Several European nations have suspended use of AstraZeneca’s COVID-19 vaccine following reports of blood clots, but the European medicine regulator says there is no evidence of a link.
- A 60-year-old woman formed a blood clot and died after being given an AstraZeneca shot
- There is no conclusive link between the vaccine and blood clots, and the suspensions are precautionary
- Other nations including Italy and Austria have stopped using some of their AstraZeneca supply until more testing is done
Denmark suspended the shots for two weeks after a 60-year-old woman who was given an AstraZeneca shot from a batch used in Austria formed a blood clot and died, health authorities said.
Austria had earlier stopped using the batch while investigating a death from coagulation disorders and an illness from a pulmonary embolism.
Italy also said it would suspend the use of a batch of the vaccine following the deaths of two men in Sicily, but added this batch was different to the one used in Austria.
However, the European Medicines Agency (EMA) said the number of cases of blood clots in vaccinated people was no higher than in the general population, and the vaccine could continue to be administered.
“There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine,” the EMA said.
“The vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing.”
The EMA said there had been 30 cases of “thromboembolic events” reported so far among the almost 5 million Europeans who had received the jab.
AstraZeneca said in a statement that it had found no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in safety data of more than 10 million records, even when considering subgroups based on age, gender, production batch or country of use.
“In fact, the observed number of these types of events are significantly lower in those vaccinated than what would be expected among the general population,” it said.
The drugmaker said this week there had been “no confirmed serious adverse events associated with the vaccine”.
It said it was in contact with Austrian authorities and would fully support their investigation.
Norway, Iceland, Estonia, Lithuania, Luxembourg and Latvia have also stopped inoculations with the vaccine while investigations continue.
COVID-19 disease itself ‘strongly associated with blood clotting’
Professor Helen Petousis-Harris, a vaccines expert from the University of Auckland, said an investigation was the safest course of action.
“I guess the worry is that every time one of these little signals comes up, that we we have this kind of panic attack and sort of halt everything and worry unduly,” she said.
“So I think we’ve just got to get used to letting the investigation sort of take place and try and carry on calmly.”
Phil Bryan, head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), said the reports of blood clotting did not exceed what would have occurred naturally in the vaccinated population.
“Available evidence does not confirm that the vaccine is the cause,” he said.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene Tropical Medicine, said the COVID-19 disease itself was very strongly associated with blood clotting.
“The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence,” he said.
The Federal Government says it remains confident the jab, which will be offered to most Australians, is safe.
Prime Minister Scott Morrison, who is also the acting Health Minister while Greg Hunt is on sick leave, said he had spoken to Health Department Secretary Brendan Murphy this morning, and there was no advice to pause Australia’s rollout.
“The [Therapeutic Goods Administration] obviously looks at these reports when they come through, but they do their own batch testing,” he said.
“I was watching them do it just earlier this week.
“We have a very robust process for examining that.”
Several other countries not halting vaccinations
Germany, France, Spain and Sweden have all announced they will continue to administer the AstraZeneca vaccine.
France’s Health Minister, Olivier Veran, said he saw no reason to suspend its use.
“The benefits of the AstraZeneca vaccine are considered higher than the risks at this point,” he said at the government’s weekly coronavirus briefing.
He said investigations were continuing in France and abroad and added that Britain — which has vaccinated almost 11 million people with the AstraZeneca shot — advised continuing with it and had not noted large-scale excess risk related to the vaccine.
Swedish authorities also said they had not found sufficient evidence to stop vaccinations with AstraZeneca’s jab.
“There is nothing to indicate that the vaccine causes this type of blood clots,” said Veronica Arthurson, head of drug safety at the Swedish Medical Products Agency.
Spain said it had not registered any cases of blood clots related to AstraZeneca’s vaccine so far, and would continue administering the shots.
Germany also said it would continue with vaccinations.