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Delayed until the end of 2021: What's happening with the Sanofi/GSK jab?

The vaccine – of which Ireland is due to receive more three million doses – will not be available until the end of the year, at the earliest.

coronavirus-mon-jan-18-2021 A pharmacist prepares to administer the AstraZeneca vaccine. PA Images PA Images

THIS WEEK, all eyes were on the increasingly bitter row between AstraZeneca and European leaders.

The pharmaceutical company announced last week that due to a ‘reduced yield’ at an EU facility, the deliveries of its Covid vaccine in the first quarter of this year would be reduced by 60%.

The bloc’s leaders aren’t best pleased with this and have demanded that AstraZeneca live up to what it says are contractual obligations.

This isn’t how the situation is viewed by the other side. In an interview with la Repubblica this week, CEO Pascal Soriot said his company’s only obligation was to do the best it could, and that the glitches are similar to what was encountered by the United Kingdom’s supply chain, which was up and running at an earlier stage.

emmanuel-macron-visits-astrazeneca-factory-dunkirk Pascal Soriot PA Images PA Images

The European Medicines Agency announced on Friday that it had approved the use of the vaccine in all age groups, paving the wall for its roll-out. However, the German health ministry said there was insufficient data to demonstrate its efficacy in those aged over 65.

This supply situation creates a significant headache for Ireland. The Oxford-AstraZeneca vaccine – cheap, plentiful, safe, easily stored and easily transported - was to be the backbone of the country’s vaccine roll-out.

The message from Minister for Health Stephen Donnelly on Thursday was that it’s not all bad news:

“Through the EU advance purchase arrangement, we have pre-purchased 14.4 vaccine million doses. AstraZeneca will not disappear and we will start receiving its vaccine very soon, but even if, hypothetically, we got no AstraZeneca vaccines, of which we have pre-ordered 3.3 million, we would still have over 11 million doses of other vaccines.”

This is true – at least for most of the 11 million referenced here.

Ireland will continued to receive a steady stream of Pfizer-BioNTech and Moderna vaccines.

Johnson & Johnson announced this week that its jab is 66% effective, and while the EMA has yet to set a date for the approval of this single-dose vaccine, it is the subject of a rolling review.

Curevac launched its phase three trial in December, with the results expected in Q1 2021, and this month announced a partnership with Bayer to boost production.

But of the millions of doses, some 3,300,000 may not be available until late this year, if not 2022.

This is the Sanofi-Pasteur/GSK vaccine. A delay due to disappointing results in clinical trials was announced before Christmas, something which flew under the radar to a certain extent but cropped up again this week with a new, positive twist.

coronavirus-vaccine-photo-illustration-in-ukraine SIPA USA / PA Images SIPA USA / PA Images / PA Images

The joint effort between France’s Sanofi and Britain’s GlaxoSmithKline (GSK) reported disappointing results in early December.

This is one of the six vaccines covered by the European Union’s advanced purchase agreements. Ireland was in line to receive 3,300,000 doses, with an earliest possible delivery date of July 2021.

However, interim results showed a low immune response in older adults, which means the two manufacturers are back to the drawing board.

They now expect the vaccine to be available – if these new clinical trials go as planned, and subject to approval by health authorities – by the final quarter of 2021.

This vaccine differs from others covered by the purchase agreement in that it is based on a protein subunit (Pfizer/BionTech, Moderna and Curevac are mRNA; AstraZeneca and J&J are a non-replicating viral vector). It is also among the more stable vaccines and can be stored in a normal consumer fridge.

What makes the delay doubly disappointing is that the jab is based on a well-established method.

Sanofi provides the all-important SARS-CoV-2 spike protein – the target of many vaccines as it is how the virus binds to human cells – which is created using what is known as recombination DNA technology.

GSK provides what is known as an adjuvant, which boosts the immune response.

This is the same method used to produce their already successful influenza vaccine, albeit with a flu virus and not the coronavirus.

Phase 1 and Phase 2 trials found that the immune response created by the vaccine was similar to what is found in those who have recovered from Covid-19, but only in those aged 18 to 49 years.

The companies believe the next attempt will be successful, using an improved antigen formulation.

In the meantime, however, the production lines won’t lie idle. Sanofi announced this week that it would produce some 125 million doses of the Pfizer-BioNTech vaccine.

These will be available across the European Union by the middle of this year.

