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ASTRAZENECA

UPDATE: Which countries in Europe have suspended AstraZeneca vaccinations?

A growing list of European countries have suspended AstraZeneca's Covid-19 shots or batches of the jab as a precaution amid fears over blood clots and other possible side effects, despite the company and the World Health Organisation and the European Medicines Agency insisting there is no risk. Here is the latest.

UPDATE: Which countries in Europe have suspended AstraZeneca vaccinations?
Vano SHLAMOV / AFP

Germany

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.

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

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.

Growing list

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.

Suspending batches

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.”

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ASTRAZENECA

AstraZeneca vaccine ‘safe and effective’ against Covid-19, European Medicines Agency concludes

The European Medicines Agency (EMA) concluded on Thursday that the AstraZeneca vaccine was a "safe and effective" tool in the battle against Covid-19 but its investigation could not rule out whether the jab had caused rare cases of blood clotting.

AstraZeneca vaccine 'safe and effective' against Covid-19, European Medicines Agency concludes
Photo: Joe Giddens/AFP

The EMA’s Executive Director Emer Cooke said the agency’s expert committee came to “a clear and scientific conclusion”.

“This is a safe and effective vaccine whose benefits in protecting people from Covid-19 hugely outweigh the risks,” she said but added that further studies would take place to probe possible links between the injection and rare blood clotting cases.

While millions of doses of the vaccine developed with Oxford University have been administered, small numbers of people have developed blood clots, which prompted countries including the European Union’s three largest nations – Germany, France and Italy – to suspend injections pending the EMA investigation.

The EMA’s expert committee was convened at short notice to hold an emergency investigation into the cases of blood clotting.

Cooke said that the vaccine was not associated with an increased risk of thromboembolic events or blood clotting but did add that based on the available evidence “we still cannot rule out definitely a link between these cases and the vaccine.”

In the report on its website the EMA said: “The vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).

“A causal link with the vaccine is not proven, but is possible and deserves further analysis.”

Cooke said the EMA was in favour of “raising awareness of the possible risks of the vaccine and making sure they are included in the product information.”

“If it was me I would want to be vaccinated tomorrow but if something happened to me after vaccination I would want to know what to do about it and that’s what we’re saying today,” said Cooke.

Chair of the EMA’s vaccine safety committee Dr Sabine Strauss said there was no higher risk of thromboembolic events happening after being vaccinated in fact the risks may be reduced.

The EMA will carry out further studies into the vaccine. Those EU countries who paused the rollout of the AstraZeneca vaccine will not have decide whether to continue the injections after the EMA’s conclusions.

‘We have found the cause’

Earlier on Thursday, a group of health experts at Oslo University Hospital concluded that the blood clots in three health workers who took the AstraZeneca vaccine were triggered by an immune system response.

Three health care workers under the age of 50 were admitted to hospital with severe blood clots after taking the vaccine. One of the three later died of a brain haemorrhage.

“We have found the cause. There is nothing but the vaccine that can explain the immune reaction that occurred,” Pål Andre Holme, professor and chief physician at Oslo University Hospital told newspaper VG.

Holme led a team that worked round the clock to find out why the health workers were admitted to hospital with blood clots after taking the vaccine.

Asked about whether the EMA had taken into account the conclusions of Oslo University the agency’s Dr Sabine Straus said committee had taken into account the cases in Norway but had not looked at the report from Norwegian health officials in Oslo.

The World Health Organization on Thursday renewed a call for countries to continue the use of AstraZeneca’s
Covid-19 vaccine, shortly before expected assessments by EU and UN agencies.

The WHO’s Global Advisory Committee on Vaccine Safety (GACVS) — created in 1999 to address safety issues related to vaccines of potential global importance — is due to publish the conclusions of its assessment of the safety of AstraZeneca’s vaccine on Friday.

But as of now, “the benefits of the AstraZeneca vaccine far outweigh its risks and its use should continue, to save lives,” the WHO’s regional director for Europe Hans Kluge told a press conference.

“In vaccination campaigns, it is routine to signal potential adverse events. This does not necessarily mean that the events are linked to the vaccination,” Kluge said

AstraZeneca billed as vaccine of choice

In Britain, which has administered more than 11 million AstraZeneca doses, experts see no evidence of more frequent blood clots among the inoculated.

Prime Minister Boris Johnson wrote in The Times newspaper that the shot “is safe and works extremely well”.

More than 382 million doses of Covid vaccines have been administered globally, the vast majority in wealthier countries while many poorer nations have yet to receive a single dose.

AstraZeneca’s shot, among the cheapest available, was billed as the vaccine of choice for poorer nations and the clot reports have had an impact beyond Europe.

Other countries that halted or delayed the rollout include Indonesia, Venezuela, Denmark, Norway, the Netherlands, Cyprus, Lithuania, Luxembourg and Sweden.

The pandemic spurred unprecedented efforts to develop vaccines, with a number of successful options now available.

Rollouts have been hampered by export controls, bitter diplomatic disputes and production issues – in addition to the AstraZeneca suspension.

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