Updated 01/08/2020: The Moderna vaccine is now authorized in the European Union, following the granting of a conditional marketing authorization by the European Commission on 6 January.
The European Union’s (EU) drug watchdog has given the green light to the Moderna COVID-19 vaccine. With this hurdle overcome, EU leaders say they are working at full speed to make it available in the EU.
Today, the European Medicines Agency (EMA) recommended granting conditional authorization for the Moderna COVID-19 vaccine for people over 18. They assessed the data on the quality, safety, and efficacy of the vaccine and concluded it meets all the necessary standards. The vaccine must now be officially authorized by the European Commission, which is expected to grant the authorization promptly.
The vaccine is set to become the second COVID-19 vaccine approved in the EU, nearly two weeks after it approved the Pfizer/BioNTech vaccine. It will become the fourth international authority to approve the Moderna vaccine, following Israel on January 4, 2021, the US on December 18, 2020, and Canada on December 23.
Moderna says the European Commission has a total order commitment of 160 million doses of their COVID-19 vaccine. The EU has also secured a supply deal with BioNTech and Pfizer for 300 million doses of their COVID-19 vaccine.
The vaccine, called mRNA-1273, is based on new mRNA technology, like the Pfizer/BioNTech vaccine. It works by injecting a small synthetic fragment of the virus's genetic code, the mRNA, into the human body. This genetic code gives instructions for our cells to make a harmless piece of the virus’s “spike protein.” The body’s cells read these instructions and produce that harmless fragment. Once this piece of protein enters the bloodstream, our immune system "learns" to produce antibodies for it.
Clinical trials of the Moderna vaccine proved very promising. A trial of 30,000 participants in the US, half of which were given two doses of the vaccine (four weeks apart) and the other half were given a placebo, found that the vaccine had an overall efficacy of 94 percent at preventing symptomatic COVID-19 cases. Importantly, it was found to be 100 percent effective at preventing severe COVID-19.
“This vaccine provides us with another tool to overcome the current emergency,” Emer Cooke, Executive Director of EMA, said in a statement. “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 WHO."
This is a breaking news story and will be updated as more information becomes available.
For more information about COVID-19, check out the IFLScience COVID-19 hub where you can follow the current state of the pandemic, the progress of vaccine development, and further insights into the disease.
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