Now, as European Union regulators edge closer to approving two of those vaccines, the commission is asking its 27 nations to get ready to work together to roll them out.
If it all goes to plan, the EU’s vaccine program could go down as one of the greatest achievements in the history of the European project.
The EU has suffered a sustained battering in recent years, fueled by the UK’s departure, a surge in nationalist parties, and Euroskeptic attitudes across the continent.
And so far, the coronavirus crisis has only exacerbated existing tensions.
Early in the pandemic, a messy bidding war for personal protective equipment raged between member states, before the commission established a joint procurement program to stop it.
In July, the bloc spent days battling over the terms of a landmark €750bn (US $909bn) coronavirus recovery fund, a bailout scheme that links payouts with adherence to the rule-of-law and the upholding of democratic ideals, including an independent judiciary. Hungary and Poland vetoed the deal in November, forcing the bloc to broker a compromise, which was agreed last week.
And in the fall, member states spent more than a month squabbling over the commission’s proposal to streamline travel guidelines around quarantine and testing.
But when it comes to the EU’s vaccine strategy, all member states — along with Norway and Iceland — have jumped on board, marking a step toward greater European unity.
The commission says its aim is to ensure equitable access to a coronavirus vaccine across the EU — and given that the virus knows no borders, it is crucial that countries across the bloc cooperate and coordinate.
But a collective approach will be no small feat for a region that encompasses disparate socio-political landscapes as well as wide variants in public health infrastructure and anti-vaccine sentiments.
An equitable agreement
The EU has secured enough potential vaccine doses to immunize its 448 million citizens twice over, with millions left over to redirect or donate to poorer countries.
This includes the purchase of up to 300 million doses of the Pfizer/BioNTech vaccine and up to 160 million from US biotech company Moderna — the current frontrunners. The European Medicines Agency (EMA) — which evaluates medicines and authorizes their use across the EU — is expected to authorize the Pfizer/BioNTech vaccine on December 21 and Moderna in early January.
The first rollout will then begin on December 27, according to European Commission President Ursula von der Leyen.
The agreement also includes up to 400 million doses of the UK-Swiss Oxford/AstraZeneca offering, whose first batch of clinical trial data is being reviewed by the EMA as part of a rolling review.
Last week, following mixed results from its clinical trials, AstraZeneca announced it would also begin a joint clinical trial with the makers of the Russian Sputnik V vaccine, to find out if a combination of the two vaccines could offer improved protection from the virus.
The EU’s deal has also secured up to 405 million doses from the German biotech Curevac; up to 400 million from US pharmaceutical giant Johnson & Johnson; up to 200 million doses from the US company Novovax; and up to 300 million doses from British and French companies GlaxoSmithKline and Sanofi, which announced last Friday that the release of their vaccine would be delayed until late next year.
These all serve as a down-payment for member states, but ultimately each country will have to buy the vaccines on their own. The commission has also offered guidance on how to deploy them, but how each country gets the vaccine to its citizens — and who they choose to prioritize — is entirely up to them.
Most governments have, however, signaled that they are planning to follow EU guidance on prioritizing the elderly, healthcare workers and vulnerable populations first, according to a recent survey by the European Centre for Disease Prevention and Control (ECDC).
On Tuesday, eight countries — Belgium, France, Germany, Italy, the Netherlands, Spain and Luxembourg (as well as Switzerland, which is not in the EU) took this a step further by making a pact to coordinate their strategies around the rollout. The joint plan will facilitate a “rapid” sharing of information between each country and will streamline travel guidelines for cross-border workers, who will be prioritized.
Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, said it is a good idea to take a coordinated approach, to instill greater confidence among the public and to mitigate the risk of any differences being exploited by the anti-vaccine movement. But he added that it is understandable that governments also want to make their own decisions.
He highlighted the cases of Ireland and France, which have both said they plan to also prioritize people working or living in high-risk environments where the disease is easily transmissible, such as in Ireland’s meat packing industry or France’s transport sector.
There’s no right or wrong approach for governments to take, McKee stressed. “What is really important is that every country has a published plan, and has consulted with the people who will be doing it,” he said.
While countries strategize, they will have one eye on the UK, where the Pfizer/BioNTech vaccine was authorized on December 2 and is already being administered, after the British government rejected the EU’s invitation to join its procurement scheme back in July.
The UK rollout could serve as a useful blueprint to EU countries in 2021.
But some are already ploughing ahead with their own plans.
Loopholes over loyalty
In October, Hungary announced a plan to import the Russian-made Sputnik V vaccine which is not authorized by the EMA — prompting a rebuke from the commission, which said the vaccine must be kept inside Hungary.