In normal times the two companies would be seen as rivals, and acts of solidarity like this are rare. Professor Brian MacCraith, head of Ireland’s high-level vaccine taskforce, described it as “highly unusual in a highly competitive industry” when speaking at an Oireachtas committee this week.

Separately, Merck announced that it will abandon two vaccine efforts which failed to produce a strong immune response: Merck’s own, and another developed with the Pasteur Institute in Paris, seen as another blow to France’s scientific pride.

Ireland’s Department of Health was asked about the delay to the Sanofi/GSK vaccine, which has been little referenced in official discussion over recent weeks.

It does not appear in the minutes of any meetings of the High-Level Task Force on COVID-19 Vaccination, as well as about whether the roll-out plan will need to be adjusted.

The vaccine strategy lists its availability as being from July 2021 – but the delay was only announced the day the plan was submitted to Cabinet, December 11, likely contributing to this misprint in the document.

“The GSK/Sanofi-Pasteur vaccine candidate was part of the portfolio of vaccines that the commission negotiated an Advanced Purchase Agreement on,” a statement from the Department of Health to TheJournal.ie read.

“The portfolio was designed to cover different vaccine platforms, given the uncertainty regarding variation in vaccine efficacy, production capacity, their performance across different cohorts, and whether all candidates would receive regulatory authorisation.
“The GSK/ Sanofi-Pasteur vaccine contract is an ‘Opt-in’ contract, predicated on certain preconditions are met regarding the progression of the vaccine. Ireland does not have to opt-in to this contract until such milestones are met.”

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    Mute Mark Matthew Hughes
    Favourite Mark Matthew Hughes
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    Jan 31st 2021, 8:15 AM

    Novartis has also just signed up to produce the Pfizer-BioNTech vaccine, further boosting supply. It’s fantastic to see so many companies contributing their resources to increase vaccine supply globally.
    https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSFWN2K40Y6

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    Mute Lads you cant do that
    Favourite Lads you cant do that
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    Jan 31st 2021, 8:26 AM

    Supply will always be an issue. Don’t think for a minute all will be well by Sep/Oct as many corners suggest. As Dr Ryan pointed out – all the talk in Europe and US is about how much of the vaccine cake we can get, third world countries aren’t even in the queue for crumbs.

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    Mute Shaun Gallagher
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    Jan 31st 2021, 9:20 AM

    @Lads you cant do that: What about our own “specialist” Dr Luke O Neill saying we’ll all be in beer gardens drinking with friends in June

    52
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    Mute Bryan Smyth
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    Jan 31st 2021, 9:21 AM

    @Lads you cant do that: Calm down, there’ll be loads of supply by mid summer.

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    Mute Dan Jacobson
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    Jan 31st 2021, 10:26 AM

    @Lads you cant do that: The UK have put £350m into supplying third world counties. Let’s hope we get some of that.

    31
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    Mute David Clements
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    Jan 31st 2021, 10:55 AM

    @Shaun Gallagher: we did that last June with no one vaccinated. Not all activity requires herd immunity to Covid. I wish people would get their heads around that again

    20
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    Mute Lads you cant do that
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    Jan 31st 2021, 10:57 AM

    @Shaun Gallagher: I see not a shred of evidence that might even vaguely support that. Mixed messages from our “Leaders”. Leo said we won’t be going on holidays, and yer man says we will be drinking in Beer Gardens.
    Dear Govt, Please reference Australia. Cheers.

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    Mute Shaun Gallagher
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    Jan 31st 2021, 11:56 AM

    @Lads you cant do that: Exactly. No wonder people are getting fed up

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    Mute Robert Clifford
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    Jan 31st 2021, 3:18 PM

    @Dan Jacobson: Very flippant remark if I may say so.

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    Mute Brian Martin
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    Jan 31st 2021, 9:28 AM

    All who can should produce the Pfizer vaccine until we are back to some sort of normality then ifba better one comes along all the better but don’t waste time on clinical trials we have a vaccine . People are dying all over the world the economies are in pieces. .
    Fair play to the ones who are but all should have done it as soon as one was found instead of the children bickering over price and who gets it first. Cop on lads and grow up this is bigger than your pride and making money

    52
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    Mute retsnuM
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    Jan 31st 2021, 9:19 AM

    Based on the qtys noted in this article are we not over ordering vaccines? If all the pre orders were to come through we could likely do the population of the 26 counties twice over and that’s taking into account the requirement for 2 doses of the Pfizer vaccine…. whereby not everyone is going to want the vaccine to begin with.

