Helen Rees on HPV Vaccine Introduction in South Africa

Helen Rees on HPV Vaccine Introduction in South Africa

October 20, 2014 Karie Youngdahl

Helen Rees, MD, MA. Courtesy WHOA few weeks ago, I attended a talk by the CDC's Anne Schuchat, MD, on US HPV vaccination that she subtitled “How Not to Introduce a Vaccine.” In spite of the promise of HPV vaccines to reduce the burden of cervical and other cancers in this country, uptake of the complete three-dose series has lagged far behind the other vaccines on the adolescent immunization platform. On Friday, I heard a more optimistic talk about HPV vaccination in South Africa by Helen Rees, MD, MA, Executive Director, Wits Reproductive Health and HIV Initiative, University of Witswatersrand. Dr. Rees is a member of the WHO immunization policy committee and has a background in pediatrics, HIV care, and obstetrics and gynecology. She spoke as a guest of the Johns Hopkins Vaccine Initiative as part of their annual Vaccine Day events.

Globally, 90% of HPV-related cancers are cervical cancers, and sub-Saharan Africa is, as Rees said, the epicenter for cervical cancer. The high prevalence of HIV infection, which is a risk factor for oncogenic HPV infection, and the lack of access to HPV screening contribute to the high HPV disease burden. And apart from HPV-related cancers, Rees also noted that genital warts are not a trivial condition in an HIV-prevalent setting: they can be debilitating in those with compromised immune systems. The quadrivalent HPV vaccine offers protection from the two most common types of oncogenic HPVs and two types that cause genital warts; the bivalent vaccine covers only the two most common types of oncogenic HPVs.

But HPV vaccines are expensive: in the US, one dose costs about $130, and three doses are recommended here. The WHO policy committee has recently recommended a two-dose vaccination series for girls under age 15 that many countries are beginning to adopt. The GAVI price is about $4.50/dose. GAVI-eligible countries can apply for cofunding for HPV vaccine introduction, but in Africa only Rwanda has done so. It is the first low-income country to introduce the vaccine as part of the Expanded Programme on Immunization (March 2014).

Several other African countries, Rees’s South Africa included, have conducted HPV vaccination pilot programs. In South Africa, they used the bivalent vaccine, because it alone was approved to be given there as a two-dose, rather than three-dose, series. Rees noted that using the bivalent vaccine would not address the problem of HPV-related genital warts on those co-infected with HIV. But the savings involved in using a two-dose regimen drove the decision to forego the quadrivalent vaccine. South Africa is not a GAVI-eligible country, but was able to negotiate with manufacturer GSK a cost of one-fifth the normal price of the vaccine. 

Rees discussed the complex decisions that went in to designing the HPV vaccination program in South African. Officials had to decide which ages to focus on, in what setting they would give the vaccine, how to ensure that the cold chain remained intact, how to secure consent, how to deliver both doses of vaccine, and more.

Research showed that school delivery of the vaccine was acceptable to learners, parents, schools, and healthcare workers. In terms of messaging about the benefits of the vaccine, the cancer prevention message was more acceptable than messages about preventing a sexually transmitted infection (though the latter message did not generate particularly negative reactions).

The pilot achieved 91% school coverage and 87% learner coverage, in total vaccinating 340,000+ girls in March-April 2014. No major adverse events were reported, though Rees noted that ensuring access to emergency supplies in case of outcomes such as anaphylaxis was problematic. 

Rees said that while most media coverage of the pilot was positive or neutral, some coverage was negative, and she thought that this had an effect on uptake. Additionally, an active social media campaign against the vaccine urged South African mothers not to allow their girls to get the vaccine. Here Rees showed what looked like a Facebook posting directed to South African mothers, which claimed that 32 girls had died in the US as a result of HPV vaccination. (Those of us who pay attention to the antivaccination network recognize this claim. The figure 32 comes from reports to VAERS that have been studied and have been found to be unrelated to HPV vaccination).

In Africa, 17 countries are approved by GAVI to seek support of HPV vaccination pilot programs. And other than Rwanda, Uganda is the only other African country that is eligible for GAVI support for a national HPV immunization program. (See GAVI: Countries Approved for Support for the complete list.)

Comments

Posted by Steve Hinks (not verified)

Our daughter had a serious adverse reaction to the MMR. When the HPV vaccine was offered we opted not to consent. However, the school nurse assured us that this vaccine is safe. Within minutes of being vaccinated she felt unwell and had to be collected from school. Each day she felt more poorly, flu-like, feeling cold, abdominal pains, severe headaches and very, very tired. Each day it got worse. The doctor was sure it was glandular fever but all tests were negative. She couldn’t walk and was sleeping up to 23 hours every day. After 4 months she went into a coma-like sleep and never opened her eyes or was able to speak for 13 weeks. Eventually she did wake but suffered constant pains and hyper somnolence. She has missed 3 years of school and still can’t walk and sleeps 18 – 22 hours every day. Doctors deny that it is caused by the vaccine but have no explanation. They have tried twice to blame us of Munchausen’s.
We researched and found thousands of other girls were suffering with similar symptoms. I obtained through FOI that the number of UK Yellow Card reports of serious adverse events (SAE) were approx. 100 times more than for other vaccines. The MHRA accept that typically only 10% of SAE are reported. SAEs for HPV vaccine, including 4 deaths, are approx. 92 per 100,000 recipients so actual SAE are expected to be 920 per 100,000. This vaccine is considered ‘safe and effective’. But so was Pandemrix flu vaccine until 900 cases of narcolepsy were reported in Scandinavia. A little further back and Pluserix MMR vaccine containing the Urabe mumps strain was withdrawn after causing meningitis. Lymerix was also considered ‘safe& effective’ but withdrawn when it caused irreversible autoimmune diseases.
Cancer Research UK report that cervical cancer deaths have reduced from 8 per 100,000 to 2 per 100,000 over the last 40 years. At this rate there should be no deaths within 10 years without this vaccine.

Posted by Karie Youngdahl

Mr. Hinks, It's distressing to learn of your daughter's illness. I've very sorry.

You refer to the increased incidence in narcolepsy in Scandinavians after receipt of Pandemrix. Safety monitoring systems -- the same ones that are in place for HPV vaccine -- picked up that signal and it was investigated. Now researchers are looking for a causal mechanism for the association. It's a terrible thing for the people affected. However, findings point to the success of monitoring programs in detecting real signals. As you know, detecting very rare events generally will only happen when large enough numbers of people get a vaccine.

AEs after HPV vaccination have been investigated and surveillance continues not to find an association between neurological, auto immune, or other serious adverse medical outcomes (the large study published in JAMA http://www.cdc.gov/vaccinesafety/Vaccines/HPV/jama.html and the Scandinavian study come immediately to mind http://www.bmj.com/content/347/bmj.f5906; also this study http://www.ncbi.nlm.nih.gov/pubmed/21973261).

As to under-reporting, there is also the converse. Serious AEs may be over-reported to passive monitoring systems, as explained here: http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-pubs-cdi-2003-cdi2703-htm-cdi2703a.htm

Cancer deaths are not the only cost of HPV infection (though we should not overlook them). Treatment of HPV-related pre-cancerous lesions is costly, uncomfortable, and sometimes harmful to a woman's reproductive capability.

I have a boy and a girl. They both got the HPV vaccine and have had no apparent harms from it.

Posted by Anonymous (not verified)

The HPV vaccines are not needed in developed countries with pap testing programs.
This vaccine can and does cause severe and/or long lasting health problems.
Ask the mothers. Ask their daughters. Adverse events are real.

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