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?
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.
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.
“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.
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.