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Moderna Ships Variant-Specific Vaccine Candidate To NIH For Clinical Study

Moderna, Inc. (MRNA), Wednesday said it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant first identified in South Africa. The company said it has shipped doses to the National Institutes of Health for a Phase 1 clinical trial.

While initial data confirms that the Moderna COVID-19 Vaccine provides neutralizing activity against variants of concern, out of an abundance of caution, Moderna is pursuing two strategies against these variants, subject to FDA review.

First, the Company is evaluating booster doses of vaccine to increase neutralizing immunity against the variants of concern. 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.

"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.

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