AN IMMUNOLOGY expert has said he is not surprised possible production problems have occurred with the mass manufacturing of the Oxford vaccine as the EU warned the company that it must meet its contractual supply obligations.
Trinity College Dublin Professor Kingston Mills said the vaccine process for this type of jab was “tricky” and was not shocked if it had encountered “teething problems” scaling up production.
This comes after the pharmaceutical firm AstraZeneca announced that supplies of its Covid-19 vaccine to Europe will be “lower than originally anticipated” due to reduced production at a manufacturing site.
President Ursula von der Leyen spoke to the Pharma firm’s chief executive Pascal Soriot by phone, while the EU health commissioner Stella Kyriakides also wrote a letter to the company.
During her conversation, president von der Leyen “made it clear that she expects AstraZeneca to deliver on the contractual arrangement foreseen in the Advance Purchase Agreement”.
A commission spokesperson added: “She reminded Mr Soriot that the EU has invested significant amounts in the company upfront precisely to ensure production is ramped up even before the conditional market authorisation is delivered by the European Medicines Agency (EMA).
“Of course, production issues can appear with a complex vaccine but we expect the company to find solutions and to exploit all possible flexibilities to deliver swiftly.”
QUESTIONS TO ANSWER
A spokesman said the AstraZeneca chief told president von der Leyen that thev company was doing everything it could to bring its vaccine to millions of Europeans as soon as possible.
As part of the Advance Purchase Agreement between the two parties, the EU issued a nine-figure sum to the pharma firm to provide reserve production capacity and for advance production.
Deputy Richmond said the company has questions to answer regarding the production setback.
The Dublin Rathdown TD said: “There is obviously very serious concerns and questions need to be asked were the company absolutely truthful with the European Commission and are they meeting their contractual obligations.
“Either they haven’t produced as much as they said they would, or they sold what the European Commission has bought to another buyer on a higher rate – both of which are extremely serious.
“I certainly welcome the intervention by Ursula von der Leyen. This has a huge impact on the whole of the European Union’s vaccination strategy. The whole advantage of being part of the EU in this is that we’ve been able to order so many vaccines from so many different providers for relatively good prices.
“If AstraZeneca can’t fulfil their contractual obligations, the European Commission needs to look at the company’s activities throughout the EU. They supply a lot of other drugs throughout the European Union that are licensed, and there are lots of other engagements. The European Commission needs to be as strong on this as possible.”
AstraZeneca applied for approval for its vaccine from the European Medicines Agency earlier this month, and it is expected to get the green light for use in the EU sometime this month.
However, the firm announced recently that it would not be able to meet expected vaccine supplies due to reduced production at a manufacturing site.
Commissioner Kyriakides said there were unsatisfactory answers given by the company during a virtual meeting yesterday.
She tweeted: “The EU wants to know exactly which doses have been produced where by AstraZeneca, so far, and if, or to whom, they have been delivered.
“The answers of the company during the Steering Board discussion have not been satisfactory so far.”
She added that vaccines exported from the EU will also be tracked, stating: “In addition, today we discussed with the 27 Member States in the Steering Board that an export transparency mechanism will be put in place as soon as possible.
“We want clarity on transactions and full transparency concerning the export of vaccines from the EU.
“In the future all companies producing vaccines against Covid-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries.”
Professor Kingston Mills said he was not shocked that the company encountered “trouble” trying to scale up production.
He said: “This is a new vaccine, a new process. No vaccine has ever been made using what’s called a live vector system before. So they’re inevitably going to be teething troubles with large scale production.
“They have done this on a small scale before when testing the vaccine, but they would’ve never done it on a mega scale that’s required for hundreds of millions of doses. So it’s not surprising that they may have run into trouble in terms of getting enough virus.
“You have to grow that virus in tissue culture, which can be tricky.”
Viral vectors are produced in genetically modified living cells that have to be nurtured in bioreactors as part of a complex procedure that requires fine-tuning of various inputs and variables.
World Health Organization’s Special Envoy on Covid-19 who said vaccine production is not straightforward and this is “part of what happens”.
Dr David Nabarro said people’s frustration and disappointment was understandable but stressed that shortfalls like this usually mean that some effort is being made to improve the quality of production.
The vaccine is considered key to the global vaccination effort because it is cheaper to produce and can be stored at fridge temperature – and it’s timely supply was instrumental to Ireland’s rollout timeline.
Following the delay announcement, Taoiseach Micheal Martin conceded that it would “disrupt our plans”, while Health Minister Stephen Donnelly described it as “a real setback”.
The health minister said yesterday that some 143,000 Covid-19 jabs have been administered here to Sunday by vaccination teams across the country.
Deputy Cullinane yesterday called on the Government to detail just what impact the delay will have on the vaccination programme here.
The Sinn Fein Waterford TD said: “Obviously it’s hugely problematic. There are question marks for AstraZeneca in relation to what promises were made, and what went wrong.
“And I very much hope that it wasn’t the case that doses which were earmarked for the European Commission and paid as part of advanced purchase agreements have gone elsewhere.
“So that can only be clarified by the Commission by the company itself.
“Our entire strategy has now been set back by what has been either a mistake by the European Commission or by AstraZeneca or both – I don’t know. But we do need answers to those questions.
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“Predictions set out by Minister Donnelly was to have 700,000 people vaccinated the end of March. All of that was on the back of an assumption that the AstraZeneca vaccine will be certified and a set number of the doses distributed.
“The latest figure was that we were expecting 600,000 doses in the first quarter of this year. And all of the targets set in relation to prioritising those on the front line, as well as starting the rollout for older people and getting the doses into GP’s surgeries and pharmacies, all of that was underpinned by this vaccine. So the minister needs to set out exactly how this is going to impact our schedule.
“There’s a lot of uncertainty now, so we need to get as much information as possible in relation to what disruption this impact will have on the rollout.”