By: Alaric DeArment
The company said it had shipped the first batch of the vaccine, mRNA-1273, for the NIH-run clinical trial. The study has an estimated start date of March 6, according to ClinicalTrials.gov, while The Wall Street Journal reported it would start in April.
A biotech company that is one of several developing vaccines and drugs for the novel coronavirus has shipped vials of its investigational vaccine for a U.S. clinical trial.
Cambridge, Massachusetts-based Moderna said Monday that it had released the first batch of its vaccine against the rapidly spreading COVID-19 virus, mRNA-1273. The vials, for a Phase I clinical trial, have been shipped to the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
A page for the clinical trial was posted on ClinicalTrials.gov on Tuesday. Sponsored by the NIAID, the safety and immunogenicity study will enroll 45 men and non-pregnant women aged 18-55 and has an estimated start date of March 6, and will recruit healthy volunteers, according to the page. Participants will receive the vaccine at doses of 25, 100 or 250 micrograms. One site – the Kaiser Permanente Washington Health Research Institute – Vaccines and Infectious Diseases, in Seattle – is listed. However, NIAID Director Anthony Fauci told The Wall Street Journal on Monday that the trial would start in April and enroll 20-25 participants, with initial results potentially available in July or August.
“I want to thank the entire Moderna team for their extraordinary effort in responding to this global health emergency with record speed,” said Juan Andres, Moderna’s chief technical operations and quality officer, said in a statement. “This would not have been possible without our Norwood manufacturing site, which uses leading-edge technology to enable flexible operations and ensure high quality standards are met for clinical-grade material.”
Moderna is one of several companies that have teamed up with the U.S. government to develop vaccines and therapeutics for COVID-19. Johnson & Johnson, Regeneron Pharmaceuticals and Sanofi are among the others. In addition, a drug developed by Gilead Sciences to treat Ebola virus, remdesivir, is being tested in a clinical trial in China.
As of Monday, 79,331 people around the world have become infected with the COVID-19 virus, and more than 2,600 have died, the vast majority of them in China, according to the World Health Organization. Since the virus emerged in the central Chinese city of Wuhan in November, there have been new outbreaks in South Korea, Iran and Italy, fueling fears of a global pandemic. However, the WHO has not yet officially declared one. With tens of millions of people in China now on effective lockdown and unable to go to work, there have been rising fears also of supply chain disruption in the drug industry, which sources many of its raw materials from China. On Sunday, Axios reported that the Food and Drug Administration has drawn up a list of about 150 drugs that face shortages if the COVID-19 outbreak worsens.