As the European Union struggles to accelerate its sluggish coronavirus vaccination campaign amid delivery delays and logistical problems, the bloc is ramping up its manufacturing capacity.
France will start manufacturing coronavirus vaccines on its territory on Wednesday, the country’s ministry of finance said, with the goal to produce 250 million doses by the end of the year.
In Germany, BioNTech is setting up a giant production facility in Marburg that it says can produce up to a billion doses this year alone.
The moves come as the World Health Organization said last week the rollout of vaccines in Europe was “unacceptably slow”.
As of April 4, only 12.7% of the EU’s population had received at least one injection, compared to 46.5% in the UK and 31.2% in the US.
The safety and supply troubles with AstraZeneca’s vaccine have further highlighted how reliant the EU is on research and manufacturing from outside the bloc.
In this context, EU officials are banking on homegrown production as the answer to reliable supply in the months and years ahead.
European Commissioner Thierry Breton told Le Parisien newspaper on Sunday that the bloc “will become the world’s leading vaccine producer by the end of the year, with a volume that could reach 3 billion doses per year, compared to 2 billion for the US.”
Can homegrown production really turn the tables in the EU’s bid to immunise 70% of its adult population by the summer?
Euronews takes a looks at the bloc’s production capabilities and the challenges ahead.
Where are Europe’s vaccine production facilities?
According to Breton, there are currently 52 vaccine production sites in the EU.
All manufacturing sites need to get the approval of the European Medicines Agency following a regulatory evaluation.
In recent weeks, the EU’s regulator approved several new sites:
- A factory in Leiden, the Netherlands, to make the active substance for AstraZeneca’s vaccine.
- A production site in Marburg, Germany, to make both the active substance and completed vaccine developed by BioNTech and Pfizer.
- A new manufacturing line for the production of active substance and finished product intermediates for Moderna’s vaccine in Lonza,Switzerland.
Other factories in the EU are involved in bottling and sterilisation rather than producing the active substance of the vaccine. This will be the case at the new facilities announced by France this week:
- French subcontractor Delpharm in the French northwestern Eure et Loire region will begin producing Pfizer-BioNTech vaccines on Wednesday.
- Swedish company Recipharm will produce vaccines for US pharmaceutical company Moderna by mid-April in its French factory in Monts (Indre-et-Loire, western France).
- Fareva should launch the production of CureVac, pending marketing authorisation, in its factories in Pau and Val-de-Reuil (Eure, western France) by early June.
- And French company Sanofi will produce vaccines for Janssen in Marcy-l’Etoile (Rhône, south-eastern France).
Other manufacturing sites in Europe include a plant in Puurs, Belgium, the first that produced the Pfizer-BioNTech vaccine in large quantities on the continent; and a factory in Sant Joan Despí, northeastern Spain, where the Janssen shot is being bottled.
Euronews reached out to EMA for a complete list of all manufacturing sites in Europe but did not get a reply at the time of publication.
What are the challenges of scaling up production?
Since COVID-19 vaccines use different technologies, the challenges vary from one manufacturer to the other.
For Pfizer-BioNTech and Moderna’s vaccines, the active ingredient is messenger RNA, which contains the instructions for human cells to construct a harmless piece of the coronavirus called the spike protein.
Scientists have known how to make messenger RNA for some time, but not for commercial mass production.
Some 400 employees in Marburg are confronting the challenges of large-scale production involving around 50,000 separate steps, some of which require months of training.
A crucial concern in handling mRNA, which is notoriously fragile, is rigorously avoiding outside contamination. Workers must wear two protective suits, boots and full-head coverings that take 20 minutes to put on.
Another challenge in the supply chain is the very low temperature required by messenger RNA vaccines.
“We bought 55 freezers and five tonnes of dry ice will be needed to ensure the shipment at -70 ° C of each batch of vaccine,” Stéphane Lepeu, deputy managing director of Delpharm told Challenges magazine.
The adenovirus-vector vaccines such as AstraZeneca also come with challenges of their own.
Production involves growing huge quantities of human cells in massive steel tanks. Scientists note human cell culture can be unpredictable, with similar conditions leading up to different yields.
Earlier this year, production problems at a plant in Belgium were said to be the main cause of big cuts in AstraZeneca’s COVID-19 vaccine supplies to the EU.
How much will homegrown production accelerate vaccine rollout?
“We have to do everything in our collective power to make sure that we have as much manufacturing capability as possible to increase the production of vaccines. Because that’s what’s going to impact the rollout across Europe,” European Medicines Agency Chief Emer Cooke told MEPs last month.
“We need to produce as fast as possible as many doses as possible,” epidemiologist and biostatistician Catherine Hill told Euronews. “So if we get more doses every week by setting up extra-plants, that’s good for everyone.”
Tinglong Dai, an associate professor of operations management and business analytics at John Hopkins University, told Euronews that the EU’s objective to produce 3 billion doses per year appeared “realistic.”
Whether that will turn the tables in the bloc’s slow inoculation campaign, however, is another story.
“The fact that France will bottle vaccines is not really earth-shattering,” Hill said.
AFP news agency noted that manufacturing vaccines in France was above all a “symbolic affair,” with French companies having a mere sub-contracting role. They will not be able to work miracles if they are not provided with enough active substance — which is produced elsewhere.
Furthermore, producing more vaccines in the EU doesn’t mean that all these doses will be injected to European citizens.
The EU approved the export of 21 million doses to the UK while none have come back since vaccinations began in December, bloc officials have said.
The row prompted the EU last month to move towards stricter export controls amid a shortage of doses and spikes in new cases.
In the long-term, Dai told Euronews, Europe’ main problem will be demand for vaccines rather than supply, especially in a context where citizen lack trust in the AstraZeneca shot.
“I know this sounds crazy, but to me, it’s not actually about manufacturing capacities. It’s about the demand.”
“Certainly you can always benefit by producing more vaccines but you also have to worry about the welcome of the vaccines you’re producing.”