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AstraZeneca is 'safe and effective' vaccine, says EMA, paving way for Ireland to begin using it again

Head of the EMA Emer Cooke said that the vaccine is safe and the benefits outweigh the risks.

THE EUROPEAN MEDICINES Agency (EMA) has said that the AstraZeneca vaccine is safe and effective and that it is not associated with an increased risk of blood clots.

The agency held an extraordinary meeting today to finalise its conclusions on a small number of blood clotting events that were reported following vaccination.

Head of the EMA, Emer Cooke said that the vaccine is a safe and effective vaccine and that the benefits of vaccination outweigh the risks.

However, the EMA “cannot rule out definitively a link between these cases and the vaccine”. The EMA’s safety committee has instead decided to draw attention to the possible rare conditions by including details within the vaccines leaflets.

“What the committee has therefore recommended is to raise awareness of these possible risks, making sure that they are included in the product information,” said Cooke.

“Drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects.”

A number of countries across Europe, including Ireland, paused use of the vaccine in recent days following reports by the Norwegian Medicines Agency of serious events in four patients.

Officials in Ireland had said the decision to pause the use of the vaccine had been made on a precautionary principle.

Cooke said that the EMA was aware that EU member states had suspended vaccination while they awaited the EMA review.

Given that thousands of people in the EU die every day – in fact over 2,500 were reported one day last week – it really was crucial for EMA to review rapidly and thoroughly all the available evidence, so we made this review our highest priority

According to Cooke, the EMA worked closely with the UK’s health regulator the Medicines and Healthcare products Regulatory Agency (MHRA) during the rapid review.

“The scientific conclusions adopted today provide member states with the information they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaigns.”

World Health Organization experts yesterday recommended countries continue to use the AstraZeneca vaccine, but said they were looking into its safety.

Following the publication of the EMA review, Italy announced that it will resume administering the vaccine tomorrow. Health officials in Sweden said they need a “couple of days” to evaluate the ruling and the pause will remain in place for now. 

Ireland’s Health Products Regulatory Authority (HPRA) said in a statement this evening that close safety monitoring of reports of blood clotting disorders will continue, and further studies are underway to provide more laboratory data as well as analysis of further real-world evidence. 

It added that it has not received any reports of cases of these blood clots.

The MHRA said earlier today that available evidence does not suggest that blood clots in veins are caused by the AstraZeneca vaccine.

In a statement, the MHRA said that the advice remains that the benefits of the Covid-19 vaccines outweigh any risks and that people in the UK should continue to get their jab when it becomes available.

“Our review has found that the available evidence does not suggest that blood clots are caused by COVID-19 Vaccine AstraZeneca,” said Professor Sir Munir Pirmohamed, the Chair of the Commission on Human Medicines.

“We have been closely reviewing all reports of blood clots in the vein (venous thromboembolism, or VTE) following vaccination. There is no evidence either that VTE is occurring more often in people who have received the vaccine than in people who have not, for either vaccine.”

The WHO, the EMA and AstraZeneca itself have repeatedly said the vaccine is safe.

The HSE has said the National Immunisation Advisory Committee (NIAC) will assess the advice from the EMA and will issue guidance to the National Public Health Emergency Team (NPHET). NPHET will then make recommendations to the Minister for Health.

It is likely that these recommendations will include updated clinician and patient information in relation to these reported conditions and the symptoms associated with them.

HSE CEO Paul Reid said it will take “a period of days” to re-start the roll-out of the AstraZeneca vaccine in Ireland once fresh recommendations are issued from public health officials.

He said the health service will attempt to deliver the vaccines – around 30,000 jabs – that were delayed last week as soon as possible. A further 10,000 doses from AstraZeneca are due to be delivered to Ireland next week.

Speaking to reporters yesterday, Taoiseach Micheál Martin said that the HSE will “immediately endeavour” to restart vaccination with the AstraZeneca vaccine when the all-clear is received from the EMA.

“It will take some time, because obviously people have to be notified again, logistics have to be put in place and the venue has to be organised and so on,” said Martin.

“But we will be doing everything we possibly can to accelerate the vaccine, particularly for those who have had their vaccinations postponed as a result of the decision taken last weekend.”

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    Mute Tony Carlito
    Favourite Tony Carlito
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    Mar 31st 2013, 6:11 PM

    amazon is great, should be in ireland by now.. Some items from amazon.co.uk don’t deliver here or have high shipping costs..

