SYNOPSIS
Data restrictions imposed by vaccine manufacturers and regulators inhibit independent researchers’ ability to conduct comprehensive and accurate assessments of HPV vaccine safety.
TITLE
Challenges of independent assessment of potential harms of HPV vaccines
CITATION
Jørgensen L, Doshi P, Gøtzsche P, Jefferson T. Challenges of independent assessment of potential harms of HPV vaccines. BMJ 2018;362:k3694.
SUMMARY
Vaccine manufacturer control over clinical study reports inhibits independent researchers’ ability to conduct comprehensive and accurate assessments of HPV vaccine safety. Researchers and regulators evaluating reports of HPV vaccine injuries often do not have access to thousands of pages of clinical study results and must rely on short journal publications. Unpublished reports are also far more likely to contain information about harms, including those that are relatively rare. After three years of efforts to obtain “all potentially eligible reports for a systematic review of HPV vaccines,” the authors had received only half “and these were incomplete and contained redactions.”