The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has granted approval for the use of a single dose of the Gardasil vaccine in the treatment of cervical cancer. This decision was announced by the Director General of NAFDAC, Prof. Mojisola Adeyeye, during a joint press conference with the National Primary Health Care Development Agency (NPHCDA) in Abuja. The approval paves the way for the NPHCDA to introduce the off-label use of the quadrivalent Gardasil vaccine as a single dose schedule into the routine immunization program in Nigeria.

The decision to deploy the off-label use of the Gardasil vaccine as a single dose schedule is based on scientific evidence that demonstrates the effectiveness of a single dose in providing protection against cervical cancer caused by human papillomaviruses (HPVs). Data from immunogenicity trials, efficacy trials, and post-licensure observational studies have shown that a single dose of the HPV vaccine can elicit an immune response that offers similar protection as a multidose regimen against initial and persistent HPV infection.

Cervical cancer is a significant health concern in Nigeria and other African countries. In 2020, Africa accounted for 22.5% of the global burden of cervical cancer, with approximately 119,000 new cases and 81,000 deaths reported. Nigeria, being the most populous country in Africa, has one of the highest incidence and mortality rates of cervical cancer on the continent, with an estimated 15,000 new cases and 10,000 deaths annually.

Several factors contribute to the high burden of cervical cancer in Nigeria, including low awareness, limited access to screening and treatment, and a high prevalence of HPV infection. The introduction of the single dose Gardasil vaccine as part of the routine immunization program aims to address these challenges and provide effective and sustainable interventions to prevent and control cervical cancer in Nigeria.

Gardasil is a vaccine that protects against HPV, a common sexually transmitted infection that can lead to cervical, vaginal, vulvar, and other types of cancers. While the vaccine is recommended for girls and boys 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 age of the recipient. The registration approval by NAFDAC for the use of Gardasil as a single dose reflects the rigorous regulatory evaluation process for vaccines conducted by the agency.

The introduction of the single dose Gardasil vaccine is expected to offer program advantages, improve coverage, and make the immunization process more efficient and affordable. The NPHCDA plans to commence the implementation of this new schedule in the last quarter of 2023, aiming to provide effective protection against cervical cancer and reduce the burden of the disease in Nigeria.

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