It will seek emergency use authorization from the U.S. Food and Drug Administration and conditional approval from the European Union on Monday.
Its analysis was based on 196 cases of COVID-19, 185 of which received a placebo with 11 receiving the vaccine. There were 30 severe cases in the placebo group and none among those that got the vaccine.
The 196 cases included 33 adults aged 65 or over, and 42 participants from diverse communities including 29 people who identified as Hispanic, 6 Black Americans, 4 Asian Americans and 3 people who are multiracial.
The success rate was just slightly less than the interim analysis result of 94.5% but Moderna said the difference was statistically insignificant. It follows a final analysis by Pfizer Inc and German partner BioNTech SE in which their experimental vaccine was 95% effective.
Moderna, which went public in 2018, has received nearly $1 billion in research and development funding from the U.S. government and has a deal worth $1.5 billion to supply 100 million doses. The U.S. government has an option for another 400 million doses and Moderna also has supply deals with other countries.
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 developing COVID-19 vaccines that use mRNA technology include Germany’s Curevac and U.S. biotech firm Arcturus Therapeutics Holdings Inc.
– An authorized, safe and effective mRNA vaccine for COVID-19 would be a first for the technology, which has previously not been used for an approved vaccine or drug.
– Moderna’s vaccine can be stored for up to six months at -20 Celsius though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F). Those are less onerous requirements than Pfizer’s, which must be kept ultra-cold temperatures of -70 degrees Celsius, but can last in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box.
REGULATORY AND PRODUCTION TIMELINE
– The United Kingdom’s health regulator started a real-time review of its experimental COVID-19 vaccine in October. The European Medicines Agency, Canada and Switzerland have also begun rolling reviews.
– Moderna expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021.
– The company was among the first to conduct COVID-19 vaccine human trials, starting in March and 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 participants who are Hispanic.
– The vaccine candidate is being tested at about 89 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.
MODERNA SUPPLY DEALS
(most recent first)
REGION DOSES FUNDING EXPECTED DELIVERIES FURTHER
U.S. 100 mln + option for $1.53 bln Unspecified
400 mln more
EU 80 mln + option for Unspecified Unspecified
80 mln more
Canada Unspecified Unspecified Unspecified
Japan 50 mln doses, to be Unspecified H1 of 2021
Israel Unspecified Unspecified Unspecified
Qatar Unspecified Unspecified As soon as vaccine is
approved and released
(Source: Reuters reporting, press releases, clinical trial registers)
Reporting by Manas Mishra, Vishwadha Chander and Mrinalika Roy in Bengaluru; Editing by Caroline Humer and Edwina Gibbs