Editorial office. Peninsula 360 Press [P360P].
The biotechnology company, Moderna, announced Monday that it plans to apply for emergency use authorization from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMEA) for its COVID-19 vaccine.
This is because the main efficacy analysis of the Phase 3 mRNA-1273 study conducted in 196 cases confirms the high efficacy observed in the first interim analysis, as the data indicate an efficacy of 94.1 percent.
The U.S. company said in a statement that the safety data continues to accumulate and the study continues to be monitored by a Data Safety Monitoring Board (DSMB).
"This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with an efficacy of 94.1 percent and, more importantly, the ability to prevent severe COVID-19 disease," said Stéphane Bancel, CEO of Moderna.
"We believe our vaccine will provide a powerful new tool that can change the course of this pandemic and help prevent serious illness, hospitalization and death," he added.
In turn, the company said it is now planning a phase 3 study, known as the COVE study, for which it has recruited more than 30,000 participants and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Advanced Biomedical Research and Development Authority.
The primary endpoint of the Phase 3 COVE study, he said, is based on analysis of confirmed and adjudicated COVID-19 cases starting two weeks after the second dose of vaccine.
"The efficacy of the vaccine has been demonstrated in the first interim analysis with a total of 95 cases according to the pre-set efficacy criteria. Today's primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1 percent," he said.
He added that a secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases - as defined in the study protocol - in this analysis.
In that regard, he explained that all 30 cases occurred in the placebo group and none in the mRNA-1273 group, since, to date, there was only one death related to COVID-19 in the study, which occurred in the placebo group.
Moderna explains that effectiveness was consistent across age, race, ethnicity, and gender demographics, as the 196 cases of COVID-19 included 33 older adults - over 65 years old - and 42 participants who identified themselves as belonging to diverse communities - including 29 Hispanics or people from the Latino community, six African Americans, four Asian Americans, and three multiracial participants.
According to the company, it has not identified any new serious safety issues, while, according to a previous analysis, the most common adverse reactions included pain at the injection site, fatigue, myalgia, arthralgia, headache and erythema/rediness at the injection site.
"Adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose," he said.
It is worth noting that the Company has already begun the ongoing review process with the EMA, Health Canada, SwissMedic, the UK's Medicines and Healthcare Regulatory Agency (MHRA), Israel's Ministry of Health and the Health Sciences Authority in Singapore, and intends to seek Pre-Qualification or Emergency Use Listing with the World Health Organization (WHO).
Additionally, Moderna announced that the FDA's Advisory Committee on Vaccines and Related Biological Products will review the safety and efficacy data package for mRNA-1273 likely on Thursday, Dec. 17.
The Company expects that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will make a recommendation on immunization priorities.
Moderna anticipates that the shipment of mRNA-1273 to designated distribution points will occur shortly after an emergency use authorization is granted.
By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 available, while it remains on track to manufacture 500 million to 1 billion doses globally by 2021.
