On January 6, the European Commission issued a conditional marketing authorization for the COVID-19 vaccine developed by Moderna. It is the second COVID-19 vaccine approved in the EU. The vaccine has been approved following a positive scientific recommendation based on a careful assessment of its safety, efficacy and quality by the European Medicines Agency (EMA) and supported by the Member States.
European Commission President Ursula von der Leyen said: We have provided Europeans with additional vaccines against COVID-19. With the Moderna vaccine, the second vaccine now approved in the Union, we are getting an additional 160 million doses and that number will grow. Europe has provided up to two billion doses of potential vaccines against COVID-19. We will have more than enough safe and effective vaccines to protect all Europeans.
Food and Health Commissioner Stella Kyriakides said: We are all united in this. That is why we have managed to agree on the largest vaccine portfolio in the world for all our Member States. Today, we are approving another safe and effective vaccine, Moderna, which, together with BioNTech-Pfizer, will ensure that 460 million doses are distributed in the Union as soon as possible, and there will be even more. Member States must allow vaccination to take place at the same rate. We will not stop until we provide a vaccine for every EU citizen.
On November 30, 2020, Moderna applied to the EMA, which had already begun a continuous review of the data in November, for approval to place the vaccine on the market. Continuous review means that the EMA assesses the quality, safety and efficacy of the vaccine as data becomes available. The EMA's Committee for Medicinal Products for Human Use (CHMP) thoroughly reviewed the data and recommended by consensus the issuance of an official conditional marketing authorization. Conditional marketing authorization is one of the EU's regulatory mechanisms to facilitate early access to medicines that meet unmet medical needs, including in emergencies such as the current pandemic.
On the basis of the EMA's favorable opinion, the Commission examined all the elements supporting the marketing authorization and consulted the Member States before issuing the conditional marketing authorization.
The Modern vaccine is based on messenger RNA (mRNA) molecules, which play a key role in biology because it transmits instructions from DNA to the cellular system for protein production. In an mRNA-based vaccine, these instructions create harmless parts of the virus that the human body uses to build an immune response to prevent or suppress disease. When a person receives the vaccine, their cells read the genetic instructions and produce the spike protein, a protein found on the outer surface of the virus that the virus uses to enter the body's cells and cause disease. The immune system then treats this protein as a foreign protein and creates a natural defense against it - antibodies and T-cells. Learn more about the next steps here