American biotechnology company Moderna has applied for United States and European emergency authorisation of its Covid-19 vaccine on Nov. 30, 2020.
This came after full results from a late-stage study that showed its vaccine reported a 100 per cent success rate in preventing severe cases and, more importantly, is 94.1 per cent effective with no serious safety concerns.
How vaccine was tested
In the more than 30,000-person trial, 196 volunteers had contracted Covid-19.
Out of this Covid-19-positive group, 185 received a placebo versus 11 who got the vaccine.
The company reported 30 severe cases all in the placebo group.
This means that the vaccine was 100 per cent effective at preventing severe cases.
The trial included one Covid-19-related death in the placebo group.
Moderna said the vaccine's efficacy was consistent across age, race, ethnicity and gender demographics.
The 196 cases included 33 adults over 65, and 42 volunteers from racially diverse groups, including 29 Latinos, six Blacks, four Asian-Americans and three multiracial participants.
Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the U.S. by the end of 2020.
This is enough to inoculate 10 million people.
Moderna's vaccine will be the second vaccine likely to receive US emergency use authorisation this year with this filing.
Moderna's announcement came after news that the vaccine from Pfizer and German partner BioNTech was 95 per cent effective.
Both vaccines use a new technology called synthetic messenger RNA (mRNA).
Pfizer's emergency use authorisation came about a week ahead of Moderna's.
Moderna added it would apply for conditional approval from the European Medicines Agency.
Positive vaccine results
Both the Moderna and Pfizer vaccines proved more effective than anticipated.
A 50 per cent benchmark was set by the U.S. Food and Drug Administration.
Positive vaccine results in the past few weeks have ignited hopes for an end to a pandemic that has killed more than 1.45 million lives worldwide.
Independent advisers to the U.S. Food and Drug Administration are scheduled to meet on Dec. 10 to review Pfizer's data, and on Dec. 17 to review Moderna's trial data and make a recommendation to the FDA.
Moderna expects the vaccine to be shipped to designated distribution points throughout the U.S. by the government's Operation Warp Speed programme and McKesson Corp, a drug distributor contracted by the U.S. government.
Its distribution is expected to be easier than Pfizer's.
Moderna's vaccine needs to be stored in a freezer, but they do not have to be held at the ultra-cold temperature needed by Pfizer's vaccine.
Top photo via Getty