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

The AstraZeneca vaccine has been on a rollercoaster ride of stops and starts since its initial approval and, in view of the latest developments, it doesn’t look like that's going to change any time soon. We explain what it means for you.

EXPLAINED: Why has Germany restricted the use of AstraZeneca in under 60s?
Entrance to the AstraZeneca building in Wedel in Schleswig-Holstein. Photo: DPA

What’s happened now?

On Tuesday, Germany’s Stiko vaccine committee advised against using the Oxford-Swedish vaccine in the under-60s in Germany because of concerns that current data showed serious clotting side effects in that population.

Chancellor Angela Merkel said the “very rare but very serious cases of thrombosis” in people who had been vaccinated with AstraZeneca could not be ignored.

This comes barely a week after the country reversed its previous suspension of the jab after the European Medicines Agency deemed the vaccine safe and effective against Covid-19.

READ ALSO: Germany ‘cannot ignore AstraZeneca findings, says Merkel

So the vaccine isn’t suspended as such?

That’s right. It’s a national recommendation rather than a suspension. People under 60 can still decide to have the AstraZeneca vaccine if they’d like to, but only after consultation with the vaccinating doctor and based on an individual risk analysis.

What about if you’re under 60 and due for your second jab with AstraZeneca?

If your doctor clears you to have it, you can choose to take it if you’d like to, or you can wait for the vaccine committee to make its recommendation on this. This is expected by the end of April.

A policeman receives his AstraZeneca vaccination in Lower Saxony. Photo: DPA

So could I have my second jab with a different vaccine?

Stiko will clarify this at the end of April, but perhaps. In the UK, there is a trial underway examining whether giving people different Covid vaccines for their first and second doses is as effective as giving the same type twice. However, there are no results on this available yet.

Although the UK’s official guidance is to give the same brand for both jabs, Public Health England said earlier this year that different ones could be used in rare circumstances, such as if the same vaccine wasn’t available or it was not known which brand was used for the first dose. 

And some scientists believe that mixing and matching the vaccines – as is already done for diseases such as Ebola – could even boost immune response.

Tell me about this rare clotting side effect…

Some people who’ve had the AstraZeneca vaccine have developed a rare condition called cerebral sinus venous thrombosis, or CSVT, a rare type of blood clot in the vein that’s responsible for draining blood from the brain. The clot prevents the blood from flowing out, which can lead to bleeding on the brain and stroke. 

The jury is out on exactly why this is happening – and whether the vaccine is definitely implicated –  but in a recent safety report, medical regulator the Paul Ehrlich Institute reported a “noticeable cluster” of these cases occurring soon after patients had had the AstraZeneca jab.

I’ve had the AstraZeneca jab, should I be worried?

It’s important to remember that this problem has not been proven to be linked to the vaccine and has only affected a tiny number of people out of the very many who have been vaccinated.

However, if you experience the below symptoms between 4 and 20 days after having a vaccination (or any other unusual or severe symptoms), you should seek immediate medical attention mentioning your recent vaccination.

READ ALSO: German health experts call for strict lockdown to quell rising Covid cases

How many cases of CSVT have there been in Germany?

As of Monday, 31 suspected incidences of cerebral sinus venous thrombosis in people who had been vaccinated with AstraZeneca had been reported to the Paul Ehrlich Institute.

A total of 19 of those also had a low platelet count (thrombocytopenia) and, sadly, nine were fatal. With the exception of two men (36 and 57), all the cases affected women between the ages of 20 and 63.

How many vaccinations with AstraZeneca have been given in Germany?

According to the Robert Koch Institute (RKI), around 2.7 million first jabs and 767 second doses had been given as of Monday.

So, it’s a serious but very rare problem?

Yes, exactly. The latest figures from the Paul Ehrlich Institute show that there have been around 1.15 cases per 100,000 vaccinations given.

If it’s so rare why is it a problem?

Because it seems to be affecting more people than you would expect. In the US general population, such a rare problem normally affects just five people in every 1 million per year, according to the John Hopkins University. 

Why are the under-60s most affected?

We don’t know. It’s possible that this could actually be a reflection of the population the vaccine was most used in. The AstraZeneca jab has been used in younger people to a greater extent than other brands in much of Europe. This is because many countries – including Germany – didn’t sanction the vaccine for use in the over-65s until later because of a lack of study data for that population.

Do we know what’s causing the clots?

This is something that is currently being widely researched, but there is no definitive answer as yet.

Some scientists have suggested the vaccine could trigger an unusual auto-immune response in a tiny number of people.

