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HEALTH

In Europe questions linger over possible AstraZeneca jab side-effects

Persistent questions on whether rare but serious blood clots among those getting the AstraZeneca jab against Covid-19 are more frequent than in the general population, and what causes them if they are, have continued to undermine confidence in the beleaguered vaccine in Europe.

In Europe questions linger over possible AstraZeneca jab side-effects

The European Medicines Agency – which has said that benefits outweigh risks such that the vaccine should remain in use – will provide an updated assessment next week.

What has been observed?

The blood clots seen in a handful of people vaccinated with AstraZeneca are described by the French Medicines Agency (ANSM) as “highly untypical”.

“This thrombosis of large veins is unusually located in the brain, and even more rarely in the digestive tract,” the agency commented.

It is also associated with a condition characterised by abnormally low levels of platelets, which are small cell fragments in our blood that form clots to stop or prevent bleeding.

In mid-March, Germany’s medicines regulator, the Paul Ehrlich Institute (PEI), was the first national health authority to flag what they described as an aberrantly high number of cases involving these rare cerebral blood clots, mostly in younger and middle-aged women.

According to some specialists, this set of symptoms pointed to so-called disseminated intravascular coagulation (DIC), in which blood clots form throughout the body.

Also seen in extreme cases of sepsis, this condition involves “both thrombosis and haemorrhaging”, Odile Launay, a member of the scientific body advising the French government on Covid-19 vaccines, told AFP.

Link with the vaccine?

“A causal link with the vaccine is not proven but is possible, and further analysis is continuing,” the EMA said last week.

The agency is scheduled to meet on the question from April 6th-9th.

Other specialists were more categorical.

“We have to stop speculating on whether there is a link or not – all the cases showed these symptoms three to 10 days after inoculation with the AstraZeneca vaccine,” Pål Andre Holme, who heads a team at Oslo National Hospital working on these cases, told Norwegian media.

“We have not found any other triggering factor.”

Norway’s national medicines agency backed this assessment, with one of their executives, Steinar Madsen, saying “there is probably a link with the vaccine”.

For its part, France’s ANSM – pointing to “the very unusual type of thrombosis, a similar clinical profile, and similar timing of onset” – said there was a “small” risk.

How big is the risk?

As of March 31st, the EMA had identified 62 cases of cerebral venous sinus thrombosis (CVST) in the world – 44 of them in Europe – among 9.2 million doses of AstraZeneca administered.

Of those, 14 have resulted in death, though it is not possible to definitively attribute fatalities to this rare form of thrombosis, the head of the EMA, Emer Cook, said last week in a videoconference.

The statistics, he added, are comprehensive, or close to it.

In Germany, there have been 31 suspected cases of CVST – 19 accompanied by a drop in blood platelets – with nine deaths, according to the Paul-Ehrlich Institute.

These cases were spread across 2.8 million AstraZeneca vaccine doses injected, or just over one case per 100,000 doses.

The comparable figures for France are 12 cases and four deaths out of 1.9 million doses, and for Norway, five cases and three deaths out of 120,000 doses.

Britain – where AstraZeneca has been administered more than in any other country – registered 30 cases as of Saturday, including seven fatalities, across a total of 18.1 million doses.

But as is true of all medications, risks must always be weighed against benefits.

“We would all prefer to have drugs that are 100 percent safe but they don’t exist,” Adam Finn, a professor of paediatrics at University of Bristol, told the London-based Science Media Centre last week, commenting on renewed bans of the AstraZeneca vaccine in Germany and elsewhere.

“Right now, the biggest risk to our lives and livelihoods throughout the world is Covid-19,” Finn added. “We need to stay focussed on the need to prevent it taking millions more human lives before it is brought under control and the only effective way to do that is through vaccination.”

The EMA has consistently echoed this view. “The benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects,” it said in a statement on March 31st.

This chart from Our World In Data shows the percentage of people in the countries covered by The Local who have received at least one dose of a Covid-19 vaccine

Risk factors?

Most cases of cerebral thrombosis have occurred in those under 65, but it is impossible to draw any conclusions about age because the vaccine has been administered to date mostly among younger populations.

The fact that a majority of cases have been among women may simply reflect the fact the health sector – predominately women – was given priority for
vaccination.

“At present the review has not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders for these very rare events,” the EMA said.

Notwithstanding, after some countries temporarily paused the AstraZeneca jab in mid-March, several countries have now suspended the vaccine again.

Germany decided last week to ban its use for anyone under 60, while in Canada – as in France – the age threshold is 55. In Sweden the age cutoff is 65.

READ ALSO: France resumes AstraZeneca vaccination – but for over-55s only

READ ALSO: EXPLAINED: Why has Germany restricted the use of AstraZeneca in under-60s?

“We do not have just one vaccine, we have several,” Sandra Ciesek, a professor of medical virology at the Goethe University Frankfurt, wrote in Science magazine.

“So, restricting the AstraZeneca vaccine to older people makes sense to me.”

Norway and Sweden have taken the more radical step of suspending the AstraZeneca vaccine altogether.

However, on March 25th, Sweden said it would restart AstraZeneca vaccines in the over-65s this week.

Possible explanations?

For the moment, there are only hypotheses, though the EMA is expected to suggest next week which are the more likely ones.

In a study released on March 28th that has not yet been peer-reviewed, German and Austrian researchers pointed to a known biological mechanism as a possible explanation for the apparent surge in atypical thrombosis.

The AstraZeneca vaccine, they wrote, is associated with a thrombosis disorder “that clinically resembles heparin-induced thrombocytopenia (HIT)”.

HIT is a rare and serious reaction of the immune system to the anti-coagulant medication heparin.

