The COVID-19 vaccine candidate being developed by Moderna has shown strong efficacy in a Phase 3 late-stage study. Moderna on Monday said that the vaccine candidate has shown 94.5% efficacy in preventing COVID-19 among participants who had not previously been infected with SARS-CoV-2 in the first interim efficacy analysis.
The news comes on the heels of Pfizer and BioNTech's announcement that its COVID-19 vaccine has shown strong efficacy in a Phase 3 late-stage study. Pfizer said that the vaccine candidate has shown more than 90% efficacy in preventing COVID-19 among participants who had not previously been infected with SARS-CoV-2 in the first interim efficacy analysis.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna.
Moderna said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at negative 4 degrees Fahrenheit.
“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, chief technical operations and quality officer.
By comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, most likely needing dry ice for shipment.
Johnson & Johnson's vaccine is expected to be stable at refrigerated temperatures of 35.6 - 46.4 degrees Fahrenheit for at least three months and for two years at -4 degrees Fahrenheit.
CureVac's CVnCo is stable for at least three months at 41 degrees Fahrenheit, which is standard refrigerator temperature. It also is stable for up to 24 hours at room temp in a ready-to-use setting.
Sanofi and GlaxoSmithKline's two-dose recombinant protein vaccine can be stored between 35.6 - 46.4 degrees Fahrenheit.
Bancel said Moderna plans to submit an EUA in the United States, and regulatory filings in countries around the world. "We remain committed to and focused on doing our part to help end the COVID-19 pandemic,” said Bancel.
Moderna is working with the CDC, Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations. By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the United States.
Moderna also said that it remains on track to manufacture 500 million to 1 billion doses globally in 2021.
The company also recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.