US pharmaceutical Moderna's mRNA vaccine has showed 94.5 per cent effectiveness against COVID-19 in its interim Phase 3 trials, the pharmaceutical announced on Monday. Moderna's mRNA vaccine follows the same technology as Pfizer-BioNTech's COVID-19 vaccine which announced 90 per cent protection last week.
Notably, there are no human vaccines currently in use that follow the mRNA technology adopted by both the US-based pharmaceuticals for its COVID-19 vaccine candidates. The interim results of both the candidates show that very few participants who received the vaccine dosage developed COVID-19 symptoms.
While Pfizer's vaccine candidate tested 94 patients with COVID-19, Moderna's interim analysis was first scheduled after 53 patients triggered symptoms of COVID-19. The Data and Safety Monitoring Board moved this number to 95 patients testing positive.
As the trials are double-blind trials, the researchers found that from the 95 participants, 90 had received the placebo while only 5 had received the vaccine candidate. Furthermore, the interim analysis also assessed the secondary end-point of whether any participant developed any adverse reactions to the vaccine. Out of the 11 participants, none of them had received the vaccine.
In the 95 who tested positive, 15 were over 65 while 20 belonged diverse communities (12 Latin/Hispanic, 4 African American, 3 Asian American, 1 multiracial).
Moderna conducted phase 3 trials with over 30,000 patients in US in collaboration with US' National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Biomedical Advanced Research and Development Authority, which is a part of the US Department of Health and Human Services. Over 25,625 participants received the second dosage. Unlike Pfizer, Moderna has not announced the duration between the second dose and the onset of COVID-19 symptoms.
All the participants were over 18 years of age while 7,000 of them were over 65. Over 5,000 participants under the age of 65 have co-morbidities such as diabetes, severe obesity, and cardiac disease which puts them at a risk of developing COVID-19. These medically high-risk groups represented over 42 per cent of the study sample.
Emergency Use Authorization
Moderna intends to apply to the US Food and Drug Administration for Emergency Use Authorization after around 151 participants have tested positive for COVID-19 and the second interim analysis for testing the primary endpoint of protecting from COVID-19 disease and SARS-CoV-2 is established. The company expects the efficacy data to change as positive cases accrue towards the final analysis.
Stephan Bancel, CEO of Moderna said that this was a pivotal moment in the development of COVID-19 vaccine. "The 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."
A part of US' Operation Warp Speed, Moderna intends to provide all its safety and efficacy data to the FDA for its emergency use authorization at least in the US.
Manufacturing Of Doses
Moderna has stated that it would be in a position to produce around 20 million cases by the end of 2020. The pharmaceutical is also ready to match its goal of manufacturing 500 million to one billion doses in 2021.
Moderna's mRNA-1273 vaccine can be stored at 2 to 8°C for 30 days. Unlike Pfizer's vaccine which requires storing at -70 to 80°C, Moderna's vaccine will survive in existing infrastructure.
The vaccine's stabilising capacity increased from 7 days to 30 days through the efforts of the team of scientists, Juan Andres, Chief Technical Operations and Quality Officer at Moderna, stated.
For shipping, the vaccine requires cooling refrigerators at -20°C. The vaccine can stay stable in these containers for up to 6 months. Post shipping it needs to be kept in refrigerators at 2-8°C where Moderna expects it to be stable for 30 days. Once removed for administration, the vaccine is likely to stay stable for 12 hours at room temperature. To further ease the vaccination process, the vaccine does not require any dilutions or special handling techniques while being administered.