The U.S. FDA has approved Moderna’s COVID-19 vaccine for emergency use. Moderna’s vaccine becomes the second to be approved by the FDA, following approval of the Pfizer/BioNTech vaccine a week ago on Friday, which is now being distributed.
The much anticipated Moderna vaccine approval can add millions more doses across the United States vaccine supply chain. The country already has an agreement with Monderna to purchase 200 million doses of the RNA-based COVID-19 vaccine named mRNA-1273, and six million may be ready to ship now.
Moderna, a biotech company pioneering messenger RNA therapeutics and vaccines today confirmed the Emergency Use Authorization (EUA) by the FDA of its mRNA-1273 vaccine against COVID-19 in individuals 18 years of age or older. The company plans to collect additional data and file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021.
Stéphane Bancel, Chief Executive Officer of Moderna stated:
“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. I also want to thank the Moderna team, our suppliers and our partners for their tireless work across research, development and manufacturing of our vaccine.
“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants. It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”
The Department of Defense (DoD), in partnership with the Department of Health and Human Services (HHS) and the U.S. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the United States.
20 million doses of Moderna’s COVID-19 vaccine to be delivered to the US by the end of December
The approval of Moderna’s vaccine in the US could not come at a better time as the country recorded more than 313,500 deaths and about 17.5 million infections, according to Johns Hopkins University.
Around 20 million doses will be delivered to the U.S. government by the end of December 2020. Moderna expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.
Moderna’s vaccine shows efficacy rate of 94.1%
The FDA has based its recommendation on the totality of scientific evidence shared by Moderna, including data from the Phase 3 clinical study announced on November 30. More than 30,000 volunteers in the U.S. participated in the Phase 3 study, known as the COVE study. The primary analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.
The most common solicited adverse reactions (ARs) after the two-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). While the majority of these ARs were grade 1 mild (grade 1) or moderate (grade 2), there was a higher occurrence of severe (grade 3) reactions after the second injection. Most of the local solicited ARs occurred within the first one to two days after injection and generally persisted for one to two days. The study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH). All participants in the COVE study will continue to be monitored for two years to assess long-term protection and safety.
The Moderna COVID-19 vaccine named mRNA-1273 is co-developed by Moderna and scientists from the NIAID Vaccine Research Center. mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. The first clinical batch, sponsored by the Coalition for Epidemic Preparedness Innovations, was accomplished and analytically tested on February 7, 2020, and delivered to the NIH on February 24, only 42 days from sequence selection.
On March 16, or 63 days from sequence selection to Phase 1 study dosing, the first participant in the NIAID-led Phase 1 mRNA-1273 study received the dosage. The mRNA-1273 Fast Track designation was issued by the FDA on May 12. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.
Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of the vaccine was published in The New England Journal of Medicine. On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. The same day, Moderna also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) with the European Medicines Agency. On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). On Friday, December 18, 2020, the U.S. FDA authorized the emergency use of the mRNA-1273 vaccine in individuals 18 years of age or older.
The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Moderna COVID-19 Vaccine with $955 million in federal funding. BARDA is reimbursing Moderna for 100% of the allowable costs incurred for conducting the program described in the BARDA contract.
About Moderna’s COVID-19 Phase 3 COVE Study
The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing the 100 μg dosage level of mRNA-1273 in 30,000 participants aged 18 years and older in the U.S. The main endpoint is prevention of symptomatic COVID-19 disease and the key secondary endpoints are prevention of serious COVID-19 disease and SARS-CoV-2 infection prophylaxis. The trial will continue to monitor for additional safety and efficacy-related evidence even after obtaining the EUA.
Both the primary and secondary end point evaluation for the vaccine efficiency, will be determined by estimation of the total data collection and analysis. Moderna has devoted efforts in collaboration with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to perform the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organisation (CRO) offering extensive, integrated drug development, laboratory and lifecycle management services, has also had a crucial impact for the COVE study performance success.
In conjunction with the FDA and NIH, the Phase 3 COVE trial was organised and dedicated to assess Americans at high risk of developing serious COVID-19 associated complications related to pre-existing conditions and age over 65 years. The study enrollment concluded in the U.S. on October 22, involving 30,000 volunteers aged 18 and older, from which more than 7,000 Americans over the age of 65 as well as more than 5,000 Americans who are under the age of 65 but with pre-existing conditions such as diabetes, severe obesity and cardiac disease. These vulnerable, high-risk groups represent 42% of the total participants in the Phase 3 COVE study. The study also involved communities, which have traditionally been under-represented in clinical research and have been adversely impacted by COVID-19. The Study involved more than 11,000 participants from communities of colour, representing 37% of the study population, relevant to the diversity in the the U.S. as well as more than 6,000 participants who identify as Hispanic or Latin, and more than 3,000 participants who identify as Black or African American.