MHRA

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. 

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.

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.