Gardasil Set For Further Growth As England Okays HPV Vaccine For Boys
Executive Summary
The decision to expand the HPV vaccination program in England to boys comes as Merck & Co sees "an unprecedented increase in global demand" for Gardasil.
The recent surge in sales of Merck & Co. Inc.'s Gardasil is going to be boosted further by the news that the National Health Service in England is expanding its human papilloma virus (HPV) vaccination program to include all boys aged 12-13.
The program has been a success since 2008 when GlaxoSmithKline PLC won the contract to supply its HPV vaccine Cervarix to girls primarily to protect against cervical cancer. However, since September 2012, Gardasil and Gardasil 9, which were originally marketed in Europe through Merck (known as MSD outside North America) and Sanofi's now-discontinued vaccines joint venture Sanofi Pasteur MSD, has been the sole vaccine used.
Worldwide, about 5% of all cancers are linked to the HPV virus, including cervical, penile, anal and genital cancers and some cancers of the head and neck – all of which Gardasil helps to protect against. Public Health England (PHE) noted that so far, 10 million doses have been given to young women in the country, meaning over 80% of women aged 15 to 24 have received the vaccine and infections of HPV 16 and 18 (the two types of HPV that cause 70% of cervical cancers) in 16 to 21 year old women have reduced by 86% in England.
There have long been calls for boys to be vaccinated as well as girls, with the rationale being that as the virus is sexually transmitted, vaccinating boys before they become sexually active (in the English case classed as year eight at school) will help protect their partners as well as themselves. Mary Ramsay, head of immunization at PHE, said the expansion "offers us the opportunity to make HPV-related diseases a thing of the past and offering the vaccine to boys will not only protect them but will also prevent more cases of HPV-related cancers in girls and reduce the overall burden of these cancers in both men and women in the future."
PHE cited modelling produced by the University of Warwick which estimates that by 2058 (50 years after the program was introduced), in the UK the HPV vaccine currently being used may have prevented up to 64,138 HPV-related cervical cancers and 49,649 other HPV-related cancers.
Louise Houson, managing director of MSD UK & Ireland, told Scrip that "we warmly welcome the decision," which means England follows several other countries "including Australia, Canada and Germany in offering vaccination to boys as part of their publicly funded programs. We are proud that we can now help protect both boys and girls in the UK."
The expansion will bring England's HPV vaccination program in line with Scotland and Wales, while the Department of Health in Northern Ireland has previously announced that it will also offer the vaccine to boys from September this year.
Gardasil was approved by the US Food and Drug Administration and the European Medicines Agency back in 2006 but Merck noted when presenting its first quarter 2019 results that "HPV vaccine recommendations and goals have changed and countries around the world have enacted new or expanded vaccination programs." This has led to "an unprecedented increase in global demand," resulting in a 31% increase in Q1 sales to $838m, up 31%. (Also see "China Appetite For HPV Vaccine Delivers Surprise For Merck" - Scrip, 2 Aug, 2018.)
News of the expansion of the HPV program in England came just a couple of weeks after a meta-analysis including 60 million individuals in high-income countries was published in The Lancet which showed that vaccination has led to an 83% reduction in HPV 16 and 18 infections in 13 to 19 year-old girls over five to eight years. Among women aged 20 to 24, infections have fallen 66%, while significant reductions were also seen for anogenital warts and precancerous lesions.
One of the authors, Marc Brisson of Laval University in Canada, wrote, "The landscape of HPV vaccination is rapidly changing, with several countries recently switching from three to two-dose schedules, gender-neutral vaccination and a newer vaccine that targets more HPV types," namely Gardasil 9. He added that the researchers believed that the World Health Organization's call for action to eliminate cervical cancer "may be possible in many countries if sufficient vaccination coverage can be achieved."