European regulator gives green light for roll-out of Moderna vaccine
Europe's drug regulator has given the go ahead for the use of US laboratory Moderna's Covid-19 vaccine - the second such inoculation the medical control body has approved. The decision comes as world health authorities accelerate vaccination efforts against a background of fears over more infectious variants of the coronavirus.
Wednesday's approval comes as countries race to contain two variants found in South Africa and Britain that are more transmissible and have driven a surge in the number of 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 the treatment can be rolled out across the European Union is approval by the bloc's executive body, the European Commission.
📢 EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent #COVID19 in people from 18 years of age: https://t.co/l9KMZlx7wa pic.twitter.com/BdvXanjOHN— EU Medicines Agency (@EMA_News) January 6, 2021
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 is a further validation of so-called genetic mRNA technology.
The week before Christmas, the EU approved a vaccine developed by Pfizer-BioNTech, 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.
Is this vaccine effective against Covid variants?
The EU has ordered 160 million doses of the shot developed by Moderna, sufficient to vaccinate 80 million people in the bloc's 27 member states.
The vaccine was about 95 percent 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 treatment. 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.
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 doses 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.
Good news for our efforts to bring more #COVID19 vaccines to Europeans!— Ursula von der Leyen (@vonderleyen) January 6, 2021
@EMA_News assessed that the @moderna_tx vaccine is safe & effective.
Now we are working at full speed to approve it & make it available in the EU.
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 more rapidly than conventional vaccines.
Moderna has raised its production target for 2021 to at least 600 million doses, up by 100 million.
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