Flu
Summary
AstraZeneca Fluenz for all children ages 2-16 inclusive.
Justification:
- Direct avoidance of large number of child flu cases
- Lowers flu transmission so indirectly protects infants, clinical risk groups, older adults
- Will raise awareness of benefits and increase uptake rates in clinical risk groups and older adults
Figures
HPA National Influenza Annual Reports
What a reasonably bad year looks like: 10,000 excess deaths in 2008-9
Current Takeup
Influenza Vaccine Uptake amongst GP Patient Groups in England Winter Season 2012/13
Influenza Vaccine Uptake amongst GP Patient Groups in England Winter Season 2012/13
Overall percentages:
- sub 2y: 24.3%
- 2-15y: 38.7%
- 16-64y: 52.8%
- All sub-65y: 51.3%
- 65+y: 73.4%
- pregnant: 40.3%
- carers: 46.3%
At-risk (Appendix A):
- All patients aged 65 years and over
- Chronic respiratory disease aged six months or older
- Chronic heart disease aged six months or older
- Chronic kidney disease aged six months or older
- Chronic liver disease aged six months or older
- Chronic neurological disease aged six months or older
- Diabetes aged six months or older
- Immunosuppression aged six months or older
- Pregnant women
- People living in long-stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality. This does not include, for instance, prisons, young offender institutions, or university halls of residence.
- Carers
- "The list above is not exhaustive, and the medical practitioner should apply clinical judgement to take into account the risk of flu exacerbating any underlying disease that a patient may have, as well as the risk of serious illness from flu itself. Flu vaccine should be offered in such cases even if the individual is not in the clinical risk groups specified above."
JCVI
13. The sub-committee noted that most of the health benefit from vaccinating children was gained from indirect protection of the high risk and older aged groups through a reduction in influenza transmission rather than derived by the children themselves. It would not be cost effective to vaccinate children if only the health benefits to children were considered. It only became cost effective to vaccinate children to lower the burden of influenza in high risk and older age groups many of whom do not themselves get vaccinated. The sub-committee suggested that attitudinal research to inform likely uptake of influenza vaccine should be conducted, including on attitudes when, whilst vaccination of children would protect them from getting influenza, most of the health benefit in terms of QALYs (which are mostly influenced by deaths) would be gained by adults rather than children. The newly authorised intranasal vaccine for children might be deemed a more acceptable than intramuscular vaccines leading to higher uptake.
14. The sub-committee noted the recent initiatives to increase uptake of influenza vaccine in high risk groups aged <65 years from around 50% to around 75%, similar to those aged 65 years and older. It was not clear what impact higher uptake of vaccine in risk groups would have on the impact and cost effectiveness of vaccinating children and this should be investigated.
Attitudes: Elderly
http://www.biomedcentral.com/content/pdf/1471-2458-6-249.pdf: Cross-sectional survey of older peoples' views related to influenza vaccine uptake: BMC Public Health, 11 Oct 2006
Abstract
Background: The population's views concerning influenza vaccine are important in maintaining high uptake of a vaccine that is required yearly to be effective. Little is also known about the views of the more vulnerable older population over the age of 74 years.
Methods: A cross-sectional survey of community dwelling people aged 75 years and over wh, previous participant was conducted using a postal questionnaire. Responses were analysed by vaccine uptake records and by socio-demographic and medical factors.
Results: 85% of men and 75% of women were vaccinated against influenza in the previous year. Over 80% reported being influenced by a recommendation by a health care worker. The most common reason reported for non uptake was good health (44%), or illness considered to be due to the vaccine (25%). An exploration of the crude associations with socio-economic status suggested there may be some differences in the population with these two main reasons. 81% of people reporting good health lived in owner occupied housing with central heating vs. 63% who did not state this as a reason (p = 0.04), whereas people reporting ill health due to the vaccine was associated with poorer social circumstances. 11% lived in the least deprived neighbourhood compared to 36% who did not state this as a reason (p = 0.05) and were less likely to be currently married than those who did not state this as a reason (25% vs 48% p = 0.05).
