- South Africa's HPV vaccination programme has by all accounts been a resounding success over the last decade, likely helping to prevent many cases of cervical cancer.
- But the programme has suffered major setbacks due to Covid-19-related disruptions and in addition to getting it back on track, some argue vaccine eligibility should be expanded to include boys as well as older girls and women newly infected with HIV.
- Amy Green takes stock of the country's HPV vaccination efforts.
overwhelmed and in complete shock. I never expected what was pretty much a
cancer scare in my twenties," says
Johannesburg-based Rachel*, who was 28 years old when she received the results
of her first pap smear in 2018.
Rachel asked Spotlight not to mention her real name fearing stigma.
She underwent a colposcopy (a procedure to investigate abnormal cells in the cervix). Her doctor found evidence of severely abnormal cells, which, although not yet cancer, poses a high risk of cancer. She then underwent a cone biopsy procedure to remove the abnormal tissue.
"My doctor told me the procedure was completely safe, but I've since found out that it probably weakened my cervix and could affect my ability to have a kid," she said.
According to Cancer Research UK, an independent research and advocacy organisation, a cone biopsy could weaken the cervix and increased the risk of miscarriage and early labour in future pregnancies.
Last month, Rachel, now 33, went for a second pap smear test.
It is recommended to repeat the test six months to a year after a cone biopsy to check if the treatment was successful, but Rachel said she was "actually too scared" and, as such, delayed having the repeat test for almost five years.
Three weeks ago, her results came back positive for abnormal cells.
"I had a panic attack. I couldn't calm myself. I was overwhelmed, anxious, [and] scared. I don't feel like I can go through this process again," she said."If I thought my fertility was compromised before, I feel like my worst fears have been confirmed now. A doctor hasn't expressly said I will struggle to conceive, but I'm terrified that that is what I'm going to be told."
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She said she was "envious" of the girls in South Africa and in many other countries who, today, have access to the HPV vaccine.
HPV stands for human papillomavirus, which is the cause of the abnormal cells detected on Rachel's cervix and also the main cause of cervical cancer. If given early enough in those without HIV, the vaccine virtually eliminates the risk of cervical cancer.
"I wish I had been educated about HPV in school. Honestly, I didn't even know it existed before my first pap smear. And, if I had one wish, it would be that I had the opportunity to be vaccinated as a girl. One or two little injections 20 years ago could have prevented all this suffering."
HPV is estimated to be the cause of more than 90% of cervical and anal cancers, 70% of vaginal and vulvar cancers, and more than 60% of penile cancers, according to the US' Centers for Disease Control and Prevention (CDC).
Although HPV vaccination is one aspect of a multi-pronged approach to eliminating cervical cancer, it is arguably the most important - especially for resource-limited countries like South Africa, where access to expensive cancer care is extremely limited.
A modelling study published last November in The Lancet Medical Journal suggested if South Africa vaccinated the required number of girls i.e., 90% of all girls aged nine to 14 years, it could reduce cervical cancer incidence from the current 47.6 per 100 000 women to just 4.5 per 100 000.
Incidence refers to the number of new cases or new infections in a particular time period, in this case, a year.
In 2020, the World Health Organisation (WHO) via the World Health Assembly adopted a global strategy to accelerate the elimination of cervical cancer, in recognition of the fact that too many women are still dying from what is essentially a preventable and treatable disease.
This strategy seeks to eliminate cervical cancer across the world within the next century and the body defines elimination as fewer than four new cases per 100 000 women.
But the vaccine works best when given to girls before they become sexually active and is not indicated for anyone above the age of 26, meaning Rachel was already ineligible when she first found out about the jab.
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What is HPV and what is the HPV vaccine?
There are over 100 varieties of HPV, but only about 14 are considered high-risk types that actually cause diseases such as cancers and genital warts.
The two types responsible for the majority of cervical cancers are HPV 16 and 18. The virus is transmitted sexually or through skin-to-skin contact and is, therefore, not fully preventable through condom use.
