London: Europe’s drug regulator says it is “firmly convinced” the benefits of the AstraZeneca vaccine far outweigh any risks, as it attempts to head off an unproven and highly damaging suspicion that the jab may cause blood clots.
European Medicines Agency executive director Emer Cooke on Tuesday took a swipe at the growing list of countries suspending use of the vaccine, noting thousands of people are still dying every day from COVID-19.
Cooke, whose agency approved the Oxford-AstraZeneca jab for use across the European Union, stressed there was still no evidence that it caused clotting and feared the speculation would damage crucial public confidence.
“We are worried that there may be an effect on the trust in the vaccines,” she said.
Germany, France, Italy, Bulgaria, the Netherlands, Spain, Sweden, Denmark, Norway, Iceland and Ireland have paused the AstraZeneca rollout while the EMA examines reports of blood clots in a very small number of recently inoculated people.
Asked why the countries had ignored the EMA’s assurances that the vaccine was safe, Cooke replied: “It is the countries’ prerogative to do so. It is our responsibility to focus on the science associated with these risks and whether there is scientific evidence to show that they are causally related to the vaccines, and that’s what we are doing.”
The EMA is investigating the cases and any potential link to the AstraZeneca vaccine and will announce its final conclusion on Thursday. However, Cooke’s strong statement on Tuesday suggests the regulator’s views are unlikely to change over the next 48 hours.
Cooke said as of March 10 there were just 30 suspected cases among 5 million people vaccinated.
The number of thromboembolic events in vaccinated people “seems not to be higher” than the rates seen in the unvaccinated population, she said.
Germany’s Health Ministry on Tuesday said seven out of 1.6 million people given the AstraZeneca shot had experienced cerebral clotting. The ministry claimed that was higher than the 1 to 1.4 cases that would normally be expected in such a population sample over a similar stretch of time.
Many EU countries are experiencing a third wave of infections fuelled by more transmissible coronavirus variants and aided by the bloc’s sluggish vaccine rollout.
Only 11.3 doses for every 100 people have been administered in the EU compared to 38.4 in the UK.
“While the investigation is ongoing, we are still firmly convinced the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risk of hospitalisation and death outweigh the risks of these side-effects,” Cooke said.
“Thousands of people are dying across the EU every day.”
Experts fear the dramatic suspensions will cost lives and further undermine confidence in AstraZeneca, which had already taken a reputation hit following untruthful claims by some political leaders and newspapers.
Belgium’s Health Minister Frank Vandenbroucke said his country would continue to use the vaccine: “When you know the virus is making the rounds, it would be very imprudent to stop.”
The United Kingdom also backed AstraZeneca and said there was no evidence it has caused any unusual blood clotting amongst the tens of millions of citizens who have received the product.
Australia’s Chief Medical Officer Professor Paul Kelly said on Tuesday, local time, that he was confident the vaccine was safe. AstraZeneca’s 54 million doses will form the bulk of Australia’s COVID-19 vaccine rollout.
If the EMA makes a link between the clots and vaccine this Thursday, the regulator could decide that the risk is so small that the only action needed might be to update the product’s medical warnings or screen patients with certain conditions to make sure they are not administered that particular vaccine.
Cooke also dismissed claims the blood clots might be linked to a problem with a particular batch of vaccines.
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