The US Food and Drug Administration on Thursday announced two revised doses per vial for the Moderna COVID-19 Vaccine to positively impact the supply of the vaccine to provide more vaccine doses to communities.
According to the agency, the first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.
Based on the type of syringes and needles used to extract each dose, there may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses. However, the dosing regimen remains unchanged. The vaccine is administered as a two-dose series, 0.5 ml each dose, one month apart, added the agency.
In conjunction, the Fact Sheet for Healthcare Providers Administering Vaccine and Prescribing Information have been revised to reflect the new information to help frontline workers administering COVID-19 vaccines understand the number of doses that can be extracted per vial, concluded the agency.
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion