New flu vaccine gets regulatory nod
A new flu vaccine has secured a regulatory approval and its limited supplies are expected to be available this winter.
Dr. Karen Midthun, a senior official at the U.S. Food and Drug Administration, “This approval represents technological advance in the manufacturing of an influenza vaccine.”
The approval for the flu vaccine came a time during one of the more severe flu seasons, with many Americans rushing to find diminishing supplies of vaccine and spot shortages being reported.
Chief Executive of Protein Sciences, Manon Cox said, “The Company could have about 15,000 doses available for distribution later on during the flu season.”
The small amount of dosage could be useful for those who do not get flu shots because they are allergic to eggs. The timing for the approval was not related to the current flu season, which is moving at a rapid pace.
Flubox has only a protein from the virus and this protein is made by putting the gene for it into a virus that infects insect cells. Those cells are grown in a culture and churn out the protein. Neither eggs nor the live virus are used, though viral genetic information is needed.
The protein-based vaccines have been used to prevent other diseases in the past, but are new to a flu vaccine. Flublok is approved for adults 18 to 49 years old, and it was 44.6% effective against all influenza strains, not just the three contained in the vaccine.