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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 Daniel Morrissey
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    Apr 17th 2021, 12:20 AM

    Roll on the 26th change…. yawn…

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    Mute Anna Carr
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    Apr 17th 2021, 12:56 AM

    @Daniel Morrissey: lol. I know how you feel. How many bloomin people over 65 are in the country. They seem to go on forever hahaha

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    Mute Peter McGlynn
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    Apr 17th 2021, 1:12 AM

    @Anna Carr: I don’t know how many. How many people voted Fianna Fáil? In or around that amount.

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    Mute Ger
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    Apr 17th 2021, 3:06 AM

    @Anna Carr: it literally tells you in the article

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    Mute Paul Gorry
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    Apr 17th 2021, 3:16 AM

    @Ger: ah lighten up ger her comment was tongue in cheek jayus what are you not seeing there?

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    Mute Dave O'Keeffe
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    Apr 17th 2021, 5:13 AM

    @Daniel Morrissey: well yeah, can’t make them deliver it faster or make it ourselves so that’s what we have to do.

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    Mute Anto Curran
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    Apr 17th 2021, 8:00 AM

    @Peter McGlynn: obsessed with FF. Unless you’re playing an online game where you can try to fit FF into every comments section?

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    Mute Barbara Stewart
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    Apr 17th 2021, 11:55 AM

    @Anna Carr: Sorry for being 69 and delaying your vaccination….I could have said the same about all over 70s but I have a bit more respect!!!

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    Mute Tony Humphreys
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    Apr 17th 2021, 1:54 AM

    You lost me at the word ‘plan’. I always thought they there was only one plan – lockdown. Why do something when you can get away with nothing.

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    Mute Dave O'Keeffe
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    Apr 17th 2021, 5:14 AM

    @Tony Humphreys: well you thought wrong and then refused to think about it anymore

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    Mute Keith Richardson
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    Apr 17th 2021, 1:54 PM

    @Dave O’Keeffe: well there is no published plan on reopening. I’m sure there’s one on a desk somewhere. If people were treated like adults and told this then there would be increased confidence.

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    Mute Dave O'Keeffe
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    Apr 18th 2021, 5:32 AM

    @Keith Richardson: no, if there was a widely publicised plan with an unpredictable pandemic and unreliable delivery schedules any changes would undermine the confidence you claim it would bring.

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    Mute Tarraing Mo Liathróidí
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    Apr 17th 2021, 8:02 AM

    The fact we still likely won’t restart tourism and hospitality till June or July is just mind boggling, especially given the fact MM despite some who said it was lies when I pointed out that leaky Leo said the same thing, that he can’t say we won’t go into another lockdown after this one. And given the fact the hse management seem to have done nothing except allow the waiting list balloon and get themselves a pay rise, any extra surge from even a few covid cases over the winter months makes this likely since they now have a great excuse to cover up they barely cope any winter before covid hit. So this means a lot of small businesses and retail included as well may only have a small window to open and make some much needed money, meanwhile north will be full steam ahead open end of May.

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    Mute Siobhan Rosemary
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    Apr 17th 2021, 8:35 AM

    So the AstraZeneca isnt safe to use on under 60s but is safe for under 60s who received 1st dose?? Think il pass on the second thanks. Back of the que I go lol

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    Mute Dave O'Keeffe
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    Apr 18th 2021, 5:34 AM

    @Siobhan Rosemary: that silly. 1 in a million died of a blood clot that nobody knew to be looking for. That’s different now. 12 in a million died of covid here and doctors were definitely looking for it.

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    Mute K Flan
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    Apr 17th 2021, 11:26 AM

    2 more weeks to flatten the curve

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    Mute Dave O'Keeffe
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    Apr 18th 2021, 5:35 AM

    @K Flan: the curve is flattened. Sadly the base rate is still over 300 cases per day.

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    Mute Sean Callan
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    Apr 17th 2021, 7:26 AM

    Boring boring boring all this lot has to offer

    13
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