    324
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    Mute thomas walsh
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    Mar 31st 2013, 6:40 PM

    Use the nightline courier and they give you a N.I address so if its free UK shipping you get that part of delivery free and they also allow delivery of anything that can be sent to the UK!!

    103
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    Mute Fergal Kelly
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    Mar 31st 2013, 6:54 PM

    Can you explain that a little more please? I don’t really get you x x x x

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    Mute Fergal Kelly
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    Mar 31st 2013, 6:55 PM

    Haha

    7
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    Mute Tony Carlito
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    Mar 31st 2013, 6:57 PM

    That’s what I don’t understand if they can deliver to the north they can’t deliver in the south when I only live an hours drive from the border..

    37
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    Mute thomas walsh
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    Mar 31st 2013, 6:59 PM

    This.should.answer all your questions…

    http://www.parcelmotel.com/faqs.html#

    48
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    Mute Nora Butler
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    Mar 31st 2013, 7:07 PM

    That’s a great idea!!

    19
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    Mute Barry
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    Mar 31st 2013, 7:20 PM

    parcelmotel.com and you;re sorted when it comes to delivery to Ireland :)

    25
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    Mute Carl Douglas
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    Apr 1st 2013, 2:45 AM

    ^
    is there an echo in here?

    6
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    Mute Stephen Doyle
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    Apr 1st 2013, 2:55 AM

    ^^Is there an echo in here?

    25
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    Mute Peter McKenna
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    Mar 31st 2013, 6:11 PM

    The desk made out of a door is now a badge of honour in Amazon. Employees who perform exceptionally well get to build their own desk from a door. When you walk around the office and see some mad looking desk, you know you’re dealing with someone who is excellent at their job.

    121
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    Mute Seán O'Sullivan
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    Apr 1st 2013, 12:33 AM

    Given the high employment and partnership ebay have with Ireland, I think you should be mor ebalanced in your coverage of online retailers

    13
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    Mute Mary Kavanagh
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    Mar 31st 2013, 6:28 PM

    Bit ironic, having an A to Z smiley when they won’t deliver half the stuff on offer to an Irish address.

    104
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    Mute Peter McKenna
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    Mar 31st 2013, 9:30 PM

    Check out Parcel Motel. They give you a UK address and deliver the parcels to you in Ireland.

    14
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    Mute Ciarán
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    Mar 31st 2013, 11:39 PM

    Its annoying as all hell when it happens but in their defence IIRC any sale that is direct from or fulfilled by Amazon.co.uk will be delivered to Ireland. However Amazon, much like other sites like play.com also acts as a store-front for smaller sellers who are allowed to set their own shipping terms. As Amazon is only getting commission on those sales they do not dictate the sellers shipping policies

    17
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    Mute Paul Wallace
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    Mar 31st 2013, 6:09 PM

    And they don’t pay tax in the UK

    95
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    Mute John Michael
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    Mar 31st 2013, 8:19 PM

    They also sold a book called ‘The paedophile’s guide to love and pleasure; a Child-lover’s code of conduct’. They have let their factory workers work in conditions bordering on slavery and have sacked workers, en-masse, because they attempted to unionise. I wonder if they sell a book about how they really operate.

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    Mute Richard Day
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    Mar 31st 2013, 9:35 PM

    And very little elsewhere. Boycott this behemoth. There is other smaller companies that need support.

    38
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    Mute Dave Fleming
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    Mar 31st 2013, 7:48 PM

    Hope they never, ever, ever set up shop here. There wouldn’t be a bookshop left in the country. Look at what Tesco have done and continue to do to small, independent retailers.

    65
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    Mute Barry O'Brien
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    Mar 31st 2013, 7:56 PM

    They do deliver books here. But I agree with your sentiment. I try to shop in local bookstores when I can, but sometimes they don’t have the books I want and to order them costs twice as much as amazon. If that’s the case then I do order from amazon, but only after trawling the local shops. I actually enjoy searching the number of shops for what I’m looking for because sometimes I come across books I wouldn’t have normally seen.

    18
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    Mute Thomas McGuire
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    Mar 31st 2013, 8:52 PM

    Nature of progress unfortunately, everything’s going digital download. Most stores are turning into storefronts for online retailers.

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    Mute Barry O'Brien
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    Mar 31st 2013, 10:24 PM

    I agree Thomas. And movies and music in digital format are very convenient. Some would say the same about kindle and ebooks but personally, even though I’m a total techie, still prefer printed books. I guess it may be that I spend so much time looking at a screen for work and in general!

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    Mute Stephen Doyle
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    Apr 1st 2013, 2:58 AM

    I green thumbed you. Not because of what you said, but because you sir, have excellent taste in profile pictures.

