Moderna reported on Friday that it received 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 a Biologics Licensing Application (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 vote of confidence in Moderna and in mRNA-1273, our vaccine for COVID-19, as reflected in the extension of the supply agreement to the European Commission," said Stephane Bansel, CEO of Moderna. As we shift our focus to shipping our vaccine, And awaiting 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 the pandemic this."
"I'm proud of what Moderna's team and our partners have accomplished. We were able to create and manufacture Moderna's vaccine for COVID-19 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 some More people from this terrible disease." Stefan Bansel, CEO of Moderna, said.
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