SAFETY AND ADVERSE EVENTS OF PROPHYLACTIC HPV VACCINES AMONG HEALTHY WOMEN: A SYSTEMATIC REVIEW & META ANALYSISAbstract
Cervical cancer (CaCx) is the third most common female cancer worldwide with an estimated 5, 27, 624 new cases and 2, 65, 653 deaths in 2014. We conducted a systematic review and meta- analysis to assess safety of prophylactic HPV vaccines compared against placebo. Four unique trials were included out of 607 publications. The total patient data evaluated was 1427(852 in vaccinated arm; 575 in the placebo arm). The pain was the major local side effects with 61% followed by swelling 22% and redness 17% in the vaccinated arm and similarly in the placebo arm pain 72% followed by swelling 18% and redness 10%. Headache was the most frequently experienced systemic side effects 42% in vaccine and placebo group. Unsolicited adverse event in vaccinated and placebo group were 39% and 37% respectively. New onset chronic disease in vaccinated and placebo arm were 3% and 2% respectively. Serious adverse event were 3% in vaccinated and 2% in placebo group. Undesirable pregnancy outcomes were same for both vaccinated and placebo arm 3%. As we had limited studies funnelled through our stringent inclusion exclusion criteria we were not able to separate exclusive adverse event in age group 25-34 and 35-45 years of age. In future, it would be interesting if we have 3 arms for comparison vaccine, Al(OH)3 and saline placebo.
V. C. Sangar *, B. B. Ghongane , G. Mathur and A. S. Chowdhary
B. J. Govt. Medical College and Sassoon General Hospital, Pune, Maharashtra, India
22 August, 2014
12 February, 2015
22 March, 2015
01 April, 2015