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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. Source: 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 Source: 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 Source: SIPA USA/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.

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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.”

About the author:

Nicky Ryan

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