Moderna reported on Friday the receipt of FDA approval for the company's COVID-19 vaccine in the US, which will also result in approval for the vaccine in Israel As happened with the Pfizer vaccine last week
The FDA has approved the distribution and use of Moderna's COVID-19 vaccine known as mRNA-1273 in adults over 18 years of age under an Emergency Authorization (EUA). Shipping to the US government will begin immediately.
Moderna will continue to collect additional data and intends to submit an application for a biological drug license (BLA) for full approval in the US during 2021.
Local distribution under cooling conditions of 2-8°C
Moderna has updated its treatment and distribution procedures for mRNA-1273 which now include local distribution under controlled conditions in a liquid state and at a temperature of 2-8°C. This important update eases the logistical burden involved in transporting the vaccine to more distant areas and ensures the removal of barriers for the vaccinators. As previously reported, mRNA-1273 remains stable at normal refrigeration temperature of 2-8°C for 30 days.
80 million additional vaccine doses for the European Union
The European Commission exercised its option to purchase an additional 80 million doses of mRNA-1273 for the member states of the European Union, thus bringing the total orders from the EU to 160 million doses of Moderna's mRNA-1273.
"We appreciate the expression of confidence in Moderna and mRNA-1273, our vaccine for COVID-19, which is reflected in the extension of the supply agreement to the European Commission," said Moderna CEO Stephan Bansel. As we shift our focus to shipping our vaccine, and await a positive opinion from the EMA and other regulatory bodies, we are more committed than ever to working with governments and partners around the world to address this pandemic."
"I am proud of what the Moderna team has achieved together with our partners. We were able to create and manufacture Moderna's COVID-19 vaccine in 11 months, advancing clinical development with pivotal Phase 1, Phase 2, and Phase 3 studies in 30,000 patients. This is a decade-long scientific, entrepreneurial and medical journey and I thank all those who helped us get here today. We continue to focus on increasing production which will help us protect as many people as possible from this terrible disease." Stefan Bansel, CEO of Moderna, said.
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