I’ve read about HIT, what’s that?

HIT or heparin-induced thrombocytopenia is a rare side effect that occurs in some patients who’ve been given a blood-thinning drug called Heparin.

So what’s the connection to the vaccine?

A team of German researchers, led by clotting specialist Andreas Greinacher of the University of Greifswald, looked at blood samples from nine affected individuals and noted that the symptoms they experienced after vaccination – clotting and a low platelet count – were similar to those seen in HIT.

The German findings suggest that in a small proportion of people, like in HIT, the vaccine may be triggering the immune system to produce a type of antibody that activates platelets, key cells in the body’s blood-clotting mechanisms. These antibodies attack the platelets and, in response, the body produces too many, causing clotting.

A team of Norwegian researchers came to a similar conclusion after examining three cases of blood clots after the vaccine.

However, these findings have not been peer-reviewed or published yet and, as other scientists have pointed out, two of the patients in the analysed group had a history of blood-clotting problems. It is also unclear whether any of the patients had had any previous infection with Covid-19, which itself is a risk factor for blood-clotting disorders.

Essentially, there’s a lot we still don’t know.

How often does this problem happen with Heparin?

More frequently. Some 1-5 percent of patients on Heparin develop CVST compared with the just over 1 in 100,000 suspected cases following the vaccination.

Can CVST be treated?

Yes, providing it’s identified promptly. 

So is this definitely happening because of the AstraZeneca vaccine?

No. We don’t know whether the vaccine is causing these side effects yet or not. However, researchers – including those at the Paul Ehrlich Institute – are carrying out further investigations.

As the head of the UK’s medical regulator MHRA Dr June Raine has said, the type of blood clots seen in those who received the vaccine could have been caused by Covid itself.

Yes, and can’t Covid-19 itself cause a drop in platelets?

It can. A 2020 study of Covid-19 patients in China found that cases of thrombocytopaenia were more common in patients with severe Covid. The lower a patient’s platelet levels, the higher their expected mortality rate.

What does this mean for the vaccination rollout?

Germany’s already been widely criticised for the slow speed of its vaccination campaign (official figures show that around 11 percent of the population have received a first dose so far), and this isn’t going to help that.

The below chart shows the percentage of people who have received at least one vaccine dose in Germany compared to the UK.

Health minister Jens Spahn acknowledged that this development was “without question a setback”, but said that Germany still expected to offer every adult a coronavirus jab by September 21st, saying the AstraZeneca jab could now be used more quickly in the over-60s age group.

Have the other vaccines caused any problems?

Yes. There have been around 20 similar cases in the US after vaccination with the Moderna and Pfizer brands, including at least one death. Several of the affected patients had had thrombocytopenia in the past. However, this is out of the over 20 million people who had received at least one vaccine by early February.

Thrombocytopenia is also a well-known side effect of several long-established vaccines, such as those against mumps, measles, rubella and varicella, as well as after natural infection with viruses like HIV and hepatitis C, MedPage Today reported.

What are the World Health Organisation and the European Medical Agency saying?

Both have deemed the AstraZeneca vaccine safe and effective against Covid-19. After recent investigations into the vaccine, they said the overall risk for clotting with this vaccine was no higher than in the general population.

The EMA said that it couldn’t definitively rule out a link between vaccination and these very rare events, but felt that due to the severity of Covid-19, the vaccine’s benefits outweighed its potential risks.

At the same time, it said that more information and advice for healthcare professionals and the public on the potential side effects should be included in the vaccine’s product information. The information and consent sheet given to patients having the vaccine now includes this (as below).

The medical regulator’s safety committee, PRAC, is continuing to assess the cases that have been reported and the outcome of its findings are expected during its plenary meeting on April 6th – 9th.  

What’s happening in other countries?

On Monday, Canada recommended stopping the use of AstraZeneca in adults under 55 while cases of CSVT were being investigated. 

France is still only using AstraZeneca for the over-55s, while Spain said on Tuesday that it would extend its use to the over-65s. It had previously only been used in the 18-to-65 age group.

Last week, Norway extended its suspension of the Oxford-Swedish vaccine until April 15th, to give health officials more time to investigate any link between the clotting problems and the vaccine. Denmark also extended its suspension of the vaccine.

And Sweden restarted jabs with AstraZeneca this week, but only in the over-65s. Finland only administers the jab to the over-65s and Iceland to the 70s and over.

READ ALSO: Norway extends pause of AstraZeneca vaccine until April 15th

What about the UK where they’ve vaccinated large numbers of people?