"We know that virtually everyone who is sexually active gets HPV, but almost all of them clear the infection," said Anna-Lise Williamson, a professor of virology at the University of Cape Town and a leading international expert on HPV and HPV vaccines.
According to the CDC, only around "10% of women with HPV infection on the cervix will develop long-lasting HPV infections that put them at risk for cervical cancer".
HPV was first identified in the 1950s, but it was only in 1983 and 1984 that a causal link between types 16 and 18 and cervical cancer was established.
Just over 20 years later, the first HPV vaccine became available in 2006 and, as of 2022, 125 countries (almost two-thirds of all nations) have introduced the vaccine into their national immunisation programmes, according to the WHO.
Williamson said the process by which most people spontaneously cleared HPV infection while others did not "is not well understood at all".
But the progression from sustained infection to cervical cancer is usually a long process that takes around 15 to 20 years.
However, the process was accelerated in those women living with HIV and was shortened to only five to 10 years, according to the WHO.
"New evidence shows that women living with HIV have a six-fold or higher risk of cervical cancer and that, in Southern Africa, almost two-thirds of cervical cancer cases are attributable to the cofactor effects of HIV," Professor Sinead Delany-Moretlwe told Spotlight.
Delany-Moretlwe is the director of research at the Wits Reproductive Health and HIV Institute.
She said women with HIV were known to be more susceptible to infection with high-risk HPV types such as 16 and 18, they have a reduced ability to clear the infection, they were persistently associated with the development of lesions on the cervix and have lower rates of these lesions regressing.
This is likely due to the impact of HIV on the immune system and its ability to respond to an HPV infection.
While antiretroviral therapy (ART) is incredibly effective in improving and restoring immune function, early initiation of ART "probably only eliminates some of the risks".Delany-Moretlwe said in a study of 17- and 18-year-olds she did in 2019, those with HIV had twice the rate of infection with high-risk HPV types compared to their HIV-negative counterparts, despite the fact the majority of those with HIV were on ART.
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SA's vaccination campaign
South Africa introduced HPV vaccination as part of the Integrated School Health Programme (ISHP) nearly a decade ago, in 2014. The ISHP is jointly managed by the departments of health, basic education, and social development.
The programme was targeted at Grade 4 girls over the age of nine years attending public schools and excluded all boys as well as those girls attending private schools. The programme uses a bivalent vaccine given in two doses.Bivalent means it targets two types of HPV, namely the most high-risk types 16 and 18. Quadrivalent and 9-valent vaccines do exist, however, and target other high-risk types in addition to 16 and 18.
In the first round of vaccinations in April 2014,
419 520 of the 503 507 eligible girls received the first dose,
representing a coverage rate of 83%.
"To participate in the programme, parents had to provide written informed consent, but acceptance was high," said Professor Lynette Denny, the director of the University of Cape Town's Gynaecological Cancer Research Centre.
In 2014, coverage of the second dose later that year dropped to 61%.
Collapse during Covid
According to Denny, there "was tremendous government input, a huge push from and strong leadership by the national Department of Health, great collaboration with the departments of basic education and social development, and a huge number of resources allocated" to the HPV vaccination rollout.
All of this resulted in "a very successful programme" that was "nearly killed by Covid".
"From 2014 to 2020, coverage of the targeted girls remained high for dose one. But, after the arrival of Covid, the coverage dropped to 3%.
"The cause of this was multi-factorial but included lockdowns, school closures, the collapse of the school health programmes, lack of facilities, cold chain [problems], and poor vaccine management," said Denny.
Cold chain refers to the system of transporting and storing vaccines within the correct temperature range to ensure they remain effective.
"This situation is gradually improving as the country moves out of the crisis created by Covid and coverage of the first dose appears to have increased to around 30%, which is still much lower than the almost 85% in 2014," she said.
To mitigate the potential long-term consequences of this disruption to the programme, the SA National Advisory Group on Immunisation recommended shifting the programme to target girls in Grade 5 who mostly missed their shots in 2020 as a result of the pandemic.
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However, some suggest the challenges faced by the programme right now go beyond the system-related hiccups caused by Covid.
