EUROPE IS THE sick man of the northern hemisphere when it comes to its vaccine strategy.
That’s the perception at least. Bedevilled by setbacks, supply issues and bad press, European Union officials and institutions are facing intense scrutiny after a chaotic week in which the roll-out crawled to a near-halt in several member states including Italy and Spain.
All aspects of the EU strategy — from the approach to procurement to the funding mechanisms to the regulatory approval process itself — have faced heavy criticism in recent days.
Speedy starts in the United Kingdom and the United States have done nothing to improve the public perception that the EU has fumbled the ball in some respects.
Some recent estimates, based on the agreed vaccine supply deals, suggest that the EU27 will have to wait until late October to reach herd immunity on foot of its vaccination programme, compared to mid-July for the UK and early August for the US.
But how valid is the critique, what sort of conclusions can we reach at this early stage of the process and what is the impact on the ground?
“The Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at fair prices.”
So said the European Commission in a press release at the beginning of January 2021.
It’s this “diversified portfolio” that defines the European vaccine strategy.
And on paper, up until last week at least, it seemed to be a successful one — the EU has secured contracts for a portfolio of 2.3 billion doses of various vaccines; over five times the population of the EU27.
It includes 400 million doses from Anglo-Swedish company AstraZeneca; 300 million doses from French firm Sanofi in partnership with UK-based GSK; 400 million doses from US-anchored Johnson & Johnson; 600 million doses from the partnership between Pfizer and BioNTech; 405 million doses from German company Curevac and 160 million doses from American outfit Moderna.
The idea was to spread the risk across a selection of different vaccines, rather than betting on any one company to hit the bullseye.
It was a strategy motivated, in part, by a fear in the early stages of the pandemic that the United States or other global powers would effectively corner the market on vaccines, securing huge pre-orders for tranches of vaccines before a coordinated European strategy had even been developed.
There was also concern among the smaller countries of Europe that Germany, France, the Netherlands and Italy would go it alone through an initiative called the ‘Inclusive Vaccine Alliance’.
Set up in the early summer, the Alliance opened negotiations with AstraZeneca, eventually inking a preliminary deal in June for between 300 and 400 million doses of the potential vaccine.
Eventually, the Commission sprung into action, outlining a coordinated vaccine strategy just a few days later.
The Commission said at the time that the four Alliance countries “who started negotiations with AstraZeneca asked the Commission to take over through an agreement signed on behalf of all Member States”.
After much wrangling between member states, it was agreed that the EU27 would cooperate on procurement with the Commission to coordinate the supply efforts, allowing Europe to collectively leverage its political weight within the market. Once the vaccines had been produced, they would be distributed to member states based on population.
By mid-August, the Commission signed its first ‘advance purchase agreement’ for a potential vaccine.
The prospect of European cooperation was welcomed at the time, given the negative publicity generated by German and French protectionism over personal protective equipment at the outset of the crisis.
But negative opinions about the approach are not hard to come by.
One frequently-made observation has been how long it took for the EU to secure its first vaccine purchase agreements, which may in turn have slowed down the approval process.
There was, after all, a three-month gap between the first EU vaccine deal being signed in August and the UK’s first formal agreement with AstraZeneca, which was signed in May.
Even in April last year, there was a sense that Europe was playing catch-up and that the spectre of unilateral agreements between countries and pharma companies would quickly dry up supply.
At the time, Sanofi warned the EU that its response lagged behind the rest of the world.
On 24 April last year, the company’s chief executive told reporters, “There has been a lack of coordination at a European level. It’s starting to move now but the level of pandemic preparedness is very, very low.”
It would be another two months before the Commission outlined its coordinated strategy in June.
One question raised by all of this is whether it would have been better to let individual member states come to their own arrangements with ‘Big Pharma’.
For Fianna Fáil MEP Billy Kelleher, the answer is no.
“If you have 27 EU countries all trying to outbid each other and outdo each other, countries with the bigger cheque books and political muscle could have done better than us. So that always would have been a high-risk strategy from an Irish perspective,” he says.
We’re better off to be in a group that can get economies of scale, value for money, and actually have political influence.
This would be an even bigger issue for tiny European economies like Malta or Bulgaria.
Members of the European Parliament have repeatedly hit out at the lack of transparency around the contracts between the Commission and the pharmaceutical companies.
Slamming the “culture of secrecy” within the Commission structures, Sinn Féin MEP Chris MacManus explained, “Access to adequate oversight in relation to the European vaccine programme so far has been worryingly limited. Up to very recently, we as MEPs could only see one of the contracts in a very redacted format in a special reading room.”
