Monday Nov 30, 2020
CAMBRIDGE: American biotechnology company Moderna Inc on Monday announced that its under-trial drug for the novel coronavirus, COVID-19, has shown 94.1% efficacy against the disease and a 100% efficacy in the severe cases.
In a press release, the Massachusetts-based company said its coronavirus drug candidate, named mRNA-1273, was "generally well tolerated" and that "no serious safety concerns [were] identified to date".
The Phase 3 COVE study of Moderna's coronavirus vaccine had 30,000 participants and 196 cases of COVID-19, 30 of which cases were 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)."
Moderna CEO Stéphane Bancel lauded the participants, scientists, and the agencies that helped and ensured the coronavirus vaccine trial was a success, terming the drug "a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death".
The biotechnology company further announced that it would submit later today a request to the US Food and Drug Administration (FDA) to approve the Emergency Use Authorization (EUA) of its coronavirus vaccine.
It also noted that it 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).
A day prior, the British government had announced securing an additional two million doses of Moderna Inc’s coronavirus vaccine candidate to be available in Europe as early as the spring.
The two million doses were in addition to the five million doses it had secured from the US company two weeks ago, with the deal coming a day after UK Prime Minister Boris Johnson named Nadhim Zahawi, a junior business minister, as the minister responsible for the deployment of COVID-19 vaccines.
In total, Britain now has access to 357 million doses of vaccines from seven developers, according to a government statement. The UK's health minister, Matt Hancock, said the country was "ready to deploy a vaccine should they receive approval from our medicines regulator" given its vast portfolio of drug candidates.
—Additional input from Reuters