The National Agency for Food and Drug Administration and Control, NAFDAC, has approved single dose of Gardasil vaccine in the treatment of cervical cancer in the country.
Consequently, the National Primary Health Care Development Agency, NPHCDA, is to commence the introduction of the off-label use of quadrivalent Gardasil vaccine as a single dose schedule into the routine immunization.
NPHCDA is expected to do this in the last quarter of 2023.
Director General of NAFDAC, Prof. Mojisola Adeyeye, who disclosed this at a joint press conference with NPHCDA in Abuja yesterday, said there was an urgent need for effective and sustainable interventions to prevent and control cervical cancer in Nigeria and other African countries.
She explained that 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.”
“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.
“Nigeria, the most populous country in Africa, 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.
“Several factors contribute to the high disease burden of cervical cancer in Nigeria, such as low awareness, poor screening coverage, limited access to treatment, and high prevalence of human papillomavirus (HPV) infection,”
”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.
“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.
“Use of Gardasil as a single dose 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.“
