AstraZeneca vaccine benefits outweigh risks, EMA says

The protection offered by AstraZeneca vaccines against Covid-19 outweighs the risks according to the available data, European Medicines Agency chief Emer Cooke said as the regulator brings together experts from across the continent to examine reports of blood clots.

It comes as a spate of national regulators across Europe including in France, Germany and Ireland paused the use of the vaccine as a precaution pending the results of the review expected on Thursday, a move that has caused hundreds of thousands of appointments to be delayed as several European countries battle a resurgence of the virus.

“Vaccines for Covid-19 help to protect individuals from becoming ill,” Ms Cooke said. “While the investigation is ongoing, currently we are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 . . . outweigh the risks of these side-effects.”

Such a safety alert was “not unexpected” as it is “inevitable” that there are cases of illness when a vaccine is given to millions of people, Ms Cooke said, explaining that the role of the regulator is to now establish “is it a real side-effect of the vaccine, or is it a coincidence”.

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The safety review has brought together experts in blood clot disorders and medical regulators from across the continent including from Britain, where the the AstraZeneca vaccine has been given to over 11 million people without reports of excess deaths or blood clots.

Causality focus

The investigation is focusing on whether there is any causal link to the vaccine in a handful of cases in Norway and Germany in which some people who had received a dose later became ill with a rare kind of brain clot and a low count of blood platelets.

In Germany, which has administered 1.6 million AstraZeneca jabs, there have been seven cases including three deaths, according to the country's independent regulator the Paul Ehrlich Institute. Younger people were affected, "especially women", the regulator said.

Seven cases were greater than the roughly one instance that would statistically be expected to occur in a group of that size, according to the regulator. It found that it was “not justifiable” to continue vaccinating before an investigation was complete, though it described the question of whether more deaths would occur due to the pause in vaccination as a “legitimate” issue.

“Vaccination is a matter of trust and not a compulsion,” the regulator said in an explanation of its decision to recommend a pause. “Every person being vaccinated must be sure that all information about the vaccine is conveyed transparently and completely, and that nothing is withheld.”

Delivery schedule

It was also “legally obliged” to give citizens the full information and there could be legal consequences if it did not, the regulator added.

Several EU governments have expressed hopes that the review will clear the AstraZeneca vaccine, and allow for campaigns to be swiftly resumed.

Nevertheless, the bloc’s vaccination efforts were bolstered by the announcement of a sped-up delivery schedule by BioNTech-Pfizer, which is now set to provide 200 million doses of its Covid-19 vaccine to the bloc between April and June.

Ireland would be in line to receive roughly 2.2 million of the doses, on top of the expected separate deliveries from the other Covid-19 vaccine manufacturers Moderna, AstraZeneca and Johnson & Johnson.

"This is very good news," European Commission president Ursula von der Leyen said in a statement. "It gives member states room to manoeuvre and possibly fill gaps in deliveries."

Overall, the EU has signed contracts for up to 2.3 billion doses – enough to vaccinate its population several times over – but fierce global competition and struggles to rapidly increase manufacturing capacity have led to delivery delays, particularly in AstraZeneca vaccines.