The National Agency for Food and Drug Administration and Control (NAFDAC) has given its approval for the use of a single dose of the Gardasil vaccine in the fight against cervical cancer in Nigeria. In response to this approval, the National Primary Health Care Development Agency (NPHCDA) is preparing to introduce the off-label use of the quadrivalent Gardasil vaccine as a single-dose schedule into the routine immunization program in the last quarter of 2023.
This significant development was announced during a joint press conference held by Director General of NAFDAC, Prof. Mojisola Adeyeye, and representatives from NPHCDA in Abuja. Prof. Adeyeye emphasized the urgent need for effective and sustainable interventions to prevent and control cervical cancer not only in Nigeria but also in other African nations.
The decision to deploy the off-label use of Gardasil as a single-dose schedule is rooted in scientific evidence that a single dose of Gardasil vaccine can offer robust protection against cervical cancer caused by human papillomaviruses (HPVs). Prof. Adeyeye highlighted the support of NAFDAC for this decision, pointing to data from immunogenicity trials, post-hoc analyses of efficacy trials, and post-licensure observational studies that demonstrate the efficacy of a single dose in providing protection comparable to a multidose regimen against initial and persistent HPV infection.
In 2020, approximately 119,000 new cases of cervical cancer and 81,000 related deaths were reported in Africa, constituting 22.5% of the global burden. Nigeria, as the most populous country on the continent, carries one of the highest burdens of cervical cancer incidence and mortality, with an estimated 15,000 new cases and 10,000 deaths each year.
Several factors contribute to the high prevalence of cervical cancer in Nigeria, including low awareness, limited screening coverage, inadequate access to treatment, and a high prevalence of HPV infection. Human papillomavirus (HPV) is the most common viral infection of the reproductive tract and can lead to various conditions in both men and women, including pre-cancerous lesions that may progress to cancer.
Gardasil is a vaccine designed to protect against HPV, a sexually transmitted infection responsible for cervical, vaginal, vulvar, and other cancers. While Gardasil is recommended for individuals aged 11 to 12 years, it can be administered as early as 9 years or as late as 26 years. The vaccine is typically given as two or three doses, depending on the recipient’s age. Gardasil received registration approval from NAFDAC, following a rigorous regulatory evaluation process for vaccines, as mandated by the NAFDAC Act CapN1, LFN 2004.
The use of Gardasil as a single dose is supported by strong evidence indicating that it provides similar protection as a multi-dose regimen against initial and persistent HPV infection. At 18 months post-vaccination, the efficacy of a single dose of the HPV vaccine against incident persistent high-risk HPV16/18 infection was found to be 97.5%. This development is expected to enhance efficiency and affordability, contributing to improved vaccination coverage.
The NPHCDA is set to introduce the use of the quadrivalent Gardasil vaccine as a single-dose schedule into the routine immunization program in Nigeria in the last quarter of 2023, marking a significant step forward in the fight against cervical cancer.