Conclusion: Vaccine uptake was high, but non uptake was still noted in 1 in 4 women and 1 in 7 men aged over 74 years. Around 70% reported they would not have the vaccine in the following year. The divergent reasons for non-uptake, and the positive influence from a health care worker, suggests further uptake will require education and encouragement from a health care worker tailored towards the different views for not having influenza vaccination. Non-uptake of influenza vaccine because people viewed themselves as in good health may explain the modest socioeconomic differentials in influenza vaccine uptake in elderly people noted elsewhere. Reporting of ill-health due to the vaccine may be associated with a different, poorer background.
In-Paper Conclusion
Health workers have a positive influence on influenza vaccine uptake and should continue to try to advise people and give individual education to all who refuse influenza vaccine, not just those who think the vaccine might make them ill. An important message for all those who decline influenza vaccine is the ability for even seasonal influenza to change from year to one where there maybe little protective immunity in the population
This work also provides an initial insight into the possible backgrounds in which particular perceptions of influenza vaccine might occur and needs to be confirmed elsewhere. Changes in the prevalence of such perceptions and associations with socio-economic status as a result of increasing experience of the health service offering vaccination against seasonal influenza each year as well as worries over an influenza pandemic would also be of interest.
In-Paper Background
Influenza is a significant cause of winter mortality as well as acute incapacity in elderly people. Complications are unpredictable but more common in older adults, who may need urgent hospitalisation or substantial increases in home care. The epidemic of 1989 was estimated to result in about 25,000 additional deaths in England and Wales, 80% of whom were over the age of 74[1]. Vaccination is currently the most effective measure against influenza. The use of killed influenza vaccine significantly reduces morbidity and mortality in elderly people
In-Paper Patient Information
Influenza or ‘flu is a cause of colds and ‘flu in winter months. About 1 in 100 people get ‘flu each year. Some years are worse than others. It can cause fever, chills, headache, cough, sore throat and muscle aches. Although most people are ill for only a few days, some have a much more serious illness and may need to go into hospital. Thousands of people die each year from influenza related illnesses. Most deaths caused by influenza are in elderly people.
There is a vaccine against influenza that is given each year. The viruses that cause influenza change often. A new influenza vaccine is made at the start of each year using viruses that are most likely to come to the UK later that year. If the vaccine includes the viruses that are the most common later that year it prevents about 6 out of 10 illnesses. The vaccine does not prevent the many other infections that also cause colds and ‘flu like illnesses. Occasionally people get mild soreness at the injection site and fever and aches for 1-2 days after vaccination.
Reasons for not having vaccine (N = 169)
| N | % | 95% | CI | |
|---|---|---|---|---|
| Attitudes to vaccination | ||||
| Don't get ill | 75 | 44.4 | 37.4 | 51.9 |
| Perception vaccine makes them ill | 43 | 25.4 | 18.1 | 32.8 |
| Not interested | 28 | 16.6 | 11.6 | 22.3 |
| Do not like injections | 19 | 11.2 | 7.1 | 17.9 |
| Perception would not work | 21 | 12.3 | 8.1 | 19.3 |
| Allergy to vaccine | 9 | 5.3 | 3.3 | 8.8 |
| Did not get around to it | 9 | 5.3 | 3.0 | 9.5 |
| Knowledge | ||||
| Never had it before | 51 | 30.2 | 22.2 | 38.1 |
| Did not know needed each year | 11 | 6.5 | 3.3 | 10.8 |
| Volunteered thought they were too old | 9 | 5.3 | 2.1 | 8.4 |
| Did not know could have it | 5 | 5.3 | 1.2 | 7.2 |
| Physical barriers | ||||
| No transport | 11 | 6.5 | 3.8 | 11.3 |
| Unable to attend because of ill health | 9 | 5.3 | 2.6 | 11.1 |
| Time of clinics not suitable | 1 | 0.6 | 0.1 | 4.5 |
| Too far away | 1 | 0.6 | 0.1 | 4.5 |
UK Government
Children’s flu immunisation programme 2013 to 2014
The flu immunisation programme 2013/14 – extension to children - 26 Jun 2013 Letter
The extension of the flu immunisation programme to children
JCVI has recommended that the routine annual flu immunisation programme be extended to all children aged two to under 17 years. The extended programme is expected to appreciably lower the public health impact of flu by directly averting a large number of cases of disease in children, and, through lowering flu transmission in the community, indirectly preventing flu in unvaccinated younger children, people in clinical risk groups, and older adults. This is expected to substantially reduce flu-related illness, GP consultations, hospital admissions and deaths. JCVI found that extending the flu immunisation programme in this way is likely to be highly cost effective.
