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Employees of the Lazio Region stick a placard reading 'as said by the Italian Medicines Agency the AstraZeneca vaccinations have been suspended until a later date' at the entrance to a new vaccination centre in Rome on March 16, 2021.

ANDREAS SOLARO/AFP/Getty Images

Global medical regulators are trying to ease growing concerns about the Oxford-AstraZeneca jab that threaten to damage public trust in vaccines and delay immunization drives around the world.

More than a dozen European countries, including France, Germany and Italy, have stopped using the vaccine in the wake of reports that 37 people developed blood clots after being vaccinated with AstraZeneca and at least two have died. The Democratic Republic of the Congo and Indonesia have also suspended its use while Thailand recently resumed administering the vaccine.

The European Medicines Agency has assembled a panel of experts to review the circumstances surrounding each case of blood clots and a final report is due on Thursday. On Tuesday, the EMA’s executive director, Emer Cooke, said scientists had yet to find any connection between clots and the vaccine.

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André Picard: COVID-19 vaccines: Separating fact from fiction on side effects, blood clots and more

“We remain convinced on the basis of the evidence that we have, that the benefits of this vaccine outweigh the risks associated with the vaccine,” Ms. Cooke said during a press conference. “At present there is no indication that vaccination caused these conditions.”

The World Health Organization has been examining the blood-clot issue as well and so far its researchers have found no link to the vaccine. Health Canada has come to a similar conclusion along with Britain’s Medicines and Healthcare products Regulatory Agency (MHRA).

Europe's medicines watchdog on Tuesday said the benefits of AstraZeneca's COVID-19 vaccine continue to outweigh the risks after several countries halted its use due to concerns about blood clots. Reuters

AstraZeneca has said that “a careful review of all available safety data of more than 17 million people” inoculated in the European Union and Britain with its vaccine has shown no evidence of an increased risk of blood clots.

Despite the reassuring words from the company and regulators, many health officials fear the controversy will weaken public acceptance of vaccines in general and prolong the COVID-19 pandemic.

“We are worried that there may be an effect on the trust of the vaccines but our job is to make sure the products we authorize are safe,” Ms. Cooke said. When asked repeatedly if countries should continue to use the vaccine, Ms. Cooke said it was up to national governments but she repeated that the EMA believes the benefits outweigh the risks.

Vaccine tracker: How many COVID-19 doses have been administered so far?

The conflicting messages have frustrated many health officials across Europe where the vaccination rollout has already been hit with delays.

The Oxford-AstraZeneca vaccine was supposed to be the backbone of the EU’s inoculation program because, unlike the Pfizer-BioNTech shot, it doesn’t require cold storage and it’s less expensive. However, bureaucratic red tape and production problems at AstraZeneca’s plants in Europe have hampered the EU’s immunization drive.

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Europe’s vaccine campaign in turmoil

Europe’s slow vaccination rollout now hangs on the

European Medicines Agency’s findings after a number

of countries suspended the AstraZeneca-Oxford shot

following reports of blood clots

European countries that have

suspended AstraZeneca vaccine

Luxembourg

Netherlands

Norway

Spain

Sweden

Austria

Denmark

Estonia

France

Germany

Iceland

Ireland

Italy

Latvia

Lithuania

March 11: European Medicines Agency says number

of clots in vaccinated people is no higher than number

seen in general population – 30 cases among five million

people who received vaccine

Public perception of AstraZeneca vaccine

Total

unsafe

Very

safe

Somewhat

safe

Somewhat

unsafe

Very

unsafe

3%

2%

Britain

54%

27%

5%

Italy

12%

42%

11%

5%

16%

Spain

24%

35%

16%

9%

25%

Germany

11%

32%

23%

17%

40%

France

7%

26%

25%

19%

44%

YouGov surveys of 1,029-2,034 adults in each country, Feb. 23-March 2

the globe and mail, Sources: graphic news (via

Associated Press, European Medicines Agency, YouGov)

