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J&J vaccine to be approved today - but will supply issues hamper Ireland's progress?

The government has been told initial supplies in April and May will be smaller, with the majority of doses arriving in June.

THE EUROPEAN MEDICINES Agency is expected to give the green light to Johnson & Johnson’s one-dose Covid-19 vaccine today, but this latest ‘game-changer’ jab may also find it difficult to meet EU supply expectations next month.

Because of its one-dose regime and the fact that it can be stored at fridge temperatures – as well as high efficacy results in trials – governments across the EU have been eagerly awaiting its approval as they struggle to roll-out vaccinations on a large scale. 

This week HSE CEO Paul Reid said 3.8 million vaccine doses are expected to be delivered to Ireland in Q2, including the 600,000 Johnson & Johnson doses. 

The health service has been challenged in the roll-out by unexpected delivery shortfalls from all three manufacturers with EU-approved vaccines. Reid acknowledged that there have been up to 17 changes to vaccine plans so far due to these supply issues, as well as sequencing adjustments.

Now it appears an 18th change is on the horizon, as the bulk of Johnson & Johnson’s deliveries are now not expected to arrive in Ireland until June. 

This week Reuters reported that Johnson & Johnson has told the European Union it is facing supply issues that may impact on its ability to deliver the level of vaccines expected in the EU in the second quarter of this year.

It is reported that the company told the EU that issues with the supply vaccine ingredients and equipment means it was “under stress” to meet its goal of delivering 55 million doses by the end of June. An EU official said the company had stated it was not impossible to meet the goal, but it showed caution.

Speaking to RTÉ’s News at One yesterday, Tánaiste Leo Varadkar said he knows the “slippage on timelines” has been frustrating for people and “undermines confidence”.

Varadkar said the information the government has is that while Johnson & Johnson will be able to provide the 600,000 doses as promised in the second quarter of the year, a significant percentage will not arrive into the country until June. 

“Instead of it arriving in equal amounts in April, May and June, we now anticipate that there will be a relatively small amount arriving in April and then more in May and then the bulk of it in June,” he said. “So it’s the same amount, but it is a further delay unfortunately.”

In a statement in response to reports of supply issues, Johnson & Johnson said it has been “working directly with governments, health authorities and other companies to help end this pandemic”.

“To achieve our ambitious goals to deliver our Covid-19 vaccine candidate, we have focused on building a global supply network in parallel,” the firm said.

“We continue to start-up and activate new manufacturing sites as quickly as possible, such as the collaborations with Catalent, Reig Jofre and Sanofi Pasteur.

“As part of our commitment to transparency, we intend to provide another update to the European Commission and member states on our supply during our next meeting mid-March when the European Union Vaccine Steering Committee meets again.”

The company said it had reaffirmed its commitment, at the meeting with members of the EU vaccine steering committee last week, to deliver 200 million doses of the vaccine to the EU this year, starting in the second quarter. 

Thierry Breton, the EU industry commissioner, has said the bloc is now on target to receive 100 million doses in each of the next three months, and possible further hiccups have been “integrated” into the planning.

“I forced companies to have many, many (contingency) actions in case something could go wrong,” Breton said.

He added that reported production shortfalls in the United States by Johnson & Johnson would not impact the EU’s outlook.

“Do not believe that because one company has a problem that overall it will jeopardise the whole programme. This is why it’s good to have today – or let’s say tomorrow – hopefully four vaccines to go, and soon five,” he said.

What we know about the J&J vaccine

The Johnson and Johnson vaccine uses viral vector technology – the same approach as the Oxford/AstraZeneca vaccine. Viral vector vaccines use a modified version of a different virus – the vector – to deliver instructions to human cells.

The Johnson and Johnson vaccine uses a common cold-causing adenovirus which has been modified so it cannot replicate.

This ‘vector’ virus tells human cells to create the spike protein of the coronavirus. It prepares the immune system, training it to respond when it does come across SARS-CoV-2, the virus that causes Covid-19.

