The EU is scrambling to expand domestic production of giant plastic bags crucial to vaccine-making, as part of a response to possible shortages and US controls on critical raw material exports.
Merck, the German drugs giant, is planning to boost EU output of the disposable vessels to ease the threat of supply squeezes and boost Brussels’ attempts to improve sluggish jab deliveries.
The EU initiative highlights growing concerns about a threat to European vaccine manufacturing if supplies of vital items from the US are squeezed by Washington’s efforts to maximise domestic US jab availability. Efforts by the EU to convince the US to release unused batches of AstraZeneca vaccine made in the country have so far failed to bear fruit.
Thierry Breton, EU internal market commissioner, is leading a task force that aims to scale up European vaccine production and deal with the growing risks of so-called “vaccine nationalism” as countries seek to hoard stocks. EU officials are particularly spooked by an executive order signed by President Joe Biden in February to review crucial supply chains to “ensure Americans have goods they need in a time of crisis”.
Imported disposable plastic bags used in bioreactors that mix vaccine ingredients are a “significant bottleneck” prioritised for action, according to an internal European Commission analysis of potential problems, which added that dialogue on the topic had been established with the US.
If capacity to make them is not increased, shortages will begin to bite within months, officials said. The review, which has been seen by the Financial Times, is due to feed into discussions among EU leaders at a summit later this month.
The goal now is to boost production of the bags in the EU, a senior bloc official said. The EU has held talks with Germany’s Merck, the main worldwide supplier of the disposable containers, to expand a factory in the bloc to make them.
The company said: “Plans are currently under way to further expand our life science manufacturing in Europe. We are in talks with the relevant authorities.”
Covid-19 jabs developed by companies including BioNTech/Pfizer, Moderna and Novavax are made in the bags — which are used as sterile liners in the tanks where vaccines are produced.
Raw material shortages were a key topic of discussion in a call last week between Breton and Jeffrey Zients, US Covid-19 co-ordinator, EU officials said. The European bloc wants to ensure flows of raw materials across the Atlantic are not interrupted by regulatory barriers.
Other items the commission has identified as at risk of import shortage include vaccine vials and so-called lipid nanoparticles, which are crucial to the pioneering mRNA vaccines produced by BioNTech/Pfizer and Moderna in the EU.
Another EU focus is on improving supply of low dead space syringes, which maximise the use of the vaccine by enabling extra doses to be taken from vials.
There are also concerns about “fill and finish” capacity, the final stage of vaccine production. The commission wants to step up “matchmaking” contacts between jab makers and fill and finish facilities to flag potential problems early.
The US has said it is working hard to minimise or eliminate the potential impacts on raw materials that could flow from its tightened rules. It has described the US and EU as reliant on each other for key components in the manufacturing process, meaning that co-operation is “critical”.