Moderna announced today that the European Commission has approved an agreement to buy 80 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, with the option to increase their purchase to a total of up to 160 million doses.
Yesterday, the President of the European Commission Ursula von der Leyen released a statement that the EC plans to sign the game-changing agreement with Moderna to secure a safe and effective COVID-19 vaccine for European citizens.
EC approves purchasing of up to 160 million doses of Moderna’s COVID-19 vaccine
President von der Leyen said:
‘”I have today good news: I am happy to announce that tomorrow we will approve a new contract to secure another COVID-19 vaccine in our vaccine portfolio. This contract allows us to buy up to 160 million doses of a vaccine produced by Moderna.”
Indeed, Moderna confirmed in a press release today, that the EC has approved the agreement to secure an initial 80 million doses of the mRNA-based vaccine. Under the terms of the proposed agreement, the EC has the option to increase their purchase of mRNA-1273, to a total of up to 160 million doses. The agreement will be finalized following a short review period by the European Union Member States.
The EC President also revealed that with this sixth in the row contract signed for the procurement of a potential COVID-19 vaccine, the commission is going to have one of the most comprehensive COVID-19 vaccine portfolios in the world.
The EC President went on to say:
“This provides Europeans access to the most promising future vaccines under development so far. Of course, all vaccines from our portfolio will be evaluated very carefully by our European Medicines Agency (EMA). They will only be authorised and placed on the market if they are safe and if they are effective. Transparency here is crucial and of utmost importance.”
Vaccine to be distributed to all EU Member States
Ursula von der Leyen went on to explain that very soon, once the safety and efficacy of the Moderna COVID-19 vaccine is proven, the contracted vaccine doses will be distributed on a pro-rata basis simultaneously to every EU Member State with the same conditions. The President emphasized that the primary goal is to quickly provide vaccinations for European citizens but at the same time, another important priority is to ensure that everyone, anywhere in the world, has access to vaccines and that the supply of vaccines needs to be affordable and fair.
Delivery of the vaccine could begin as early as Q1 next year if it is approved for use by the European Medicines Agency (EMA) human medicines committee (CHMP), which started a rolling review of mRNA-1273 on the 17th of November.
Stéphane Bancel, Chief Executive Officer of Moderna stated:
“We appreciate the confidence the European Commission has demonstrated in our mRNA vaccine platform by including mRNA-1273 in their portfolio of vaccines. We recognize that tackling this global pandemic will require a number of solutions, and we are proud of the role Moderna has been able to play in this global effort. We have scaled up our manufacturing capacity outside of the United States with our strategic partners, Lonza and Rovi, to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year beginning in 2021, if approved.”
Moderna could start shipping its COVID-19 vaccine in December
In Europe, Moderna is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside of the United States. This is a dedicated supply chain set up by Moderna to support Europe and countries other than the United States that enter into purchase agreements with the American mRNA vaccine specialist. Moderna says it remains on track to produce 500 million to 1 billion doses globally in 2021. If the relevant regulatory approvals are granted, Moderna expects to begin shipping it’s COVID-19 vaccine mRNA-1273 to the European Union beginning in December 2020.
Moderna’s vaccine has shown efficacy of 94.5%
On November 16, Moderna announced that the independent, U.S. NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of its vaccine candidate mRNA-1273 has informed Moderna that the trial has met pre-specified the statistical criteria for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
To learn more, visit www.modernatx.com.