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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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MADRID

UPDATE: What next for the 2 million people in Spain who had the first dose of AstraZeneca vaccine?

Due to side-effect concerns, the Spanish government has decided that the AstraZeneca vaccine is now only going to be given to those aged 60 to 69. But hundreds of thousands of other people in Spain who have received the first dose of this vaccine now find themselves in limbo.

UPDATE: What next for the 2 million people in Spain who had the first dose of AstraZeneca vaccine?
People in the northern Spanish city of León queue to get the Covid vaccine. Photos: CESAR MANSO, GABRIEL BOUYS / AFP

On April 7th, the Spanish government announced it would reserve the AstraZeneca vaccine for those over 60, after an EU regulator said blood clots should be listed as a rare side effect of the jab.

This decision has left 23 percent of those who received at least one dose of the vaccine, in limbo. 

The circa two million people who received just their first AstraZeneca dose, before this announcement was made, mostly includes key workers such as teachers, police, firefighters, physiotherapists and chemists, the majority of them under the age of 59.

Spain’s Ministry of Health has confirmed that only 97 people received both AstraZeneca doses, which were spaced 10 weeks apart.

Those who received the first dose who are between ages 60-69 will still receive their second AstraZeneca vaccine, but what will happen to those who are younger?

Currently, there are two different scenarios that are being considered. 

READ ALSO: Spain reserves AstraZeneca vaccine for those over 60

Will the AstraZeneca vaccine be combined with another inoculation?

A clinical trial conducted by the Carlos III Health Institute is currently taking place, with 600 participants in two hospitals in Madrid, two in Barcelona and one in Bilbao to determine what should be done.

Director of the Institute Raquel Yotti announced that those taking part in the trial will be receiving a second dose of the Pfizer vaccine instead of the AstraZeneca one.

The volunteers were all given their first AstraZeneca vaccine nine weeks previously and out of these, 400 of the participants will receive their second dose of Pfizer.

“This will assess the impact of the intensification of the immune response when the second dose is the Pfizer one,” explained Jesús Antonio Frías, coordinator of the Carlos III Health Institute’s clinical research network.

If the trial is successful, this same method could be carried out on all of the roughly two million people in Spain, who have only received one dose of the AstraZeneca vaccine. 

The study, which has been named CombiVacs, has already been approved by the European Medicines Agency.

The goal was to have the results of the trial as soon as possible, but on April 30th the Health Ministry announced that would delay the fate of those who had received just one dose by an extra four weeks. 

This will take the amount of time between most people’s doses from 12 to 16 weeks. The decision will give extra time for the results of the clinical trial. 

However, the announcement has caused opposition from the Community of Madrid, as well as authorities in Castilla-La Mancha and Aragón.

Even experts from the Spanish Vaccine Commission have proposed that it would be safe to administer the second dose of Astrazeneca to those over the age of 40.

Will those who have been vaccinated with AstraZeneca receive only one dose? 

The second option being considered is that those left in limbo won’t receive a second dose at all. 

It is believed that even a single dose of AstraZeneca provides 70-75 percent protection against Covid-19, according to the news site OK Diario.

Will Spanish regions change their vaccine strategy?

The current government vaccine strategy in principle is to vaccinate those between 60-69 with AstraZeneca and those 70 and above with either Pfizer, Moderna or Janssen.

However, the government recently announced that it will give each autonomous community free reign on which vaccine it will use for the over 60s, depending on its availability.

The Health Ministry said: “Regions can vaccinate with all available vaccines” given that “there will be more than enough”.

AstraZeneca will not be used on a voluntary basis

The government however has categorically rejected the proposals of some regions, including Madrid and Catalonia, to allow those under 60 to be vaccinated with AstraZeneca on a voluntary basis.

It said that it does not seem appropriate to offer the vaccine to those under the age of 60, who wish to be vaccinated with AstraZeneca. 

“Once again, we must remember that which vaccine people receive cannot be based on individual choice, but must be based on efficacy and different population groups,” the Health Ministry wrote. 

READ ALSO: Region by region: What foreigners in Spain should do to register for the Covid-19 vaccine

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