Several countries, including Sweden, have temporarily suspended the use of Astra Zeneca's coronavine vaccine since reports of various blood clots and bleeding.
On Tuesday, the head of the European Medicines Agency reiterated what both the EMA and the WHO have previously said, that there is no evidence that Astra Zeneca's covid-19 vaccine causes blood clots.
"Unusual and serious incidents"
The situation around the Swedish-British vaccine is not really unexpected, according to Emer Cooke.
- When vaccinating millions of people, it is inevitable that you have unusual and serious incidents that occur after vaccination.
Our task is to evaluate this so that we can see if it is really side effects or just coincidences, she says.
- We continue to evaluate.
We continue to receive information.
We have called in experts.
This is an ongoing process.
Cooke also stressed that the reported cases of blood clots after vaccination are rare.
- The benefits continue to outweigh the risks, even though we are seriously concerned.
During the press conference held via the web from Amsterdam, Cooke described the ongoing safety investigation as a thorough review, which also includes reviewing specific batches of the vaccine.
The authority has also called in extra staff to speed up the investigation of the side effects.
Notice is expected this week
The EMA chief did not want to answer the question of whether it is right or wrong for some Member States to suspend vaccination for the time being.
- The decision at national level is made on the basis of the information available nationally.
It is up to the countries to do so.
Our responsibility is to focus on science.
We need to do a thorough analysis of all cases to determine if they are coincidences or a side effect, says Cooke.
The authority is expected to present the results of the investigation in the near future.
On Thursday, it is intended that the EMA will make a decision if any further action is needed.