Hungary is also in talks with China and Israel about their vaccines.
Using an EU regulatory loophole, Hungary pressed forward with its plan to use the Russian vaccine last week, announcing that between 3,000 and 5,000 of its citizens could participate in clinical trials of Sputnik V.
Germany is also casting its net wide, having signed additional deals with three federally-funded national biotech firms including BioNTech and Curevac earlier this month, bringing the total number of doses it has secured — inclusive of the EU deal — up to 300 million, for its population of 83 million people.
On Tuesday, German health minister Jens Spahn said his country was also planning to sign its own deal with Moderna. A health ministry spokesperson told CNN that Germany had secured additional doses in the event that some of the other EU-procured vaccine candidates did not get authorized.
Suerie Moon, co-director of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva told CNN that it “makes sense” that Germany wants to ensure it has enough safe and effective vaccines.
Beyond the public health rationale, Germany’s plan could also serve to boost domestic interests, and to wield global influence, she said.
But David Taylor, Professor Emeritus of Pharmaceutical and Public Health Policy at UCL, believes EU countries are aware of the dangers of prioritizing their needs over those of others, having seen the behavior of other wealthy nations like the US.
A recent British Medical Journal report found that a quarter of the world’s population may not get a Covid-19 vaccine until 2022, due to high income countries hoarding planned doses — with Canada, the UK and the United States the worst offenders. The US has ordered roughly four vaccinations per capita, according to the report.
“America is setting an example of vaccine nationalism in the late stages of Trump. Europe will be warned about the need for fairness and solidarity,” Taylor said.
A rollout like no other
Most experts agree that the biggest challenge for the bloc will be the actual rollout of the vaccine across the population of its 27 member states.
Both Pfizer/BioNTech and Moderna’s vaccines, which use new mRNA technology, differ significantly from other more traditional vaccines, in terms of storage.
Moderna’s vaccine can be stored at temperatures of -20C (-4F) for up to six months and at refrigerator temperatures of 2-8C (35-46F) for up to 30 days. It can also be kept at room temperature for up to 12 hours, and doesn’t need to be diluted prior to use.
The Pfizer/BioNTech vaccine presents more complex logistical challenges, as it must be stored at around -70C (-94F) and lasts just five days in a refrigerator. Vials of the drug also need to be diluted for injection; once diluted, they must be used within six hours, or thrown out.
Jesal Doshi, deputy CEO of cold chain outfitter B Medical Systems, explained that many public health systems across the EU are not equipped with enough “ultra-low” freezers to handle the requirements of the Pfizer/BioNTech vaccine.
Only five countries surveyed by the ECDC — Bulgaria, Hungary, Malta, the Netherlands and Sweden — say the infrastructure they currently have in place is sufficient enough to deploy the vaccines.
Given how quickly the vaccine has been developed and authorized, it’s likely that most health systems simply haven’t had enough time to prepare for its distribution, said Doshi.
Central European countries might be better prepared than the rest in that regard, according to McKee, since their public health systems have recently invested significantly in infectious disease control.
From 2012 to 2017, the largest expansions in current healthcare expenditure were recorded in Romania, Bulgaria, Estonia and Lithuania, according to Eurostat figures.
But an unusual scenario in this pandemic is the fact that countries will likely end up using two or more different vaccines to cover their populations, said Dr. Siddhartha Datta, WHO’s Europe program manager for vaccine-preventable diseases.
Vaccine candidates such as Oxford/Astrazeneca’s offering — which experts say is likely to be authorized by European regulators after Moderna’s — can be kept at normal refrigerator temperatures for at least six months, which will be of benefit to those EU countries which are ill-equipped to handle the additional demands of cold chain storage on their health services.
More than cold chains
But when it comes to rolling out these vaccines, a strong cold-chain network is just one part of a 10-point plan, said Datta.
He stressed that factors such as monitoring systems, community engagement and human resourcing are all crucial to a successful rollout. “There cannot be any cherry picking,” Datta told CNN.
Without a robust monitoring mechanism in place, McKee said people may not turn up for a second dose, risking vaccine wastage. It could also lead to concerns that the vaccines are not effective.
“A vaccination program requires a comprehensive systems approach where everybody knows what they are meant to be doing, and who they are communicating with,” said McKee. “You almost need to do rehearsals and run-throughs and iron out all the problems.”
Countries such as Sweden, Denmark, and the Netherlands (as well as the UK) will likely excel with those monitoring systems, he said.
But others including Bulgaria, Cyprus, France, Hungary and Slovakia have weaker monitoring systems in place, including a paper registry, according to the ECDC report.