Unlike its European neighbours, the UK has delivered the AstraZeneca vaccine continuously.

Up to mid-March, the UK’s medical regulator MHRA had received five reports of cerebral sinus venous thromboses together with lowered platelets in people who had had the vaccination, including one death. This was out of 11 million doses administered, putting the risk rate well below that of dying of Covid.

However, unlike the picture seen in much of Europe, the cases were all men, aged between 19 and 59. 

Member comments

  1. The EU goes to WAR on supply of Astra Zeneca then Germany refuses to use it.

    It appears that the EU is fracturing

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Pandemic in Germany unlikely to end this year, says top virologist

High profile German virologist Christian Drosten believes Germany will see a severe spike in Covid infections after summer, and that the pandemic will not become endemic this year.

Pandemic in Germany unlikely to end this year, says top virologist

Drosten previously said that Germany would probably be able to declare the end of the pandemic this year.

But in an interview with Spiegel, Drosten said he had reevaluated his opinion. 

“When the Alpha variant came, it was very surprising for me. When Delta appeared I was sceptical at first, then with Omicron we had to reorient ourselves again. And since January there have already been new Omicron subtypes.

“So I would actually like to correct myself: I no longer believe that by the end of the year we will have the impression that the pandemic is over.”

READ ALSO: End is in sight for pandemic in Germany, says virologist 

Drosten also said that Germany will not see a largely Covid-free summer, which has been the case in previous years, and a further increase in infections in autumn. 

“We are actually already seeing an exponential increase in case numbers again,” Drosten said.

“The BA.5 variant (of Omicron) is simply very transmissible, and people are losing their transmission protection from the last vaccination at the same time.”

In other countries, he said, when the number of cases become high, hospitalisation and death rates also rise again. “Unfortunately, that will also be the case here,” said Drosten, but added: “Overall, however, far fewer people will become seriously ill and die than in 2021.”

Drosten said he expected many more infections from September.

“I hope that the school holidays will dampen the increase in cases somewhat. But from September, I fear we will have very high case numbers,” the head of the virology department at Berlin’s Charité hospital told Spiegel.

READ ALSO: German Health Minister lays out autumn Covid plan

Virologist Christian Drosten at a Covid press conference in 2021.

Virologist Christian Drosten at a Covid press conference in 2021. Photo: picture alliance/dpa | Kay Nietfeld

If the government does not take any action, he predicted there would be a lot of sick leave across all industries. “That will become a real problem,” he said.

Drosten said he did not expect overcrowded intensive care units in Germany.

But the new BA.5 sub-variant, which is becoming dominant in Germany, may affect people more strongly. 

“The wheel is turning more towards disease again,” said Drosten. It is not true that a virus automatically becomes more and more harmless in the course of evolution. “That makes me even more worried about the autumn,” he said.

Drosten recommends wearing masks indoors during the colder months, saying it is “the least painful” measure.

If, in addition, “up to 40 million people could be immunised or given a booster vaccination” before winter, for example by urgently calling for company vaccinations, that would “really make a difference”, Drosten said.

In the long term, he said it’s inevitable that people will become infected with coronavirus.

He said the population immunity due to vaccinations and infections will at some point be so strong that the virus will become less important. “Then we will be in an endemic state,” said Drosten. In the worst case, however, this could take “several more winters”.

However, Drosten warned against people trying to deliberately infect themselves with Covid, saying getting the infection in summer doesn’t mean people will be protected in winter. 

Drosten himself said he has not yet contracted Covid-19.

“So far, I guess I’ve just been lucky,” he said. “I rarely put myself in risky situations, but I’m not overly cautious either.”

‘Pandemic depends on behaviour’

According to the Robert Koch Institute (RKI)’s latest weekly report, more outbreaks are occurring in care homes, and the number of patients in intensive care units is slightly rising as infections go up. 

The institute said there had been a 23 percent increase in the 7-day incidence compared to the previous week. On Friday the 7-day incidence stood at 618.2 infections per 100,000 people. There were 108,190 infections within the latest 24 hour period and 90 deaths. 

“The further course of the pandemic depends not only on the occurrence of new virus variants and the uptake of vaccinations on offer, it also depends to a large extent on the behaviour of the population,” said the RKI.

According to the DIVI intensive care register, the number of Covid-19 patients in ICUs had increased to 810 on Thursday this week, from about 600 at the beginning of the month.

However, that number is still low compared to previous Covid peaks when thousands of people were in intensive care in Germany.