Human papillomavirus (HPV) immunisation programme - a vaccine to prevent cervical cancer.
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The Medicines and Healthcare products Regulatory Agency (MHRA) today announced that it has found no evidence that Cervarix – the human papillomavirus (HPV) vaccine – may cause chronic fatigue syndrome..
MHRA's 2012 review of Cervarix safety at end of 4 years use in the human papillomavirus (HPV) routine immunisation programme
In September 2012, Cervarix was replaced in the national HPV immunisation programme by another HPV vaccine called Gardasil▼ (external link). The MHRA and Commission on Human Medicines (CHM) performed a comprehensive ‘end of routine use’ review of all reports of suspected adverse reactions with Cervarix received since the start of its use in September 2008 up to 31st July 2012.
Over the four year vaccination programme more than 6 million doses of Cervarix have been given across the UK. Based on reports of suspected adverse reactions received by the MHRA, the overall reporting rate of suspected adverse reactions was approximately 1 report per 1,000 doses, which is an expected reporting rate for a newly marketed vaccine with high exposure.
The number and nature of the suspected adverse reactions received was in line with expectations, and included reactions to the injection process (so-called ‘psychogenic reactions') rather than the vaccine itself. This end-of-use review supports the conclusions of earlier reviews that the balance of benefits and risks for Cervarix remains clearly positive.
Further information on the safety experience during the entirety of the Cervarix HPV immunisation programme is provided in the following Public Assessment Report and Drug Safety Update article:
Drug Safety Update article, November 2012: Human papillomavirus vaccine Cervarix: safety review shows balance of risks and benefits remains clearly positive.
Previous safety reviews of the HPV immunisation programme
The MHRA has been closely monitoring the safety of Cervarix since it was first used in the HPV immunisation programme in September 2008.
Information on the safety experience during the first year of the HPV immunisation programme is provided in the following article from the October 2009 issue of Drug Safety Update:
Human papillomavirus (HPV) immunisation programme - first year safety review (81Kb)
The documents below from July 2010 summarise the reports of suspected adverse reactions received by the MHRA in association with Cervarix vaccine as well as HPV vaccine for which the brand was not reported. Please read the introductory information provided with this information to assist in interpretation of the data.
Information on the safety experience during the first two years of the Cervarix immunisation programme (2008-2010) is provided in the following articles:
Following the tragic death of a young girl in October 2009 who had received Cervarix vaccine batch AHPVA043BB, investigations into the quality of the batch were carried out by the manufacturer, GlaxoSmithKline, and two independent Official Medicines Control laboratories (the UK National Institute for Biological Standards and Control and the Belgian National Control Authority). These included tests on retained samples as well as samples received from the girl’s school.
The investigations, which have been completed, revealed no evidence of any quality defect and the batch conformed to its licensed specifications. There remains no evidence to link this tragic event to administration of the vaccine.
A routine immunisation programme for human papillomavirus (HPV) started across the UK on 1 September 2008 for 12 to 13 year-old girls (school year 8). The vaccine used at the time was called Cervarix, which protects against infection with HPV types 16 and 18.
Infection with HPV is one of the most common sexually transmitted diseases. Genital infection with a high-risk (or ‘oncogenic’—potentially cancer-causing) HPV virus is the main cause of cervical cancer and is responsible for nearly 3000 cases of cervical cancer every year in the UK: HPV types 16 and 18 cause around 70% of cases.
Immunising girls before they become infected could eventually prevent up to 400 deaths every year in the UK.
As well as routine immunisation of girls in school year 8, there was an initial phased catch-up of girls currently aged up to 18 years.
From September 2012 Gardasil replaced Cervarix in the routine HPV immunisation programme (external link). Gardasil protects against infection with HPV types 16 and 18 and the vaccine is also very effective at protecting against genital warts caused by HPV types 6 and 11.
The safety and efficacy of both Cervarix and Gardasil vaccines have been extensively studied in clinical trials before licensing. The most common side-effects identified are injection-site reactions, fever, headache, fatigue, muscle pain, nausea, vomiting, and diarrhoea, which are listed in the product information (please refer to the Summary of Product Characteristics and Patient Information Leaflet available via the Electronic Medicines Compendium (external link)).