Vaccine hesitancy, spurred by the momentum gained by the anti-vaccine lobby around Covid vaccines, has been raised as a potential barrier to achieving the exceptionally high pre-Covid coverage rates.
"The challenges faced by the HPV vaccination campaign include both demand and supply side issues. Demand side issues relate primarily to a lack of signed informed consent forms.
"Vaccine hesitancy has not been prevalent in the past but has increased since the roll-out of Covid-19 vaccination. [But the real] impact of increased vaccine hesitancy is still being quantified," said Dr Lesley Bamford, the acting chief director of child, youth, and school health at the national Department of Health.
She added the supply side issues related to "challenges in reaching all the 15 000 targeted schools during the campaign, especially in rural provinces and due to contingencies such as heavy rain as well as educator SADTU [SA Democratic Teachers Union] meetings and strikes".
Delany-Moretlwe said her team was hoping to do some research this year to find out exactly what was driving vaccine hesitancy or a "lack of confidence" in these vaccines.
"The hypothesis is that vaccination has become a more contentious issue in the past three years and we may need to plan for the possibility of seeing more vaccine hesitancy than previously.
"The things we took for granted may be more challenging in the current context where there are much higher levels of anti-vaccine sentiment," she added.
However, Delany-Moretlwe said these concerns were "only observational" and "it would be good to have more robust data" to confirm the extent of the impact of anti-vaccine sentiment which would also help inform the necessary action needed to mitigate this challenge.
One suggestion is that to combat vaccine hesitancy, the programme should shift from an "opt-in" strategy to an "opt-out" one where parents would be required to provide a written request to not have their daughter vaccinated instead of the other way around.
However, the proposal is contentious.
"I would not support any programme that obviates the need for parental consent, even though it is cumbersome. Avoiding informing the public, the community, and their children is always a mistake," said Denny.
Instead, Delany-Moreltwe added there was a "fairly simple solution".
"If we put the same amount of energy that the anti-vaccine lobby puts into their campaigns, to promote vaccines as well as to respond to the concerns people raise in an evidence-based way, we may see some positive changes."She said once-off information campaigns or events would not suffice in our current climate and we needed to have sustained educational programmes.
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Cost and funding
There were, and still are, concerns about the high cost of the HPV vaccine as a barrier for low- and middle-income countries.
It is certainly a factor in South Africa's current programme design, namely that it only targets young girls in public schools as opposed to making other age groups and boys eligible for the jab.
Documents Bamford shared with Spotlight show a vial of the bivalent vaccines costs the health department about R350 and one vial delivers two doses.
However, the vaccine price is only one factor in terms of the total costs of the programme.
According to Bamford, other key budget items related to the HPV vaccination programme included cold chain capacity, i.e., fridges, cold boxes, and ice packs; ancillaries like syringes, needles, waste management, and disposal; cotton wool swabs; hiring of additional campaign staff for the duration of the campaign; car rentals to add on to the existing government fleet (since 2019, vehicles have been procured to strengthen the ISHP activities); training of the seasonal workers; and data management, including hiring data capturers.
For the 2022/23 financial year, the conditional grant for the HPV programme was R226 million.
At the start of the programme, the grant was "initially managed as an indirect grant but now the funds go directly to provinces as a direct grant".
Bamford added, contrary to some claims, "in general, provinces do not underspend on the HPV conditional grant".
Single dose strategy
In April 2022, the WHO announced its Strategic Advisory Group of Experts on Immunisation's (SAGE) review on the HPV vaccine concluded a single dose delivers solid protection against HPV, comparable to two-dose schedules.
It noted this could be a "game-changer" in the fight against cervical cancer that could see "more doses of the life-saving jab reach more girls".
"There is no doubt that we should move to single-dose HPV vaccination. It will be much cheaper, and it does not appear that the two-dose strategy is better than the one-dose," said Denny.
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February and March
This year's HPV vaccination campaign in South Africa kicked off on 20 February and the first round of vaccinations will end on 31 March.
The health department is still operating on the two-dose regimen and the second round is scheduled to happen from the 4 to 31 October.
