AstraZeneca

Britain’s Regulator Missed Early Blood Clot Cases Linked to AstraZeneca Vaccine

By the time cases of blood clotting in patients who had received the AstraZeneca vaccine had begun to emerge on the Continent (in March), Britain had already administered 11 million doses (the first ones having been given in January). No such adverse events had been reported publicly in Britain, but not for a lack of cases, according to the findings of a new investigation. Clotting cases were recorded in the UK’s Yellow Card database (a website for reporting adverse drug reactions) in January but were missed at first by the Medicines and Healthcare products Regulatory Agency (MHRA) – possibly due to the algorithms it uses to interrogate UK data. The Telegraph has the story.

On March 11th, the MHRA put out a statement saying it could see no evidence of a problem…

But the MHRA was, it appears, wrong. An investigation by the Telegraph has established that signals had been firing unnoticed in the UK’s Yellow Card database for at least a month, perhaps longer.

In January, a patient suffered a brain clot following their first dose of the AstraZeneca jab… Then in early February, two similar cases followed, including a death and a life-changing CVST clot in a young adult. All had low platelets and all were reported into the Yellow Card system.

On Friday, the MHRA told the Telegraph: “We are aware of thromboembolic events that occurred in January, however, our first report was received in the week commencing February 8th…. we cannot disclose information about individual cases to protect patient and reporter confidentiality.”

… The MHRA faces serious questions as to why it did not detect the signals sooner. The issue is not that it has been left looking flatfooted or even that earlier detection would necessarily have altered its advice, but that the delay left it unable to shape international policy and confidence in what remains a vital vaccine in the fight against Covid for the world.

Professor Stephan Lewandowsky, a psychologist at the University of Bristol studying the rollout of Covid vaccines, told the Financial Times on Friday: “The MHRA was slow in responding to the emergence of a specific constellation of symptoms associated with the AstraZeneca vaccine and slow to communicate what they were finding – and I am not the only one who thinks so.”

This slow repose was caused, it is said, by algorithms which were not as sensitive as the ones used by European health agencies to sift through data.

From January 4th to March 14th, a total of 532 “blood system events”, including 20 deaths, came through the UK’s Yellow Card system relating to the AstraZeneca jab, according to an analysis of published MHRA data by Dr Hamid Merchant, a pharmaceutical scientist at the University of Huddersfield. There were thousands of non-blood-related reports besides.

Of the thrombotic events recorded, four related to CVST (but no deaths were recorded), 55 were non-site specific and there were clusters of 64 and 66 cases in the lungs and deep veins respectively. There were then 267 general bleeding events and six deaths, three of which resulted from cerebral haemorrhage. Finally, there were 60 cases of thrombocytopenia, including two deaths.

To sift such data, regulators build algorithms that must balance “sensitivity” against leg-work. The more sensitive the algorithm, the more warning signals it will throw up to investigate – and many of those labour-intensive investigations will prove fruitless.

It is not known exactly what parameters the MHRA set but it is clear they were not as sensitive as those used by some regulators in Europe. 

Young People Should Not be Strong-Armed Into Getting Vaccinated

We’re publishing an original piece today by Bella Wallersteiner, a Senior Parliamentary Assistant, setting out the case against trying to induce young people to get the jab by making entry to pubs/clubs/festivals conditional on showing a ‘Covid Status Certificate’. Here is an extract:

After a year in which many young people have lost their jobs, missed out great chunks of the curriculum in schools and universities and were forbidden from seeing their friends, coercing them into taking the jab is a perverse strategy. Altruistic young people worked in food banks, collected medicine and went shopping for elderly neighbours who were shielding or, inspired by the example of Captain Tom Moore, raised funds for the NHS. Instead of receiving praise for demonstrating resilience and kindness, young people are now being maligned for showing ambivalence in coming forward to take a vaccine which may do them harm. More needs to be done to convince them that the vaccine is safe and effective and that the eradication of COVID-19 requires all citizens to join together in an act of solidarity.

