A decade into South Africa's HPV vaccination programme, the health department is switching from a two-dose to a single dose vaccine regimen and girls in private schools are set to start receiving government subsidised jabs. The vaccine provided, GlaxoSmithKline's Cervarix, will remain the same. The move is backed by evidence showing one-dose regimens provide similar protection against HPV infection as multi-dose regimens.

Cervical cancer is the second leading cause of cancer in women in South Africa. To protect women against cervical cancer, government launched a national human papilloma virus (HPV) vaccination campaign in 2014. HPV infection is the leading cause of cervical cancer, accounting for around 95% of cases globally.

With a decade of cervical cancer vaccination under our belts, most girls and women between the ages of 10 and 20 living in South Africa should now be vaccinated against HPV. The vaccine has been given to grade 5 girls that are age 10 turning 11 since 2020 - prior to this it was offered to grade 4 girls.

Acting Chief Director of Maternal, Child and Women's Health in the Department of Health, Lesley Bamford, told Spotlight that HPV vaccination coverage among eligible learners in South Africa has consistently been between 80 and 85%. The department did not provide Spotlight with detailed data. The between 80% and 85% range is higher than coverage rates reported in relevant academic work and estimated by the World Health Organization.

The South African government now aims to increase HPV vaccination coverage to 90%, as part of global efforts spearheaded by the World Health Organization to eliminate cervical cancer by 2030.

To achieve the new 90% target, South Africa has moved from a two-dose to a single-dose HPV vaccine schedule and will now also be offering government funded HPV jabs in private and independent schools.

The HPV vaccine procured by government and provided through the national HPV vaccination campaign is GlaxoSmithKline's Cervarix. The vaccine, which contains two doses per vial, costs government R394 per vial - or R197 per dose. When procured through the private sector, GlaxoSmithKline's Cervarix costs R964 for a single dose formulation, excluding dispensing fees.

Moving from two doses to one

From 2014 to 2023, the HPV vaccination campaign ran twice a year in public schools across the country. During the first campaign cycle, which typically fell between February and March, eligible girls were offered their first dose of the vaccine against HPV. During the second campaign cycle, which typically fell between September and November, girls were offered the second dose.

But as of this year, girls who received their first dose of HPV vaccination during February or March will not be offered a second dose later in the year. Instead, the second round of the campaign, which is scheduled to run from 1 October to 15 November, will be used to offer catch up doses to girls who were not vaccinated in previous campaigns and to provide HPV vaccination in private and independent schools.

This is the first year that government procured HPV vaccines will be provided through private and independent schools. According to Bamford, reaching girls in private and independent schools is essential to eliminating cervical cancer in South Africa. Bamford told Spotlight that the departments of health and basic education are currently engaging with private sector schools to prepare for this campaign.

As in public sector schools, the parents of girls at private and independent schools must provide consent for their daughters to be vaccinated. Bamford said there are concerns that vaccine hesitancy may be more widespread in private schools, which may pose a challenge to eliminating cervical cancer in the country.

What is the evidence for moving to single dose HPV vaccination?

While the move from a two-dose to a single-dose vaccine regimen will save costs and simplify logistics for government, it is also backed by strong scientific evidence.

The WHO Strategic Advisory Group of Experts on Immunization's (SAGE) reviewed evidence for single-dose HPV vaccination and concluded in 2022 that single-dose vaccination provides solid protection against HPV that is comparable to two- or three-dose regimens.

A randomised controlled trial in Kenya demonstrated the effectiveness of single-dose HPV vaccination regimens in preventing HPV infections over an 18 month study timeframe, while observational studies in India and Costa Rica have demonstrated that single-dose HPV vaccination works as well as multi-dose regimens in preventing HPV infections 10 years after vaccination.

Bamford said that the evidence for single dose HPV vaccination has been "reviewed by the National Advisory Group on Immunisation and they recommended that we should move to one dose".

But what about girls living with HIV?

While there is strong evidence warranting a shift to single dose HPV vaccination in HIV negative girls, there are still outstanding questions as to whether a single dose of HPV vaccination provides adequate protection against HPV infection in girls and women living with HIV.

Bamford said that in 2024, girls with HIV will not be offered a second dose of HPV vaccination but in coming years the intention of the Department of Health is to make second doses of HPV vaccination available at clinics for girls with HIV.

"That won't happen this year," said Bamford, "but in 2025, or possibly 2026 we would look to doing that."

She said the biggest anticipated challenge in offering HPV vaccines at public health facilities is related to supply chain management and it may be that second doses are offered in clinics during the same period as school-based vaccination campaigns.

Professor Lynette Denny, a leading cervical cancer expert at the University of Cape Town, last month told Spotlight that while more evidence is needed on the effectiveness of single-dose HPV vaccination in preventing HPV infection in HIV positive women, there is already evidence demonstrating that girls with HIV generate protective antibodies against HPV following single dose vaccination.

"We did a randomized trial comparing the response of the body to the HPV vaccine in HIV positive versus HIV negative woman and we didn't show a difference," said Denny. She passed away on 9 June 2024.

Interview: Prof Lynette Denny reflects on an extraordinary life of service https://t.co/OCyD5fy9KP Celebrate the life of an extraordinary human being! ? THANK YOU 4 providing the foundations 4 CACX Elimination in ??. Hamba Khalhe. @Cancer_ZA @AORTIC_AFRICA @WHO @PresidencyZA

-- Salome Meyer (@SalomeMeyer1) June 9, 2024

Professor Sinead Delany-Moretlwe, Director of Research at Wits RHI, told Spotlight that existing data suggests "if you're on antiretroviral therapy, you're likely to have the same response to a single dose as someone who is not living with HIV".

A very small fraction of girls in South Africa are HIV positive at the age that they are eligible for HPV vaccination, she said, adding that HIV-positive girls in this age group are typically infected perinatally and are already on antiretroviral treatment.

But Delany-Moretlwe cautioned that, in addition to data on the effectiveness of single dose HPV vaccination in HIV-positive girls, more data is needed on the effectiveness of single dose vaccination in girls who become HIV-positive following vaccination.

She said a study called HOPE 2 will begin this year to assess the benefits of providing a second dose of HPV vaccination to girls that were HIV-positive at the time of their first vaccination or who subsequently contracted HIV. The study will have sites in South Africa, Rwanda and Botswana. Delany-Moretlwe says data from this study will be available in the next three years.

We still have time to catch girls with HIV and provide them with a second dose of HPV vaccination at clinics in coming years, if needed, as the average age of sexual debut in the country is 17 years, she added.

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