NIH Launches Variant-Specific COVID-19 Vaccine Clinical Study

Massachusetts-based Moderna, Inc. announced that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 virus variant known as B.1.351 and has shipped doses to the National Institutes of Health (NIH) for a Phase 1 clinical trial.

This new study will be led and funded by the NIH’s National Institute of Allergy and Infectious Diseases.

Furthermore, Moderna is pursuing two strategies against these variants, subject to U.S. Food and Drug Administration (FDA) review.

First, the Company is evaluating booster doses of vaccines to increase neutralizing immunity against the variants of concern. Moderna plans to evaluate three approaches to boosting, including:

• A variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant was first identified in the Republic of South Africa, at the 50 µg dose level and lower.
• A multivalent booster candidate, mRNA-1273.211, combines mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine at the 50 µg dose level and lower.
• A third dose of mRNA-1273, the Moderna COVID-19 Vaccine, is a booster at the 50 µg dose level. The Company has already begun dosing this cohort with the booster.

Second, Moderna plans to evaluate mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series for those who are seronegative. These candidates will be evaluated in a two-dose series at the 100 µg dose level and lower.

Consistent with the recently updated FDA Guidance for Industry, the Company plans to evaluate immunogenicity and safety in participants who have not received a COVID-19 vaccine and participants in clinical studies who previously received the mRNA-1273 vaccine.

Stéphane Bancel, CEO of Moderna, commented in a press statement issued on February 24, 2021, “Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control."

"We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary.”

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing. Today, 13 programs have entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years.