Germany on Monday halted the use of AstraZeneca’s coronavirus vaccine after reported blood clotting incidents in Europe, saying that a closer look was necessary.
“After new reports of thromboses of the cerebral veins in connection with the vaccination in Germany and Europe, the PEI considers further investigations to be necessary,” said the German health ministry, referring to a recommendation by the country’s vaccine authority, the Paul Ehrlich Institute.
France, Italy and Spain follow Germany
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, Spain, Portugal and Slovenia.
Macron announced the suspension himself which he said was taken “as a precaution” and would only be effective for 24 hours to give time to the European Medicines Agency to issue advice.
Just on Sunday French Prime Minister Jean Castex defended his country’s decision to carry on with the AstraZeneca jab saying France had found no reason to suspend the rollout.
“At this stage, we must have confidence in this vaccine,” he said, highlighting instead the danger of leaving large sections of the population unprotected from Covid.
Italy’s decision on Monday to suspend the use of the vaccine as a “precautionary and temporary measure pending European Medicines Agency (EMA) rulings” came after talks between Health Minister Roberto Speranza and ministers in Germany, France and Spain.
Nordic countries sound alarm
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. The Danish medicines agency said it had seen “highly unusual” symptoms in a 60-year-old recipient of the AstraZeneca vaccine who later died.
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 after recording 10 cases of “noteworthy adverse side-effects” following the AstraZeneca vaccine being administered.
Sweden initially said it would not halt the AstraZeneca vaccine rollout, arguing the data did not show a link. But on March 16th it said it too would suspend its use as a “precautionary measure” pending EMA’s investigation.
Bulgaria suspended the use of the vaccine on March 12th as it investigated the death of a woman with several underlying conditions who received the jab in the past week.
An initial probe suggested the woman died from heart failure and an autopsy found no link with the vaccination.
Austria announced on March 8th that it has stopped administering a batch of the vaccine following the death of a 49-year-old nurse from “severe bleeding disorders” days after receiving it.
Austria did however say on Tuesday that it would continue to administer the vaccine while waiting for a decision from the EMA.
Estonia, Lithuania, Latvia and Luxembourg also suspended the use of doses from the same batch, which has been delivered to 17 countries and included one million vaccines.
Italy’s medicines regulator on March 11th also banned the use of a batch as a precaution, triggering a similar decision from Romania.
And on March 14 Italy’s northern Piedmont region suspended use of the vaccine after the death of a teacher who had received it the day before.
In Spain the regional governments of Andalusia, Catalonia, Castilla y León and the Canary Islands suspended the use of the suspect batch on Friday, followed by Valencia and Asturias over the weekend.
WHO, EMA and AstraZeneca defend vaccine
AstraZeneca, an Anglo-Swedish company which developed the vaccine with Oxford University, has defended the safety of its product.
“Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” AstraZeneca’s chief medical officer Ann Taylor said in a statement.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” Taylor also said.
The World Health Organization said on Monday that countries should continue using AstraZeneca’s Covid vaccine,
after many governments halted rollouts because of blood clot fears.
“We do not want people to panic and we would, for the time being, recommend that countries continue vaccinating with AstraZeneca,” WHO chief scientist Soumya Swaminathan told a press briefing.
“So far, we do not find an association between these events and the vaccine,” she said, pointing out that some blood clot incidents among the general population were to be expected.
When looking at those who had received the jab, the incidence is “in fact, less than what you would expect in the general population at the same time”, she said.
On March 11th the European Medicines Agency (EMA) told AFP that information available so far indicated the risk of blood clots in those vaccinated against Covid-19 was “no higher than that seen in the general population.”
The EMA also said that European countries could keep using the AstraZeneca vaccine while the issue was investigated, concluding that “the vaccine’s benefits continue to outweigh its risks”.
Stephen Evans, a professor of pharmaco-epidemiology at the London School of Hygiene and Tropical Medicine said: “The risk and benefit balance is still very much in favour of the vaccine.”
Referring to the suspensions he said: “This is a super-cautious approach based on some isolated reports in Europe.”