LONDON – The European Commission is laying plans for joint procurement of COVID-19 vaccines on behalf of all 27 EU member states, and is in discussions to agree on a harmonized approach to access and who gets vaccinated first.
“Our job, working together with member states and other international partners, is to provide the right framework,” said Martin Seychell, deputy director of the EU health directorate DG Santé. “There are a number of dimensions to this and, inescapably, a political dimension – it can’t be allowed to degenerate into a race about who gets there first.”
The framework will allow the EU to present a united front. “For a challenge on this scale, procurement has to be done as jointly as possible. European member states won’t be able to do it better on [their] own,” Seychell told attendees of a webinar, titled “United in the search of a COVID-19 vaccine,” organized by the European Federation of Pharmaceutical Manufacturers and Associations.
When faced with shortages of equipment and drugs at the beginning of the pandemic, there were examples of EU member states blocking exports, and of shortages, as supply lines to China dried up. The European Commission stepped in to organize a joint procurement, using the combined purchasing power of member states to secure supplies.
In the case of vaccines, “we want to avoid member states competing for resources,” Seychell said. “We’ve already got positive experience of procuring jointly. That shows all member states can get access to vaccines at the same time, regardless of size.”
Working together in that way will incentivize investment and help manufacturers with planning, because they won’t have to spend time negotiating contracts with 27 different governments, said Seychell.
Jean Lang, associate vice president of vaccines manufacturer Sanofi Pasteur, of Paris, and chair of the research working group at the lobby group Vaccines Europe, said the industry is moving at unprecedented speed, and not waiting for clinical trial results before scaling up.
“For manufacturing, we are having to buy raw materials right now,” Lang said. That is why advance purchase agreements are important. “We have got to balance our investment [against] what will be needed at the end.”
The French government was stung last month when the CEO of Sanofi suggested that, if approved, the U.S. will be first in line to receive supplies of the two COVID-19 vaccines the company is developing, because it was first to fund the research.
Similarly, the German government reacted strongly to a rumor the U.S. administration had made an offer to acquire Curevac AG, which is developing an mRNA-based COVID-19 vaccine.
Last week, France, Germany, Italy and the Netherlands announced the formation of an “inclusive vaccines alliance” and said they are in joint discussions with pharmaceutical companies to accelerate production of a COVID-19 vaccine “on European soil.”
The alliance said it wants to involve the European Commission and other member states in the negotiations.
In another move to attract vaccines developers to Europe, the Belgian government is investing €20 million (US$22.7 million) in setting up a quarantine unit at the University of Antwerp, where COVID-19 human challenge studies will take place.
Pierre van Damme, vice dean of the faculty of medicine at the university, said that with incidence of the infection falling, it will be “tricky” trying to show vaccines are effective in phase III field trials. The facility will house 30 young, healthy adults, who will be vaccinated, with half challenged with COVID-19 and half with placebo.
Ethical approval is not yet in place, and challenge trials will only go ahead once there is an effective therapy, but van Damme said, “It’s a very quick way to show a vaccine is effective.”
Currently, there are challenge trial facilities in the U.S. and U.K., but no such unit on mainland Europe. “It is independent, so we can work with [multiple] companies on contract work,” said van Damme.
‘One continuous process’
The European Commission has only a limited role in health care, which is entirely a matter for member states. But it has mobilized several instruments it does have at its disposal to promote research and development, including the Innovative Medicines Initiative, which has switched funding to the COVID-19 response; the European Investment Bank, which is providing loans for biotechs working on vaccines; the European Center for Disease Control, which is studying the epidemiology of the disease across Europe to help understand who to prioritize for vaccination; and the EMA, to speed up regulatory approvals.
Now, Seychell said, the EC is working on a strategy to “maximize the chances of success” of vaccines in development, and to do that “in the shortest possible timeframe.”
“We see this as one continuous process,” said Seychell. “You need to provide certainty; you can’t separate research from what happens next, so there need to be talks about advance purchase agreements.”
The commission also wants to set out a plan on prioritizing access to COVID-19 vaccines that all member states agree to. “We need clarity on the criteria we will use to prioritize,” Seychell said. “Ultimately, governments will buy the vaccines, but access needs to be based on science, on who is suitable for [a product], and on what is known about the disease – for example, some groups are more exposed than others,” he said.
For Seychell, it is very important the public understands that looking for ways to accelerate timeframes does not involve cutting corners, or changing rules. “What we are talking about is working in parallel, not sequentially.
“To accelerate, we need to work as much as possible in parallel, knowing that we will incur a certain financial hit,” said Seychell. “But bear in mind, we are taking a big hit every day on the economy.”