W 2-04Review on HPV vaccine safety

05. HPV prophylactic vaccines
P.L. Lopalco 1.
1University of Pisa (Italy)

Background / Objectives

HPV vaccines are available for prophylactic use since a decade and, up to date, more than 180 million doses have been distributed worldwide. Vaccine uptake varies widely; some country programmes have been extremely successful, but vaccine hesitancy and obstacles to high acceptance of HPV vaccination is reported in many countries. The main obstacle to achieving high coverage levels is fear of alleged adverse events and rumours on HPV vaccine safety that easily spread across the globe. 


Methods

Vaccine safety data collected during both pre-marketing and post-marketing phase have been critically reviewed and analysed.


Results

Pre-marketing studies on bi- tetra- and nona- valent vaccines have been carried out involving tens of thousands female and male subjects 9 to 26 years old. In addition, post-marketing safety evaluation have been carried out by both national and international public health agencies in order to assess the potential link between HPV vaccines and rare neurological syndromes. Most common adverse events following HPV vaccination are local reactions and some not serious general reaction linked to vaccine administration. No serious adverse event causally linked to HPV vaccines have been reported.


Conclusion

Safety assesement of all HPV vaccine products currently in use has been carefuly carried out and the results are reassuring. HPV vaccines provide a very good safety profile also when co-administered to other adolescent vaccinations.


References

Lopalco PL. Spotlight on the 9-valent HPV vaccine. Drug Des Devel Ther. 2016 Dec 20;11:35-44. Review.

Stillo M, Carrillo Santisteve P, Lopalco PL. Safety of human papillomavirus vaccines: a review. Expert Opin Drug Saf. 2015 May;14(5):697-712. Review.