Analysis Finds Bivalent HPV Vaccine (2vHPV) to be Safe

Vaccine HPV healthcare

Infection with human papillomavirus (HPV) can cause certain cancers in women and men, but HPV vaccines are highly effective in preventing infection with oncogenic HPV types. A new British Journal of Clinical Pharmacology review of post-licensure data did not identify any new or unexpected safety concerns of the bivalent HPV vaccine.

Infection with human papillomavirus (HPV) can cause certain cancers in women and men, but HPV vaccines are highly effective in preventing infection with oncogenic HPV types. A new British Journal of Clinical Pharmacology review of post-licensure data did not identify any new or unexpected safety concerns of the bivalent HPV vaccine.

The journal is published in behalf of the British Pharmacological Society.

Photo 1.0: Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant | GlaxoSmithKline). Immunization with Cervarix consists of 3 doses of 0.5-mL each by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm.

Indication
Human papillomavirus bivalent (types 16,18) vaccine (2vHPV, Cervarix?, GSK) was originally licensed by the United States Food and Drug Administration (FDA) in 2009.

The vaccine is approved for use in girls and young women (9-25 years of age) indicated for the prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1, which is caused by oncogenic HPV types 16 and 18).

In the study the authors analyzed reports submitted to the Vaccine Adverse Event Reporting Systems (VAERS) following bivalent HPV vaccination from 2009-2017. While most HPV vaccine used in the United States during this period was quadrivalent HPV vaccine, 720,000 doses of bivalent HPV vaccine were distributed.

VAERS received 241 adverse event reports after bivalent HPV vaccine; 95.8% of the adverse events reports were classified as non-serious. Dizziness, headache, nausea and injection site reactions were the most common symptoms.

The findings should provide reassurance to patients, parents, and healthcare providers.

Although the drug is only approved for the treatment of girls and young woman, 64 of adverse events were reported in males?and 19 reports came from individuals with unknown sex.

In the Unites States the 2vHPV vaccine was not widely used (<2% of all HPV vaccines distributed during 2009-2017. As a result, GlaxoSmithKline, the manufacturer, stopped marketing the agent in 2016.

?[However,] bivalent HPV vaccine is used in more than 134 countries around the world. This review provides additional evidence that bivalent HPV vaccine is safe, and that most adverse reactions are mild and resolve quickly on their own,? noted lead author Tiffany Suragh, of the Centers for Disease Control and Prevention (CDC), in Atlanta.

Bivalent HPV vaccine (2vHPV | Cervarix?; GlaxoSmithKline) is currently not commercially available in the United States.

Reference
[1] Suragh TA, Lewis P, Arana J, Mba?Jonas A, Li R, Stewart B, Shimabukuro TT, Cano M.
Safety of bivalent human papillomavirus vaccine in the U.S. Vaccine Adverse Event Reporting System (VAERS), 2009?2017. Br J Clin Pharmacol


Last Editorial Review: September 19, 2018

Featured Image: Immunization. Courtesy: ? 2010 ? 2018 Fotolia. Used with permission. Photo 1.0: Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant). Courtesy: ? 2013 GlaxoSmithKline.

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