Once vaccines for under-30s get the green light, the Government needs to come up with a new social contract for young people. What is the duty of a young person to society? Does a young adult have a moral obligation to protect an older one? The message should be that society is the glue which binds us together in a moral compact which transcends self-interest. By getting the vaccine you are helping the community at large. Young people should want to take the vaccine because they have decided that it is the right thing to do for their own health and for the safety of others. They should not be bullied into taking the vaccine out of fear of becoming second-class citizens or because they will be denied the pleasures of techno, house and trance dance music in clubs. The Government must treat young people like grown-ups and be prepared to have an adult conversation with them. The Prime Minister, who is such an effective communicator, particularly when addressing young people, should deliver a special broadcast specifically targeting UK citizens under 30 who have given up so much over the last year. He should thank them for their solidarity and support and exhort them to make one final collective effort to beat COVID-19 by having the vaccine. If this doesn’t happen, the whole project to eradicate the scourge of coronavirus could stumble at the last fence.

Worth reading in full.

EU Commission to End AstraZeneca and Johnson & Johnson Vaccine Contracts at Expiry

The EU Commission will not renew Covid vaccine contracts with AstraZeneca and Johnson & Johnson (J&J) when they expire, according to reports. The vaccines produced by both of these companies are facing scrutiny over their links to blood clotting and have been subject to numerous medical reviews. Reuters has the story.

The EU Commission has decided not to renew Covid vaccine contracts next year with AstraZeneca and J&J, Italian daily La Stampa reported on Wednesday, citing a source from the Italian health ministry.

“The European Commission, in agreement with the leaders of many (EU) countries, has decided that the contracts with the companies that produce (viral vector) vaccines that are valid for the current year will not be renewed at their expiry,” the newspaper reported. …

A spokesman for the EU Commission said it was keeping all options open to be prepared for the next stages of the pandemic, for 2022 and beyond.

“We cannot, however, comment on contractual issues,” the spokesman added.

Later on Wednesday the President of the European Commission said the EU was in talks with Pfizer and BionTech for a new contract for 1.8 billion doses, confirming a Reuters report from last week.

“We need to focus on technologies that have proven their worth. mRNA vaccines are a clear case in point,” she added.

La Stampa reports that Brussels would rather prioritise Covid vaccines from Pfizer and Moderna – both of which use mRNA technology – in the UE’s rollout efforts. Studies from across Europe have shown that many people are refusing the AZ vaccine due to concerns over its link to blood clots (for example, 33% of Danes and up to 80% of Sicilians would reportedly turn the vaccine down). The rollout of J&J Covid vaccines in Europe has also recently been delayed by the company, following reports on its relationship with rare blood clots.

The Reuters report is worth reading in full.

Stop Press: The Danish Health Authority has announced that it will no longer be recommending the AstraZeneca vaccine.

There is a possible link between very rare cases of unusual blood clots, bleeding, low blood platelets counts and the vaccine from AstraZeneca. This, coupled with the fact that the Covid epidemic in Denmark is currently under control and other vaccines are available against Covid, has been instrumental in the Danish Health Authority’s decision to continue its vaccination programme against Covid without the vaccine from AstraZeneca.

Worth reading in full.

Up to 80% of Sicilians Refuse AstraZeneca Vaccine

Despite attempts by the Sicilian President to soothe fears over the relationship between the AstraZeneca vaccine and blood clots, as many as four in five people in the Southern Italian region are refusing the AZ jab. According to the Telegraph, President Nello Musumeci said: “In Sicily, there is an 80% refusal rate of the AstraZeneca vaccine. Every 100 people, 80 say no.” His spokeswoman clarified that the refusal rate is “up to” 80%, rather than 80% dead-on, citing the town of Syracuse as an example, where the rate is 30%. Musumeci urged people to look beyond their personal concerns and to take the vaccine when given the opportunity:

“It is natural [for people to be particularly concerned], but we have a duty to believe scientists when they say it is more dangerous not to get vaccinated than to get vaccinated.”

Italy was among the first nations to suspend the use of the AstraZeneca vaccine in early March due to concerns about its link to blood clots. In an interview with La Stampa, Franco Locatelli, the Italian Government’s top scientific advisor on Covid, said that fears over the AZ vaccine are “understandable, but unjustified”.

“I say that we are offering a vaccine that is safe and effective, which people must accept. That said, if we find ourselves facing a disarming number of defections, we will reconsider the issue.”

Sicily’s refusal rate is indicative of the damage done to the reputation of the AstraZeneca vaccine by reports on its side effects. Similarly, in Denmark, a recent survey found that far more Danes would decline to get an AstraZeneca Covid vaccine than would refuse to get a Covid jab altogether. Reuters reported:

One in three Danes would decline to get a Covid shot using AstraZeneca’s vaccine, local media outlets TV 2 and Politiken reported late on Wednesday, citing a recent survey. …

The survey, conducted by Megafon among 1,053 persons, showed 33% of Danes would decline to get a shot with AstraZeneca’s vaccine. However, only 7% would decline regardless of which Covid vaccine they were offered.