Unlike the two-dose vaccines we’re using currently, this vaccine only requires one dose. The vaccine can also be stored at fridge temperatures which opens it up to use in settings like GP surgeries, pharmacies and mass vaccination centres.

The manufacturer has said that its large Phase 3 trial included “significant representation” from those who are over the age of 60. The EMA, on approval of the vaccine, will provide guidance to member states on the use of this vaccine in specific age cohorts.

In large clinical trials, the vaccine’s efficacy against severe disease was 85.9% in the US, 81.7% in South Africa and 87.6% in Brazil. 

What the supply issues mean for Ireland

This vaccine was only due to make up about 15% of Ireland’s overall stocks in the second quarter of the year, so these shortfalls are not likely to have a catastrophic impact on the vaccination programme.

However the health service has been making plans based on the assumption that it would have access to large supplies in Q2 of a one-dose vaccine that could be used in community settings as it ramps up the programme. These supply issues may mean another reshuffle of the plans. 

Yesterday the Tánaiste said despite supply issues, the government still expects “roughly a million [doses] or just under” in April, 1.25 million May and 1.68 million June.

“This does come with a health warning that deliveries are out of our control and schedules change regularly,” he added.

When asked about the impact of potential shortages, the HSE said as the Johnson & Johnson vaccine has yet to receive EMA approval “we are awaiting confirmation of forecast delivery dates and volumes”.

“The HSE is putting plans in place in the event of EMA approval to ensure the swift distribution of the vaccine, if and when it is made available.”

- With reporting from AFP. 

 

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    Mute AL
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    Mar 11th 2021, 12:44 AM

    We are the 14th fastest country in the world in rolling out this vaccine. Every supply that has come in has been given out very efficiently. No other country has spare doses yet and won’t have for some time. I cannot understand how people are giving out about the rollout.

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    Mute bmul
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    Mar 11th 2021, 12:49 AM

    @AL: because they are only looking at the uk .

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    Mute Paul Furey
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    Mar 11th 2021, 1:10 AM

    @AL: because the main core of journal whingers don’t deal in facts only emotions. Incidentally this was how brexit was voted in. Emotions…not facts! We’re in a bit of a twisted world these days.

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    Mute Asid
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    Mar 11th 2021, 3:57 AM

    @Paul Furey: you are deluded

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    Mute Tommy Roche
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    Mar 11th 2021, 4:30 AM

    @Asid: You’ve just commented on the article previous to this, saying that TV programs are called Programs because they are designed to program our brains. You also trotted out the loon mantra of ‘Go educate yourself before it’s too late”. And you have the neck to call someone else deluded ?

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    Mute Viv Forde
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    Mar 11th 2021, 4:57 AM

    @AL: I can understand people’s frustration. I’m frustrated. Only 3% fully vaccinated in almost 3 months. I can’t work a fourth wave.

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    Mute artur fil
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    Mar 11th 2021, 7:09 AM

    @AL: No Ireland is 34th at the moment where did you get 14 figure?

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    Mute D. Memery
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    Mar 11th 2021, 7:25 AM

    @Aileen Lawlor: I would call it efficient, the vacinnes the HSE have are distributed quickly and efficiently. The problem though, as you yourself have outlined, isn’t efficiency, it’s communications. We have been promised so much vacinnatiins within a given time frame and the HSE and politicians come on the airwaves giving the most optimistic projections of the data meaning they constantly under-deliver. Expectation management is not existent.

    24
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    Mute Damo
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    Mar 11th 2021, 8:05 AM

    @Paul Furey: Paul you are biggest whinger on the Journal, constantly putting people down for having an opinion

    25
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    Mute sean o'dhubhghaill
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    Mar 11th 2021, 8:14 AM

    @artur fil: Where did you get ’34th’? And could you give a link, please?

    4
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    Mute Betty Doran
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    Mar 11th 2021, 8:25 AM

    @AL: People, like myself, are “giving out” because of all the mixed messages being aired by this government. As a senior citizen I have been locked down for a year and have had my hopes raised on several occasions by statements on vaccine roll out only to be plunged back into despair. I think this kind of bungling is doing more for the deterioration of people’s mental health than anything else. Oh to have a strong government who have the peoples well being as a priority.

