(Reuters) – Moderna Inc’s COVID-19 vaccine appeared set to receive regulatory authorization by the end of the week, after U.S. Food and Drug Administration staff endorsed it as safe and effective in documents released Tuesday.
Moderna’s vaccine could become the second to be considered by the FDA. Last week, the agency authorized Pfizer Inc and BioNTech’s vaccine.
Below are more details on Moderna’s vaccine:
– The experimental vaccine, called mRNA-1273, is based on messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. Pfizer’s vaccine also uses mRNA technology.
– Other firms using mRNA technology for developing COVID-19 vaccines include Germany’s Curevac and U.S. biotech firm Arcturus Therapeutics Holdings Inc.
– Pfizer’s mRNA vaccine for COVID-19 was the first authorization of any treatment developed using the technology.
– Moderna’s vaccine can be stored for up to six months at -20 degrees Celsius, though it is expected to be stable for 30 days at normal fridge temperature of 2 to 8 degrees Celsius (36 degrees Fahrenheit to 46 degrees Fahrenheit). Those are less onerous requirements than Pfizer’s, which must be stored at ultra-cold temperatures of -70 degrees Celsius, but can last in normal refrigeration for up to five days, or 15 in a thermal shipping box.
– Moderna was among the first to conduct COVID-19 vaccine human trials, starting in March. Its late-stage 30,000 participant testing began on July 27 in the United States. It finished enrolling participants in October.
– The company slowed enrollment in September to increase the diversity of the trial population. It ultimately enrolled 3,000 Black American participants and more than 6,000 Hispanic participants.
– The vaccine candidate is being tested at 100 clinical research sites in the United States.
– Moderna’s U.S. trial was the first under the government’s Operation Warp Speed program and is funded by Biomedical Advanced Research and Development Authority and National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
(Reporting by Manas Mishra, Vishwadha Chander and Mrinalika Roy in Bengaluru; Editing by Caroline Humer, Edwina Gibbs and Shinjini Ganguli)