Still, most EU countries are preparing for their dress rehearsal, including the ramping up of human resources needed for this mass effort.
The ECDC report states that 12 countries have reported plans to mobilize and train additional medical staff to administer the vaccines. That includes France, which plans to bring doctors out of retirement to help, and Germany, which in addition to recalling retired doctors, plans to enlist the help of NGOs, the armed forces and volunteers to coordinate its efforts.
Germany is also constructing dozens of vaccination centers where up to 1,000 people a day could be vaccinated, and Italy plans to build 1,500 pop-up vaccine pavilions. Eleven other countries, including Romania and Lithuania, also plan to administer the vaccine at dedicated centers.
The remaining countries say they plan to use — and build on — existing vaccination delivery services and structures for the roll-out, specifying that places used for the seasonal flu shot would be leveraged for this campaign. Six countries — Austria, Denmark, Estonia, Germany, Latvia, Luxembourg and Spain — are also deploying mobile vaccination units.
None of that will matter, though, if people across the EU aren’t willing to take the vaccine in the first place.
‘A blink of an eye’
Global vaccine hesitancy has grown in recent years, with the WHO identifying it as one of its top ten global health threats last year. Now, the speed at which Covid-19 vaccines are being developed has brought concerns about their safety to new levels — with significant levels of doubt reported across the EU.
A survey by Imperial College London’s Institute of Global Health Innovation and pollsters YouGov in November (before the Pfizer/BioNTech vaccine was authorized for use anywhere) found that only 35% of respondents in France said they would get vaccinated in 2021, with 41% saying they were unwilling to do so.
The study reported similar trends in Spain and Sweden, where only 41% and 44% of people said they would be willing to get the vaccine next year.
Recent surveys from the US and the UK, however, indicate that confidence in Covid-19 vaccines is growing.
But the fact is that most countries in the bloc have reported at least some degree of hesitancy among their populations, which will likely impact efforts to bring the pandemic under control.
Moon said what is different about the coronavirus vaccine is the hesitancy seen from a group of people not typically aligned with hard and fast anti-vaccine views.
“Studying a virus for less than a year is a blink of an eye in scientific time, and the accelerated pace of development of the vaccines has led some to have anxieties around taking it,” she said.
WHO’s Datta agrees, noting that those people questioning why a 10-year cycle has come to an end after 10 months aren’t necessarily vaccine hesitant, but rather are searching for answers to calm any fears that corners may have been cut in the development or approval process.
He added that it’s a sign of a “healthy behavior of a population” if they have questions about vaccines.
Moon says she wouldn’t be surprised if some countries decide to take a slower approach to the rollout, noting that some governments may choose to watch what happens in other countries first, in order to build vaccine confidence in their own populations.
“Everyone wants answers and certainty, and we just don’t have it yet,” she said.
This means governments and health agencies need to be transparent when communicating to the public, said Datta.
But Moon believes this won’t be easy.
“In this environment, in 2020, just the mere questioning of scientific evidence or facts can spread like wildfire and can change what people believe and decide to do,” she said.
“No matter what government authorities or public health experts say or do, there are limited tools at our disposal to really address that challenge.”
Once vaccination programs are underway, they could be used to determine movement across the EU in order to control the spread of the virus.
While no nation has yet announced plans to introduce a “vaccine passport,” travelers may find themselves having to prove that they’ve been vaccinated in order to avoid quarantine or travel restrictions.
Coronavirus testing has been used for similar purposes in recent months.
Italy’s national airline Alitalia recently trialled a “Covid-tested” domestic flight where every passenger had to prove they were virus-free; an international pilot of that program began last week.
And Hungary has only allowed people into its borders if they are able to prove that they have recovered from Covid-19 by showing both a positive and negative test recorded within the past six months.
A vaccine passport would take that idea one step further.
It’s not a new idea, given that visas to some countries in Sub-Saharan Africa, for example, are dependent on a traveller being able to show they’ve been vaccinated against yellow fever.
But vaccine trials haven’t been able to give scientists a clear picture of how vaccines affect transmission, or how long their protection lasts, so experts believe ethical concerns could remain a sticking point.
McKee says that there are still too many variables for countries to start considering the possibility of those passports.
“I’d suggest that decisions for now should be driven by the numbers of infections, rather than the number of people who are vaccinated,” he said.
But with infections climbing across the EU, leaving many countries once again tightening restrictions as a second wave spreads, hope inevitably lies in the vaccine — presenting an ideal opportunity for the bloc to overcome its many divisions and truly deliver on its vision of unity.
Correction: A previous version of this story misstated Luxembourg’s status in the European Union. It is an EU member country.
Source : Cnn