    4
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    Mute Jim Healy
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    Apr 1st 2013, 10:28 AM

    Too late for that. They already have offices in Cork and Dublin.

    4
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    Mute Michael Sullivan
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    Mar 31st 2013, 7:35 PM

    Another interesting fact that many people might not know is that they are one of the worst employers in Cork, who punish you with a point system if you are genuinely sick.

    http://www.politics.ie/forum/culture-community/206202-amazon-best-reason-support-your-local-bookshop-8.html#post6431477

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    Mute Jim Brady
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    Mar 31st 2013, 8:03 PM

    On any given Monday, 5% of teachers in Ireland are “genuinely” sick.
    Ive no idea what the same stats are for the self-employed, but I’d hazard a guess they are considerably lower.
    Amazon’s points system disincentives absenteeism, quite frankly I don’t take issue with it.

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    Mute Michael Sullivan
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    Mar 31st 2013, 10:36 PM

    Sure bud, I bet you’d agree with those conditions when your dying sick with the swine flu and get pointed as a result.

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    Mute Emily Elephant
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    Apr 1st 2013, 1:57 AM

    I heard that 40% of sick days taken by teachers are on Mondays and Fridays. Shocking.

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    Mute Aran Fitzpatrick
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    Mar 31st 2013, 6:37 PM
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    Mute Adam Martin
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    Mar 31st 2013, 6:31 PM

    I knew all those things. Just because the majority of your readers are brainless sheep then don’t presume that we all are.

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    Mute Ed Mooney
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    Mar 31st 2013, 6:37 PM

    On behalf of all sheep, Get over yourself!

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    Mute sean o reilly
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    Mar 31st 2013, 6:54 PM

    Baa

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    Mute jim melia
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    Mar 31st 2013, 7:12 PM

    I’d say you’re great craic Adam.

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    Mute Thomas McGuire
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    Mar 31st 2013, 8:41 PM

    Have you applied to Mensa yet?

    34
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    Mute Little Jim
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    Apr 1st 2013, 12:05 AM

    Moo

    14
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    Mute Little Jim
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    Apr 1st 2013, 12:06 AM

    Dammit.!!!

    10
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    Mute Denzil
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    Mar 31st 2013, 6:18 PM

    Slow news day?

    12
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    Mute Padraig Stapleton
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    Mar 31st 2013, 8:28 PM

    There’s always one….

    47
    Dave
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    Mute Dave
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    Apr 1st 2013, 2:33 AM

    I’ve never bought anything on amazon. So there you go

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    Mute Wastrel
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    Apr 1st 2013, 5:33 AM

    Thanks for the informative article, amazonpublicrelations.ie

    5
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    Mute Mark osullivan
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    Apr 1st 2013, 1:17 AM

    Awesome company. I have had 3 kindles smash due to my own clumsiness and every time they have sent me new ones free of charge including delivery.

    5
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    Mute Niall Dooley
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    Apr 1st 2013, 11:28 AM

    That’s because they don’t make money from the devices but the content that you will buy.

    8
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    Mute Paddy O'Reilly
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    Apr 1st 2013, 1:44 PM

    You forgot to mention how Amazon almost power most of the internet with their Amazon Web Services. Lots of popular internet services live on top of Amazon, e.g. Foursquare, Netflix etc. And that Dublin in the European home for these services with multiple Amazon data enters around the capital.

    3
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    Mute Niall Dooley
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    Apr 1st 2013, 11:29 AM

    What most people don’t know

    http://www.stallman.org/amazon.html

    2
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    Mute Janine Torell Galvin
    Favourite Janine Torell Galvin
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    Apr 1st 2013, 12:32 PM
    2
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    Mute Alan McNamara
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    Mar 31st 2013, 11:13 PM

    You can’t use your amazon.com gift card balance on amazon.co.uk which means you end up paying higher shipping costs, customs fees and duty and you’ll be waiting longer to get it.

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    Mute Seamus McGinty
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    Apr 1st 2013, 7:47 PM

    I thought it was a river.

    1
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    Mute Seán O'Sullivan
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    Apr 1st 2013, 12:34 AM

    Given the high employment and partnership ebay have with Ireland, I think you should be more
    balanced in your coverage of online retailers

    1
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    Mute Stephen Doyle
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    Apr 1st 2013, 2:52 AM

    Yes, we heard you the first time.

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    Mute Paul Laffan
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    Apr 2nd 2013, 9:21 AM

    Use ParcelHotel

    1
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