"We need to have the facts first, we cannot come to a conclusion until we have done a thorough scientific analysis," says the European Medicine Agency chief Emer Cooke. "We owe it to our citizens."
Safety committee met all last week, and received extra info it is examining today.
Safety committee met all last week, and received extra info it is examining today.
"A situation like this is not unexpected," EMA's Emer Cooke says, "when you vaccinate millions of people it’s inevitable" that there will be cases of illness.
The role of the EMA is to figure out "is it a real side effect of the vaccine, or is it a coincidence."
The role of the EMA is to figure out "is it a real side effect of the vaccine, or is it a coincidence."
"Vaccines for Covid-19 help to protect individuals from becoming ill," EMA's Cooke says.
"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."
"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."
Asked whether national regulators were wrong to suspend, Cooke says she can only answer that when the evaluation concludes.
"Our position is that the benefits continue to outweigh the risks, but this is a serious concern and it does need serious scientific evaluation."
"Our position is that the benefits continue to outweigh the risks, but this is a serious concern and it does need serious scientific evaluation."
“We are worried that there may be an effect on the trust of the vaccines, but our role is to make sure that the products that we authorised are safe and can be trusted by European citizens," EMA chief Emer Cooke says.
EMA at this point "cannot rule out" that something in the manufacturing process could have a role, but at this point "it’s unlikely" that events are related to specific batches of AstraZeneca, Cooke says, because as more reports come in it's clear they involve different batches.
The initial figure of 30 cases of blood clots in 5mln people vaccinated with AstraZeneca that was given by the EMA is not correct, Emer Cooke says, as additional reports are being received "as we speak" and increased reporting has been prompted by the review, as you would expect.
EMA's Emer Cooke firmly rejects suggestion that review of AstraZeneca is political, when asked to respond to allegations of a deliberate attempt to undermine trust in the vaccine.
"Our evaluation is guided by science and independence and nothing but."
"Our evaluation is guided by science and independence and nothing but."
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