France, Italy and Germany have announced plans to resume AstraZeneca coronavirus vaccinations after Europe’s drug regulator said the vaccine was not linked to an overall increased risk of blood clots, and that the benefits of use outweighed the risks.
The European Medicines Agency (EMA) also said it had found no quality or batch issues with the vaccine. Concerns over the blood clots led more than a dozen European countries to suspend the use of the vaccine over the past week.
Emer Cooke, head of the EMA, said the agency “cannot rule out definitively a link” between rare types of blood clots and the vaccine. The EMA recommended adding a description of these cases to the vaccine leaflets so health workers and patients would be aware.
“Our scientific position is that this vaccine is a safe and effective option to protect citizens against COVID-19,” Ms Cooke said.
The agency has been under growing pressure to clear up safety concerns after a small number of reports in recent weeks of bleeding, blood clots and low platelet counts in people who received the shot.
Blood clots have been reported in at least 37 people, with four deaths recorded from more than 45 million who have received at least one dose of the AstraZeneca vaccine in the European Economic Area (EEA).
The agency’s review, covering 5 million people, included 30 cases of unusual blood disorders in people in the EEA, which links 30 European countries.
Italy, France to resume vaccination rollout
At least 13 European countries, including France and Germany stopped administering the shot pending the review.
On 18th March, Italy became the first to announce it was resuming its rollout of the AstraZeneca, followed by France and Germany. In a news conference, Prime Minister Jean Castex said France would resume inoculations now that the European Medicines Agency had confirmed it was safe.
British Prime Minister Boris Johnson said he would also be receiving his vaccination on 19th March.
Germany’s Health Minister Jens Spahn confirmed on Thursday (local time) that the country was set to resume administering AstraZeneca vaccines on Friday. Mr Spahn said the move to previously suspend the vaccinations was the correct one.
Spain, Portugal and the Netherlands said they would also resume AstraZeneca vaccinations this week.
UK regulator also backs vaccine
Millions of people in the UK have already received at least one dose of the AstraZeneca vaccine.
Britain’s medicines regulator said it was investigating five cases of CVST among recipients, but reaffirmed that the benefits far outweighed any possible risks.
The World Health Organization also this week reaffirmed its support for the shot. Many governments have said the decision to pause inoculations was made out of an abundance of caution.
But experts have warned the political interference could undermine public confidence and hobble the bloc’s slow vaccination campaign as governments struggle to tame more infectious variants. The bloc’s vaccine roll-out has lagged the United States and former EU member Britain.
In Australia, the federal government says the rollout of the AstraZeneca vaccine will continue.