Gardasil clinical trial and post-marketing data should raise a red flag about HPV vaccine safety.
Comment on: Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.
Martinez-Lavin M. Comment on: Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Database of Systematic Reviews. 2018 October 1.
This brief comment disputes as flawed the conclusions of a Cochrane systematic review of human papillomavirus (HPV) vaccine safety (Arbyn et al., 2018). The earlier review reported no increased risk of serious adverse events and dismissed post-HPV-vaccine deaths as a “chance occurrence.” However, other published studies show significantly more serious adverse events in (1) women who received Gardasil versus aluminum placebo and (2) women who received 9-valent Gardasil-9 versus 4-valent Gardasil. Stating that “hard statistical data must take preeminence over the expert’s opinion,” the author argues that Gardasil clinical trial and post-marketing data “should raise a red flag on HPV vaccine safety.”