***15,000 new cases, 10,000 deaths annually
By Tobias Lengnan Dapam
The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Christianah Adeyeye, said Nigeria has one of the highest cervical cancer incidence and mortality rates in the continent, with an estimated 15,000 new cases and 10,000 deaths annually.
“Cervical cancer is a major public health problem in Africa, where it is the leading cause of cancer death among women. According to the World Health Organization, about 119,000 new cases and 81,000 deaths from cervical cancer occurred in Africa in 2020, accounting for 22.5% of the global burden.”
The NAFDAC boss stated this on Tuesday during a joint press conference with the Executive-Director, National Primary Healthcare Development Agency (NPHCDA) on the approval by NAFDAC on the use of Gardasil vaccine as single dose in the routine immunization against cervical cancer.
On factors that contribute to the high disease burden of cervical cancer in Nigeria, she said low awareness, poor screening coverage, limited access to treatment, and high prevalence of human papillomavirus (HPV) infection were responsible.
“Human Papilloma Virus infection (HPV infection) is caused by a DNA virus belonging to the family Papillomaviridae. The virions are non-enveloped and contain a double-stranded DNA genome. HPV is the most common viral infection of the reproductive tract and causes a range of conditions in men and women, including pre-cancerous lesions that may progress to cancer.
“There is an urgent need for effective and sustainable interventions to prevent and control cervical cancer in Nigeria and other African countries.”
While giving details on the vaccine, she said
Gardasil is a vaccine that protects against human papillomavirus (HPV), a common sexually transmitted infection that can cause cervical, vaginal, vulvar, and other cancers. Gardasil is recommended for girls and boys aged 11 to 12 years, but it can be given as early as 9 years or as late as 26 years. The vaccine is given as two or three doses, depending on the age of the person receiving it. Gardasil has been granted registration approval by the National Agency for Food and Drug Administration and Control (NAFDAC) in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 and after rigorous regulatory evaluation process for vaccines.
“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.
“At 18 months post vaccination, the efficacy of a single dose of HPV vaccine against incident persistent high-risk (HPV16/18) infection was 97.5% (95% CI 82–100) for the nonvalent vaccine and 97.5% (95% CI 82–100) for the bivalent vaccine. Current evidence suggests that a single dose has comparable efficacy and duration of protection as a 2-dose schedule and may offer programme advantages, is more efficient and affordable, and contribute to improved coverage.
“The National Primary Health Care Development Agency (NPHCDA) will commence the introduction of the off-label use of quadrivalent Gardasil vaccine as a single dose schedule into the routine immunization in Nigeria in the last quarter of 2023. The decision to deploy the off-label Gardasil as a single dose schedule is based on the scientific evidence that shows that a single dose of Gardasil vaccine can provide solid protection against cervical cancer caused by human papillomaviruses (HPVs).
“NAFDAC is in support of this decision as 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.
“Also the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) has recently updated its recommendations on HPV vaccination schedule and has advised that a single dose schedule can be used for girls aged 9-14 years and young women aged 15-20 years, instead of the previous two or three-dose schedules.”