The third-phase trial, dubbed COVE (Coronavirus Efficacy), will include around 30,000 US participants at multiple clinical sites.
“We are pleased to have started the Phase 3 COVE study,” Moderna CEO Stephane Bancel said in a Monday news release. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
The trial will give participants 100-microgram doses of the mRNA vaccine, which is called mRNA-1273, on the first day. Participants will also receive another 100-microgram dose of the vaccine 29 days later. Some of the patients in the trial will only be given a placebo.
The trial will take place at around 100 clinical research sites, which, according to Moderna, are “working with their local communities to reach a diverse population” and to ensure that the study is “representative of the communities at highest risk for COVID-19 and of our diverse society.”
On Monday afternoon, Moderna’s share price spiked by more than 8% after the biotech company announced the upcoming trial of its vaccine. One day prior, the company also announced that it had received $472 million from the US government’s Biomedical Advanced Research and Development Authority (BARDA) to support its vaccine’s development. In April, the company received $483 million from BARDA.
Messenger RNA, or mRNA, is the set of instructions used by cells to make proteins, and mRNA vaccines are a relatively new type of treatment that work by providing instructions to healthy cells to generate antibodies for a certain virus or bacterium. Conventional vaccines, on the other hand, introduce a weakened or dead virus or bacterium into the body. This induces an immune system response, allowing the body to recognize and fight the pathogen in the future.
Moderna is not the only company racing to develop a COVID-19 vaccine. Another promising candidate is being co-developed by the University of Oxford and British-Swedish pharmaceutical company AstraZeneca. Their vaccine is expected to enter a third-phase study in the US in August. Another vaccine being developed by American pharmaceutical company Pfizer and Germany company BioNTech SE is supposed to start phase three testing some this month.