Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announces that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and has shipped doses to the National Institutes of Health (NIH) for a Phase 1 clinical trial that will be led and funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The Company also is providing an update on its strategy for addressing SARS-CoV-2 variants of concern.
While initial data confirms that the Moderna COVID-19 Vaccine (mRNA-1273) provides neutralizing activity against variants of concern, out of an abundance of caution, 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 vaccine 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 first identified in the Republic of South Africa, at the 50 µg dose level and lower.
• A multivalent booster candidate, mRNA-1273.211, which 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, as a booster at the 50 µg dose level. The Company has already begun dosing this cohort with the booster.
Second, the Company 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 as well as participants in clinical studies who previously received the mRNA-1273 vaccine.
NIAID, part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial to determine if mRNA-1273.351 can boost immunity against the variants of concern. Moderna will provide doses of mRNA-1273.351 to the NIH. NIAID will initiate this study after receiving safe-to-proceed authorization from the FDA. NIAID will provide additional information when the trial begins, and details will also be available on clinicaltrials.gov. In parallel, the Company will be conducting its own clinical studies to support regulatory filings for any booster vaccine or updated primary vaccine.
“We look forward to beginning the clinical study of our variant booster and are grateful for the NIH’s continued collaboration to combat this pandemic,” said Stéphane Bancel, Chief Executive Officer of Moderna. “As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. 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.”
These studies will inform the Company’s regulatory strategy with the U.S. FDA and regulatory agencies outside of the U.S. The current Moderna COVID-19 Vaccine protocol calls for two 100 µg doses.