Polling suggests that Brits are more trustworthy of the AstraZeneca vaccine regardless of its links to blood clots. In a new YouGov survey, at least 75% of British respondents said that they trust the AZ jab.

Under-40s Could Be Asked to Take an Alternative Covid Vaccine to AstraZeneca

Less than a week after the Medicines and Healthcare Products Regulatory Agency (MHRA) said people below the age of 30 should be offered alternatives to the AstraZeneca Covid vaccine because of its possible link to blood clots, members of the Joint Committee on Vaccination and Immunisation (JCVI) have said that the same rule could apply for those aged 30-39. The Telegraph has the story.

Thirtysomethings could be asked to take an alternative jab to AstraZeneca, members of the JCVI have said. 

The Government’s independent scientific advisers said a fresh risk/benefit assessment of the vaccine in different age brackets would be made before the rollout reaches those under the age of 40.

Professor Anthony Harnden, the Deputy Chairman of the JCVI, said safety data will be examined “in scrupulous detail” and that “everybody should remain confident” in the vaccine programme, which he said was going “full steam ahead”.

He said any link with blood clots was a “very, very rare, extremely rare safety signal”, adding that the latest change in the medical advice – that those under 30 should be offered Pfizer or Moderna in preference to AstraZeneca – is unlikely to change.

But Professor Harnden said scientists would be looking closely at the safety data for those in other groups, and should have “much more clear” data by the time the programme moves to thirtysomethings.

He made his comments as Matt Hancock, the Health Secretary, stressed that the benefits “spectacularly outweigh the risks” for those in their 40s. …

[Another JCVI member] Professor [Jeremy] Brown told the Telegraph: “We’re going to start vaccinating phase two healthy adults, starting with the 40 to 50-year-olds, and then we’ll go to the 30 to 40-year-olds.

“When we are approaching that point we’ll need to think about this a little bit more to be absolutely sure at what point in that age cut-off – given the situation we are facing at that time, and any more data that comes through on this rare complication, because more data will come through – then that might alter the age range.”

He said the risk-benefit analysis would be likely to tilt in favour of continuing to give the AstraZeneca Jab to thirtysomethings if infection rates are high, as the chance of severe disease in this age group are about five times higher than among people in their 20s. If the virus rates were under control, the balance could tip in favour of an alternative, he suggested. 

Worth reading in full.

Stop Press: The Telegraph has produced this table on the potential benefits of taking the AstraZeneca vaccine compared with the potential risks for different age groups.

Under-30s to Be Offered Alternative to AstraZeneca Vaccine Following MHRA Investigation

Britain’s vaccine rollout is to undergo a “course correction” that will see people below the age of 30 being offered alternatives to the AstraZeneca vaccine, following advice from the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA said there is a possible link between this vaccine and “extremely rare and unlikely to occur” blood clots. Government advisors have stopped short of restricting the use of the AZ jab in younger people altogether, despite considering doing so.

Up to March 31st, 79 people in the UK developed blood clots following their first AstraZeneca jab. Nineteen of these people have died. The Chief Executive of the MHRA said: “The risk [of getting blood clots after receiving the AZ vaccine] is four people in a million.” Sky News has the story.

Britons aged 18-29 will be offered an alternative to the AstraZeneca vaccine following 79 people developing blood clots after the jab, Government advisors have decided.

The MHRA concluded there is a possible link between the AZ vaccine and “extremely rare and unlikely to occur” blood clots with lowered platelets.

Younger people are much less likely to die from Covid so the Joint Committee on Vaccination and Immunisation (JCVI) has decided it is safer to advise that age group are offered a different jab, where possible. …

The advice is being given after a total of 79 people in the UK have had blood clots following their first AstraZeneca jab up to March 31st, Dr June Raine, chief executive of the MHRA said. More than 20 million people have been given the AZ vaccine.

Of those 70 people, 19 have died – three under the age of 30.

A total of 51 women and 28 men aged 18 to 79 were affected but Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said there is no evidence women have a predilection to develop blood clots after having the AZ jab.

“The risk is four people in a million,” Dr Raine added.

The UK is currently also rolling out the Pfizer Covid vaccine and, most recently, the Moderna vaccine, but people below the age of 30 will only be given these alternatives where possible.