Extending the flu immunisation programme to all children will also raise awareness of the benefits of flu immunisation amongst parents and children. We anticipate that as flu immunisation for children becomes accepted as routine, this will have a positive impact on uptake rates for others who are eligible for flu immunisation, particularly those in clinical groups for whom the risk of serious complications is highest, and for whom coverage is presently only around 50%.
The children’s flu immunisation programme 2013/14
There are two elements to the children’s flu immunisation programme this year:
- a routine offer of vaccination to all two and three year olds (but not four years or older) on the 1 September 2013; and
- geographical pilots for four to ten year olds (up to and including pupils in school year 6).
Extending the flu programme to all children will involve considerable planning and work in order to obtain a high level of uptake. For this reason, the programme will be rolled out over a number of seasons and will include pilots, allowing Public Health England and NHS England time to ascertain the most effective way of implementing it.
The Department of Health has secured Fluenz® vaccine for use in 2013/14 to allow the roll-out of the programme to all two and three year olds through general practice, as well as through a small number of local geographical pilots targeted at four to ten year olds.
Roll-out to two and three year olds
All GP practices in England should offer immunisation to all registered patients aged two and three years (but not four years or older) on the 1 September 2013 (i.e. date of birth on or after 2 September 2009 and on or before 1 September 2011). The vaccine should be offered on either:
- a proactive call basis, if not considered at-risk, or
- a proactive call and recall basis, if considered at-risk.
JCVI Recs
Recommendations
9. On the basis of the findings of the cost effectiveness study and the committee’s previous conclusions, JCVI recommends that the annual influenza vaccination programme be extended to include school-aged children (spanning ages five to less than 17 years) as this is highly likely to be cost effective and well within accepted cost effectiveness thresholds. It is the most cost effective option evaluated. Extending the vaccination programme to include low risk children aged six months to less than five years as well as aged five to less than 17 years is also likely to be cost effective, although the additional benefit may be relatively small in comparison. However, JCVI is not in a position to recommend inclusion of all low risk children aged six months to less than five years. This is because there is no demonstrably equivalently effective vaccine to the vaccine of choice (see below) available for children aged less than two years. The application for market authorisation of an adjuvanted inactivated influenza vaccine for use in children aged six months to less than nine years with equivalent effectiveness has been withdrawn13 and the authorised alternative unadjuvanted inactivated influenza vaccines are of uncertain effectiveness in young children. In light of this situation, JCVI recommends that an extended influenza vaccination programme should include low risk children aged two to less than five years in addition to children aged five to less than 17 years. An analysis suggests that additionally vaccinating low risk children aged two to less than five years is also likely to be cost effective. However, attitudinal research suggests that the annual influenza vaccination of pre-school children may be less well accepted by parents than vaccination of school-aged children.
10. Extending vaccination beyond low risk children to age groups of low risk adults aged under 65 years is unlikely to be cost effective and is not recommended.
11. JCVI advises that the live attenuated intranasal influenza vaccine (Fluenz®) should be the vaccine of choice for the extension to the programme, given the evidence of effectiveness, protection against drifted strains and safety, and in the absence of any equivalently effective alternative authorised vaccine. There may also be longer-term immunological advantages to the use of a live attenuated influenza vaccine. However, arrangements should be made to offer alternative authorised vaccines for the small proportion of children for whom the live attenuated vaccine is not suitable as most will be in clinical risk groups and need direct protection against influenza.
12. JCVI considers that the extension to the influenza programme to children aged five to less than 17 years may be best delivered through schools. For the purposes of implementation this could include children in reception to school year 12 in England and equivalent school years in other UK nations. Influenza immunisation of pre-school children from two years of age will necessitate a different mode of delivery for example, through general practice.
