Moderna Inc (MRNA)

[Billydakidd]

Moderna confirms receipt of FDA Advisory Committee vote supporting EUA for mRNA-1273, the company''s COVID-19 vaccine 12/17/2020

Moderna today confirmed that the FDA''s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the company''s COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained.
The FDA will take the VRBPAC''s recommendation into consideration in making a final decision on approval or authorization.
Also presented at today''s VRBPAC meeting, Moderna has expanded the handling guidance for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2-8C (36 to 46F). In some cases, this may be the only practical means of distribution from clinics and for remote locations. This important update will help facilitate distribution to the final site of administration. Recognizing that shipping and handling of product can be a barrier to vaccination, Moderna remains committed to supporting efficient distribution.
Moderna previously announced that mRNA-1273 remains stable at standard refrigerator temperatures of 2 to 8C (36 to 46F) for 30 days.