Moderna testing booster shots for variants

[M_T]

Moderna announced yesterday that first doses of their boosters for the SARS-Cov-2 variants have been given in a clinical trial.

he 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.

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.
In parallel, NIAID, part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial to assess the monovalent and multivalent modified mRNA-1273 vaccines as a primary series in naïve individuals and as a booster vaccine in those previously vaccine with mRNA-1273. NIAID will initiate this study after receiving safe-to-proceed authorization from the FDA. NIAID will provide additional information when the trial begins. The clinicaltrials.gov identifier is NCT04785144.