SunstarTV Bureau: US-based pharma company, Moderna Inc, is ready to apply for US and European emergency authorization of its Covid-19 vaccine on Monday. As it shows its vaccine was 94.1% effective with no serious safety concerns.
After Pfizer-BioNTech’s vaccine candidate .The drug Company also reported a 100% success rate in preventing severe Covid-19 cases. The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorization this year.
Moderna stated,”A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the company.”
Of the 196 volunteers who contracted COVID-19 in the more than 30,000-person trial, 185 had received a placebo versus 11 who got the vaccine. The company reported 30 severe cases – all in the placebo group – which means the vaccine, was 100% 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, and ethnicity and gender demographics. The 196 cases included 33 adults over 65 and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants.
It also announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for Moderna’s vaccine (mRNA-1273) will likely be scheduled for Thursday, December 17.
Both the Moderna and Pfizer vaccines proved more effective than anticipated and far superior to the 50% benchmark set by the U.S. Food and Drug Administration.