EMA ‘convinced’ Astrazeneca vaccine benefits outweigh risks

Emer Cooke, executive director of the European Medicines Agency: "Trust in the safety and efficacy of the vaccine is of paramount importance." [EPA-EFE]

There is currently no indication of a direct link between the AstraZeneca vaccine and rare cases of blood clotting, the European Medicine Agency (EMA) has said, although the agency is set to offer its conclusion on the matter on Thursday (18 March). 

During a press conference on Tuesday (16 March), the agency reiterated it is “firmly convinced” that the benefits of the Swedish-British vaccine outweigh the risks.

“I have very clearly said that we have outlined that the benefit-risk of these vaccines remains positive,” said EMA executive director Emer Cooke, suggesting that countries should carry on vaccination for the time being.

“Trust in the safety and efficacy of the vaccine is of paramount importance,” she added.

The EMA’s comments come as concerns mount over the safety of the AstraZeneca vaccine after reports emerged linking it to isolated cases of thrombosis, resulting in Germany, France and Italy pausing administration of the shot. They were later joined by Spain, Portugal, Slovenia and Latvia.

Major EU nations halt AstraZeneca while WHO insists the jab is safe

The EU’s largest countries joined a stream of states halting their rollouts of AstraZeneca jabs on Monday (15 March) over blood clot fears, as the World Health Organization and Europe’s medicines watchdog insisted it was safe to use.

Not clear whether link ‘causal or coincidental’

The EMA underscored that while it was taking the allegations seriously, it is currently unclear whether the link between the vaccine and the thrombosis cases was causal or coincidental.

The agency’s expert committee is currently in the process of investigating this further and is expected to reach a conclusion on the matter on Thursday (18 March) afternoon, Cooke said.

However, the agency took the opportunity to highlight that the current rate of blood clots in those vaccinated did not exceed the normal rate found in the population and pointed to the fact that thrombotic incidences occurred in both vaccinated and placebo groups in clinical trials.

“Many thousands of people develop blood clots for many reasons,” Cooke said.

This contradicts a statement from the German government outlining why the country opted to halt vaccinations suggesting that the number of cases of cerebral vein thrombosis was “above average,” despite the “high number of vaccinations with [AstraZeneca]” which totals 1.6 million.

The statement also explicitly says that it would not have been “justifiable” to keep vaccinating
after experts unanimously came to the conclusion that the cases “could be related to the vaccination.”

Batch-specific?

In response to questions over whether these side effects were linked to specific batches, the EMA said that it is currently looking into any such disparities.

While the agency confirmed that reports have so far come from Germany and Norway, Cooke said that the agency is “receiving additional information from member states as we speak” but that it was currently not possible to indicate whether or not these were the only cases.

The latest development comes amid rising tensions between the EU and AstraZeneca after deliveries of promised doses were severely delayed.

The EMA was keen to distance itself from the idea that decisions to halt the roll-out of the vaccine were in any way political, stressing that this decision had been based purely on an “independent, scientific basis”.

The suspensions came as a major blow to a global immunisation campaign widely hoped to herald the end of a pandemic that has already claimed more than 2.6 million lives and decimated the global economy.

[Edited by Josie Le Blond]

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