Available Vaccines
Human Papillomavirus Infections
Introduction
The Human papillomavirus (HPV) is a small, double-stranded DNA virus that belongs to the Papillomaviridae family. HPVs are highly tissue-specific and infect both cutaneous and mucosal epithelium. More than 200 HPV types have been identified and about 40 HPV types infect the anogenital tract. The virus is classified into: low-risk HPVs (LR-HPVs), which cause anogenital and cutaneous warts, and high-risk HPVs (HR-HPVs), which are responsible for oropharyngeal cancers and anogenital cancers. Individuals infected with one HPV type may be co-infected or subsequently infected with other types.
Worldwide, 1 in 10 women carries an HPV infection at any point in time. Globally, 610,000 incident cancers per annum are attributable to HPV infection. The cervix is the predominant HPV-associated cancer with 530,000 incident cases per annum. Genital warts are caused by HPV with an annual incidence of 0.1 to 0.2%.
HPV-16 and HPV-18 are the most frequent types worldwide, with HPV-16 being the most common in all regions. Globally, high-risk HPV types 16 and 18 cause about 70% of cervical cancer cases, 85% of HPV-related head and neck cancers, and 87% of anal cancers. HPV types 16, 18, 45, 31, 33, 52, and 58 together account for approximately 90% of squamous cell carcinomas that are positive for HPV DNA.
In Malaysia, 28 HPV genotypes were identified, with HPV16, HPV18, HPV58, HPV52, and HPV33 being the most prevalent high-risk HPV (HR-HPV) genotypes. Genotype distribution varied significantly across the Malaysian states and ethnic groups. HPV accounts for 99% of cervical cancer in Malaysia.
Table 12.1 Vaccines Registered in Malaysia
Table 12.2 High-risk Group in Malaysia
Implications for Healthcare Workers (HCWs)
There are no special recommendations for health care workers; they should follow the same vaccine recommendations as other adults, based on age or other individual risk factors.
Evidence of Safety and Effectiveness
Among males and females of all ages receiving HPV vaccine, injection site reactions included pain (35–88%), redness (5–40%) and swelling (4–35%). Severe pain (spontaneous pain or pain that prevented normal activity) was reported by around 6% of vaccinees.
HPV vaccination is recommended for eligible individuals. In high-risk females, vaccination should preferably be completed before pregnancy where indicated. HPV vaccines are not recommended for use in pregnant women. If pregnancy occurs after initiation of the vaccination series, the remaining dose(s) should be deferred until after pregnancy; the series does not need to be restarted. Inadvertent administration during pregnancy is not an indication for termination of pregnancy, as available safety data have not demonstrated adverse pregnancy outcomes. HPV vaccination may be administered during the postpartum period and is not contraindicated during breastfeeding.
Evidence for HPV vaccine Effectiveness
Bivalent HPV Vaccine (2vHPV – Cervarix®): Efficacy of 93–100% against CIN2+ caused by HPV 16/18 in HPV-naive women of 15–26 years. Offers 30–50% cross-protection against HPV 31, 33, and 45. Protection lasts more than 10 years.
Quadrivalent HPV Vaccine (4vHPV – Gardasil®): Nearly 100% efficacy against HPV 16/18-related CIN2+, vaginal & vulvar lesions; 90% efficacy against male genital warts; 75% efficacy against male anal pre-cancers; and 95% efficacy against intra-anal HPV infection in men who have sex with men. Antibody levels last for at least 10 years.
Nanovalent HPV Vaccine (9vHPV – Gardasil 9®): 96.7% effectiveness against CIN2+ caused by HPV 31/33/45/52/58 in HPV-naive women age 16–26 years; around 97% against any HPV-related high-grade lesion; and about 99% against genital warts. Protection so far lasts for at least 6–8 years.
Use of single dose of HPV vaccine
Data from immunogenicity trials, post-hoc analyses of efficacy trials, and post-licensure observational studies among females have demonstrated that a single dose of HPV vaccine is sufficient to elicit an immune response that provides similar protection as a multidose regimen against initial and persistent HPV infection. Systematic reviews have shown seropositivity among subjects who received one dose to be non-inferior to that after 2 or more doses. Key evidence supporting one dose HPV schedule for age 15-20 years:
- KEN SHE Study (Kenya, 2022 – NEJM): A single dose of 2vHPV or 9vHPV was 97.5% efficacious against persistent HPV-16/18 infection at 18 months, comparable to 2-dose and 3-dose schedules, indicating high efficacy and strong immunogenicity.
- IARC-India Study (Lancet Oncol, 2023): A 10-year follow-up study involving girls age 10–18 showed that a single dose of the HPV vaccine provides protection comparable to that of 2 doses, supporting a single-dose approach
References
- de Sanjose, S., Quint, W. G., Alemany, L., et al and the Retrospective International Survey and HPV Time Trends Study Group (2010). Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. The Lancet. Oncology,11(11), 1048–1056. https://doi.org/10.1016/S1470-2045(10)70230-8
- Forman, D., de Martel, C., Lacey, C,J., et al. (November 20, 2012). Global Burden of Human Papillomavirus and Related Diseases. Vaccine, 30(5), F12–F23. https://doi.org/10.1016/j.vaccine.2012.07.055
- Serrano, B., de Sanjosé, S., Tous, S., et al. (2015). Human papillomavirus genotype attribution for HPVs 6, 11, 16, 18, 31, 33, 45, 52, and 58 in female anogenital lesions. European Journal of Cancer, 51(13), 1732–1741. https://doi.org/10.1016/j.ejca.2015.06.001
- Chee, S. M., Lim, K. H., Abdullah, N. H., & Wong, L. P. (2025). Human Papillomavirus (HPV) genotype distribution in Malaysia: A systematic review. BMC Infectious Diseases, 25(1010). https://doi.org/10.1186/s12879-025-11441-0
- National Pharmaceutical Regulatory Agency (NPRA) Sistem Pendaftaran Produk & Perlesenan. https://quest3plus.bpfk.gov.my/pmo2/index.php
- World Health Organization. (December 16, 2022). WHO position paper on HPV vaccines – Weekly Epidemiological Record, No. 50, 97, 645–672. https://www.who.int/publications/i/item/who-wer9750-645-672
- Whitworth, HS., Gallagher, K.E., Howard, N., et al. (2020). Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: a systematic review of evidence from clinical trials. Vaccine, 38(6):1302-1314. DOI: 1016/j.vaccine.2019.12.017
- Barnabas, R. V., Brown, E. R., Onono, M. A., Bukusi, E. A., Njoroge, B., Winer, R. L., Kiarie, J. (2022). Efficacy of single-dose human papillomavirus vaccination among young women. The New England Journal of Medicine, 386(24), 2302–2312. https://doi.org/10.1056/evidoa2100056
- Bhatla, N., Nene, B. M., Joshi, S., Esmy, P. O., Poli, U. R. R., Jayant, K., Sankaranarayanan, R. (2023). Efficacy of a single dose of quadrivalent HPV vaccine in young women in India: Interim results of the randomised, controlled, non-inferiority IARC India HPV vaccine study. The Lancet Oncology, 24(5), 594–605. https://doi.org/10.1016/S1470-2045(23)00120-3