a bit more bruising around the injection site.

The UK’s medicines and health regulator, the MHRA, has already issued a statement in response to the vaccine scare that more than 11million doses have been given in the UK with no adverse consequences.

After Ireland’s decision to suspend its use, MHRA vaccines safety leader Dr Phil Bryan said about blood clots: “We were aware of the action in Ireland.

“We are closely reviewing reports but given the large number of doses administered and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause.

Dr Bryan said people “should still go and get their COVID-19 vaccine when asked to do so”.

Director General of the World Health Organisation (WHO) Dr Tedros Adhanom Ghebreyesus said his organisation is continuing to keep a close eye on the safety of vaccines.

Dr Tedros said it was important to note the EMA “has said there is no indication of a link between the vaccine and blood clots and that the vaccine can continue to be used while its investigation is ongoing”.

His comments reiterated remarks made by WHO spokesperson Dr Margaret Harris, who described the vaccine as “excellent”.

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AstraZeneca to share latest data with panel after U.S. trial data doubts

(Reuters) – AstraZeneca will share primary analysis of its COVID-19 vaccine with the most up-to-date data, with an independent panel looking into its U.S. trial, the drugmaker said on Tuesday, following doubts expressed by a U.S health body over the trial data.

The Anglo-Swedish drugmaker said data presented on Monday was based on analysis with a cut-off date of Feb. 17, adding that it had reviewed the preliminary assessment of the primary analysis and found it to be consistent with the interim report.

“We will immediately engage with the independent data safety monitoring board (DSMB) …. We intend to issue results of the primary analysis within 48 hours,” AstraZeneca said.

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AstraZeneca says to release more data on US trials soon

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UK-based pharmaceutical giant AstraZeneca said Tuesday it will release further data “within 48 hours” on US trials of its COVID-19 vaccine, after health officials raised concerns about the initial information disclosed.

The company pushed back against a statement from the US National Institute of Allergy and Infectious Diseases (NIAID) which said that “outdated information” may have been used to conclude that its vaccine was highly effective against COVID.

“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” AstraZeneca said in a statement.

“We intend to issue results of the primary analysis within 48 hours,” it added.

The US health agency’s evaluation comes after AstraZeneca said on Monday that stage three US trials of the vaccine had shown it was 79 percent effective.

It follows controversy over the vaccine’s rollout in Europe.

France, Germany and a number of other nations said last week they would resume using the jab after its introduction was suspended over potential links to blood clots among recipients.

Global health experts as well as AstraZeneca insist the vaccine is safe.

EU officials have also hit out at AstraZeneca for delivering its UK supply contract in full so far, while falling short on supplies to the continent.

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Poll shows plunge in Europeans’ trust in AstraZeneca jab

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Trust in AstraZeneca’s coronavirus vaccine in many European countries has plunged following controversy around the jab in recent weeks, according to a new survey unveiled Monday by British pollsters YouGov.

A majority of people in the biggest European Union member states, including Germany, France, Spain and Italy, now see the inoculation as unsafe, the recent poll found.

However, views of the Anglo-Swedish pharma giant’s jab remain overwhelming positive in Britain, where two-thirds of respondents said it is safe, compared to just nine percent believing it is not.

The findings come at a tumultuous time for the AstraZeneca vaccine and the EU’s troubled inoculation campaign, as a third virus wave on the continent prompts renewed social restrictions.

Meanwhile, Britain and the bloc are embroiled in an increasingly acrimonious war of words over supplies, with Brussels warning it may halt AstraZeneca vaccine exports.

The drop in Europeans’ faith in the jab, developed in partnership with Oxford University in the UK, follows weeks of turmoil on the continent over safety fears.

Earlier this month several EU countries suspended its use, pending a review by the European Medicines Agency (EMA) after dozens of isolated cases of blood clots and brain haemorrhages.

The EMA last week declared the AstraZeneca jab “safe and effective”, with the WHO and Britain’s drugs watchdog issuing similar endorsements.

That led European countries to resume administering the vaccine, but not before severely damaging confidence in it.

