Vaccine-maker Moderna on Monday said its mRNA COVID-19 vaccine was 100 per cent effective against severe disease, after releasing final results of its 30,000-person efficacy trial. Only 11 people who received two doses of the vaccine went on to develop COVID-19 symptoms, compared to 185 symptomatic cases in the placebo group, with the data analysis indicating a vaccine efficacy of 94.1 per cent.
In addition, the company said its vaccine was 100 per cent effective in terms of preventing severe cases of the disease, with zero such cases among vaccines but 30 in the placebo group.
Promisingly, efficacy was consistent across age, race and ethnicity, and gender demographics. “The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants)” the company said in a release.
The company says it will file a request for emergency use authorization for its vaccine in the US with the Food and Drug Administration (FDA), and is also seeking approval from the European Medicines agency.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273. Finally, I want to thank the Moderna team and our suppliers and partners for their tireless work on the research, development and manufacturing of our vaccine. We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe,” he added.
The Moderna vaccine uses the novel messenger RNA (mRNA) technology to develop a vaccine that trains the body genetically to develop the required proteins to simulate a virus by itself and develop the necessary protections. One benefit of this method is it speeds up the vaccine development process—Moderna’s vaccine’s mRNA sequence was developed just two days after China released the genome sequence of the SARS-nCoV-2019 virus.
Both the Moderna and Pfizer vaccines, with above 90 per cent effectiveness, are mRNA candidates. Both, however, require ultra-cold storage facilities, making them difficult to deliver at scale to developing nations.