The National Agency for Food and Drug Administration and Control (NAFDAC) has promised to ensure quality and efficient Gardasil vaccine.
The agency also promised to continue to monitor its impact and performance in Nigeria.
Director General of NAFDAC, Professor Mojisola Christianah Adeyeye, said this at a joint press conference with the Executive-Director, National Primary Healthcare Development Agency (NPHCDA), recently in Abuja.
Professor Adeyeye said the Gardasil is recommended for girls and boys aged 11 to 12 years, but 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,” she stated.
She said the 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 multi dose regimen against initial and persistent HPV infection.
Professor Adeyeye further states that 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 non valent 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, more efficient and affordable and contribute to improved coverage,” she said.
The DG added that the benefits of single dose approach is to reduce the cost and logistical challenges of delivering multiple doses, especially in resource-limited settings.