‘Undoubtedly suffered’

In its mid-March survey, YouGov found 55 percent of Germans now say the vaccine as unsafe—a 15 point rise in a month—compared to 32 percent viewing it as safe.

In already more vaccine-hesitant France, 61 percent of respondents said it was unsafe, while Italy and Spain both saw a 27-point monthly jump in the number of people saying they did not trust the jab.

No similar increases in safety fears were seen for rival vaccines by Pfizer and Moderna, YouGov said.

The pollsters interviewed 2,024 Germans, and around 1,000 adults in each of the other countries between March 12 and 18.

“After concerns about its protection and potency were raised by leaders across Europe, the Oxford/AstraZeneca vaccine has undoubtedly suffered damage to its reputation for safety on the continent,” said Matt Smith, lead data journalist at YouGov.

“With a third wave of infections potentially emerging now across the Channel, officials everywhere will be worried if ongoing rows about AstraZeneca’s vaccine ends up damaging the rollout.”

Even prior to its recent woes in Europe, the jab—which is among the cheapest available, relatively easy to store and billed as the vaccine of choice for poorer nations—had suffered several setbacks.

They include South Africa asking to send back one million doses after researchers found it had failed to prevent mild and moderate cases of a more contagious virus variant there.

Confidence in the vaccine has also been hit by mixed messaging.

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AstraZeneca vaccine headache: What causes Covid vaccine headache?

Boris Johnson reveals he will receive AstraZeneca vaccine

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AstraZeneca jab fears have led health officials to issue a warning to the general public. They have identified a symptom – headaches – which could signal a more severe underlying disorder. People who experience a four-day-long headache must report the issue to their health provider.

What causes Covid vaccine headaches?

Headaches which last for four days have emerged as a concerning sign for Covid vaccine recipients.

The announcement to report such symptoms follows fears the AstraZeneca jab could cause blood clotting.

These headaches are a hallmark sign of Cerebral Venous Sinus Thrombosis (CVST), a clotting disorder.

CVST causes a range of symptoms, which include:

Headaches

Abnormal vision

One-sided weakness of the face and limbs

Seizures

A coma

Five men aged between 19 and 59 suffered from the disorder, which can prove deadly.

But CVST is “extremely rare” according to Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA).

The link to the Covid vaccine remains unproven as well.

The UK cases are similar to dozens of clotting disorder cases found across Europe.

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Some of these have resulted in deaths, but health agencies have concluded the Covid vaccine remains safe after investigation.

MHRA vaccines lead Dr Phil Bryan told journalists yesterday there is “no proven causal association”.

He said: “We have had five reports of a unique form of blood clot, Cerebral Venous Sinus Thrombosis concurrent with low blood platelets.

“This is similar to some of the cases reported through Europe.”

“What we don’t know is whether these have been caused by the vaccines.

“We are working closely to determine this because these illnesses do very rarely happen naturally.

“We do know that after more than five million jabs this is extremely rare – less than one in a million cases of this even after vaccination.

“There is no proven causal association with what is still an extremely rare medical event.”

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AstraZeneca vaccine safe, but rare risk of blood clots not ruled out, EU regulator says

The COVID-19 vaccine made by AstraZeneca and the University of Oxford is safe and not linked to an increased risk of blood clots, according to an investigation by the European Union’s European Medicines Agency (EMA).

“This is a safe and effective vaccine. Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalization outweigh the possible risks,” Emer Cooke, the EMA’s executive director, said at a news conference Thursday (March 18). 

However, the EMA investigation uncovered a few “rare and unusual but very serious clotting disorders” that the committee probed more closely, Cooke said. These included conditions such as disseminated intravascular coagulation (DIC), in which clots form extensively throughout the body, and cerebral venous thrombosis (CVT), a rare form of stroke. 

“As of last night, seven cases of this disseminated intravascular coagulation and 18 cases of cerebral venous sinus thrombosis were reported out of almost 20 million vaccinated people,” Cooke said. “After days of in-depth analysis of lab results, clinical reports, autopsy reports and other information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine,” she said. 