Cervarix and Gardasil have now been used in tens of millions of people and their safety is well established. However, as with all vaccines and medicines used in the UK the MHRA will continue to monitor the safety of Cervarix and Gardasil vaccines.
Reporting of suspected side effects (adverse reactions)
One way that MHRA monitors vaccine safety is through reporting of suspected side effects (adverse reactions) via the Yellow Card Scheme.
Please report suspected adverse reactions that may have occurred after administration of HPV vaccine via the Yellow Card Scheme. You can send Yellow Cards by post, but we strongly encourage you to report online. This will allow us quick access to your Yellow Card report.
When submitting a Yellow Card, please include:
- suspected adverse reaction(s): please report only the main diagnosis as the suspected side-effect - signs and symptoms can be included as additional information if necessary
- vaccine brand name
- vaccine batch number (if available)
- time to onset (if known)
- age and gender of the person who had the adverse reaction
- your contact details, should we need further information.
Many adolescents are immunised with HPV vaccine over a relatively short time each academic year. Adherence to the specific guidance outlined below will help us monitor the safety of the HPV vaccine effectively and communicate any information promptly.
Faints and panic attacks
Fainting can occur during, following, or even before vaccination and occurs most commonly in adolescents. Some individuals may also experience panic attacks before vaccination. The clinical features of fainting and panic attacks are described in detail in chapter 8 of the Department of Health's ‘Green Book’ (external link). Fainting can result in traumatic injury, and local procedures should be in place to observe and manage such events. It is important that any sudden loss of consciousness or generalised reaction is distinguished from a possible anaphylactic (or severe allergic) reaction (see below).
Fainting and panic attacks can occur during any injection procedure. When an episode occurs during or very shortly after vaccination, it is highly unlikely to be a true-side effect of the vaccine itself and is most likely a psychogenic response to the injection process. Only reactions that are suspected to be related to the vaccine (and not those associated with the injection process) should be reported via the Yellow Card Scheme.
If having considered this advice, you wish to report a possible psychogenic response, please include only the main diagnosis or event as the suspected reaction (eg, ‘faint’, ‘vasovagal syncope’, or ‘panic attack’). Any signs or symptoms associated with these events (eg, loss of consciousness, injury, limb jerking or tingling, difficulty in breathing, hyperventilation) should not be reported as a suspected adverse reaction. If necessary, they can be included as ‘additional information’ on the Yellow Card.
Since episodes of mass fainting and/or panic attacks can occur during a large immunisation session we ask that you follow the above guidance to allow an appropriate assessment and a proportionate response to such incidents.
Reporting of anaphylaxis and other allergic reactions
Anaphylaxis is an acute, severe allergic reaction that is a very rare, recognised side-effect of most vaccines. Suspected cases should be reported via the Yellow Card Scheme. Chapter 8 of the Green Book (external link) gives detailed guidance on distinguishing between faints, panic attacks, and the clinical features of anaphylaxis.
If a case of suspected anaphylaxis meets diagnostic criteria, please report it via the Yellow Card Scheme as a case of ‘anaphylaxis’ (or if appropriate ‘anaphylactoid reaction’). Cases of less-severe allergic reactions (ie those that do not have the full clinical features of anaphylaxis) should be reported as ‘allergic reaction’, not ‘anaphylaxis’. Any relevant signs or symptoms should be reported only as 'additional information' on the Yellow Card.
Please find below a letter from MHRA’s Chief Executive, Professor Kent Woods, summarising an overview of the first year safety and a copy of a 2009 Drug Safety Update article.
Published safety and efficacy studies
- Harper DM, et al. Lancet 2004; 364: 1757–65 (external link)
- Harper DM, et al. Lancet 2006; 367 1247–55 (external link)
- Paavonen J, et al. Lancet 2007; 369: 2135–37 (external link)
For facts on the immunisation programme
NHS Immunisation website (external link)
For further facts on the HPV programme and diseases
- Department of Health Green Book on immunisation against infectious disease (external link)
- Health Protection Agency (external link)
- Vaccine in pregnancy surveillance (external link)
Facts on the MHRA and the Yellow Card Scheme (external link)
Cervarix information from the European Medicines Agency (external link)
Gardasil information from the European Medicines Agency (external link)