Editorial staff. Peninsula 360 Press [P360P].
Biotechnology company Moderna announced Monday that it plans to seek emergency use authorization from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) for its COVID-19 vaccine.
This is because the primary efficacy analysis of the Phase 3 study of mRNA-1273 in 196 cases confirms the high efficacy observed in the first interim analysis, with data indicating 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 94.1 percent efficacy 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, hospitalizations and death," he added.
At the same time, the company said that today it is 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 Biomedical Advanced Research and Development Authority.
The primary endpoint of the phase 3 COVE study, he said, is based on the analysis of confirmed and adjudicated COVID-19 cases from 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-established 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 COVID-19 cases and included 30 severe cases - as defined in the study protocol - in this analysis.
In that sense, he detailed that the 30 cases occurred in the placebo group and none in the group vaccinated with mRNA-1273, since, to date, there was only one death related to COVID-19 in the study, which occurred in the placebo group.
Moderna explains that efficacy was consistent across age, race, ethnicity, and gender demographics, as the 196 COVID-19 cases included 33 older adults - over age 65 - and 42 participants who identified themselves as belonging to diverse communities - including 29 Hispanic or Latino, six African American, four Asian American, 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/redness at the injection site.
"Adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose," he said.
Notably, the Company has already initiated the ongoing review process with the EMA, Health Canada, SwissMedic, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Israeli Ministry of Health and the Health Sciences Authority in Singapore, and intends to seek Prequalification or Emergency Use Listing with the World Health Organization (WHO).
Additionally, Moderna announced that the FDA's Vaccines and Related Biological Products Advisory Committee will review the safety and efficacy data package for mRNA-1273 likely on Thursday, December 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 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 remaining on track to manufacture 500 million to one billion doses globally by 2021.
