The pharmaceutical company also said the vaccine had an efficacy rate of 100 per cent against severe coronavirus cases.
Moderna on Monday plans to request an emergency use authorization from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).
The filing sets Moderna‘s product up to be the second vaccine likely to receive U.S. emergency use authorization (EUA) this year. On Nov. 20, drug company Pfizer applied for EUA after it said its coronavirus is 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
The Phase 3 trial data showed the vaccine is “generally well tolerated” and there are no serious safety concerns identified to date, the company said in a press release.
Moderna has been manufacturing its mRNA-1273 vaccine for several months and says approximately 20 million doses will be available by the end of the year.
The company also remains on track to manufacture 500 million to one billion doses globally in 2021, it said.
Canada signed a deal in September for 20 million doses to be delivered at the beginning of 2021, with the option of increasing the supply to 56 million doses.
About the COVID-19 vaccine
The vaccine, which is administered in two shots 28 days apart, was studied in 30,000 volunteers who received either the real thing or a placebo shot.
The data released Monday said out of 196 coronavirus cases, 185 cases were in the placebo group and 11 were given the vaccine. This means the vaccine has an efficiency rate of 94.1 per cent, the company stated.
The latest data is slightly lower than an interim analysis released on Nov. 16 of 94.5 per cent effectiveness.
There were also 30 severe cases of COVID-19, and every case was identified in the placebo group and none in the vaccinated one.
There was one COVID-19-related death in the study to date, which occurred in the placebo group, the company added.
The safety of the Phase 3 trial is still ongoing, but the most adverse reactions to the vaccine are site pain, fatigue, myalgia, headache and redness at the injection site.
Moderna said the efficiency rate was also consistent across age, race, ethnicity and gender, Moderna said.
The 196 cases of coronavirus were in 33 older adults (ages 65 plus) and 42 participants identifying as being from diverse communities (including 29 Hispanic people, six Black or African Americans, four Asian Americans, and three multiracial participants).
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe COVID-19 disease. 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,” said Stéphane Bancel, CEO of Moderna.
Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another trial in even younger volunteers early in 2021. The company hopes to have the vaccine available for adolescents by September of next year, Zaks said.
— With files from ReutersView link »