The development of vaccines seems to have been picking up some pace currently, after Pfizer announced results of its vaccine. Now, another mRNA-based COVID-19 vaccine being developed by Moderna has been reported to be 94.5% effective. The first interim analysis of the phase-3 trial (which started in July this year) of mRNA-1273, the coronavirus vaccine by Moderna, was conducted on 95 participants with active COVID-19 cases.
Of these 95 subjects, 90 were tested with the placebo group, whereas, only 5 were observed with Moderna’s mRNA-1273 vaccine group, which resulted in a point estimate of vaccine efficacy of 94.5%. The mRNA is being developed under the supervision of the National Institutes of Health (NIH) appointed, independent Data Safety Monitoring Board (DSMB) of Moderna.
The biotech company said, “The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns.”
The Cambridge-based biotech company, based on this positive efficacy outcome of the mRNA-1273 vaccine, intends to attain an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in the coming weeks for its vaccine. The EUA is expected to be based on the efficacy of the final analysis of 151 COVID cases and a follow-up of more than 2 months. The company has also planned to submit applications for authorizations to global regulatory agencies. The EUA batch of the vaccine will be intended to use in extreme emergency situations.
Stéphane Bancel, Chief Executive Officer of Moderna, said, “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. 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.”
Moderna is also working with U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed, McKesson (a US government-appointed vaccine distributor), and several global stakeholders to start preparing for the distribution of mRNA-1273 if it is approved for EUA and other global authorizations. The company has set a target of preparing 20 million doses of mRNA-1273 by the end of 2020 and is claiming to be on track for producing 500 million to 1 billion doses globally in 2021.
