Moderna On Track To Start Phase 3 Coronavirus Vaccine Trial In July

Moderna Inc MRNA, one of the frontrunners in the SARS-CoV-2 vaccine race, offered an update on its vaccine program Thursday, sending the stock higher. 

Moderna Set For July Start: The Cambridge, Massachusetts-based company said it has finalized the Phase 3 protocol, based on feedback from the FDA, to evaluate mRNA-1273, its vaccine candidate against the novel coronavirus.

The company said the trial would be a randomized 1:1 placebo-controlled study that would evaluate 30,000 participants in the U.S. The study is to be conducted in collaboration with the National Institute of Allergy and Infectious Diseases. 

Based on the results of the Phase 1 study, Moderna said it has zeroed in on 100 micrograms as the optimal dose level to maximize response while minimizing adverse reactions.

The primary endpoint would be preventing symptomatic COVID-19 disease and the key secondary endpoints would be prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2, the company said.

Moderna Fully Stocked: The company also said it has sufficient stock of vaccine needed to start the Phase 3 study. The dosing in the late-stage study is set to begin in July, according to Moderna.

Moderna reiterated its goal of supplying about 500 million doses of the vaccine per year and up to 1 billion doses per year beginning in 2021, leveraging on its own manufacturing capacity and its strategic collaboration with Swiss CDMO Lonza.

Moderna's Early, Midstage Coronavirus Update: For the early- and mid-stage studies that are ongoing, Moderna said the original cohorts in the Phase 1 study are in long-term follow-up and enrollment is complete in nine of the 12 cohorts that were subsequently added. The NIH will submit the Phase 1 data to a peer-reviewed publication, the company said. 

The first cohort of healthy adults ages 18-54 in the Phase 2 trial is fully enrolled, and sentinel participants in the cohort of older adults ages 55 and up are also enrolled.

Moderna is one of the five companies the U.S. government has shortlisted in the vaccine development race. 

Earlier this week, Johnson & Johnson JNJ said it is pushing forward the schedule for the commencement of Phase 1 study of its SARS-CoV-2 vaccine from September to July.

MRNA Price Action: At last check, Moderna shares were trading 4.73% higher at $62.91. 

Related Links:

Moderna Analyst Says Coronavirus Vaccine Candidate Has 65% Chance Of Success

Moderna Analyst Says Biotech Has 'First-To-Market' Potential For Coronavirus Vaccine