Pharmaceutical company Moderna announced that its lead vaccine candidate is nearly 95% effective based on an early analysis from an independent board.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” Moderna CEO Stephane Bancel said on Monday. “This milestone is only possible because of the hard work and sacrifices of so many.”
Like Pfizer and BioNTech’s vaccine candidate, which independent analysis found to be more than 90% effective last week, Moderna’s vaccine is an mRNA-based drug. The vaccine inserts genetic information from the coronavirus into the body, which cells use to produce a protein found on the coronavirus. The body’s immune system is then able to develop antibodies that can target the virus, according to a study in RNA Biology.
Appointed by the National Institutes of Health, the independent data safety monitoring board found that of Moderna’s 30,000 enrolled participants, 95 tested positive for COVID-19, according to a press release. Of those who tested positive, only five received Moderna’s vaccine candidate. The other 90 participants received a placebo. The analysis reported 11 cases that were considered “severe” — of those, none had received the vaccine.
“Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data,” Moderna said.
Moderna’s EUA application will follow a final analysis of 151 coronavirus cases and a median follow-up of more than two months.
Moderna is participating in the federal government’s Operation Warp Speed program, a massive effort to accelerate the development and distribution of a coronavirus vaccine. Moderna was awarded up to about $1.5 billion to manufacture and distribute its vaccine.
“I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point,” Bancel said. “I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. … We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
