NAFDAC approves HPV vaccine for single dose use in routine immunisation

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved Gardasil vaccine, a human papillomavirus (HPV) vaccine, for single dose use in the routine immunisation schedule.

HPV vaccines are vaccines that prevent infection by certain types of human papillomavirus, a common sexually transmitted infection that can cause a range of conditions in men and women, such as cervical cancer.

Gardasil is recommended for girls and boys aged 11 to 12, but it can be given as early as nine 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.

In a statement on Tuesday, NAFDAC said it granted Gardasil vaccine regulatory approval as a single-dose schedule based on the scientific evidence that shows that a single dose of the vaccine can provide solid protection against cervical cancer.

“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,” the statement reads.

“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.

“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.”

SIX MILLION TO RECEIVE HPV VACCINE FROM OCTOBER 24

Speaking at a press briefing on Tuesday, Faisal Shuaib, executive director of the National Primary Health Care Department Agency (NPHCDA), said the agency has secured six million doses of the vaccine.

He said vaccination of young girls between the ages of nine and 14 years with a single dose of the Gardasil vaccine would commence on October 24.

“This vital vaccine introduction will occur in two phases. The first phase will encompass 16 states, including Abia, Adamawa, Akwa Ibom, Anambra, Bauchi, Bayelsa, Benue, Enugu, Jigawa, Kano, Lagos, Nasarawa, Ogun, Osun, Taraba, and the Federal Capital Territory Abuja,” he said.

“The second phase is scheduled for the first quarter of 2024 and will encompass the remaining states: Borno, Cross River, Delta, Ebonyi, Edo, Ekiti, Gombe, Imo, Kaduna, Katsina, Kebbi, Kogi, Kwara, Niger, Ondo, Oyo, Plateau, Rivers, Sokoto, Yobe, and Zamfara.

“Subsequently, we will continue routine vaccination within health facilities for the same age group. By 2025, we anticipate transitioning to full routine immunisation with the HPV vaccine, focusing on girls aged nine.”