JOINT PRESS BRIEFING
NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) AND NATIONAL PRIMARY HEALTH CARE DEVELOPMENT AGENCY (NPHCDA)
APPROVAL BY NAFDAC ON USE OF GARDASIL VACCINE AS SINGLE DOSE IN THE ROUTINE IMMUNIZATION AGAINST CERVICAL CANCER
Background – Disease Burden of Cervical Cancer in Africa and Nigeria:
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. 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.
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.
The Gardasil Vaccine and Regulatory Approval
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. 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.
Benefits of the single dose Schedule
The benefits of this single dose approach include:
- Reducing the cost and logistical challenges of delivering multiple doses, especially in resource-limited settings
- Increasing the coverage and equity of HPV vaccination, as more girls and women can access the vaccine.
- Accelerating the elimination of cervical cancer as a public health problem, as part of the global strategy launched by WHO in 2020.
- Global cost-effectiveness analysis suggests that vaccinating pre-adolescent girls is usually cost-effective for cervical cancer prevention, particularly in resource constrained settings where screening and other cervical cancer prevention and control measures often have limited coverage.
Conclusion
In line with its mandate to protect Public Health, NAFDAC is committed to ensuring the safety, quality and efficacy of the Gardasil vaccine, and will continue to monitor its impact and performance in Nigeria.
Let us together reduce drastically or eliminate the incidence of cervical cancer in our country by taking advantage of this opportunity.
https://www.who.int/initiatives/elimination-of-cervical-cancer
THANK YOU.
NAFDAC………safeguarding the health of the Nation!!!
Director General
