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]"
"The committee will be looking at clinical trial results, it will be looking at the epidemiolgocial evidence, ie how many blood clots we would expect to see in the European population, seven days, and 14 days after vaccination"
• • •
Missing some Tweet in this thread? You can try to
force a refresh
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..."
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.
BREAKING: The EU will take legal action today against the UK over its unilateral move to change the terms of the Northern Ireland Protocol, @rtenews understands.
2/ The European Commission will issue legal proceedings through two letters to the British government, following its decision on March 3 to unilaterally extend grace periods which eased the full implementation of the Protocol.
3/ There will be a letter of formal notice, triggering an infringement procedure due to an alleged breach of EU law, and what sources describe as a second “political” letter, alleging a breach of the good faith provisions of the Brexit Withdrawal Agreement.
The European Parliament has postponed a decision on ratifying the EU UK free trade agreement in protest at the UK’s unilateral move on how the Northern Ireland Protocol should be implemented.
2/ The Trade and Cooperation Agreement (TCA) was concluded by the EU and UK on December 24, but it has only been applied provisionally because of a lack of time for both member states and the European Parliament to follow ratification procedures.
3/ The European Parliament was expected to finally ratify the treaty on March 24.
However, according to sources, senior officials in the parliament have decided to delay a decision on when to ratify the TCA.