"This matter [a one-dose strategy] has been tabled for discussion at NAGI [National Advisory Group on Immunisation]. They are responsible for advising our minister on matters regarding vaccine introduction and selection, including schedules," said Bamford.
However, the WHO noted this evidence might not extend to those women and girls living with HIV and recommended a two-dose or three-dose strategy should be continued in this group.
Catch up and vaccinating those living with HIV
Quoted in the one-dose guideline announcement, SAGE chairperson Dr Alejandro Cravioto said, "SAGE urges all countries to introduce HPV vaccines and prioritise multi-age cohort catch-up of missed and older cohorts of girls".
The hope is such "catch-up" strategies will reach those girls and women who, until now, have been ineligible for state-funded vaccination programmes.
Williamson said we should see the move to a one-dose strategy as an opportunity to reach those most at risk - i.e., girls and women living with HIV.
"All HIV-positive girls and women should be vaccinated. I think it should be policy that newly HIV-diagnosed girls and women be vaccinated against HPV immediately. We know there's going to be disease in this group, and we should lobby for them to get access to this life-saving vaccine," she said.
Some experts, such as Professor Michael Herbst, suggests boys be included, should resources permit.
"I am a proponent of offering the vaccine to boys as well. Many women die of cervical cancer and of course, it is important they be targeted first, but men carry the virus as well and we're hearing more and more men come out to say they have been affected by HPV-related cancers of the throat, penis, anus, neck, and head," said Herbst, who is the health specialist consultant for the advocacy group the Cancer Association of South Africa.
However, Bamford told Spotlight it was unlikely the programme would be extended in the near future, despite the possible financial benefit of moving to a one-dose regimen.
"For now, the department's focus is on achieving high coverage amongst the current target population. Although there are benefits to vaccinating boys, it is not considered to be cost-effective in most settings, especially where coverage in girls is greater than 50% as it is in South Africa," she said.
"Catch-up campaigns and vaccination of HIV-infected young women would require introducing service delivery platforms which currently do not exist.
"The direct and indirect benefits and costs of introducing such alternative service delivery platforms would need to be carefully weighed given that the current programme has ensured that more than 80% of young women 18 years and younger are already protected through vaccination."
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Should we accept the status quo?
Cervical cancer is the second most common cancer in South African women after breast cancer, yet it is the most deadly.
More than 5 000 cases of the disease are diagnosed in the country each year, and most of these cases are fatal.
As the SAGE communication stated, cervical cancer was "often referred to as the silent killer" but, paradoxically, it was "almost entirely preventable". As such, "cervical cancer is a disease of inequity of access".
"Every two minutes, a life is lost to cervical cancer. In 2020, 342 000 women died from the disease and almost a quarter of these deaths [22.5%] occurred in Africa.
"It does not have to be this way," noted the authors of a report released last year by the International Agency for Research on Cancer, the Union for International Cancer Control, and the African Cancer Registry Network.
Since the inception of the HPV vaccination programme in South Africa in 2014, more than five million doses have been administered to girls and more than 80% of girl pupils have been reached annually.
This can be objectively regarded as a resounding success, but some believe more can be done to reach girls and women who are currently excluded from the programme.
"It's frustrating for me to be in a country, or to be in a continent, with such a high burden of disease and we sit and look at the countries that have essentially controlled their cancer pretty well through cervical screening programmes, and those countries without the screening programmes [such as South Africa] don't have access to the best vaccines and don't have access to catch up," said Williamson, referring to the fact the 9-valent vaccine is not yet registered or available in South Africa.
"And we've just got to be grateful that the 9-year-olds are getting vaccinated, and we wait [to see the benefit] and I'm not happy with that."
Dr Princess Nothemba Simelela, who is currently the assistant director-general for family, women, children, and adolescents at the WHO expressed a similar concern about the SAGE announcement.
"We need political commitment complemented with equitable pathways for the accessibility of the HPV vaccine. Failure to do so is an injustice to the generation of girls and young women who may be at risk of cervical cancer."*This article was published by Spotlight - health journalism in the public interest.