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.”
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