Moderna Doses First Patients in Phase 2 Study of COVID-19 Vaccine

Moderna recently announced that the first participants in each age cohort have been dosed in the company’s Phase 2 study of two potential COVID-19 vaccines that use its mRNA vaccine candidate, mRNA-1273.

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The Phase 2 study intends to evaluate the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273. These will be given 28 days apart, Moderna said. 

The biotechnology company, which pioneers in messenger RNA therapeutics and vaccines, intends to enroll 600 participants in two groups: adults aged 18 to 55 years of age and older adults aged 55 and older. 

The two groups will individually receive 50 μg or a 100 μg dose of both vaccinations. Experts will follow up with participants 12 months after the second vaccination. 

On May 6, FDA completed its review of the company’s Investigational New Drug (IND) application for mRNA-1273. On May 12, the FDA granted it fast track designation.

In mid-May Moderna announced positive clinical data for mRNA-1273, from the Phase I study, led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The agency found that mRNA-1273 was safe and well-tolerated, with results consistent with prior Moderna infectious disease vaccine clinical studies.

All participants, aged 18 to 55 years, received a 25 µg, 100 µg, or 250 µg, with 15 people in each dose group. Participants received two doses of the vaccine about 28 days apart. 

The levels of neutralizing antibodies at day 43 were at or above levels normally seen in blood samples from those who have recovered from COVID-19. Those who received 100 µg had antibodies that “significantly exceeded levels” in recovered patients. Data on a second dose was not available for the 250 µg. 

Given that the 25 μg and 100 μg dose levels in the Phase 1 study showed neutralizing antibody titers at or above convalescent sera and were generally well tolerated, Moderna stated that it decided not to pursue the 250 μg dose level in the Phase 2 study.

The company also noted that it intends to collaborate with NIAID to implement the Phase 3 study. The dose for the Phase 3 study is expected to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July 2020.

The Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR), , supported the planning for these studies and will also support the late-stage clinical development program, Moderna concluded. 

At the end of April, Moderna received $483 million from BARDA to bolster COVID-19 vaccine development using its mRNA vaccine candidate.

Under the terms of agreement, BARDA funded the advancement of mRNA-1273 to FDA licensure. The funding supported the late-stage clinical development programs and will boost mRNA-1273 manufacturing in late 2020.

Additionally, Moderna noted that it will hire about 150 new team members in the US this year to accelerate the scale-up. This includes a boost in its skilled manufacturing staff to expand capacity from two shifts per day, five days per week, to three shifts per day, seven days per week.

“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said Stéphane Bancel, Moderna’s chief executive officer. 

“Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”