Moderna’s novel coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, showed 94.5% efficacy in preventing the virus, according to preliminary results from the ongoing phase 3 COVE trial. In data submitted to an independent data and safety monitoring board (DSMB) overseeing the trial, the interim review showed that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults, according to a press release from the National Institutes of Health (NIH).

“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,” said Stéphane Bancel, chief executive officer of Moderna, in a press release. “This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our phase 1, phase 2 and phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus.”

The interim analysis included 95 cases of symptomatic COVID-19 among volunteers. The DSMB found that the vaccine was safe and well-tolerated with a statistically significant vaccine efficacy rate. Ninety of the cases occurred in the placebo group and 5 occurred in the vaccinated group. Among the 95 total cases, there were 11 cases of severe COVID-19, all of which occurred in the placebo group.

The phase 3 COVE vaccine efficacy trial is a multi-agency collaboration led by the Department of Health and Human Services (HHS) and the Department of Defense (DoD) seeking to hasten the development, manufacturing, and distribution of medical countermeasures for COVID-19. The study, which launched on July 27, 2020, includes more than 30,000 participants across 100 clinical research sites in the United States.
 

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The majority of adverse events (AEs) in the trial were mild or moderate in severity. Grade 3 AEs greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%), all of which were generally short-lived, according to Moderna. 

The mRNA-1273 vaccine was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, a part of the NIH. The first clinical batch was finished on February 7, 2020, and underwent analytical testing at that time. That first batch was then shipped to NIH on February 24, which was 42 days following the sequence selection.

Based on the interim safety and efficacy data, Moderna said it will submit for an Emergency Use Authorization (EUA) with the FDA in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data.  

In August, the HHS and DoD announced a deal with Moderna, Inc, to manufacture and deliver 100 million doses of the manufacturer’s novel COVID-19 vaccine candidate. Moderna will manufacture these vaccine doses, which will be owned by the US government, as clinical trials are conducted simultaneously.

In a press release, the DoD and HHS said that manufacturing the vaccine while clinical trials are ongoing will expedite the traditional development timeline.

If the vaccine doses are used as part of a COVID-19 vaccination campaign, it would be available to Americans at no cost; however, health care providers may charge for the cost of administering the vaccine, according to HHS.

In May, Moderna, Inc, announced a collaboration with Lonza Ltd, to manufacture the mRNA vaccine (mRNA-1273) candidate, for immunization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), on a larger scale.

The data on Moderna’s vaccine candidate follows the first interim analysis released last week from a phase 3 study of Pfizer and BioNTech’s COVID-19 vaccine candidate, which also showed promising results, with more than 90% efficacy in preventing COVID-19 among study participants.