Another argument that has reared its head in recent days is that the EU has lagged behind the UK and the US in terms of upfront funding to support research, development and the scaling up of production facilities.
Earlier this week, analysis by UK life sciences analytics company Airfinity indicates that the UK and the US could have spent roughly seven times more than the EU on this kind of activity.
Speaking to TheJournal.ie, Airfinity chief executive Rasmus Bech Hansen said he believes that this funding discrepancy is key to understanding the difference between the UK and EU rollouts.
There are limits to the data, he explained.
Because many of the European deals remain shrouded in secrecy, there are gaps in our knowledge and the types of funding may not be exactly comparable.
“So I think the correct way of seeing it is that it’s an indicator,” Hansen said.
But I think what the data tells us is that there has been a very different approach to this. The EU has very much treated the vaccine space as a procurement challenge; how do we buy vaccines and which ones should we buy?
By contrast, he says the UK and the US saw it as more of a “comprehensive biosecurity issue”, marshalling “cross-departmental” efforts and expertise.
“Also one of the things that has struck us for a long time, is that the individual member states didn’t do more on the vaccine front themselves — even countries with a successful life sciences industry,” Hansen said.
So what seems to be in the cases that member states said, ‘Ok, the EU takes care of that. We don’t have to do anything.’It was never meant to be like that.
Defenders of the EU strategy are quick to point out that the bloc has pumped resources into the vaccine effort.
Noelle O’Connell, chief executive of the European Movement Ireland, pointed out that some €2.1 billion has been allocated by the Commission for vaccine funding and development through a mechanism instrument called the Emergency Support Instrument.
“The Advanced Purchase Agreements signed between the Commission and six vaccine manufacturers during the summer and autumn provided money up front to fund research and production capacity,” she said.
This included an initial payment of €335 million to AstraZeneca.
“Europe probably is a little bit behind the curve in terms of investment in research and development and innovation in general,” said Billy Kelleher. “And that is something that we have to look at. But specifically relating to the vaccines, in fairness [the EU and its member states] did put money up front and forward purchase.”
Given the paucity of data and the fact that all bar one of the vaccine contracts remain under wraps, it’s difficult to reach concrete conclusions one way or the other about the adequacy of the EU’s funding.
But significant question marks remain.
As Wolfgang Munchau, head of UK-based think tank Eurointelligence, wrote recently, European officials seemed preoccupied with the price of the vaccines from the get-go.
“The EU paid 24% less for the Pfizer vaccine than the US, for example. For the Oxford/AstraZeneca vaccine, the price gap is 45%. The UK almost certainly paid a lot more,” he argued.
“It is no wonder that the manufacturers are prioritising orders on a first-come, first-serve basis, and from countries that pay the full price. The price difference is macroeconomically irrelevant. But if vaccine shortages lead to longer lockdowns, the indirect effect of that short-sighted policy will be massive.”
Another criticism of the strategy is that the EU has placed itself at the back of the distribution queue because its approval of the leading vaccines came later than in other countries.
Both the UK and US have given emergency authorisation to vaccine developers, while the European Commission has required companies to apply for conditional marketing authorisation. The level of data required on efficacy and safety is similar, but emergency authorisation essentially allows an unlicensed product to be used on a temporary basis.
The conditional marketing authorisation process is similar to the one used for vaccines and medications before the pandemic, but it has been significantly sped up as the European Medicines Agency has been assessing data on a rolling basis, rather than waiting until the end of all of the developers’ trials when an application is submitted.
Developers are required to go through three trial phases:
In Phase 1, the vaccine is given to a small number of people to assess safety for human use, to confirm it generates an immune response and to test dosage levels.
In Phase 2, the vaccine is given to hundreds of people. They are monitored for any side effects – mainly the more common side effects would be picked up at this stage.
At this stage developers also collect data on the efficacy of the vaccine in preventing disease, but numbers are too small for a clear picture. A proportion of the volunteers in this phase will receive a placebo or in some cases another vaccination. This is known as a control group – it allows researchers to make comparisons between those who receive the vaccine and those who do not.
In Phase 3, the vaccine is given to thousands, or tens of thousands of volunteers. Again, there will be control groups and a proportion will receive a placebo so data from the groups can be compared. This phase gives a clearer picture of how effective the vaccine is in eliciting an immune response and the appropriate dosage.
