Peninsula 360 Press [P360P].
The U.S. biotechnology company Moderna announced Monday that its candidate vaccine against COVID-19 has met the statistical criteria pre-specified in the study protocol for efficacy, which showed 94.5 percent effectiveness, including in people infected with the SARS-CoV 2 virus, which causes the disease.
"This is a crucial time in the development of our COVID-19 candidate vaccine. Since early January, we have been pursuing this virus with the intention of protecting as many people as possible around the world," said Stéphane Bancel, CEO of Moderna.
The executive said: "We have known all along that every day is important. This positive interim analysis of our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe cases.
In a statement, the Cambridge, Massachusetts-based company said the study, conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), enrolled more than 30,000 participants of different ages and ethnicities.
The primary endpoint of the Phase 3 COVE study, he said, was based on analysis of confirmed and adjudicated COVID-19 cases starting two weeks after the second dose of vaccine.
Thus, the first interim analysis was based on 95 cases, of which 90 were observed with COVID-19 in the placebo group, versus five cases in the possible "mRNA-1273" vaccine group, resulting in a point estimate of the vaccine's efficacy of 94.5 percent, they said.
In turn, a secondary endpoint analyzed severe cases of VOC-19 and included 11 with these characteristics.
The 95 cases of COVID-19 included 15 older adults-over 65 years of age-and 20 participants who identified themselves as belonging to diverse communities (including 12 Hispanic or Latino, four African Americans, three Asian Americans, and one multiracial).
The interim analysis included a simultaneous review of available safety data from the Phase 3 VOCA study by the Data Safety Monitoring Board (DSMB), which reported no significant safety issues.
A review of the adverse events requested indicated that, overall, the vaccine was well tolerated, while most adverse events were of mild or moderate severity.
They noted that grade 3 (severe) events with a frequency greater than or equal to 2.0 percent after the first dose included pain at the injection site (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/rediness at the injection site (2.0%).
Such adverse events, the company said, were generally of short duration, and are subject to change based on ongoing analysis of data from the additional Phase 3 VOCA study and final analysis.
Therefore, they noted that the preliminary analysis suggests a broadly consistent safety and efficacy profile in all subgroups evaluated.
Based on these interim safety and efficacy data, Moderna intends to apply for emergency use authorization with the U.S. Food and Drug Administration (FDA) in the coming weeks.
Similarly, it envisages that emergency authorisation will be informed by final safety and efficacy data (with an average duration of at least two months), and plans to send authorisation requests to global regulatory agencies.
By the end of 2020, the company expects to have approximately 20 million doses of "mRNA-1273" ready for shipment, "with the company still on track to manufacture 500 million to 1 billion doses globally by 2021," he added.
Finally, Moderna recently announced further progress to ensure that vaccine distribution, storage and handling can be done using existing infrastructure.
