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Wednesday, March 10, 2021

Moderna: First Participants Dosed in Covid Booster Trial

 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participants have been dosed with the Company’s modified COVID-19 vaccines, designed to address the potential need for booster vaccine candidates, in an amendment to the ongoing Phase 2 clinical study.

mRNA-1273.351 encodes for the prefusion stabilized Spike protein of the SARS-CoV-2 variant B.1.351, first identified in the Republic of South Africa, and is being assessed as a booster vaccine to increase the breadth of response to emerging variants with key-receptor-binding domains (RBD) mutations. mRNA-1273.211 is a multivalent candidate which combines mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine, designed to elicit a broad immune response as both a primary series and when administered as a boost to those who have previously received mRNA-1273.

Previously published data has shown that vaccination with the Moderna COVID-19 Vaccine produced neutralizing titers against all key variants tested, including B.1.1.7, first identified in the UK, and B.1.351, with a 6-fold reduction in neutralizing titers against B.1.351. Out of an abundance of caution, Moderna is pursuing a clinical development strategy against these emerging variants. An amendment to the Phase 2 study will enroll 60 participants previously vaccinated with mRNA-1273 to receive a single booster dose of either:

  • 20 µg of a variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant first identified in the Republic of South Africa (N=20)
  • 50 µg of mRNA-1273.351 (N=20)
  • 50 µg of 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 (N=20)

In a previous protocol amendment, Phase 2 study participants vaccinated with mRNA-1273 have been offered a single 50 µg booster dose of mRNA-1273. Dosing in this protocol extension is ongoing.

https://www.businesswire.com/news/home/20210310005932/en/Moderna-Announces-First-Participants-Dosed-in-Study-Evaluating-COVID-19-Booster-Vaccine-Candidates

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