Human papillomavirus vaccine [types 16, 18](GlaxoSmithKline Plc)

The World Health Organization (WHO) has published a new report to guide vaccine developers when creating innovative vaccines to treat human papillomavirus (HPV) infections in adults. Currently the main cause of cervical cancer – the fourth most common cancer in women globally – HPV is a very common group of viruses that leads to cervical cancer in more than nine out of every ten cases. Despite already-existing WHO-prequalified vaccines, including Merck & Co’s – known as MSD outside the US and Canada – Gardasil 9 (HPV 9-valent, recombinant) and GSK’s Cervarix (HPV bivalent (types 16, 18) vaccine, recombinant), to prevent HPV infections, there are currently no vaccines that can treat them. However, new therapeutic vaccines are being developed using the latest immunotherapy advances to clear HPV or treat precancerous cells in people already exposed to the virus. The WHO Preferred Product Characteristics for Therapeutic HPV Vaccines report calls on developers and outlines how they can ensure that their products meet global public health needs and how to quickly roll out vaccines if approved, while considering medical indications for potential use of such a vaccine, target populations, safety and efficacy criteria, as well as practical considerations such as delivery strategy, storage and dosage schedules, and affordability. Currently, there are more than 20 therapeutic HPV vaccine candidates that are at different stages of development, with several in clinical trials, that are likely to be most beneficial for adult women who did not receive the HPV vaccination prior to contracting the virus. In addition, these new potential therapeutic vaccines align with WHO’s Cervical Cancer Elimination Initiative, which aims to vaccinate 90% of girls with preventive HPV vaccines, screen 70% of women with a high-performance test and treat 90% of women who have precancerous cells in the cervix or cervical cancer by 2030. Dr Sami Gottlieb, medical doctor and epidemiologist, department of sexual and reproductive health and research, WHO, commented: “Therapeutic HPV vaccines could be a catalytic innovation to complement these efforts, increasing options for the millions of women who have already acquired HPV and reducing their risks of developing life-threatening cancer in the future.”

HPV vaccines have substantially reduced the prevalence of HPV infections and precancerous lesions. As a new report shows the human papillomavirus vaccine can also protect men and boys, we take a look at HPV vaccines, and their impact on world health Latest global HPV vaccine study The study included an estimated 1.7 million volunteers who were vaccinated against HPV since 2010. Volunteers were aged between nine and 39. There were equal numbers of unvaccinated volunteers. In total, about 44% of those who took part were male. Vaccinated males had lower rates of head and neck cancers in particular. Previously, it was believed smoking was the biggest single cause of head and neck cancers. The study showed that per 100,000 vaccinated patients, 3.4 cases (head) and 2.8 cases (neck) of cancers, compared with 7.5 (head) and 6.3 (neck) per 100,000 of unvaccinated patients. Boys and men can benefit from human papillomavirus ( HPV ) vaccination, which can cut the risk of a range of cancers, a new study shows. The study of around 3.4 million people is one of the first long-term analyses of the vaccine's efficacy on preventing HPV-related cancers of the head and neck, anal areas, penis, vulva, vagina and cervix, Reuters reports. Previous HPV vaccine studies have focused on cervical cancer. The most recent significant research along those lines was conducted in Sweden in 2020, and showed cervical cancer rates were 47 for every 100,000 vaccinated women and 94 per 100,000 in unvaccinated women. The latest study will be presented to the upcoming American Society of Clinical Oncology ( ASCO ) meeting in Chicago, which takes place from May 31 to June 2. ASCO President Dr Lynn Schuchter says the new study “extends what we know and shows that preventing infection with the vaccine helps prevent these additional HPV-related cancers”. In light of the HPV vaccine study findings, we take an in depth look at the evolution of the vaccine, the pharmaceutical companies involved, and how HPV vaccination programmes play out in different territories. Merck & GSK in HPV vaccine vanguard Merck's HPV vaccine was approved in 2006 for girls and women ages 9 to 26 and in 2009 for boys and men in that age group. The most recent version, Gardasil 9, has been approved in the U.S. since 2018 for use in children and adults ages 9 through 45. A separate study to be presented at the ASCO meeting found that between 2011 and March 2020, U.S. uptake of the HPV vaccine rose from 23.3% to 43.0% of the eligible population, improving from 7.8% to 36.4% in males and from 37.7% to 49.4% among females. HPV vaccines help ease the significant global healthcare burden that these diseases pose. Cervical cancer is the third most common cancer globally, and the second most frequent cause of cancer deaths among women aged between 15 and 44 years. Vaccines for HPV first became available in the early 2000s, after research by pharmaceutical companies including Merck and GlaxoSmithKline (GSK). Merck's Gardasil, approved in 2006, and GSK’s Cervarix (2009) were the first vaccines to target strains of HPV responsible for cervical cancer and genital warts . Merck's vaccine is for girls and women ages nine to 26 and in 2009 for boys and men in the same age group. The most recent version, Gardasil 9, was approved for use in the US in 2018 for use in children and adults ages Nine to 45. Gardasil 9 protects against nine HPV strains responsible for cervical, vulvar, vaginal and anal cancers. In terms of sales, Merck and GSK enjoy significant revenue from their HPV vaccine portfolios, with earnings estimates suggesting Merck's Gardasil franchise and GKS’s Cervarix generate billions of (US) dollars annually for the companies. HPV vaccine uptake affected by socioeconomic conditions The introduction of HPV vaccines has led to a substantial reduction in the prevalence of HPV infections and precancerous lesions in countries with high vaccination coverage rates. In North America, where HPV vaccination programs have been in place for over a decade, there has been a noticeable decline (by 51%) in cervical cancer rates among women aged 20-24. Similar trends have been reported in Canada, and also in European countries with HPV vaccination programs. In total, as of November 2022, 38 of 53 countries in the WHO European Region have introduced the HPV vaccine. In the Asia-Pacific (APAC) region, the uptake of HPV vaccines has been uneven, with varying levels of implementation across countries. Australia introduced a national HPV vaccination program in 2007, and has reported a substantial decline in HPV infections and precancerous lesions among vaccinated age groups. But in the developing world, especially Africa, HPV vaccine uptake is adversely influenced by factors such as poor healthcare infrastructure, lack of awareness campaigns and unfavourable socioeconomic conditions. Leading the way in Africa is Nigeria, which in 2023 ran a vaccination programme reaching 7.7 million girls, the largest number in a single round of HPV vaccination on the continent.