13. JCVI considers that the implementation of the recommendation needs very careful planning and handling. Routine annual influenza vaccination of children would be a huge expansion of the childhood immunisation programme as a whole; more than doubling the number of vaccinations offered currently to children before they reach adulthood. New large-scale supply, storage and distribution arrangements for vaccine would be required to facilitate the programme. Furthermore, current resources are insufficient to deliver an expanded programme through established routes (e.g. school nursing services) and solutions would be needed before an expanded programme could be implemented. It would be very important to mitigate potential opportunity costs to the current national immunisation programme and vital that the introduction of the extended programme does not adversely affect the programme as a whole in terms of resources and public perceptions. Resources should not be removed from the current national immunisation programme to implement and deliver an expanded influenza vaccination programme. Additionally, it would be inadvisable to introduce such a large immunisation programme into the NHS until the large scale restructuring of the health and public health system in England has been completed and the new system is running smoothly.
14. As attitudinal research suggests there may be mixed reactions to extending influenza vaccination to children, JCVI recommends that a campaign to inform and educate parents, children, healthcare professionals and others about influenza, the live attenuated intranasal vaccine and the benefits of the extending the programme to children and to the wider population would be needed in advance of, and alongside, an extended vaccination programme for successful implementation. Consideration should also be given as to whether the programme could provide an opportunity for the introduction of other health and/or health promotion programmes in schools.
15. Therefore, given the need for an extensive information/education campaign, the development of a strategy to implement and adequately resource an extended programme, ensure the large-scale supply, storage and distribution of vaccine and to allow the impending changes to the health and public health system in England to be completed, JCVI suggests that any expanded programme cannot be implemented until autumn 2014 at the very earliest and it may be longer before it can be implemented.
16. As with all immunisation programmes, JCVI will keep its advice and recommendations under review in light of new information that may emerge. JCVI recommends that the impact and cost effectiveness of the influenza programme be reviewed within five years of the introduction of the extended programme to assess whether the expected impact of the vaccine and the extension to the programme has been realised and to inform possible adjustments to the programme. Data to allow this retrospective evaluation should be collected. The review should include assessment of new improved alternative influenza vaccines, especially if shown to be effective in young children.
17. Until the extension to the programme can be implemented, the committee recommends that the influenza vaccination programme should continue to target all those aged 65 years and older and those aged six months to below 65 years in the influenza clinical risk groups (including pregnant women) for whom the burden of influenza is greatest. Increases in vaccine uptake in clinical risk groups are likely to be cost effective and should remain a priority, particularly for the youngest age groups where influenza vaccine uptake is poorest.
Pandemrix
In England, a monovalent pandemic strain vaccine containing the oil-in-water adjuvant AS03 (Pandemrix) was introduced in October 2009 during the second wave of infection, initially for people with high risk clinical conditions and then in healthy children aged under 5 from mid-December 2009. By March 2010, around 24% of healthy children aged <5 and 37% aged 2-15 in a risk group had been vaccinated in England.
It seems pretty clear that there is a link to early-onset narcolepsy among children receiving Pandemrix. Estimates of absolute incidence range from 2 to 7 in 100,000. Most recent UK estimate is 2 in 100,000.
The problem appears tied to a specific generic marker and there is speculation that at least part of the action may be as an "accelerator", eg some of the victims at least would have developed narcolepsy - just far later in life.
It surfaced first in Finland, where they got 54 cases of sub-17-year-olds in 2010, where they would normally have expected 3 or 4. 50 of the 54 cases had received Pandemrix 0 to 242 (median 42) days before onset Reference To The Paper Here
Relative Risk & 95% CIs: something like 6?
- Finland 12.7 6.1 - 30.8
- Sweden 4.06 2.87 - 5.58
- Ireland 13.0 4.6 - 34.7
- France 5.09 2.11 - 12.26
- Norway 14.5
- UK 9.9 2.1 - 47.9
The international picture is not consistent. Eg Canada's very closely related Arepanrix is not showing the increase. Arepanrix is formulated in a separate process in Canada and this may be giving rise to the difference - eg something going on in Europe's Pandemrix production.
