Peninsula 360 Press [P360P].
The U.S. biotechnology company Moderna announced Monday that its candidate vaccine against COVID-19 has met the pre-specified statistical criteria 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 pivotal moment in the development of our COVID-19 vaccine candidate. 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.
He said, "We have known all along that every day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe cases.
Through a statement, the Cambridge, Massachusetts-based company said that 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 the analysis of confirmed and adjudicated COVID-19 cases from 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 mRNA-1273 candidate vaccine group, resulting in a point estimate of vaccine efficacy of 94.5 percent, they said.
In turn, a secondary endpoint looked at severe COVID-19 cases and included 11 with these characteristics.
The 95 COVID-19 cases included 15 older adults - over age 65 - and 20 participants who identified themselves as belonging to diverse communities (including 12 Hispanic or Latino, four African American, three Asian American, and one multiracial).
The interim analysis included a concurrent review of available safety data from the Phase 3 COVE study by the Data Safety Monitoring Board (DSMB), which reported no significant safety concerns.
A review of the adverse events reported indicated that the vaccine was generally well tolerated, while most adverse events were mild or moderate in severity.
In that sense, they specified that the 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/redness 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 COVE study and the final analysis.
Therefore, they noted that the preliminary analysis suggests a broadly consistent safety and efficacy profile across 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 submit applications for authorisations to global regulatory agencies.
By the end of 2020, the company expects to have approximately 20 million doses of "mRNA-1273" ready to ship, "the company remains 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.