The authors, led by Andreas Greinacher from the University of Greifswald, proposed a name for what they described as a new syndrome: “vaccine-induced prothrombotic immune thrombocytopenia (VIPIT).”

Researchers at Oslo National Hospital had earlier suggested that cases might have been triggered by a “powerful immune response” to the vaccine.

An association of French scientists and doctors called “On the Side of Science” have said such an immune response could come from the accidental insertion of the needle into a vein in the upper arm, rather than muscle.
 

Member comments

  1. I am a Type 1 diabetic and also have had a heart attack, a number of vascular stenting procedures and also a double heart bi-pass. I have been offered an appointment to have the Astra Zeneca vaccine this Thursday but am worried over the risks of blood clotting associated with the AZ vaccine. Has anyone had similar experiences please?

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HEALTH

What is the average waiting time across Spain to see a doctor?

Find out the average amount of time you'll have to wait to see your GP, a specialist and get a non-urgent surgery in your region of Spain.

What is the average waiting time across Spain to see a doctor?

Where you live in Spain greatly affects the amount of time you’ll have to wait, from the first appointment with your family doctor to seeing a specialist and even through to an operation, if you need one. 

Two and half years after the beginning of the Covid-19 pandemic, which almost brought the country’s clinics and hospitals to breaking point, how is the situation now?

Here are the average waiting times in each region of the country, with data published by the regional health authorities. 

Andalusia
In Andalusia, the average wait time to see a doctor is four days. To see a specialist such as a dermatologist or a cardiologist, however, you will be waiting three months. Wait times for non-urgent surgeries vary depending on what you need. 

Aragón
Those living in Aragón will typically be able to get a doctor’s appointment within three days, but to see a specialist, it is one of the worst regions in the country, with an average waiting time of four months.

Asturias
The latest waiting times to see a doctor or a specialist in Asturias have not yet been published, but if you need a special test such as an MRI, you will be waiting more than three months.

Balearic Islands
In the Balearics, the average waiting time for an appointment to see your GP is one week, while if you need to see a specialist, you will be waiting around two months. For a non-urgent surgery, you will be on the waiting list for an average of four and a half months. The Balearic Islands are one of the worst places if you need a diagnostic test though with an average wait of more than six months. 

Basque Country
Data from the Basque Country has so far not been made available. 

Canary Islands
Like in Aragón, the Canary Islands is one of the worst places to live if you need to see a specialist with the longest waiting time of more than four months.

Cantabria
Cantabria has so far not updated its data on waiting times to see a specialist, but if you need a non-urgent surgery it has one of the longest waiting times at six months.

Castilla-La-Mancha
Those in Castilla-La-Mancha have one of the shortest wait times to see a GP, being able to book an appointment within just 48 hours. They’ll have to wait longer to see a specialist, however, with an average wait of two months. Those waiting for non-urgent surgery will be waiting another four months.

Castilla y León
In Castilla y León you’ll wait an average of six days before being given an appointment and two months to see a specialist.

Catalonia
Residents of Spain’s northeastern region wait an average of five days in order to get a doctor’s appointment. For diagnostic tests, the wait time depends on what you need. You will be on the list for five months on average for a colonoscopy and two months for an MRI.

If you need to see a specialist again it will completely depend on what type of specialist you need to see. For example, if you need to see a urologist you’ll have to wait five months, but if you need to see a neurologist you’ll be able to get an appointment in less than three months. If your doctor thinks you require non-urgent surgery, you will need to wait another four and half months.

Extremadura
In Extremadura, you’ll have to wait an average of four days for an appointment, while the waiting time to see a specialist will be around two months. Like Cantabria, Extremadura is one of the worst places to live if you need non-urgent surgery, as you’ll be waiting around half a year.

Galicia
Those in Galicia will be able to see a doctor in just three days, however, they have not published recent data on the wait time to see a specialist. They have however published data for non-urgent surgery which is an average wait of three months.

Madrid
Like in Galicia, in Madrid the waiting time for an appointment is just three days, but two months to see a specialist. For a test like an ultrasound or a CT scan, you will be waiting two months. If you need a non-urgent surgery, you’ll be on the waitlist for a further three months.

Murcia
The average wait time to see your GP has not been made available yet, but like in Andalusia, you’ll be waiting more than three months if you need to see a specialist. It’s one of the best regions for wait times for diagnostic tests though as you will be waiting less than one month. 

Navarre
Navarre has one of the shortest wait times for an appointment, available in just 48 hours. If you need to see a specialist, you’ll be waiting a further two months. Those waiting for a non-urgent surgery will have to wait an average of three months.  

La Rioja
Along with Castilla-La Mancha and Navarre, La Rioja has the shortest wait time to get a doctor’s appointment. Here, you’ll be able to see your GP in just 48 hours. This region is also the best to live in if you need to see a specialist or get a specialised test, with a wait of less than one month. If you need non-urgent surgery though it’s not so good, as you’ll be waiting an average of four months.

Valencia
Those living in Valencia have the longest wait out of all the regions for an appointment, where you’ll wait more than a month just to see a GP. When it comes to seeing a specialist you’ll need to wait another three months. And if you need surgery, you will have to wait four and half months on top of that.

The types of non-urgent surgeries the data refers to are hip and knee replacements. For other types of surgeries, it will depend on how urgent it is and what type of surgery it is. At the beginning of the year, there were more than 706,000 people waiting for an operation in Spain, according to data from the Ministry of Health.

You should be aware, however, that official data doesn’t always represent reality. Some readers have told us that currently, they are having to wait a month to see their GP in Catalonia and seven months to see a specialist.

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