Moderna says its COVID-19 vaccine '100% effective' against severe cases
United States pharmaceutical company Moderna on Monday said that it will seek emergency approval for its COVID-19 vaccine in the US and Europe. The company cited new trial data to assert that its vaccine had been found 94% effective against COVID-19 and 100% effective at preventing severe cases of the viral disease. The findings are consistent with previous trial data. Here are more details.
Out of 196 COVID-19 cases, 185 among placebo group
Moderna said primary efficacy analysis from the randomized, 1:1 placebo-controlled Phase III clinical trial showed that the vaccine continues to be well-tolerated and has no serious safety concerns to date. The trial involved 30,000 participants, among whom, 196 cases of COVID-19 were observed. Thirty of these infections were severe. Also, 185 of 196 infections were in the placebo group, including all 30 severe cases.
Efficacy consistent across age, race, ethnicity, and gender
Efficacy was consistent across age, race, and ethnicity, and gender demographics, the company said. The 196 COVID-19 cases included 33 older adults (aged above 65) and 42 participants identifying as being from diverse communities. Moderna will submit data from the study to a peer-reviewed publication.
Moderna to seek emergency approval in US
Moderna said it will seek emergency approval on Monday from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for the vaccine will likely be scheduled for December 17, Moderna said.
Moderna to seek emergency approval from WHO
Moderna has initiated the rolling review process with the EMA, Health Canada, SwissMedic, the UK Medicines and Healthcare products Regulatory Agency, Israel's Ministry of Health, and Health Sciences Authority in Singapore. It also intends to seek Prequalification and/or Emergency-Use Listing with the World Health Organization.
Our vaccine may change course of pandemic: Moderna CEO
Moderna CEO Stéphane Bancel said, "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." "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," Bancel added.
Moderna to have 20 million doses ready by 2020-end
Moderna is planning to start a new trial for adolescents before the end of the year, followed by another for even younger volunteers in early 2021. The company hopes to make the vaccine available to adolescents by September next year. It said that it is on track to have about 20 million doses—enough to vaccinate 10 million—ready to ship in the US by 2020-end.
