US-based pharmaceutical company Moderna Inc said it will apply for emergency authorization from the US and Europe of its COVID-19 vaccine on Monday based on the full results of a late-stage study showing that their vaccine was 94.1% effective without serious safety concerns.
The pharmaceutical company also reported a 100% success rate in preventing severe cases of Covid-19. The filing states that Moderna’s product will be the second vaccine likely to receive US emergency use authorization this year after Pfizer-BioNTech’s candidate vaccine, which is 95% effective.
The results of the trial come at a time when the coronavirus pandemic has infected more than 63 million people and killed more than 1.4 million worldwide.
Of these, US hospitals have been stretched to the limit, as the nation has seen more than 160,000 new cases per day and more than 1,400 deaths daily.
“An ongoing review of security data is underway and the company has not identified serious new security issues,” Moderna said in a statement.
Of the 196 volunteers who contracted COVID-19 in the trial of more than 30,000 people, 185 had received a placebo versus 11 who received the vaccine. The company reported 30 serious cases, all in the placebo group, meaning the vaccine was 100% effective in preventing serious cases. The trial included one COVID-19-related death in the placebo group.
Moderna said the vaccine’s efficacy was consistent based on age, race, ethnicity and gender demographics. The 196 cases included 33 adults over the age of 65 and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans, and 3 multiracial participants.
The vaccine, mRNA-1273, met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study with a vaccine efficacy of 94.5% earlier this month.
Shortly after obtaining emergency use authorization, Moderna expects the vaccine to be shipped to designated distribution points throughout the United States by the government’s Operation Warp Speed program and McKesson Corp, a government-contracted drug distributor. from United States.
In addition to filing its application in the US, Moderna said it would seek conditional approval from the European Medicines Agency, which has already begun an ongoing review of data, and will continue to speak with other regulators conducting ongoing reviews.
He also announced that the FDA’s Vaccines and Related Biologicals Advisory Committee (VRBPAC) meeting to review the 1273-mRNA safety and efficacy data package is likely scheduled for Thursday, December 17.
Shortly after obtaining emergency use authorization, Moderna expects the vaccine to be shipped to designated distribution points throughout the United States by the government’s Operation Warp Speed program and McKesson Corp, a government-contracted drug distributor. from United States.
It is expected to be easier to distribute than Pfizer’s because, while it must be stored in a freezer, it does not require the ultra-cold temperature that Pfizer’s vaccine requires.
In addition, Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another trial in even younger volunteers in early 2021, the Reuters news agency reported. Other vaccine manufacturers have said they are studying their vaccines in young people as well.
The US-based firm also said it was on track to have about 20 million doses of its vaccine ready to ship to the United States by the end of 2020, enough to inoculate 10 million people.
“By the end of 2020, the company expects to have approximately 20 million doses of 1273-mRNA available in the US. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021,” Moderna stated. .
Britain has also secured an additional two million doses of Moderna’s Covid-19 candidate vaccine, the government said in a statement Sunday.
Both the Moderna and Pfizer vaccines were shown to be more effective than anticipated and well above the 50% reference set by the US Food and Drug Administration.
Britain’s AstraZeneca has announced an average efficacy rate of 70% for its vaccine and up to 90% for a subset of trial participants who received half the dose first, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.
With contributions from agencies
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