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VACCINE

UPDATE: What you need to know about Germany’s suspension of the AstraZeneca jab

The German Health Ministry accounted on Monday that it was suspending the use of the AstraZeneca Covid-19 vaccine due to concerns about a possible link to blood clots. Here is everything we currently know about the decision and its implications.

UPDATE: What you need to know about Germany's suspension of the AstraZeneca jab
Doses of the AstraZeneca jab. Photo:Chaiwat Subprasom/DPA

Why has German decided to suspend use of the AstraZeneca jab?

German Health Minister Jens Spahn told a press conference on Monday that the decision was made on the basis of a recommendation he received that morning from the country’s vaccine control agency – the Paul Ehrlich Institute (PEI).

The PEI has evaluated indications that the vaccine could cause thrombosis in the brain and recommended its suspension as a precautionary measure.

Spahn confirmed that there have been seven cases in Germany where a blood clot has occurred after someone has received the vaccine. Three of the cases were fatal.

The thrombosis identified is a rare type, which made the relatively small number of cases suspicious.

“Last week it looked as if the problems that had occurred were ordinary thromboses. They are quite common,” Anke Huckriede, professor of vaccinology at the University of Groningen in the Netherlands, told Science Media Center. “Now there is apparently newer information that it is a very rarely occurring form of thrombosis, of which some cases now seem to have occurred shortly after vaccination.”

On Tuesday, the PEI clarified that six of the cases were of sinus venous thrombosis in women aged between 20 and 50.

“Two of these cases, tragically, were fatal,” PEI head Klaus Cichutek told Die Welt.

A further thrombosis case was identified in a male of unknown age.

“We did a further analysis and saw that for a number of about 1.5 million vaccinations, the number of these cases is above the threshold of the normal occurrence,” Cichutek said.

Spahn said that while this is a “very low risk” compared to the 1.6 million jabs already given in the country, it would be above average if confirmed to be linked to the vaccine.

According to Spiegel, this type of thrombosis occurs normally in around around two to five people per million in a year. 

Is Germany the only country to have suspended the jab?

No.

Denmark was the first country on March 11th to say it was going to suspend use of the AstraZeneca vaccine as a precautionary measure over fears of blood clots in vaccinated people.

Iceland and Norway followed the same day, temporarily suspending use of all their supply of the vaccine citing similar concerns.

READ ALSO: Which countries in Europe have suspended AstraZeneca vaccinations?

On Saturday Norwegian health officials reported three more cases of blood clots or brain haemorrhages in younger people who received the jab, but said they cannot yet say they were vaccine-related.

The next day Ireland and the Netherlands joined the list of countries temporarily deferring the use of the vaccine.

Not long after Germany suspended the use of the vaccine, French president Emmanuel Macron followed suit and announced a similar temporary halt. That move was then repeated by Italy.

What has the reaction been in Germany?

High profile experts have questioned the decision to suspend use of the vaccine.

Frank Ulrich Montgomery, head of the World Medical Association told the Redaktionsnetzwerk Deutschland that “the fact that people get thromboses and pulmonary embolisms does not necessarily have anything to do with the vaccination.”

He added that international studies show that the frequency of thrombosis is about the same in a placebo group and in a group with the vaccine.

READ ALSO: ‘Take AstraZeneca now’: German health officials plead with public to get jab amid scepticism

“The bottom line is, this is a good and effective vaccine and is not gaining much acceptance among the population because of the fuss and the vaccination suspension in many countries,” he said.

Politicians also questioned the move. Social Democrat health spokesperson Karl Lauterbach described it as “a big mistake” which would cause uncertainty in the population.

His colleague Katarina Barley (SPD) wrote on Twitter: “The latest generation of birth control pills has thrombosis as a side effect in eight to twelve out of 10,000 women. Has that ever bothered anyone?”

When will we know whether the vaccine is still considered safe to use?

The European Medicines Agency will now consider the evidence and make a new recommendation on the vaccine.

Spahn said that the expects the EMA to announce its decision within a week

What does this mean for people who’ve already had a first dose of AstraZeneca?

Germany has suspended the use of AstraZeneca even for those who have had their first jab with the vaccine. Spahn said that all the doses will remain in storage, distributed across the country, so that they can be used immediately once the EMA has given its verdict.

If, on the other hand, the EMA decided to make the suspensions permanent, it is unclear which vaccine people will get who’ve had their first dose with AstraZeneca.

Spahn would not comment on this point at Monday’s press conference but said that “if it isn’t possible to give the same vaccine for the second inoculation we will find a solution for our citizens.”

Has any other guidance been published?

Yes. Spahn stressed that the decision was purely cautionary. At the same time, he stated that if four days after receiving the jab “someone has acute headaches or blood spots on their skin they should immediately seek the advice of doctors.”

What is AstraZeneca saying?

An AstraZeneca spokesman said it had found no evidence of increased risk of blood clot conditions after analysing reported cases from more than 17 million doses.

“In fact, the reported numbers of these types of events for COVID-19 Vaccine AstraZeneca are lower than the number that would have occurred naturally in the unvaccinated population,” said the spokesman.

What would it mean for Germany’s vaccine campaign if the suspension becomes permanent?

Spahn was asked by several reporters what it would mean if the country could no longer use the AstraZeneca vaccine. He declined to comment, saying that such decisions were too theoretical at this stage.