JCVI chairman Professor Wei Shen Lim said: “We are advising a preference of one vaccine over another vaccine for a particular age group out of utmost caution rather than any serious safety concerns.”

He added that people who are just over 29 years-old should make their decision, but getting the vaccine is much safer than not getting it.

Worth reading in full.

Stop Press: A review by the European Medicines Agency has also concluded that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the AstraZeneca vaccine.

Stop Press 2: In an article for the Spectator, Ross Clark asks whether the writing is on the wall for the AZ jab.

The Government has invested a huge amount of money and faith in the AstraZeneca vaccine, and has rightly been praised for its rapid rollout, which was based on the best evidence at the time. The AstraZeneca vaccine has been wrongfully attacked by President Macron among others, who declared it to be “quasi-ineffective” in the over-65s – without any evidence. It will take political courage to admit that the AstraZeneca vaccine is second-best, and should perhaps be phased out as other vaccines become available in substantial quantities. But it is beginning to look as if that might be the most likely outcome.

Very much worth reading in full.

Child Jabs Halted in Trial as Adult Clot Link Probed

Concern over the link between the AstraZeneca vaccine and rare cases of blood clots has led to the halting of trials of the jab on children aged six to 17. The BBC has the story.

A trial of the AstraZeneca Covid vaccine on children has stopped giving out jabs while the UK’s medicines regulator investigates a possible link with rare blood clots in adults.

Professor Andrew Pollard from the University of Oxford told the BBC there were no safety concerns with the trial itself, but its scientists were waiting for further information.

Around 300 volunteers signed up.

Earlier, PM Boris Johnson said people should get their jab when invited.

More than 31.6 million people in the UK have had a first vaccine dose.

A total of 5.4 million people have received a second dose.

Two vaccines – developed by AstraZeneca and Pfizer – are being used in the UK, while a third – from Moderna – has been approved.

The trial of the AstraZeneca vaccine on children, which started in February, is assessing whether the jab produces a strong immune response in those aged between six and 17.

Its suspension comes after a European Medicines Agency (EMA) official, speaking in a personal capacity, said there appeared to be a link with the jab and rare blood clots.

Confirming that the trial on children was being paused, Prof Pollard said: “Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial.”

Participants are advised to continue to attend all scheduled visits and can contact the trial sites if they have any questions.

The Chair of the European Medicines Agency’s vaccine evaluation team has said there is a connection between the AstraZeneca vaccine and rare blood clots, although the exact cause of the adverse reaction remains uncertain. Meanwhile, the MHRA is being urged to consider restricting the rollout of the jab due to the occurrence of blood clots in younger people – especially young women.

The BBC’s report is worth reading in full.

AstraZeneca Vaccine Linked to Blood Clots, EMA Official Says

The Chair of the European Medicines Agency’s vaccine evaluation team has said there is a connection between the AstraZeneca vaccine and rare blood clots, although the exact cause of the adverse reaction remains uncertain. This news comes as Britain’s medicines agency weighs up whether to restrict the AZ jab for younger people. The Independent has the story.

A senior official at the European Medicines Agency (EMA) has said he believes there is a link between the AstraZeneca vaccine and extremely rare cases of blood clots reported in people who recently had the jab. 

In an interview with Italy’s Il Messaggero newspaper, Marco Cavaleri, Head of Vaccines Strategy at the EMA, said it was “clear there is a link with the vaccine” but there was still uncertainty about what exactly was causing such a reaction.

Mr Cavaleri said that among younger vaccinated people there was a higher than expected number of cases of cerebral thrombosis – blood clotting in the brain – compared with the general population.

He suggested that the EMA would make a statement on the situation later on Monday. The Independent contacted the EMA for comment.

The EMA has insisted as recently as last week that the “causal link with the vaccine is not proven” and continues to recommend people take the opportunity to get vaccinated when it is offered.

Last month, the agency said it “cannot rule out definitively” a link to a rare clotting disorder but that it is still “safe and effective” to use. In another statement, it said the benefits of the vaccine outweigh any risks.

EMA is of the view that the benefits of the AstraZeneca vaccine in preventing Covid, with its associated risk of hospitalisation and death, outweigh the risks of side effects

Channel 4 News has reported that Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) is considering issuing new advice on the AstraZeneca vaccine for younger people.

The UK [medicines] regulator, the MHRA, and the Joint Committee on Vaccination and Immunisation are urgently scrutinising whether younger people – particularly women – could be at greater risk of getting a potentially fatal blood clot after the AstraZeneca jab than they are of dying from Covid. In either case, though, the risk is very small.