With a large – and more diverse – pool of volunteers, this phase also aims to catch less common side effects and examine the prevalence of side effects overall.
Once the results of these clinical trials are available, reviews of efficacy, safety and manufacturing are carried out before approval by regulatory authorities.
The rolling review of data involves scientific experts from across the 27 member states, including Ireland’s Health Products Regulatory Authority (HPRA).
When asked about criticisms of the European approach, the HPRA pointed out that the period of time from a firm’s application for authorisation to the approval by the EMA has been “extremely efficient”.
Pfizer/BioNTech submitted their application to the EMA on 1 December 2020 and authorisation was recommended by the agency on 21 December. On this same day, prescribing information for healthcare workers and leaflets for members of the public were also published.
The EMA also received an application for the Modern vaccine on 1 December and on 1 January it was given the green light.
There was an even shorter timeframe of 17 days between the submission of an application to the decision today to approve the AstraZeneca vaccine.
“In other jurisdictions, a temporary authorisation of supply has been granted in the emergency use setting. An emergency use authorisation is not a marketing authorisation and the medicine remains unlicensed,” the HPRA said in a statement to TheJournal.ie.
“An emergency use authorisation differs from a conditional marketing authorisation in the level of evidence submitted and checks required. They are specifically designed to enable temporary availability and use in emergency situations and last only as long as emergency circumstances apply.
As for all marketing authorisations, a conditional authorisation provides a controlled and robust framework, which ensures that all safety monitoring, manufacturing controls, including batch controls for vaccines, and other post-approval obligations apply in a legally binding manner and are evaluated and acted upon by the EMA’s scientific committees on a continuous basis.
“These are essential elements to ensure a high level of protection to citizens during the course of a mass vaccination campaign.”
The first vaccines were administered in the EU on 27 December, 19 days after the first vaccine in the UK and 13 days after the US rollout began.
Speaking to TheJournal.ie, Noelle O’Connell, CEO of European Movement Ireland, said the collaborative approach, whereby the Commission jointly purchased vaccines on behalf of all member states, likely sped up the process for the individual countries.
“Had the Commission not undertaken this action there would likely be member states that would have not yet started vaccinating their populations and national governments would be wasting time and resources bidding against one another for the limited vaccine supplies that are available,” she said.
She pointed out that while vaccinations per head of populations have been slower to date in the EU than the UK, USA or Israel, progress across the EU is more advanced than in countries like China, Japan, Australia and New Zealand.
MEP Billy Kelleher has questioned why a more collaborative working arrangement was not put in place across regulatory authorities.
“I felt why not just have a reciprocal collaborative, and even potentially mutual recognition, if the FDA are using the same benchmarks or even higher to approve vaccines, and then we have to go through the whole process again,” he said.
“I think that in the event of an emergency like this, the European Medicines Agency could assess one particular vaccine, let the US assess another one and the UK assess another. And they could collaboratively work on that.”
However, he said he does not believe the approach taken by the EU – a conditional marketing authorisation – had a significant impact on the timeframe compared to the UK and US emergency use authorisations.
“Emergency means that you remove any burden of risk in terms of liability afterwards on companies. Any country could do that, I mean Ireland could approve it conditionally, but you would have to procure the vaccines outside of the scope of the European Union’s agreement.
“But that still would have only meant a few weeks in the difference. The issue is we just can’t get enough vaccines.”
While the European Commission is working to push manufacturers to deliver the agreed supplies quickly to member states, the management of their own stocks of doses and the implementation of their individual programmes is out of the Commission’s hands.
There has been cohesion across the EU in terms of priority groups, with a focus on healthcare workers and older people. However, some individual countries have gone out on their own with other decisions, such as additional vaccine orders or interpretation of the data provided by manufacturers.
Germany has done both of these things. The German health minister has confirmed his country signed a memorandum of understanding last September for 30 million additional doses of the Pfizer/BioNTech vaccine.
This agreement pre-dates the contracts signed between the companies and the European Commission but it is out of step with the theme of ‘solidarity’ the EU has been promoting with its vaccine strategy.
Germany authorities have also decided the AztraZeneca vaccine should not be used in over 65s. This is despite guidance from the EMA today which states that while there is not significant data around efficacy in this age cohort, it can be used and is likely to result in an immune response in all all age groups.
Hungary has also, independently of the EU, given preliminary approval to the Russian vaccine Sputnik V. And it gave the AztraZeneca vaccine the green light earlier this month, before EMA approval.