It seems clear though that such a decision would have a big impact, at least in the short term, on Germany’s vaccine strategy. The AstraZeneca vaccine is the second most used in Germany after the BioNTech one.

Experts in Germany estimate that the complete termination of vaccine with AstraZeneca would delay Germany’s roll out by roughly one month.

There is already serious discontent in Germany about the pace of the vaccine rollout. Some 6.5 million people have so far had their first jabs, while 2.9 million have had both. 

What will this decision do to public trust in the AstraZeneca jab?

Spahn said he was aware that the suspension would have a big impact on public trust in the vaccine. But he underlined that the only way of maintaining trust during the pandemic was in being as transparent as possible. He said he made the decision on a scientific recommendation and that this was the most transparent decision.

The AstraZeneca jab has already had bad headlines in Germany, although the company says these have been down to bad reporting. In January two German media outlets reported that it was not effective in the elderly. These reports appear to have been based on confusion about the data.

READ ALSO: German panel keeps advice against AstraZeneca jabs for over-65s

The PEI did not recommend it for use in the over-65s until earlier this month based on what it said was a lack of evidence that it was effective in this age group. But it changed its mind based on studies from the UK.

There has been anecdotal reports that some medical staff have not turned up for vaccination appointments because they did not want the AstraZeneca jab.

Member comments

  1. ALL of the UK will have been vaccinated before Putin trickles in some Sputnik V, then you will be forced to open up NordStream2

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NEWSLETTER

Should Germany shorten Covid vaccine intervals to combat Delta?

A single vaccine dose has been shown to be largely ineffective against the Delta variant of Covid-19 - so German health experts are considering whether a shorter gap between the first and second dose is needed.

Should Germany shorten Covid vaccine intervals to combat Delta?
A sign directs people to the vaccination centre in Berlin's now-defunct Tegel Airport. Photo: picture alliance/dpa | Soeren Stache

With the the proportion of Delta variant Covid cases rising in Germany, experts are currently mulling over a new strategy to combat it: shortening the intervals between the first and second dose of the vaccine.

The new approach is being considered in light of the fact that vaccinated people are likely to be protected highly infectious variant – but only if they have had all necessary doses of the vaccine. 

READ ALSO: Share of Delta variant Covid cases in Germany almost doubles in a week

“The question is not a trivial one,” Thomas Mertens, the head of the Standing Vaccination Commission (STIKO), told DPA.

According to the Ulm-based virologist, there are various pros and cons to shortening the gaps between doses.

“We are currently trying to secure the necessary evidence,” he added.

So far, Stiko has been recommending longer intervals between the two vaccinations than the intervals stipulated by regulators when the vaccines were approved. 

There are good reasons for this: with AstraZeneca, for example, evidence suggests that the longer you wait between vaccines, the better immunity you have.

With limited doses of vaccines available – and ongoing supply issues – there is also an argument for providing as many people as possible with the first dose, so that as many people as possible are at least partly protected against the virus.

READ ALSO: ‘Vaccinate quickly’: German states seeing surge in Delta variant Covid cases

For AstraZeneca, the previous advice from the panel of experts at Stiko is to allow twelve weeks to elapse between the first and second dose. For the mRNA vaccines – Pfizer/BioNTech and Moderna – the recommended interval is six weeks.

According to the pharmaceutical regulators, however, a faster course would be possible: two BioNTech doses three weeks apart, with Moderna and AstraZeneca given four weeks apart.

In the case of the AstraZeneca vector vaccine, according to the Health Ministry, those wishing to be vaccinated are free to agree the interval individually with doctors within the permitted period of four to twelve weeks.

“A certain distance improves the effectiveness of the vaccine”

Helge Braun (CDU), Chancellor Angela Merkel’s chief of staff, told the Morgenmagazin on Thursday that the government’s main challenge was to offer all over-12s at the least one dose of the vaccine by the end of summer.

READ ALSO: ‘This can be a good summer’: Half of Germans vaccinated at least once against Covid

Regarding the timing of the second dose, the main concern should be effectiveness, he said.

“We just know that a certain distance improves the effectiveness of the vaccination,” he told reporters. 

When pressed on whether shortening the intervals between doses was the advice of the hour, Braun said it wasn’t.

On Twitter, German immunologist Carsten Watzl pointed out that, while cases of Delta were rising as a proportion of infections due to falling infection rates overall, the actual number of infections with Delta was still stable – and may even be declining. 

This means that the longer, 12-week interval for AstraZeneca vaccinations could be still be used as long as people were fully vaccinated by autumn, he said. 

The virologist Christian Drosten has been pointing out for a long time that the first jab is not particularly effective against Delta. 

This is also the view of Watzl, who would like to see the majority of people fully protected in time for a potential fourth wave of the virus. 

“The second vaccination is urgently needed in order to be able to properly ward off the mutations,” he said in a recent interview with the German Press Agency.

“Shortening the current vaccination intervals, especially of BioNTech, of course makes sense in order to achieve complete inoculation as quickly as possible,” said the chief executive of the National Association of Statutory Health Insurance Physicians, Andreas Gassen, on Wednesday.

“The maximum vaccine interval for BioNTech is only justified by the lack of vaccines.”

In Germany, increased shares of the Delta variant, first discovered in India, are now being recorded.

However, the number of cases caused by the mutation has only increased relatively slightly so far, while the trend for infections caused by the still dominant Alpha variant is declining more sharply.

In the future, it is expected that Delta will overtake Alpha as the dominant variant of Covid-19 in Germany. 

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