Moderna will begin late-stage coronavirus vaccine trial on July 27, according to ClinicalTrials.gov
We have more good news on multiple fronts in the race to develop vaccine against the deadly coronavirus. According to a posting published Tuesday on ClinicalTrials.gov, biotech company Moderna will begin its late-stage trial testing a potential vaccine to prevent Covid-19 on July 27. The trial study will evaluate efficacy, safety, and immunogenicity of Moderna mRNA-1273 vaccine in adults aged 18 years and older to prevent COVID-19.
According to the information, the trial will enroll 30,000 participants across 87 locations, according to the website. Participants in the experimental arm will receive a 100 microgram dose of the potential vaccine on the first day and another 29 days later. Some patients will also receive a placebo.
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273.
Moderna’s experimental vaccine contains genetic material called messenger RNA, or mRNA. The mRNA is a genetic code that tells cells what to build — in this case, an antigen that may induce an immune response to the virus. It became the first candidate to enter a phase one human trial in March.
On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Moderna’s Investigational New Drug (IND) application for mRNA-1273 allowing the biotech company to proceed to a Phase 2 study. On May 12, the FDA granted mRNA-1273 Fast Track designation. Moderna started finalizing the protocol for a Phase 3 study, which was expected to begin in July 2020. A summary of the company’s work to date on SARS-CoV-2 can be found here.
In June, Moderna reported successful trials of its mRNA vaccine against coronavirus and finalized plans for final phase 3 trials. According to the company, the Phase 3 trials will primarily study the efficacy of the vaccine in preventing symptomatic Covid-19 disease and secondarily, the prevention of severe cases of Covid-19 which require hospitalization. The company also provided an update on its phase 2 trials which are currently underway. Moderna said that it had enrolled 350 out of its total planned 600 participants for the study.
The effort by Moderna is one of several working on a potential vaccine for Covid-19, which has infected more than 13 million people and killed at least 573,200 across the globe as of Tuesday, according to data compiled by Johns Hopkins University. More than 100 vaccines are under development globally, according to the World Health Organization.