Addressing a press conference on Tuesday, Cooke said that a “very thorough” analysis of all reported cases linking possible blood clots to people who have had the AstraZeneca jab were now being investigated by the EMA’s expert committee.
She said, “Trust in the safety and efficacy of vaccines authorised by us is paramount and we must maintain trust in these vaccines. This is why we have put such high priority on this [investigation].”
The results of the EMA’s deliberations are expected on Thursday, she told reporters. The EMA risk assessment committee comprises national experts from each Member State.
Cooke also downplayed concerns that the decision by some Member States to suspend the use of the vaccine had been politically motivated, saying, “The implication is that this might be guided by other motives so I want to firmly put on record that our evaluation at the EMA is guided by science and nothing else.”
The World Health Organization has urged countries not to halt vaccinations and both the EMA’s expert committee and vaccine safety experts from the WHO met on Tuesday to review the Oxford-AstraZeneca jab.
AstraZeneca says a review of 17 million people who received doses in Europe found there were 37 cases of people who had developed blood clots.
Cooke said the number of blood clots reported in vaccinated people is no higher than that seen in the general population.
“I am worried that, maybe, there will be an effect on the trust in vaccines, but our job at the EMA is to ensure that any product we authorise for use is safe and can be trusted by citizens”
Emer Cooke, European Medicines Agency Executive Director
But she conceded trust in vaccines could diminish as a result of the current probe.
She said, “I am worried that, maybe, there will be an effect on the trust in vaccines, but our job at the EMA is to ensure that any product we authorise for use is safe and can be trusted by citizens.”
She added, “I am convinced that the benefits of this particular vaccine outweigh the risks.”
She said the agency was “seeing more events” [of reported blood clots in vaccinated patients] being reported, adding, “we are looking at events across the EU but the focus of our review now is on the AstraZeneca vaccine.”
“If similar events come in about other vaccines then we will do the same with these.”
She said, “It should not be unexpected, when millions of people have been vaccinated, to have such rare events, but we have to ask: is this a real side effect to the vaccine or a coincidence?”
“Blood clots have occurred in a very small number of people who had this vaccine but many thousands of people develop blood clots for many different reasons all the time and our expert committee wants to find out if there is a causal link or not.”
“Blood clots have occurred in a very small number of people who had this vaccine but many thousands of people develop blood clots for many different reasons all the time and our expert committee wants to find out if there is a causal link or not” Emer Cooke, European Medicines Agency Executive Director
“This requires a rigorous analysis of all the data in order to see if the vaccine contributed to these side events [blood clots] or if it is due to other causes. We will evaluate each incident on a case by case basis with all surrounding information.”
“You have to remember that these vaccines help protect people from becoming ill and this is a very important to consider. If, however, anyone has had the vaccine and has concerns they should contact their healthcare professional.”
She added, “Thousands are dying in Europe daily and the four vaccines we have approved are highly effective. These blood clots are very rare events and we will evaluate them.”
“The EMA is taking this very, very seriously and we are also looking at all events associated with all vaccines in circulation. We are also looking at the storage conditions for these vaccines.”
She said the decision to suspend use of the vaccine had been taken at national level “and that is their prerogative,” adding, “our responsibility is to focus on the science and to establish if there is any scientific evidence that there is a causal effect and if these side effects are related to the vaccine.”
“There will be a thorough analysis of all reported cases. This is a serious and needs a serious, detailed scientific evaluation.”
Asked what might happen if a link is found, Cooke said, “there are a large number of options available to us that are possible, but I don’t want to speculate on what the final conclusions might be. The aim is to ensure all vaccines can be used safety but, if necessary, it might be that an additional warning is given. But all this depends on the outcome of our expert evaluation.”
“If a cause is found then have to ask a how best to manage it and my understanding is that Member States are awaiting the outcome of our analysis before deciding what action to take. But these vaccines have very high levels of efficacy.”
“Today, I am not in a position to say what might happen. That is up to what the experts find.”