Moderna on Track to Submit Data for Emergency Use Approval for its COVID-19 Vaccine Candidate

In Phase III first-interim tests during its COVE clinical study, Moderna Therapeutics’ two-dose COVID-19 vaccine candidate, mRNA-1273, met criteria established by the US FDA, with efficacy of 94.5%, the company reported in a press release issued on Nov. 16, 2020.

These results, reviewed by the independent Data Safety Monitoring Board (DSMB) appointed by the US National Institutes of Health, were based on data from 95 clinical trial participants who had confirmed cases of COVID-19 and began two weeks after participants had received the second and final dose of vaccine.

Out of the 95 trial participants, 90, who received placebo, developed COVID-19, compared with five of the patients who had received the candidate vaccine, reflecting vaccine efficacy of 94.5%, according to Moderna.

Another endpoint that was analyzed in this round of testing included 11 patients with severe cases of COVID-19 (as defined by Moderna in its study protocol), all of whom had received placebo in the clinical trial.

The demographics of Moderna’s clinical studies closely reflected trends in overall COVID-19 demographics, including participation of ethnic groups that have been inordinately affected by the disease in the US. Participants included 15 people aged 65 or older, 12 Hispanic, four African American, three Asian American, and one multiracial person.

The DSMB review did not report any significant patient-disclosed safety concerns, Moderna reported in its press release. Most of the adverse events were mild or moderate in severity, the company reported in its press release. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%).

Side effects reported by subjects after the second dose 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%), Moderna disclosed in its press release.

These solicited adverse events were generally short-lived, Moderna reported, noting that these data are still subject to change based on ongoing analysis of other Phase III COVE study data and final analysis.

Data for EUA approval will be based on analysis of 151 additional patients, each with a median follow up of more than two months.

Moderna’s COVE study enrolled more than 30,000 participants in the US, and involves collaboration from the US National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, as well as the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

The primary endpoint of the Phase III COVE study was based on analysis of COVID-19 cases, starting two weeks following the second dose of vaccine.

Preliminary analysis suggested a broadly consistent safety and efficacy profile across all evaluated subgroups, the company reported.

As more cases are analyzed, the company acknowledged in its press release, the accuracy estimates may change, but Moderna plans to submit data from the full Phase III COVE study to a peer-reviewed publication, as it did for previous phases of the clinical work.

“Since early January, we have chased this virus with the intent to protect as many people around the world as possible… This positive interim analysis from our Phase III study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna, who thanked study participants, Moderna staff, and the leadership of partners including NIH and NIAID, BARDA, and Operation Warp Speed, as well as the company’s suppliers and business partners.

“We look forward to the next milestones of submitting for an EUA in the US, and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic,” Bancel said.

By the end of 2020, Moderna’s senior executives expect the company 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, according to the company’s press release.

On Nov. 10, 2020, the American Medical Association (AMA) issued current procedural terminology code 91301 with which healthcare providers will be able to report patient vaccination with mRNA-1273. Moderna has already reported that it is making progress toward ensuring that the vaccine will be efficiently distributed, and handled, using existing infrastructure.

For more information on developments with its candidate COVID-19 vaccine, Moderna has published a dedicated web page with updates.​