    28
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    Mute Jim Buckley Barrett
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    Mar 11th 2021, 8:26 AM

    @Tommy Roche: actually Tom, I was reading a book yesterday that did provide examples where radio and TV shows were used to influence the behaviour of people.

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    Mute Jim Buckley Barrett
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    Mar 11th 2021, 8:31 AM

    @bmul: AZ and UK dealing smells rotten, it wouldn’t surprise me to find out that AZ shipped stock from EU before brexit, violating the principles of the EU agreement.

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    Mute artur fil
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    Mar 11th 2021, 8:33 AM

    @sean o’dhubhghaill:
    https://www.howmanyvaccinated.com/stats/country
    7.56% which makes Ireland 30th at this moment so very far from 14th. Considering some Eu countries got russian vaccine probably we going to see some big changes soon

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    Mute WiseUp
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    Mar 11th 2021, 8:39 AM

    @AL: Thanks Al, so refreshing to read a comment that is actually correct and gives a proper and fair overview of what is happening and the lay of the land!

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    Mute WiseUp
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    Mar 11th 2021, 8:42 AM

    @Tommy Roche: Brilliant Tommy, so glad to see someone calling BS and looney commentary for what it is. These people have to be called out for the rubbish they spout. Thank you.

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    Mute DJ François
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    Mar 11th 2021, 8:45 AM

    @Asid:lay off the acid

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    Mute Dan Jacobson
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    Mar 11th 2021, 9:11 AM

    @Asid: careful, you’ll disturb the Journal’s SF Propaganda team.

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    Mute AL
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    Mar 11th 2021, 9:26 AM

    @artur fil: I got 14th from another site which excludes countries with very small populations like Gibraltar, Monaco, Seychelles, Faroe Islands etc. Also 4 areas of uk is put together as one. https://youtu.be/_MzBmOURnB8

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    Mute Conor Egan
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    Mar 11th 2021, 9:30 AM

    @artur fil: that list is all over the place. It says Oman are 10th but only have 1.48% vaccinated.

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    Mute AL
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    Mar 11th 2021, 9:38 AM

    @Conor Egan: yeah that list is very good for the actual numbers but the order is not correct and I think including tiny places like Gibraltar at top spot is misleading

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    Mute artur fil
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    Mar 11th 2021, 10:30 AM

    @Conor Egan: I did calculations using % so Ireland is 30th. Few EU countries purchased additional vaccination outside of EU so this will change soon. I can see already how Hungary going up on that list I think they started using russian vaccine 2 weeks ago.

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    Mute sean o'dhubhghaill
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    Mar 11th 2021, 5:19 PM

    @artur fil: Have you checked the link? Some of the ‘countries’ above us are not independent countries, and at least 2 of the countries ‘above’ us have lower percentages than us! So not really reliable!

    1
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    Mute John Fairclough
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    Mar 11th 2021, 12:25 AM

    Leo says that they are going to vaccinate the Protestants first, according to Sinn Féin

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    Mute Paul Mc
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    Mar 11th 2021, 12:43 AM

    Tomorrow is another day and tomorrow we will get a new figure plucked out of someones wishful thinking.

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    Mute Robert Clifford
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    Mar 11th 2021, 12:08 AM

    As sure as night follows day.

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    Mute Brian Madden
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    Mar 11th 2021, 12:16 AM

    @Robert Clifford: I am second last on the list to be vaccinated. Initially it was hoped I may get vaccinated by the end of june but that won’t happen. I will be lucky to have it by christmas.

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    Mute bmul
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    Mar 11th 2021, 12:21 AM

    @Brian Madden: massive amount of vaccines coming on line in July .

