CAMBRIDGE: One of the companies in the race to develop a vaccine to cure the novel and deadly coronavirus has announced that its drug candidate under trial indicated a 94.1% efficacy against COVID-19 and 100% efficacy in severe cases.
According to a press release issued Monday, American biotechnology company Moderna said its coronavirus drug candidate — mRNA-1273 — was “generally well tolerated” and that had “no serious safety concerns”.
The Massachusetts-based company’s Phase 3 COVE study of the coronavirus vaccine had 30,000 participants and 196 cases of COVID-19, of which 30 were identified as severe.
“Efficacy was consistent across age, race and ethnicity, and gender demographics,” it said. “The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).”
With regard to the development, Moderna Chief Executive Stéphane Bancel expressed pleasure towards the participants, scientists, and the agencies that helped and ensured the coronavirus vaccine trial was a success.
Bancel termed the drug “a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death”.
The press release further stated that Moderna would submit a request later today to the US Food and Drug Administration (FDA) for the Emergency Use Authorization (EUA) approval of its coronavirus vaccine.
Moderna said it also intended “to apply for a conditional marketing authorization with the European Medicines Agency (EMA) and to progress with the rolling reviews, which have already been initiated with international regulatory agencies”, as per the press release.
The FDA, in response to the development, has told Moderna it should expect a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) under its Center for Biologics Evaluation and Research (CBER).