EU regulators have recommended approval of US drugmaker Moderna’s Covid-19 vaccine, paving the way for its rollout on a continent in urgent need of more supply.
The European Medicines Agency on Wednesday recommended a conditional marketing authorisation of the jab, leaving only the formality of sign-off by the European Commission.
Moderna’s vaccine is the second to be approved by the Amsterdam-based regulator after BioNTech/Pfizer’s jab late last year.
The EU has ordered 80m doses of the Moderna vaccine, with an option to double the amount. The Massachusetts-based company expects to be able to manufacture up to 1bn doses this year.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, the head of the EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by the World Health Organization.”
Progress in inoculating the EU’s population has so far been slow, intensifying the pressure on governments to deliver more supply and eliminate bottlenecks.
The Moderna jab uses a novel type of technology known as mRNA that is delivered in tiny fatty particles, which are in short supply at the moment. The vaccine is Moderna’s first approved product, which it is selling at a higher price than rivals.
In the US, where regulators have already approved the injection, demand continues to outpace supply. Moncef Slaoui, chief adviser to the US’s Operation Warp Speed, has said scientists are considering halving doses in an effort to get more patients some measure of protection quickly, although a decision on whether to do so is not expected soon.
The price agreed with the EU is about €20 a dose, according to people familiar with the matter, higher than others agreed in forward-order deals negotiated by the bloc.
The Financial Times reported over the weekend that Moderna was among the drugmakers racing to secure a supply chain for the vaccine, especially for the molecules used to deliver the active ingredient of the vaccine, known as lipid nanoparticles.