The Independent’s report is worth reading in full.

UK Health Regulator May Restrict AstraZeneca Covid Vaccine for Younger People

The Prime Minister received his first dose of the AstraZeneca Covid vaccine last month and said that all Brits should get theirs when told to do so. But now, the UK’s medicines regulator is being urged to restrict the AZ jab for younger people because of fears over blood clotting.

At the end of March, Canada’s National Advisory Committee on Immunization (NACI) said that the risk of blood clots is greatest for women aged under 55. In response, both Canada and Germany limited their AstraZeneca vaccine rollouts to those over 55 and 60, respectively. Channel 4 News has revealed that Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) is also considering issuing similar advice. Reuters has the story.

Britain’s health regulator is considering a proposal to restrict the use of the AstraZeneca vaccine in younger people over concerns about very rare blood clots, Channel 4 News [has] reported…

“Two senior sources have told this programme that while the data is still unclear there are growing arguments to justify offering younger people – below the age of 30 at the very least – a different vaccine,” the broadcaster reported.

The UK’s regulator, the MHRA, has previously said the benefits of the vaccine in the prevention of Covid far outweigh any possible risk of blood clots.

The MHRA did not immediately respond to a comment on the Channel 4 report.

After receiving his first dose, Boris Johnson said: “The Oxford jab is safe… The thing that isn’t safe is catching Covid, which is why it is so important that we all get our jabs as soon as our turn comes.” Channel 4 News reports that authorities are now investigating whether the AstraZeneca vaccine might actually pose a greater risk for younger people – particularly young women – than Covid itself.

The UK [medicines] regulator, the MHRA, and the Joint Committee on Vaccination and Immunisation are urgently scrutinising whether younger people – particularly women – could be at greater risk of getting a potentially fatal blood clot after the AstraZeneca jab than they are of dying from Covid. In either case, though, the risk is very small.

Last month, the European Medicines Agency said the AZ Covid vaccine is “safe and effective” to use, but highlighted that it “cannot rule out definitively” a link to a rare clotting disorder.

Channel 4 News’s full report can be viewed here.

Blood Clot Cases Could Reduce Take-up of AstraZeneca Vaccine Among Young Women

Younger people – particularly young women – may turn down the AstraZeneca vaccine because of fears about blood clotting, health officials have warned. Thirty blood clot cases were recorded after the first 18 million doses of the jab. Two-thirds of patients with these rare conditions are female. The Observer has the story.

Health officials are becoming increasingly worried that younger people will reject Covid jabs as concerns about the AstraZeneca vaccine continue to grow. A total of 30 cases of rare blood clots have been linked to the jab in the UK, resulting in seven deaths. Eighteen million doses of the vaccine have been administered so far.

It is feared that younger women will be particularly anxious and may refuse to accept the vaccine because two-thirds of patients with these types of blood clots are female.

The link with blood clots, known as cerebral venous sinus thrombosis, CVST, has led Germany and the Netherlands to halt giving the vaccine to people under 60. However, the European Medicines Agency has said there is “no evidence” to support such restrictions, while the WHO has also urged countries to continue giving the jab.

Professor Paul Hunter, of the University of East Anglia, said that it was not uncommon to get clusters of rare events purely by chance. “But once you find that cluster in one population and it then crops up in another – such as previously in the German and now in the English – then I think the chances of that being a random association is very, very low,” he said.

“Clearly more work needs to be done, but I think the evidence is shifting more towards it being causally related at the moment.” However, he added that the risks of taking the AstraZeneca vaccine were still far outweighed by the risks of not getting it.

Faith in the AstraZeneca vaccine has fallen on the Continent because of reports of blood clots. A recent survey suggested that concerns about the AZ jab are now widespread in Denmark. More Danes would decline to get an AZ vaccine than would refuse to get a Covid jab altogether, highlighting that lower take-up is not simply the product of general vaccine scepticism. Reuters reported:

One in three Danes would decline to get a Covid shot using AstraZeneca’s vaccine, local media outlets TV 2 and Politiken reported late on Wednesday, citing a recent survey. …

The survey, conducted by Megafon among 1,053 persons, showed 33% of Danes would decline to get a shot with AstraZeneca’s vaccine. However, only 7% would decline regardless of which Covid vaccine they were offered.

British officials fear that the same concerns may be emerging here.

The Observer’s report is worth reading in full.