Is the HPV Vaccine Safe and Effective?
There are two vaccines on the market that protect against the high-risk strains of the human papillomavirus (HPV), which has been linked to cervical cancer. Gardasil has been around for longer and protects against four strains of HPV – 16 & 18 (high-risk), and 6 & 11, which cause genital warts. Sanofi Pasteur makes it, and it was licensed in the UK in 2006 for females aged 9-26. Cervarix protects girls from strains 16 & 18 but not genital warts. GlaxoSmithKline makes it, and it was licensed in the UK in 2007 for females aged 10-25.
A Political Choice
Cervarix was chosen for the NHS HPV vaccination programme, which means it is free for girls aged 12-18 years in the UK. At the time, this decision levelled a lot of criticism as some experts believe it is an inferior vaccine, does not offer full protection from HPV, and was chosen because it was the cheaper option despite a lack of track record. Gardasil has been used in Europe and the US for longer, and was made compulsory in Texas in February 2007. However, at present, parents in the UK have to “opt in” and the vaccine isn’t compulsory.
The Department of Health said at the time that [we] “chose Cervarix for the national HPV immunisation programme as it offered the NHS best overall value.” Simply put, each vaccination costs them £400.
Benefits of HPV Vaccination
In the UK, all 12-13 year old girls are offered a course of three injections over a six-month period, which must be completed to maximise immunity. The vaccine is injected into the muscle of the upper arm or thigh. Dose two is administered two months later, and the final dose, six months later. Parents will receive a letter of consent from the school.
“The vaccine means they are much less likely to get cervical cancer but they still could do, and smears are still necessary for the time being,” says Dr Rupal Shah, a GP in South London. “Three injections are required to achieve enough immunity against HPV.” The vaccine is given to younger girls because results shows that it works best before they are sexually active and likely to contract HPV — a common STI that most of us will have at some stage.
Can I Have My Daughter Vaccinated Privately?
Yes. If you’d rather your daughter was vaccinated for the four strains of HPV, you can arrange for private vaccination with Gardasil. However, this isn’t cheap and you may have to pay £400-£500 to do so. A survey by the British Association for Sexual Health and HIV (BASHH) asked 520 health professionals for their preference and 93% said they would opt for private vaccination rather than the NHS one because of the lack of full protection against genital warts.
Are There Any Side Effects?
The NHS says that girls may experience “usual” side effects post-vaccination that include:
* Redness and swelling at the site of injection
* Raised temperature
* Feeling dizzy and/or sick
* Muscle aches and pains
In September 2009, there were reports about the death of a 14-year-old girl after a cervical cancer jab and investigations were carried out to determine whether Cervarix or an underlying health condition caused this. The batch was quarantined and later reports showed that there were other health issues and her death was unlikely to have been caused by the jab.
Both vaccines have undergone rigorous testing, and the safety record is high but a vaccine can never be 100% safe. As both are relatively new to market (six years of testing), it is difficult to gauge long-term safety at this stage. However, the Medicines and Healthcare Regulatory Agency (MHRA) estimate that the risk of life-threatening reactions to the vaccine is no more than one per million doses
Phase III Clinical Trials
Two research trials were carried out to test the efficacy against HPV. These were “Futurell” and “Patricia.” The former was a phase III trial of over 12,000 women aged 16-26. Half the women (5,258) were given a placebo and the other half had Gardasil. They were monitored for two years after competing a course of injections over six months. In the group that had been vaccinated, there were no pre-cancerous changes to the cervix or HPV infection against strains 6,11, 16 and 18. In the placebo group, 21 (0.4%) had pre-cancerous changes.
Patricia was two phase III clinical trials of Cervarix and involved 18,000 women worldwide. The first studied use in women under 26 and the second, 26 and over. Results found that it prevented HPV infection in the high-risk strains 16 & 18, which are linked to cervical cancer.
The Experts’ View
Anne Szarewski, who was involved in trials for Cervarix at the Wolfson Institute of Preventative Medicine in London, is in favour of the vaccine. She told BBC Radio 4 Woman’s Hour that “It can prevent 70-75% of cervical cancers,” adding that the current cervical screening programme is costly and stressful for the women who have abnormal smears (300,000 pa). She believes that the vaccine could prevent half of these results, and could eventually phase out smear tests.
Jacqueline Laing, a senior lecturer in Law at London Metropolitan University and a specialist in medical ethics doesn’t agree with the idea of a universal mandatory vaccine for minors, arguing that HPV isn’t a typical childhood disease like polio. She argues that no vaccine is 100% safe, and points out that vaccination on this scale is highly lucrative for the drug companies and shareholders but at what risk to public health and safety?
Have Your Say
The HPV vaccine is a big step forward in preventing cervical cancer and in time we will know how efficient it is and how long it can protect girls. However, it isn’t a substitute for cervical screening and women still need to go for smears every three years. I do think that it’s a problem that boys aren’t being offered the vaccine given that there have been reported rises in oral cancers caused by HPV in this age group. It also doesn’t offer gay men any protection. When quizzed on this, the official line from the Department of Health is that more evidence is required to ensure that vaccinating boys would be cost effective for the NHS. Let’s hope this policy will be reconsidered.