EU regulator says AstraZeneca clot risk 'very rare' as nations battle virus surges


The EU’s medicines regulator said Wednesday that blood clots should be listed as a rare side effect of the AstraZeneca jab but the benefits continue to outweigh risks, as several countries battle fresh virus surges amid vaccine shortfalls.

A number of nations have suspended the use of AstraZeneca’s vaccine for younger populations after it was earlier banned outright in several places over blood clot scares.

The United Kingdom on Wednesday said it will adopt new medical advice to offer most people under 30 an alternative to AstraZeneca if possible, after reporting 19 deaths from clots among people who received the shot.

The debate comes as countries from Germany to Ukraine and India face new waves of the virus that has now killed more than 2.8 million people.

Governments are scrambling to secure much-needed vaccine doses, with Australia the latest nation to complain of shortages that it blamed on EU export controls.

Boris Johnson at AstraZeneca facility
Britain’s Prime Minister Boris Johnson visits an AstraZeneca facility in England Photo: POOL / Dave Thompson

The European Medicines Agency (EMA) said Wednesday that blood clots should be listed as a “very rare” side effect, encouraging countries to continue its use.

The announcement came after the EMA examined 86 blood clotting cases, 18 of which were fatal, out of around 25 million people in Europe who received the AstraZeneca vaccine. Most of the cases were in women aged under 60.

India has now recorded 12.8 million cases — the third-highest behind the United States and Brazil Photo: AFP / INDRANIL MUKHERJEE

But EMA chief Emer Cooke said no particular risk factor had been identified and the clots may be linked to an immune response to the vaccine.

“The benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects,” she told a news conference.

“It is saving lives.”

The World Health Organization’s vaccine experts on Wednesday echoed EMA’s findings, saying a causal relationship between the vaccine and blood clots was “plausible but is not confirmed”.

“We believe the benefit-risk balance is very much in favour of the vaccine,” said the WHO in response to an AFP query.

AstraZeneca itself said two studies by British and European regulators “reaffirmed” that the benefits of its vaccine “far outweigh the risks”.

Covid swab test
A man gets a Covid test in Mexico City Photo: AFP / PEDRO PARDO

Canada, France, Germany, Italy, Belgium, Spain and the Netherlands are among countries not recommending the shot for younger people.

Britain’s decision to offer an alternative jab if possible to most people under 30 came after data showed 79 blood clots and 19 deaths among people who had received one of 20 million AstraZeneca doses administered in the UK.

AstraZeneca’s vaccine has been administered in at least 111 countries, more than any of its rivals, according to AFP data. It is being used both in wealthier countries and poor nations, largely as part of the Covax scheme to ensure equitable access to vaccines.

EMA chief
No specific risk factors for clots with AstraZeneca says EMA chief Photo: EMA VIA EBS

The controversy surrounding the jab has marred a global vaccine rollout that will help countries emerge from a pandemic that has ravaged the world’s economy and subjected much of humanity to some form of confinement.

In Germany, Chancellor Angela Merkel expressed support for a snap lockdown to stem rising cases, after decentralised measures failed to quell outbreaks.

Hard-hit France imposed tighter measures this week, as French Open organisers announced the tennis tournament would be delayed by one week until May 30 in the hopes of accomodating more fans.

Ukraine on Wednesday reported record new deaths and hospitalisations after tightening measures in the capital.

Canada’s most populous province of Ontario was ordered into a four-week lockdown, while Qatar reimposed strict measures.

India, which registered a 24-hour record of almost 116,000 new cases on Wednesday, said it too would rollout tougher curbs with new curfews in place in 20 cities, including the capital New Delhi.

Brazilian President Jair Bolsonaro however doubled down on his opposition to lockdown measures, despite the country registering its deadliest day yet on Tuesday with more than 4,000 deaths.

“We’re not going to accept these policies of ‘stay home, close everything, lock down,'” he said.

Australia was facing vaccine woes of its own, after just 700,000 of a contracted 3.8 million doses of the AstraZeneca vaccine were delivered.

Prime Minister Scott Morrison blamed the EU for the shortages, accusing the bloc of “strict export controls”.

More than 694 million doses of coronavirus vaccines have been administered globally, according to an AFP tally, with just a handful of countries leading the pack by a wide margin.

Israel has inoculated 61 percent of its people with one dose, while the US has administered 33 percent with a first shot.

Amnesty International said in its annual report that wealthy countries are failing a test of global solidarity by hoarding Covid vaccines.

Echoing calls to help hard-hit nations, G20 finance ministers and central bankers agreed to extend a moratorium on debt interest payments for the poorest countries.

Meanwhile in the United Kingdom, where around 60 percent of adults have received a first dose, health workers started rolling out the Moderna jab, the third approved after AstraZeneca and Pfizer.

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