Monitoring HPV vaccination programmes

Vaccines based on human papillomavirus (HPV) types 16 and 18 virus-like particles (VLPs) are highly effective in preventing the development of HPV 16/18 related high grade cervical intraepithelial neoplasia (CIN2+) in HPV naive females. Gardasil (Merck) is a quadrivalent HPV 16/18/6/11 vaccine formulated with a proprietary aluminium adjuvant; and Cervarix (GlaxoSmithKline) is a bivalent HPV 16/18 vaccine incorporating a novel adjuvant, AS04. In the linked study (doi:10.1136/bmj.c712), Wacholder and colleagues report a pooled analysis of data on pregnancy loss from two randomised controlled trials of Cervarix vaccine.1

The bivalent vaccine was licensed in the European Union in 20072 and approved by the Food and Drug Administration in the United States in October 2009,3 and has been selected for use in the national public HPV vaccination programmes of the Netherlands and the United Kingdom. In the UK, vaccination started in September 2008, and at least 3.5 million doses have been administered.4 In England, three dose coverage in 12-13 year old girls is estimated at 80%; catch-up to age 18 will be conducted over approximately two years, with recent three dose coverage reported as 32% in 17-18 year old females.5

Prophylactic VLP HPV vaccines do not contain live virus. A broad consensus exists among regulatory authorities that, although no evidence suggests that HPV vaccines confer additional risk during pregnancy, the safety of vaccinating pregnant women has not been established.2 3 4 Thus, neither of the HPV vaccines are recommended for use in pregnancy or in women planning to become …