http://www.fda.gov/cber/adpromo/typhave040204.htm Violative Advertising and Promotional Labeling Letter Typhoid Vi Polysaccharide Vaccine (Typhim Vi)
(Aventis Pasteur Inc) False or Misleading Effectiveness Claim
The reverse side of the referenced flashcard contains the statement, “Provides typhoid protection that requires just 1 shot.” The placement of this statement without the mention of the need for a booster in close proximity leads the reader to believe that the shot gives complete protection with just one dose.
This statement, as it is presently written, is false or misleading because it implies that Typhim Vi is effective in protecting against typhoid without the need for reimmunization. Cf. 21 C.F.R. § 202.1(e)(6)(i). Your approved PI specifically states, “An optimal reimmunization schedule has not been established. Reimmunization every two years … is recommended at this time.” Your PI further states, “Based on the available efficacy data, vaccination with Typhim Vi may not be expected to protect 100% of susceptible individuals.”
We would recommend this statement be revised to state, “Provides typhoid protection for 2 years [emphasis added] that requires just 1 shot.”
(Aventis Pasteur Inc) False or Misleading Effectiveness Claim
The reverse side of the referenced flashcard contains the statement, “Provides typhoid protection that requires just 1 shot.” The placement of this statement without the mention of the need for a booster in close proximity leads the reader to believe that the shot gives complete protection with just one dose.
This statement, as it is presently written, is false or misleading because it implies that Typhim Vi is effective in protecting against typhoid without the need for reimmunization. Cf. 21 C.F.R. § 202.1(e)(6)(i). Your approved PI specifically states, “An optimal reimmunization schedule has not been established. Reimmunization every two years … is recommended at this time.” Your PI further states, “Based on the available efficacy data, vaccination with Typhim Vi may not be expected to protect 100% of susceptible individuals.”
We would recommend this statement be revised to state, “Provides typhoid protection for 2 years [emphasis added] that requires just 1 shot.”