These types of decisions are likely to create further disparity in the speed of vaccination programmes across different EU countries and the level of vaccines administered in different age cohorts.
The German decision on AstraZeneca, for example, will speed up that country’s delivery of vaccines to younger age cohorts and this may shift its restriction policies.
Noelle O’Connell of European Movement Ireland said there are “good reasons” that member states oversee their own programmes, aside from the obvious fact that the EU does not have the legal power to administer public healthcare in member states.
Each has its own national healthcare system as well as different supply chains and logistical arrangements.
She said there are also “differing opinions and perceptions of the vaccinations across member states.
“Scepticism in France, for example, is high comparatively and national governments
are best placed to provide information and communications to reassure citizens,” she said.
The EU has vaccinated just 2.2% of its population, compared to more than 11% in the US and 7.1% in the UK.
Yes, they started vaccinating their populations slightly earlier, but the key barrier for EU countries has been a shortage of supplies.
Currently, there are three different vaccines approved by the EMA; the Pfizer/BioNTech vaccine, the Moderna jab and now the AstraZeneca vaccine.
And there have been issues with all three – even before approval when it comes to AstraZeneca.
On 15 January Pfizer warned vaccine deliveries would be reduced temporarily while it carried out work at its manufacturing plant in Belgium to ensure it can scale up its production capacity to meet larger supplies later in the year.
Just today Moderna told Italian and French authorities that it will deliver 20-25% fewer doses than expected in February to those countries.
In response to a query from TheJournal.ie, the HSE said the Moderna delivery next week of 6,000 doses will not be impacted but it expects subsequent deliveries in February to be reduced.
“We remain engaged with the manufacturer to understand the scale of these reductions,” it said.
“While we can plan for different scenarios with regard to vaccine volumes and deliveries, we cannot provide certainty at this time. The projected volumes and deliveries of vaccines remain subject to change.
“Notice for delivery can be short, so we must be in a position to respond quickly. This underlines the fluidity of the process of rolling out vaccines against evolving information, in a constantly changing landscape.”
And the expected cuts to AztraZeneca’s early supplies are now well publicised. This day last week, the firm warned supplies of its vaccines to Europe would be “lower than originally anticipated”. The company said this was due to reduced production at a manufacturing site.
Last week Irish officials this will mean there would be 300,000 fewer doses in the first three months of the year, though EU negotiations may now have reduced that shortfall.
The cuts to supplies, particularly the Pfizer reductions, have had a clear impact on the ability of countries to successfully roll-out their vaccination programmes in the way they had initially planned.
Spain, which managed to secure early supply deals, was running out of vaccine doses this week.
Delays in shipments of the Pfizer/BioNTech and Moderna vaccines have put pressure on the country’s regional vaccination campaign.
In Madrid, officials said they would have to suspend new first doses for two weeks due to a lack of supply, so they can ensure people receive their second doses.
Catalonia’s health chief also said the region had practically finished its reserve supplies, warning that within days “the refrigerators will be empty”.
The southern Andalucia region also temporarily halted its programme due to the supply shortage.
The government sent in emergency supplies earlier this week so the campaign could resume.
Some regions said they had only received half their expected supply and had only managed to keep going using their strategic reserves.
In Ireland, deliveries of more than 40,000 doses should be arriving into the country every week by now – this week the figure is 32,700.
The reduced deliveries from Pfizer mean the roll-out of the vaccine to those aged over 70 will be delayed as the HSE is still trying to work its way through residents at longterm care facilities and frontline healthcare workers.
Today Professor Brian MacCraith, head of the national vaccination taskforce, said Ireland is “sticking to the principle of administering vaccines as soon as they arrive”.
“We’re right to the edge of the supply that’s available. There are no vaccines resting in the fridges or freezers in any given week.”
Uncertainties around deliveries make it significantly more difficult to plan vaccinations on this two-dose schedule.
Next week there will be no first doses administered in Ireland as the supply is needed to ensure those who received a first dose already get their second dose within the required 28-day timeframe.
EU officials have come out swinging this week, telling AstraZeneca that it will be held to its contractual commitments.
The Commission’s President, Ursula von der Leyen said this week that companies “must deliver”.
“They must honour their obligations. And this is why we will set up a vaccine export transparency mechanism,” she added. “Europe is determined to contribute to this global common good, but it also means business.”
With news of supply issues coming from vaccine manufacturers on a now weekly basis and some member states already branching out on their own, the European Commission will be under increasing pressure from member states to prove the worth of its collective approach.
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