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    Mute JillyBean
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    Jan 31st 2021, 9:26 AM

    @retsnuM: We over ordered with the expectation some wouldn’t pull through the trials. The eu put plenty of eggs in the Sanofi basket and it blew in their faces.

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    Mute Gearailt O'Treasaigh
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    Jan 31st 2021, 9:45 AM

    @retsnuM:it would seem unlikely that immunity is going to last beyond 6 months
    Likely going to need repeat injections while such high levels of virus in community

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    Mute Vanessa
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    Jan 31st 2021, 9:55 AM

    @retsnuM: You see now a delay already. We just want to get through as fast as possible. Those lockdowns don’t come for free. Alone the economic value outweighs the costs. (Along all other benefits)

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    Mute retsnuM
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    Jan 31st 2021, 10:19 AM

    @JillyBean: @JillyBean: if you look at the Pfizer and Moderna orders, they total 11 million according to Stephen Donnelly. There is approx. 5 million people in the 26 counties whereby according to recent poles on the journal approx. 70% of people will take a vaccine which is 3.5 million people times 2 doses is 7 million vaccines. Round that up to 10 million to take all manner of reasons into account just to be extra certain. I just cant see why we have another 3.3 million orders in with Astra zeneca and that’s before even looking at all the other company’s mentioned recently.

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    Mute retsnuM
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    Jan 31st 2021, 10:21 AM

    @Gearailt O’Treasaigh: sorry but that makes no sense. Repeat injections? If you need a repeat injection it means the vaccine will have lost its effectiveness whereby another injection is going to have little to no impact.

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    Mute retsnuM
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    Jan 31st 2021, 10:23 AM

    @Vanessa: dont disagree with the economic costs at all, I still believe we are over ordering vaccines however and these vaccines certainly wont be coming for free either.

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    Mute TL55
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    Jan 31st 2021, 10:48 AM

    @retsnuM: You have to take into account the length of time the vaccine gives you immunity for. Some sources are saying as little as 6 months so if that’s correct we will need over 30 million of the 2 jab vaccine over the next 2 years

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    Mute retsnuM
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    Jan 31st 2021, 10:55 AM

    @TL55: the vaccine will have lost its effectiveness after 6 months if that’s the case whereby redosing with the exact same vaccine would have little to no impact at that stage.

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    Mute Joe Vlogs
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    Jan 31st 2021, 11:38 AM

    @retsnuM: it’s like a booster. Doesn’t mean it is no longer effective. The same happens for a lot of commons vaccines, such as MMR where the first dose is given at a few months old, and then the next dose when a young child.

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    Mute retsnuM
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    Jan 31st 2021, 12:01 PM

    @Joe Vlogs: Professor Luke O’Neill said that your own immune system is more effective than the vaccine lasting at least 8 months and most likely longer. If the vaccine only lasts 6 months this means that even less people will require it initially so as anyone who already has had and beaten Covid has a longer lasting immunity that the vaccine itself delivers, which begs the question why we are ordering these at the qtys we are.

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    Mute Francis Devenney
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    Jan 31st 2021, 12:55 PM

    @retsnuM: Many of the more developed countries are over ordering so the excess can got Covax, And also it helped fund the RnD on the vaccines,

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    Mute retsnuM
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    Jan 31st 2021, 7:10 PM

    @Francis Devenney: looks like we will be top of that table given the qtys of vaccines we’re bringing in!

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    Mute Kjell Nolke
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    Jan 31st 2021, 10:52 AM

    Let’s cut to the chase and be adults and say it like it is and agree.
    This is a global catastrophe.
    Vaccine is the only way out.
    The world can’t make enough for everyone.
    The virus will mutate.
    Annually (At least) the world will need new shots.
    This Turns vaccine into the same essential commodity as water or food.
    So. Every country needs to have a secure vaccine supply not just soon – but actually and more importantly for the future.
    Vaccine / Pharma companies will therefore control the world. – unless we recognise this and look at how this current state of vaccine purchasing and distribution can be controlled by governments.
    I’m not a politician and know nothing about how that will happen, but we need to start building vaccine factories and Pharma needs to share with generics

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    Mute Geoff Bateman
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    Jan 31st 2021, 10:54 AM

    This vaccine lark gets crazier by the day

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