US-based Moderna Inc is expected to commence the third-stage clinical analysis of its coronavirus vaccine on Monday, 27 July. The candidate mRNA-1273 will be tested on around 30,000 participants in the country for its ability to protect people from the virus.
The Phase 3 study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The biotech company Moderna was the first to launch human trials for COVID patients in the US.
The primary endpoint of the trial will be to assess whether the vaccine candidate prevents symptomatic COVID-19, a press release by Moderna stated. “Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2.”
Early Phases
A preliminary report on the vaccine’s early-stage phase 1 trial published in The New England Journal of Medicine on 14 July informed that the vaccine produces antibodies that can neutralise the coronavirus. The data also showed that the experimental vaccine caused minor side effects in many patients.
US National Institute of Allergy and Infectious Diseases, headed by Dr Anthony Fauci, ran the trial. The results showed that the antibodies made in those who took the shot were more than those seen in recovered patients. But a second shot, four weeks after the first one, was required to produce an immune response.
Stéphane Bancel, Moderna’s Chief Executive Officer, said in the press release, “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”
How Does an mRNA Vaccine Work?
The technology in use is relatively new - it involves using genetic material from the virus called mRNA. This method has not been used to create a vaccine so far.
It uses a genetic platform called mRNA, short for messenger RNA, which directs the body’s cells to stimulate the immune system. The vaccine, developed using previous studies of related coronaviruses such as SARS and MERS, has already shown promise in animal models.
The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16. Phase 2 testing involved around 600 healthy volunteers.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)