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Law360 (November 30, 2020, 3:06 PM EST) -- Moderna on Monday said it is filing an emergency approval request with the U.S. Food and Drug Administration, asking the regulator to sign off on its COVID-19 vaccine that the drugmaker claims is 100% effective at preventing severe cases and 94% effective at preventing infection.
The Massachusetts-based biotechnology company said if its proposed vaccine — dubbed mRNA-1273 — is approved, it expects to be able to produce 20 million doses for U.S. distribution by the end of the year and 500 million to 1 billion doses around the world by 2021. Distribution will begin within hours of approval, the company said.
The FDA said on Monday that it will meet with the Vaccines and Related Biological Products Advisory Committee on Dec. 17 to discuss Moderna's request. The company is also seeking the green light from the European Medicines Agency and has already entered a supply agreement with the U.K. to begin distribution in March.
Moderna CEO Stéphane Bancel said in a statement Monday that an initial review of the vaccine candidate's third clinical trial phase confirms its efficacy.
"This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease," Bancel said. "We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death."
The independent Data and Safety Monitoring Board confirmed on Nov. 16 that Moderna's vaccine candidate is 94.5% effective. The phase three study included 30,000 participants in the U.S. who were given either a placebo or the vaccine, and of those, only five participants who had been given the vaccine developed COVID-19, while 90 participants who were given the placebo caught the virus, according to the company.
Monday's request for FDA emergency approval comes as the regulator is scheduled to meet with the VRBPAC on Dec. 10 to consider a request by Pfizer and its German partner BioNTech for emergency approval of their vaccine, which they said is 95% effective.
Last week, U.K.-based pharmaceutical giant AstraZeneca said it is seeking approval in multiple countries around the world for one of its coronavirus vaccine candidates that achieved 90% effectiveness. It is also seeking an emergency use listing from the World Trade Organization to make the vaccines available in low-income countries. If approved, AstraZeneca expects to be able to produce up to 3 billion doses in 2021.
Global development charity Oxfam urged Moderna on Monday to commit to ensuring global access to "a people's vaccine."
"While the amazing effectiveness of the vaccine candidates is encouraging, we must remember they will be zero percent effective for those who cannot access them," the organization said in a statement. "That's why every COVID-19 vaccine must be a people's vaccine: patent-free, mass produced, distributed fairly and made available free of charge, to every individual, rich and poor alike."
That call comes amid a global push for access to affordable vaccines. Countries have called on the World Trade Organization to suspend the trade body's intellectual property protections to mitigate barriers to affordable vaccines. Wealthy countries, including the European Union and the U.S., have said solutions to the pandemic can be sought through the existing intellectual property system. The WTO has failed to reach an agreement to date.
But Moderna said in October that it won't enforce seven patents related to its coronavirus vaccine during the pandemic, an unprecedented move in an industry known for vigorously protecting its intellectual property.
Oxfam said although that promise is a move in the right direction, the company should do more to share the vaccine with the world.
"Moderna's vaccine was funded largely by U.S. taxpayers and should therefore be a public good," Oxfam said. "The company has yet to make a public commitment to sharing its COVID-19 vaccine knowledge, technology, intellectual property, data and know-how to boost supply, reduce price and enhance equity."
--Additional reporting by Dorothy Atkins. Editing by Stephen Berg.
Update: This article has been updated with additional information.
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