The European Commission has granted conditional marketing authorisation (CMA) for the Moderna COVID-19 vaccine – the second one to be authorised in the EU.
The approval follows the scientific recommendation that the Moderna vaccine is safe and effective by the European Medicines Agency (EMA) and its endorsement from Member States. EMA’s human medicines committee (CHMP) assessed the data and recommended by consensus that a formal conditional marketing authorisation is granted. This is one of EU’s regulatory mechanisms for facilitating early access to medicines that fulfil an unmet medical need, including in emergency situations such as the current pandemic.
Moderna will deliver the total amount of 160 million doses between the first and third quarters of 2021 – adding to the 300 million doses of the vaccine distributed by BioNTech/Pfizer.
The Moderna vaccine is based on messenger RNA (mRNA) which plays a fundamental role in biology, transferring instructions from DNA to the cells’ protein-making machinery.
In an mRNA vaccine, these instructions produce harmless fragments of the virus, which the human body uses to build an immune response to prevent or fight disease by reading the genetic instructions and producing a spike protein which it uses to enter the body’s cells and cause disease and produce natural defences.
The President of the European Commission, Ursula von der Leyen, said: “We are providing more COVID-19 vaccines for Europeans. With the Moderna vaccine, the second one now authorised in the EU, we will have a further 160 million doses. And more vaccines will come. Europe has secured up to two billion doses of potential COVID-19 vaccines. We’ll have more than enough safe and effective vaccines for protecting all Europeans.”
Stella Kyriakides, Commissioner for Health and Food Safety, added: “We are all in this together and united. This is why we have negotiated the broadest vaccine portfolio in the world for all our Member States. Today we are authorising a second safe and effective vaccine from Moderna, which together with BioNTech-Pfizer, will ensure that 460 million doses will be rolled out with increasing speed in the EU, and more will come. Member States have to ensure that the pace of vaccinations follows suit. Our efforts will not stop until vaccines are available for everyone in the EU.”