(Reuters) – The European Union’s drug watchdog on Wednesday authorized emergency use of Moderna Inc’s COVID-19 vaccine, nearly two weeks after approving Pfizer Inc and BioNTech SE’s shot for the virus.
On Tuesday, Israel became the first country outside North America to grant authorization to Moderna’s vaccine. The United States and Canada have already started rolling out the two-dose vaccine.
Below are more details on Moderna’s vaccine:
VACCINE TECHNOLOGY
– The 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 mRNA vaccine for COVID-19 was the first authorization of any treatment developed using the technology.
– Other firms using mRNA technology for developing COVID-19 vaccines include Germany’s Curevac and U.S. biotech firm Arcturus Therapeutics Holdings Inc.
– 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.
TRIALS
– The vaccine was shown to be nearly 95% effective, with no serious safety concerns in a late-stage study.
– 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.
(Source: Reuters reporting, press releases, clinical trial registers)
(Reporting by Manas Mishra, Vishwadha Chander and Mrinalika Roy in Bengaluru; Editing by Caroline Humer, Edwina Gibbs, Ramakrishnan M., David Gregorio, Shinjini Ganguli and Anil D’Silva)
