"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.
"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."
"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."
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."
“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."

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More from @NaomiOhReally

17 Mar
Ursula von der Leyen says the EU has exported 44 million vaccine doses to 33 countries, and some countries that are receiving EU vaccines have blocked exports in the other direction (eg US).
The EU will evaluate whether to make exports conditional on reciprocity, she says...
In addition, the EU will evaluate whether to curb exports "to countries that have higher vaccination rates than us", European Commission President Ursula von der Leyen announces.
Figures for EU vaccine deliveries from von der Leyen:
100 million in Q1 (Pfizer and Moderna as expected, AstraZeneca cut from 90mln to 30mln)
In Q2:
- 55 mln Johnson & Johnson
- 200 mln Pfizer (an increase)
- 30 mln Moderna
- 70 mln AstraZeneca (down from 180 mln)
Read 5 tweets
15 Mar
EMA says AstraZeneca benefits outweigh risks as more countries pause use of vaccine.
"The decision in Ireland has been driven by an abundance of caution," said @Paschald.
"I believe the right decision has been made." irishtimes.com/news/world/eur…
The EMA says it has been working with blood disorder experts, AstraZeneca and national regulators including Britain's to analyse the blood clotting incidents.
They are set to release conclusions on Thursday. Pending that, some national regulators made the decision to pause.
Authorities in Germany and Norway say the blood clotting rare, but there was a cluster in both countries of a specific unusual type.
This is what prompted regulators including Ireland's to pause AstraZeneca as a precaution.
Germany's regulator explains: pei.de/EN/newsroom/hp… Image
Read 4 tweets
23 Feb
AstraZeneca expects to deliver less than half of contracted second-quarter vaccines to EU -- a shortfall already taken into account that does not affect Ireland's vaccination schedule irishtimes.com/news/world/eur…
Looks like this Reuters report was old news that EU governments already knew about.
Came out at an unfortunate time for Ireland, muddying the announcement of the national vaccination schedule.
The European Commission tells me talks with Astrazeneca are ongoing and it expects deliveries to revised up, potentially by tapping production sources outside of Europe.
As it stands, Ireland expects to give 82% of adults at least one jab by end June irishtimes.com/news/world/eur…
Read 5 tweets
20 Feb
Israeli forces have destroyed Irish aid donated to Palestinian families in repeat demolitions of a village in the West Bank.
My story here: irishtimes.com/news/world/eur…
📷 @NRC_Norway and @btselem
In the last three months in the village of Humsah -- home to roughly a dozen families who raise sheep and goats -- Israeli forces have destroyed almost 70 structures donated by the EU and members states as humanitarian aid, according to the European Commission.
This Tuesday, the Israeli army broke up and seized shelters that had just been donated as EU aid in front of a group of diplomats from donor countries who were visiting the spot.
This happened after the EU and Ireland had issued statements condemning demolitions in the village.
Read 6 tweets
18 Feb
CNN reports the UK's contract with Astrazeneca was actually also signed in August - like the EU's just one day prior - and uses the same 'best efforts' language.
It goes against the reasoning for prioritising UK deliveries given by its CEO in an interview amp.cnn.com/cnn/2021/02/17…
It helps us understand why the EU reacted so dramatically to that interview by Pascal Soriot. The contract also said EU factories would supply the UK, contrary to the claim of separate supply chains he put forth. But we still don't understand why Astrazeneca took this approach.
The EU is now working on new contracts for booster vaccines tweaked for Covid variants.
Pfizer and Moderna clearly first in line - mRNA can be updated fast, and von der Leyen said yesterday it makes sense to work with existing contractors and experience with "most" had been good.
Read 4 tweets
15 Feb
Research indicates mental health conditions are a major risk factor for Covid-19.
People with conditions like schizophrenia, bipolar disorder, or depression with psychosis were seven times more likely to catch Covid-19, and had double the death rate.
irishtimes.com/life-and-style…
This is reflected in vaccine priority in the UK, where severe mental illness such as schizophrenia is included as among the "underlying health conditions which put them at higher risk of serious disease and mortality".
They are next in line for vaccines after the over-65s. ImageImage
However, in Ireland's vaccine allocation groups, no mental illnesses are included among the listed medical conditions deemed to put people at high risk of severe disease.
gov.ie/en/publication… ImageImage
Read 5 tweets

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