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EU regulator ‘firmly convinced’ AstraZeneca jab benefits outweigh risks

March 16, 2021

The EU’s medicines regulator said Tuesday it was “firmly convinced” the benefits of AstraZeneca’s jab outweigh potential risks, insisting there was no evidence linking the vaccine to blood clots after a host of nations suspended the shot over health fears.

The suspensions have led to intense debate over whether it was prudent to put AstraZeneca inoculations on hold just as vaccination campaigns begin to gather pace in many countries.

Experts at both the World Health Organization and the European Medicines Agency are meeting Tuesday to discuss the vaccine, with the European organisation expected to publish conclusions Thursday.

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

But the EMA insisted Tuesday countries should continue using the vaccine.

“We are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 with its associated risk of hospitalisation and death outweigh the risk of these side effects,” EMA chief Emer Cooke said.

“At present there is no indication that vaccination has caused these conditions,” she added, echoing the WHO and drugmaker AstraZeneca itself.

Cooke noted however that the regulator was “looking at adverse events associated with all vaccines.”

Meanwhile deaths across the continent have topped 900,000, making it the worst-hit global region in absolute terms, according to an AFP tally from official figures.

In Britain, which has administered more than 11 million AstraZeneca doses and where 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”.

And Poland’s vaccination chief Michal Dworczyk charged that those suspending vaccination “have succumbed to the panic caused by media coverage of alleged complications”.

But French immunologist Alain Fischer, who heads a government vaccination advisory board, said a higher number than normal of pulmonary embolisms — blood clots in the lungs — had caused alarm at the weekend.

“There were a few very unusual and troubling cases which justify this pause and the analysis,” Fischer told France Inter radio.

“It’s not lost time.”

Doubts hit global rollout

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.

Indonesia delayed its AstraZeneca rollout on Monday, and Venezuela announced it would not authorise the jab over fears of “complications”.

In Ukraine, even medical staff were succumbing to doubts, which were already widespread among the public before the blood clot scare.

“Out of 40 people who initially wanted to be vaccinated, only 10 still do,” said Dr Yuriy Shylenko of his colleagues at a Kiev hospital.

But in Canada, Prime Minister Justin Trudeau urged citizens to get the AstraZeneca shot after reports of hesitancy based on the suspensions.

And Thai Prime Minister Prayut Chan-O-Cha was himself injected Tuesday as his country lifted its own AstraZeneca suspension.

“I am an example today,” he said.

‘Critical situation’

The AstraZeneca debate comes as a number of countries battle worrying infection surges.

Norway’s capital Oslo announced tougher measures, including closing secondary schools, as it reported a record number of cases last week.

And a fresh spike pushed the main Covid-19 hospital in Bosnia to the edge, forcing it to declare a state of emergency.

“The staff is exhausted” and “more and more of our employees are sick,” hospital director Sebija Izetbegovic wrote on Facebook.

Most of Italy re-entered lockdown on Monday, with schools, restaurants, shops and museums closed, while intensive care doctors in Germany issued an urgent appeal for new restrictions to avoid a third wave in the country.

Vaccine options

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

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

But a new agreement for Germany’s IDT Biologika to help produce the single-shot Johnson & Johnson vaccine would offer Europe greater certainty, Germany’s economy minister said Monday.

The developers of Russia’s successful Sputnik V vaccine also said they had reached production agreements in key European countries.

And on Tuesday Brussels sealed a deal to step up deliveries of 10 million doses of the Pfizer/BioNTech vaccine, now scheduled to arrive in the EU before July rather than in the third quarter.

China, where the virus first emerged in late 2019, has also developed Covid-19 vaccines and begun exporting them.

Its embassy in the US was one of several worldwide to say it would begin to process “visa applicants inoculated with Chinese Covid-19 vaccines”.

China has largely brought its outbreak under control, but maintains strict travel restrictions and has yet to approve any foreign-made shots.

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