Infectious disease experts have recommended that stockpiles of several promising vaccine candidates be created as they enter late stage development.
The increase in productive potential was driven by the biotech company’s new partnership with Lanza Group, a Swiss biopharmaceutical manufacturing firm.
Moderna has also finalized the study protocol for a Phase 3 trial of mRNA-1273, its coronavirus disease 2019 (COVID-19) vaccine, among 30,000 volunteers.
The finalized study protocol was developed based on feedback from the US Food and Drug Administration (FDA) and will likely by executed in collaboration with the National Institute of Allergy and Infectious Diseases. The trial is expected to begin in July at the 100 μg dose level.
According to Moderna’s statement, the trial’s primary endpoint will be the prevention of symptomatic COVID-19 disease and secondary endpoints include prevention of severe illness (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19.
“We look forward to beginning our Phase 3 study of mRNA-1273 with some 30,000 participants in July,” said Tal Zaks, MD, PhD, Moderna’s Chief Medical Officer. “Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
In related news, the first cohort of 300 healthy adults between 18-54 years of age is now fully enrolled In the company’s Phase 2 Study of mRNA-1273.
On May 11, the FDA granted mRNA-1273 “fast track” regulatory designation. Infectious disease experts have recommended since early in the COVID-19 pandemic that stockpiles of several promising vaccine candidates be created as they enter late stage development. The investigational vaccine continues moving forward through an unprecedented accelerated development process, but conclusive answers still wait ahead.
Patient stratification, demographic representations, and plasma collection could aid the pursuit for an efficacious prophylaxis.