EU regulator approves Moderna vaccine as fears mount over virus variants

Europe's drug regulator gave the green light to Moderna Inc's Covid-19 vaccine on Wednesday, the second shot it has approved, as authorities accelerate inoculation efforts amid fears about more infectious variants of the coronavirus.

Vaccinating the European Union's 450 million people could be crucial to ending a pandemic that has killed almost 1.9 million people globally. The approval comes as countries are racing to contain two variants found in South Africa and Britain that are more transmissible and have driven a surge in infections.

The EU's European Medicines Authority (EMA) said it had given the go-ahead for the use of the Moderna vaccine on people aged over 18 following an assessment of the data on quality, safety and efficacy.

The final step before it can be rolled out across the European Union is approval by the bloc's executive body, the European Commission, which is expected to follow soon.

The decision, coming just over a year since the first outbreak of the virus was identified in China, marks the second regulatory authorisation for Moderna's vaccine after the United States, and further validation of new genetic mRNA technology.

"This vaccine provides us with another tool to overcome the current emergency," said Emer Cooke, EMA executive director.

The EU approved a shot from Pfizer Inc and BioNTech SE, also based on mRNA technology.

The regulator has given a conditional marketing approval for both, rather than the ultra-fast emergency use clearance issued by Britain, which the EMA says requires more detailed study of the data.

Effective against variant?

The EU has ordered 160 million doses of the shot developed by Moderna, a U.S. biotech company, enough to vaccinate 80 million people in its 27 member states.

The vaccine was about 95% effective at preventing illness in clinical trials, which found no serious safety issues. It has to be stored and shipped frozen, but does not require the ultra-cold temperatures of the Pfizer/BioNTech vaccine. Once thawed, it can be kept at typical refrigerator temperatures.

The Dutch national drugs authority, the CBG, said the Moderna vaccine was expected to be effective against the variant of the coronavirus detected in Britain, but cautioned this had to be confirmed by further research.

The CBG added that the European Commission was expected to give the final stamp of approval to the shot later on Wednesday.

Synthetic Genes technology

The campaign to vaccinate the EU's population has already gotten off to an uneven start, with officials in Germany and France frustrated at the slow rate of progress.

Hundreds of thousands of Europeans have received the Pfizer-BioNTech shot since the rollout began just over a week ago. By comparison, Britain has administered more than a million of the vaccine in just under a month.

The Netherlands started vaccinations with that shot on Wednesday, giving its first injection to a 39-year old care home nurse.

The Moderna vaccine is administered in two doses 28 days apart. Like the Pfizer shot, it relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines.

Earlier on Monday, Moderna raised its production target for 2021 to at least 600 million doses, up by 100 million.

Switzerland's Lonza Group has a contract to supply ingredients for the vaccine, while Spain's Rovi is assembling the shots for fill-finish services.
 

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