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    Mute Brian Madden
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    Mar 11th 2021, 12:28 AM

    @bmul: they keep saying that and then it all changes. I live alone and spend the majority of the day in the house. I go out for a walk and pop to the supermarket and that’s about it. No personal interaction whatsoever. I’m not doing too bad at all but we need to get shots in our arms so we can open up and start to re-live our lives.

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    Mute bmul
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    Mar 11th 2021, 12:29 AM

    @Brian Madden: they don’t keep saying that new production plants opening once in full flow supply will be fine .

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    Mute Brian Madden
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    Mar 11th 2021, 12:33 AM

    @bmul: let’s hope do. I don’t have a lot of confidence in the rollout when there will be bulk vaccinations, let’s hope we will be pleasantly surprised.

    29
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    Mute Paul Mcnevin
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    Mar 11th 2021, 1:25 AM

    @bmul: A million a month they said. Wait and see it not happen.

    48
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    Mute bmul
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    Mar 11th 2021, 3:17 AM

    @Paul Mcnevin: all depending on supply !!

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    Mute Teresa O'Halloran
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    Mar 11th 2021, 7:33 AM

    @Brian Madden: me too, and it is frustrating, but all we can do is wait and as more people are vaccinated before us the weaker the virus will get. There is a supply problem and I am not going to tear my hair out over it because I know I will be vaccinated eventually. I am thankful that I am not living in a poor country in the third world that doesn’t have any vaccine at all and no money to buy any.

    28
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    Mute Marc Power
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    Mar 11th 2021, 12:18 AM

    Our government is not every Irish voters government and their handling of the vaccine rollout has been pathetic regardless of supply issues or where we stand on global rollout tables. What’s important is what they do from now to source vaccines and to reboot their ineffective rollout to rescue our economy and the mental health of our citizens

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    Mute bmul
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    Mar 11th 2021, 12:22 AM

    @Marc Power: they pre ordered 14 millon doses ?

    49
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    Mute DERRY1973
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    Mar 11th 2021, 12:29 AM

    @Marc Power: no government is every voters government, unless you know of a election somewhere that everybody voted the same, silly statement.

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    Mute bmul
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    Mar 11th 2021, 12:34 AM

    @DERRY1973: north korea

    23
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    Mute DERRY1973
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    Mar 11th 2021, 1:14 PM

    @bmul: even in NK not everybody votes the same.

    1
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    Mute Paul Gorry
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    Mar 11th 2021, 12:27 AM

    Just get the Sputnik vaccine over the line. We all know it will be eventually be approved, like the rest were. The Russians aren’t stupid ye know.

    109
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    Mute devotional
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    Mar 11th 2021, 12:51 AM

    @Paul Gorry: very true , unfortunately Drago despite his scientific training and “vitamin” shots couldn’t beat Rocky Balboa of course
    Reckon their vaccine could work though ..

    32
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    Mute Paul Gorry
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    Mar 11th 2021, 1:03 AM

    @devotional: No one beats Rocky, that’s a given.

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    Mute Paul Gorry
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    Mar 11th 2021, 1:04 AM

    @Paul Gorry: clubber lang not included by the way.

    12
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    Mute Joe Johnson
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    Mar 11th 2021, 1:05 AM

    @Paul Gorry: Yea if you don’t want to take Sputnik then skip over and wait for the AstraZeneca one later in the year.

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    Mute Asid
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    Mar 11th 2021, 3:56 AM

    J&J?? Remember what they used to put in baby powder…

    41
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    Mute Felicity Hensen
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    Mar 11th 2021, 5:28 AM

    @Asid: Care to elaborate?

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    Mute Phil Keenan
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    Mar 11th 2021, 7:21 AM

    @Asid: nothing to do with vaccines

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    Mute Linda Daly
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    Mar 11th 2021, 8:17 AM

    @Asid: The vaccine is made by Janssen, the Cork plant being one of them. J&J is the umbrella company, the vaccine will be as safe as the others.

