Worth noting by Sandra Gallina, EU's chief vaccine negotiator: last year the Commission entered advanced purchase agreements with pharma companies, ie buying doses of vaccines which did not yet exist.
2/ In order to conclude the contract the pharma companies needed a commitment of a certain amount of doses, ie an incentive to research + produce, so they would need a commitment to produce 300m doses for example
3/ However, as the negotiator, the European Commission needed to be sure the doses were being bought by member states. At the beginning, member states had to decide whether to stay in or out of the programme.
4/ Member states had to collectively decide if they could stay in only on the basis of a pro-rata distribution, ie did they have to keep all doses on the basis of population? Or could they stay in the programme and get fewer doses than pro-rata?
5/ Gallina says the trend last year among member states was to have fewer doses than pro-rata, again, because they were committing money to vaccines that did not yet exist.
6/ It was then agreed that other member states could "soak up" the excess doses gather from those member states who were taking fewer doses than their pro-rata allocation
7/ Gallina says this was an example of the principle of solidarity: ie, some member states would pay more to pick up extra doses of vaccines that did not yet exist
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Ireland's Minister for Foreign Affairs @simoncoveney says if the UK delivers a clear road map setting out how it will implement the NI Protocol, then the atmosphere would change and the EU would be in a position to “look at” flexibilities and extensions to grace periods.
2/ Coveney was speaking in Brussels after meeting the European Commission vice president @MarosSefcovic, co-chair of the EU-UK Joint Committee.
Mr Coveney said there had been contacts between EU and UK officials with a view to resuming more formal talks around the Protocol
3/ “I think certainly the EU side wants to get a process underway again so that both sides are talking to each other,” he told @rtenews
Peter Arlett EMA: "If we look at what we would expect in the European population for thromboembolic events the number of reported events is far lower than we would expect in the background population
"The review is focusing on a small number of case reports of very rare + rather unusual thrombotic events, including thrombosis combined with thrombocytopenia. When you get down to individual cases,1, 2, 3 or 4 cases - then the epidemiological approach becomes much more difficult
"firstly it becomes difficult to get the background rates, there is less published in the literature, there is less available in electronic health care databases, therefore the focus is much more on looking at the clinical features of the individual reported case..."
Peter Arlett, head of EMA pharmacovigilance and epidemiology: With these vaccines we had very large clinical trials which gave very good evidence they were safe.
"Once the product gets on market you use the vaccine in far, far greater numbers and we therefore put in place lots of measures to ensure we're colleting date very quickly"
"In addition we are putting in place real world data studies which are extremely useful, they tell us the background rates of certain rare events, including thromboembolic events [blood clots etc]"
NEW: European Medicines Agency (EMA) says it continues to evaluate data on blood clot concerns related to AstraZeneca, and any additional possible side effects, and has pulled in experts on blood clots. "It's an ongoing process," according to director Emer Cooke
[Blood clot] events have occurred in a very small number of people - Cooke. EMA has called on expert committee to establish if there has been a causal relationship between blod clots + AZ vaccine
EMA is evaluating each reported incident on a case by case basis
“We have received the letters from the European Commission and will respond in due course.
2/ “We’ve been clear that the measures we have taken are temporary, operational steps intended to minimise disruption in NI and protect the everyday lives of the people living there. They are lawful and part of a progressive and good faith implementation of the NI Protocol.
3/ “Low key operational measures like these are well precedented and common in the early days of major international treaties. In some areas, the EU also seems to need time to implement the detail of our agreements.
The European Commission has formally taken legal action against the UK for what it describes as a “deliberate” breach of international law over its unilateral action on the Northern Ireland Protocol.
2/ In a strongly worded letter to @DavidGHFrost Commission vice-president @MarosSefcovic accused London of unilaterally departing from the rules of the Protocol, and of not implementing the measures agreed by both sides.
3/ Šefčovic said: “The UK has resorted to this unilateral action without any discussion or consultation with the EU side in the bodies established by the [Withdrawal] Agreement.