Even if there is a link, if every one of these cases was caused by the vaccine, this would translate to a rate of roughly 1.25 per million vaccinated people. 

The committee will launch further investigations of these extremely rare clotting events and will continue to monitor any additional cases that crop up. In the meantime, they concluded that the vaccine is safe and effective enough to warrant its continued use in the general public.

The EMA initially launched its investigation after many European countries — including Germany, France, Italy and Spain — halted their distribution of the AstraZeneca vaccine, citing concerns about blood clots and abnormal bleeding among vaccinated people, CNBC reported. In response to these reports from Europe, Indonesia also decided to delay its rollout of the vaccine, and Thailand briefly suspended use of the shots last weekend, The Associated Press reported

More than 17 million people in the U.K. and EU have already received the AstraZeneca shot, according to a March 14 statement from AstraZeneca. “The number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” Ann Taylor, AstraZeneca’s chief medical officer, said in the statement. 

Furthermore, the company has not observed any evidence of increased bleeding among the tens of thousands of people in clinical trials for the vaccine, according to the statement. 

As of March 8, the company had received 22 reports of pulmonary embolism (blood clots in the arteries of the lungs), and 15 reports of deep vein thrombosis (blood clots in the deep veins of the body), across the EU and U.K. “This is much lower than would be expected to occur naturally in a general population of this size,” the company stated. 

The company noted that “available evidence does not confirm that the vaccine is the cause” of these clots. However, the nature of the more unusual clotting disorders, like CVT, drew concern from some doctors. 

For instance, numerous patients showed widespread blood clots, internal bleeding and low platelet counts; platelets are small blood cells involved in clotting. And several people in Germany developed CVT, Science Magazine reported. Germany received seven reports of these rare strokes and found that the events occurred four to 16 days after each patient’s vaccination; three of these patients died. This pattern is what prompted Germany to pause use of the shots, Science reported.

In theory, the clotting and bleeding disorders could stem from an overblown immune reaction to the vaccine, Dr. Steinar Madsen, medical director of the Norwegian Medicines Agency, told Science. Future EMA investigations will likely explore this possibility.  

Other scientists have wondered whether the problem may lie with specific batches of the vaccine, which they posit may have become contaminated or contained a higher dose than usual. In general, AstraZeneca supplies European countries with vaccines produced at several different facilities. But the EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), has “found no evidence of a quality or a batch issue,” PRAC Chairwoman Sabine Straus said at the news conference.  

Just because the clots and bleeding disorders emerged after vaccination “does not necessarily mean that the events are linked to vaccination itself, but it is good practice to investigate them,” the World Health Organization noted in a statement released March 17. Blood clots are the third-most-common cardiovascular condition globally, and they occur frequently in the general population, according to the statement. 

For instance, an estimated 300,000 to 600,000 U.S. residents develop blood clots in their lungs or deep veins each year, according to the Centers for Disease Control and Prevention (CDC). EU residents develop blood clots at similar annual rates, and in clinical studies of the AstraZeneca vaccine, the rate of clotting episodes did not exceed the expected rate, the EMA reported, according to The Associated Press

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But again, rarer conditions such as DIC and CVT will need to be investigated more closely in vaccinated people.

Echoing the EMA’s conclusions, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) also found no link between the vaccine and blood clots, according to BBC News

Those who have received the AstraZeneca vaccine can submit reports to the company about any potential side effects or health-related issues they experience. The U.K. publishes summaries of these reports online, and so far, the most commonly reported symptoms include mild to moderate side effects, like headache, fatigue, soreness at the injection site and chills. Scattered reports of thrombosis, or blood clots, can also be seen in these summaries.  

Clearly, not all of these reported conditions could be caused by the vaccine. People have reported post-vaccine conditions such as “sunburn,” “breath odor,” “hiccups,” “arthropod stings” and “genital herpes,” as seen in the summary from early January to late February. One recipient reported getting a face-lift after being vaccinated. In other words, some medical conditions reported post-vaccination may be totally unrelated to the shots. 

Originally published on Live Science. 

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