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    Mute SheepleDog
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    Mar 11th 2021, 4:45 AM

    The EU need to treat this NOW as a combined national security threat and stop exporting outside the bloc, or the far-right will ascend in future elections (France particularly) 6.5% vaxd in EU, 33% in lying UK (pretending to co-operate but not exporting…got 9m doses from bloc, sent none from AZ). It’s UK first, US first….stop the waffle Ursula VdL and ACT.

    40
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    Mute Jack Inman
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    Mar 11th 2021, 8:26 AM

    @SheepleDog: that’s to do with how supply distribution within agreements have been set up. AstraZeneca’s agreement has segregated supply lines and when a supply issue hits one it simply doesn’t roll to fill the shortfall with others in order to fulfil prior made agreements.
    Pfizer (which is the vast majority of the 9m) on the other hand has supply agreements based on using its European hubs (where most of its drugs are produced) to then distribute from.
    It’s very telling that after the tit for tat from the EU and AstraZeneca back in Jan/Feb the EU have quietly backed down about their shouting about breached agreements.
    We were late signing agreements, we obviously didn’t enforce safeguards in the event of supply issues(UK had three months to iron their kinks out)
    Stop chatting rubbish

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    Mute Theportobello
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    Mar 11th 2021, 8:27 AM

    @Jack Inman: correct.

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    Mute Gert McNulty
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    Mar 11th 2021, 8:33 AM

    @SheepleDog: I’d love to learn more about this. Any links?? It seems to me that soft power of the eu has been trampled on in favour of both the uk and Us. I agree with your sentiments. We should either produce a home grown vaccine here using existing infrastructure if possible. At least cut out a few middlemen. If the pharma companies wont agree, nationalise them for a year or so. They practically did it with the private hospitals and see no problem with locking people down for the guts of 2 years. So I dont see my solution as extreme anymore .

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    Mute SheepleDog
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    Mar 11th 2021, 11:07 AM

    @Jack Inman: You call it rubbish – many people vote on perception and this is a PR disaster. The ‘waffle house’ Commission talk contract law! with smiles and no urgency on tv, whilst Paris is under curfew, Northern Italy cases surge, and the UK is laughing. EU exported 35 million doses in February…what!? The far-right pig Marine LePen is waiting to pounce on Macron; stop tottering about in high heels Ursula and don a pair of trainers…we need to see you be urgent.

    3
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    Mute Angela Jones
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    Mar 11th 2021, 8:38 AM

    Meanwhile the U.K. are accelerating their rollout. Never have I been so envious. How are we still vaccinating the over 85’s? It’s painfully slow.

    33
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    Mute Olga Levis
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    Mar 11th 2021, 8:01 AM

    I really dont understand. WHY is the government constantly providing information on the roll-out and the expected delivery of vaccines into the country. The delivery dates change not by weeks but months. I fully appreciate and understand the supply issues, but for goodness sake, giving the general public fixed dates only enhances anxiety and retribution when it doesnt materialise, or if they have to back track, it makes them look incompetent

    27
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    Mute Elizabeth Doyle
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    Mar 11th 2021, 9:16 AM

    @Olga Levis: they don’t have to look,they are.

    18
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    Mute John Quinn
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    Mar 11th 2021, 12:56 AM

    Supply issues, no.
    It’s inept government, of course

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    Mute bmul
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    Mar 11th 2021, 1:00 AM

    @John Quinn: name a government that has not had supply issues ??

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    Mute Shkavo
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    Mar 11th 2021, 7:51 AM

    @bmul: Israel

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    Mute Gert McNulty
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    Mar 11th 2021, 8:36 AM

    @bmul: uk, UAE, fcking ghana has got more vaccines than us

    20
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    Mute Kevin O'Hara
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    Mar 11th 2021, 8:19 AM

    The E.U made a big song and dance about 4 million extra doses of the Pfizer vaccine, all the while 25 million doses manufactured in the E.U in were exported in February alone. 8 million to the UK and also to the U.S despite no reciprocal arrangements. Apparently it’s all the fault of the pharma companies according to the comments and you are a whinger on here if you even ask these questions.
    How many people will get infected and sick in this country as a result of such actions?
    https://www.irishtimes.com/news/world/europe/eu-exported-more-than-8-million-vaccines-to-uk-in-february-1.4506764

