Therapy Areas: Vaccines
Moderna delivers variant specific mRNA-1273.351 vaccine candidate to NIH for clinical study to address SARS-CoV-2 variants
25 February 2021 -

Biotechnology company Moderna Inc (Nasdaq:MRNA) reported on Wednesday the completion of the manufacturing of clinical trial material for its variant-specific vaccine candidate mRNA-1273.351 against the SARS-CoV-2 variant (B.1.351) first identified South Africa.

In conjunction, the company has shipped the doses of mRNA-1273.351 vaccine candidate 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).

Subject to US FDA's review, the company plans to evaluate a variant-specific booster candidate mRNA-1273.351 based on the B.1.351 variant first identified in South Africa at the 50 µgdose level and lower, a multivalent booster candidate mRNA-1273.211 in a single vaccine at the 50µg dose level and lower as well as a third dose of mRNA-1273 as a booster at the 50µg dose level.

According to the company, it intends to evaluate mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series for those who are seronegative in a two-dose series at the 100µg dose level and lower.

Based on the updated US FDA guidance for Industry, the company proposes 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.



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