Moderna Signs EU Deal for COVID-19 Vaccine Hopeful
Biotech firm Moderna has finalised a deal with the European Commission (EC) to supply 160 million doses of its mRNA-based COVID-19 vaccine candidate, bringing the region's overall supply to more than 2 billion doses.
The contract is the sixth such contract for Europe under the European Union (EU) Vaccines Strategy, providing for the initial purchase of 80 million doses on behalf of all EU Member States, plus an option to request a further 80 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. It joins contracts already signed with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer and CureVac.
Moderna's drug, known as mRNA-1273, has reported 94.1% efficacy with no serious safety concerns in final results from its Phase 3 study. It also reported a 100% success rate in preventing severe cases. The U.S FDA has a 50% efficacy benchmark for approving new vaccines. No official pricing details have been released but the EU is believed to have agreed a per-dose price of around $25. Moderna is aiming to submit the vaccine for emergency use authorisation to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the coming week. One of the key advantages of mRNA-1273 is that it remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. The company confirmed that it remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.
European Commission President Ursula von der Leyen said: "I'm very happy to announce today's agreement with the company Moderna to purchase up to 160 million doses of their future vaccine. This is our sixth contract with a vaccine producer, and we are working on yet another one. We are setting up one of the most comprehensive COVID-19 vaccine portfolios in the world, providing Europeans access to the most promising future vaccines under development so far. A safe and effective vaccine can help us end the pandemic, and return gradually to normal life."
Stella Kyriakides, Commissioner for Health and Food Safety, added: "Today's agreement with Moderna is yet another important milestone of our EU Vaccines Strategy. I am happy that we have now concluded six vaccine agreements so far. This is a clear demonstration of the European Health Union in action: a European Union that delivers tangible results for its citizens and a blueprint for our cooperation in the area of health in the future. A safe and effective vaccine is more important than ever in helping to restore normality and overcome this pandemic. No one is safe until everyone is safe."
In related news, Regeneron received FDA emergency use authorisation for its COVID-19 antibody cocktail, casirivimab and imdevimab, last week. The decision comes a week after Eli Lilly's single coronavirus antibody drug, Bamlanivimab, to treat mildly or moderately ill COVID-19 patients, became the first antibody drug to receive similar FDA approval. Regeneron's REGN-COV2, a combination of monoclonal antibodies casirivimab and imdevimab, is also designed to treat mild-to-moderate COVID-19 patients at least 12 years of age who are not hospitalised but, are at high risk for progressing to severe COVID-19.