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    Mute Gert McNulty
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    Mar 11th 2021, 8:42 AM

    @Kevin O’Hara: thanks for the link Kevin. It’s time the EU acted in its citizens interest and block these exports. Nationisle the production facilities if the companies wont play ball. The very least the companies should be sued. I cant believe more is not made of the export issue. They stopped one shipment to Australia as a gesture. People need to know more about this issues. On a national level it could be viewed as treason to allow a life saving vaccine be sent to other countries. Martin saying he understands boris has to vaccinate his people first while the EU are sending him the vaccines to do it. This goes beyond private business at this stage. Governments should treat this like a war. I cant believe people are not protesting outside the factories exporting these vaccines. I am absolutely livid with this treachery. It is being kept very quiet

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    Mute Joan Murray
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    Mar 11th 2021, 9:09 AM

    @Gert McNulty: the UK pre-ordered millions of doses of vaccine while Ursula and her committee were still deciding which vaccines to approve and then haggling over price and supply (signing contracts which in typical bureaucrat fashion they failed to understand). Based on pre-orders from UK, both UK and EU vaccine factories were able to invest in ramped up production. The uK also directly invested billions of taxpayer money in upgrading manufacturing capacity in the UK. Well done UK, who will soon have 80% vaccinated and excess manufacturing capacity to export worldwide. So before the EU even thinks of banning exports, they might consider which countries will be in a position to provide supplies later in the year.

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    Mute Alan Kenny
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    Mar 11th 2021, 9:03 AM

    The vaccine isn’t even approved yet and already they are saying that they can’t supply the full amount. That is a joke really.

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    Mute Joe Johnson
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    Mar 11th 2021, 12:18 AM

    Don’t you know

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    Mute Spbeak
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    Mar 11th 2021, 7:41 AM

    Given this vaccine is just one shot – it makes it so much more important. Trivally saying it can be offset by others is not honest or transparent – e.g. when we say doses of J and J we mean one person fully vaccinated vs. doses of all other drugs meaning half a person fully vaccinated. So the exact numbers of the different vaccines matter – if j and j is 15% of doses, it is actually a much higher weight – as the 85% are 2 shot doses, so j and j would make up 26% of targeted people to be vaccinated – more of a shortfall than just 15%.

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    Mute Helpless In The Face Of Your Beauty
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    Mar 11th 2021, 12:35 PM

    It’s been a year. I’ve been good. I double mask, disinfect assiduously, restrict my movements and those of my kids. I haven’t seen my elderly mother, who lives alone, since Christmas 2019, she was sick in that new year and so as soon as word got out about this new virus from China she was into self isolation. She’s now fully vaccinated, but I’m not allowed to travel to see her.

    But my patience is finally wearing thin.

    By my reckoning the government/HSE have got until about the end of May to vaccinate the most vulnerable. That will be a full five months after vaccines first became available for emergency authorisation. It’s not their fault that there’s limited supply of the authorised vaccines, but it is their fault that they haven’t sought emergency authorisation for others like Sputnik and Sinovac. If people were dropping dead from these vaccines we’d have heard about it by now.

    Once we’re into June, when we’ll have had two months of the much heralded “million doses a month” supply, even the most patient people will be taking to the streets one way or another. Some late middle aged people might have to isolate themselves whilst they wait for their jabs to take full effect.

    Already compliance with arbitrary restrictions is slipping. My cycling friends have after many weeks of compliance, started breaching the 5km limit, at absolutely no risk to themselves or anyone else (self-supported so don’t stop at shops). The golfers have similar reasonable complaints – why can’t the courses open with the buildings closed? Outdoors is safe.

    The current messaging of living with endless restrictions had better be a massive bluff to keep cases low for as long as possible, because if they seriously think the population of this country is going to put up with much more house arrest they’re deluding themselves.

    So that’s what I think. Govt: you have about ten weeks to sort this out.

    6
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