Moderna says its coronavirus vaccine appears to be 94.5% effective
New Delhi, Nov 16: Moderna Inc says its experimental vaccine is 94.5% effective in preventing COVID19 based on interim data from a late-stage clinical trial.
"This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," said Stephane Bancel, Moderna's CEO.
This comes just a week after Pfizer Inc and BioNTech SE announced that their vaccine candidate was more than 90 per cent effective in preventing COVID-19.
"...the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 per cent," the company said in a statement. This study, known as the COVE study, enrolled more than 30,000 participants in the US, it added.
"This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible," Moderna CEO Stephane Bancel said.
"All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," he added.
Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the US Food and Drug Administration (USFDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data, the statement said.
The company also plans to submit applications for authorisations to global regulatory agencies, it added.
"By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the US. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021," Moderna said.
The company recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure, it added. First interim analysis included 95 participants with confirmed cases of COVID-19, Moderna said.
If the USFDA allows emergency use of Moderna's or Pfizer's candidates, there will be limited, rationed supplies in the US before the end of the year, the AP reported. Both require people to get two shots, several weeks apart.
Both the Moderna and Pfizer vaccine candidates are frozen but at different temperatures. Moderna said once thawed, its doses can last longer in a refrigerator for up to 30 days. Pfizer's shots require long-term storage at ultra-cold temperatures.
The vaccines are among 11 candidates in late-stage testing around the world, including four in the US.
Last week, Russia's health ministry had announced that according to interim trial results, Russia's Sputnik V vaccine had shown 92 per cent efficacy in preventing COVID-19. The coronavirus pandemic has killed more than 1.3 million people worldwide.