Influenza vaccine clinical pharmacology
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohamed Moubarak, M.D. [2]
Clinical Pharmacology
Flublok contains recombinant HA proteins of the three strains of influenza virus specified by health authorities for inclusion in the annual seasonal vaccine. These proteins function as antigens which induce a humoral immune response, measured by hemagglutinin inhibition antibody (HAI).
Antibodies against one influenza virus type or subtype confer limited or no protection against another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual replacement of one or more influenza virus strains in each year's influenza vaccine. Therefore, influenza vaccines are standardized to contain the hemagglutinins of influenza virus strains (i.e., typically two type A and one type B), representing the influenza viruses likely to be circulating in the U.S. in the upcoming winter.
NONCLINICAL TOXICOLOGY
Flublok has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.
Reproduction studies performed in female rats revealed no evidence of impaired fertility due to Flublok.[1]
References
- ↑ "FLUBLOK (INFLUENZA VACCINE) INJECTION, SOLUTION [PROTEIN SCIENCES CORPORATION]". Text " accessdate" ignored (help)
Adapted from the FDA Package Insert.