Europe’s vaccine campaign in turmoil

Europe’s slow vaccination rollout now hangs on the

European Medicines Agency’s findings after a number

of countries suspended the AstraZeneca-Oxford shot

following reports of blood clots

European countries that have

suspended AstraZeneca vaccine

Luxembourg

Netherlands

Norway

Spain

Sweden

Austria

Denmark

Estonia

France

Germany

Iceland

Ireland

Italy

Latvia

Lithuania

March 11: European Medicines Agency says number

of clots in vaccinated people is no higher than number

seen in general population – 30 cases among five million

people who received vaccine

Public perception of AstraZeneca vaccine

Total

unsafe

Very

safe

Somewhat

safe

Somewhat

unsafe

Very

unsafe

3%

2%

Britain

54%

27%

5%

Italy

12%

42%

11%

5%

16%

Spain

24%

35%

16%

9%

25%

Germany

11%

32%

23%

17%

40%

France

7%

26%

25%

19%

44%

YouGov surveys of 1,029-2,034 adults in each country, Feb. 23-March 2

the globe and mail, Sources: graphic news (via

Associated Press, European Medicines Agency, YouGov)

Europe’s vaccine campaign in turmoil

Europe’s slow vaccination rollout now hangs on the European Medicines Agency’s findings

after a number of countries suspended the AstraZeneca-Oxford shot following

reports of blood clots

European countries that have

suspended AstraZeneca vaccine

March 11: European Medicines

Agency says number of clots in vac-

cinated people is no higher than

number seen in general population

– 30 cases among five million

people who received vaccine

Luxembourg

Netherlands

Norway

Spain

Sweden

Austria

Denmark

Estonia

France

Germany

Iceland

Ireland

Italy

Latvia

Lithuania

Public perception of AstraZeneca vaccine

Very

safe

Somewhat

safe

Somewhat

unsafe

Very

unsafe

Total

unsafe

3%

2%

Britain

54%

27%

5%

Italy

12%

42%

11%

5%

16%

Spain

24%

35%

16%

9%

25%

Germany

11%

32%

23%

17%

40%

France

7%

26%

25%

19%

44%

YouGov surveys of 1,029-2,034 adults in each country, Feb. 23-March 2

the globe and mail, Sources: graphic news (via Associated Press,

European Medicines Agency, YouGov)

Initial fears that the vaccine was less effective in older people also slowed down the rollout although most countries now use it for all age groups. As a result, only about 10 per cent of the EU’s population has been vaccinated compared to nearly 40 per cent of people in Britain.

The head of Italy’s medicines authority blamed politics for the decision-making. “We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations ... to put them on hold in order to carry out checks. The choice is a political one,” Nicola Magrini told la Repubblica.

Karl Lauterbach, an epidemiologist and health spokesman for Germany’s Social Democrats, also blamed politics and told German radio: “I would even now get vaccinated with the AstraZeneca.”

In a joint statement Tuesday, Italian Prime Minister Mario Draghi and French President Emmanuel Macron said their countries would resume inoculations with the vaccine if the EMA gave reassurances on Thursday.

Dr. Peter Arlett, who heads the EMA’s pharmacovigilance and epidemiology department, said the expert panel will review vaccination data from across the EU as well as the medical reports from each of the blood-clot cases. Among the questions the panel will consider is “How many blood clots would we expect to see in the European population seven days after vaccination or 14 days after vaccination?” he said during the press conference. “Blood clots are very common, thousands of blood clots occur in European individuals every day.”

He added that “There will be a very careful consideration of whether there are any particular features of the individuals that have been vaccinated and have these [clots] that might put them at risk.” If that connection is made, the EMA could issue a warning about the potential side effect and alert practitioners to the types of people who may be at risk.

Story continues below advertisement

Scientists in Britain have been especially perplexed by the doubts raised about the Oxford-AstraZeneca vaccine, which was developed at the University of Oxford and has been used in Britain for months.

“More than 11 million doses of the [Oxford-AstraZeneca] vaccine have now been administered across the U.K., and the number of blood clots reported after having the vaccine is not greater than the number that would have occurred naturally in the vaccinated population,” said Phil Bryan, head of vaccine safety at the MHRA.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said the vaccine could actually be helping to reduce cases of blood clots.

“It still remains the case that a very likely explanation of at least some of the clotting disorders seen are a result of COVID-19 rather than the vaccine,” Dr. Evans said Tuesday. “There are published papers that make clear that these problems definitely occur in COVID-19 and there is no doubt that all the vaccines in use prevent that disease.”

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