The European Medicines Agency has recommended to the European Commission that two vaccines against influenza A(H1N1) (‘swine flu’) be granted a marketing authorisation. Vaccines are one of the most important tools in the management of an influenza pandemic, helping to reduce illness and deaths by building up immune protection against the pandemic flu virus. To ensure that authorised vaccines are available before the start of the flu season in the coming autumn and winter months, the Agency’s Committee for Medicinal Products for Human Use (CHMP) expedited its assessment.
The vaccines concerned are Focetria (Novartis) and Pandemrix (GlaxoSmithKline). Decisions on the granting of European Union-wide marketing authorisations for the vaccines by the European Commission are expected shortly. Vaccination strategies are decided by the government in each EU Member State, taking into account the information provided by the Agency for each vaccine.
Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine should not substantially affect the safety or level of protection offered. The Committee’s recommendation to authorise these two vaccines is based on the information on the quality, safety and immunogenicity, including information on clinical trials in more than 6,000 subjects, generated at the time of the authorisation of the mock-up vaccines, as well as on information relating to the change in strain from H5N1 to H1N1.
Further clinical trials in adults and in children are ongoing and more results will become available from October/November 2009 onwards.
The vaccines recommended for authorisation, Focetria and Pandemrix, contain ‘adjuvants’ (substances that enhance the immune response so that less viral material can be used in each dose of vaccine). They are widely used in vaccine manufacture and have a good safety record. The adjuvant in Focetria has been used in another flu vaccine since 1997 in more than 45 million doses. The adjuvant in Pandemrix has been tested in clinical trials involving several thousand subjects.
27 Aug 2010: European Medicines Agency starts review of Pandemrix
The European Medicines Agency has launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. A limited number of cases was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland. Pandemrix, an influenza vaccine, has been used since September 2009 for vaccination against H1N1 influenza in at least 30.8 million Europeans.
On 24 August 2010, Finland’s National Institute for Health and Welfare recommended that vaccination with Pandemrix be discontinued until the suspected link with narcolepsy is thoroughly evaluated.
23 Sep 2010: European Medicines Agency updates on the review of Pandemrix and reports of narcolepsy
As per 17 September 2010, there are 81 reports from healthcare professionals suggestive of narcolepsy, all collected through spontaneous reporting systems. Of these, 34 reports come from Sweden, 30 from Finland, 10 from France, 6 from Norway and 1 from Portugal. In addition, there are a further 13 consumer reports from Sweden and 2 from Norway. The age range of patients is between 4 and 52 years.
The ongoing review is complex and will take some three to six months to complete. The Agency is working with experts from across the European Union to carefully scrutinise all available reports. Owing to a potential overlap of narcolepsy symptoms with several other neurological and psychiatric disorders, diagnosis is very often not confirmed until several years after symptom onset.
The number of reports of narcolepsy that occurred in children in some countries seems to be higher than expected in comparison with data from previous years. However, there are many uncertainties in the available information that need to be clarified. These include a possibility that earlier diagnoses of narcolepsy have contributed to this apparent increase. Also, the influenza pandemic itself may have contributed to a change in the rates of narcolepsy. These factors need to be assessed before firm conclusions can be drawn.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed further data from Finland on the suspected link between narcolepsy in children and adolescents and Pandemrix. The Committee concluded that the new evidence added to the concern arising from case reports in Finland and Sweden, but that the data were still insufficient to establish a causal relationship between Pandemrix and narcolepsy. Further analyses and study results are awaited to clarify the observations in Finland.
In addition to the data from Finland, research is ongoing in Sweden where there has also been an unexpected number of narcolepsy reports following vaccination with Pandemrix. However, other non-Nordic countries have not seen similar increased rates of reporting of narcolepsy. Additionally in Canada, where there has been substantial use of this type of vaccine, there has been no evidence of an increase in reports of narcolepsy. Therefore, at present definitive conclusions cannot be drawn and no changes to the recommendations for use of Pandemrix are proposed.
15 Apr 2011: European Medicines Agency recommends interim measures for Pandemrix
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Pandemrix should be amended to advise prescribers to take into account preliminary results from epidemiological studies on Pandemrix and narcolepsy, and to perform an individual benefit-risk assessment when considering the use of Pandemrix in children and adolescents. This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.
The exact wording to be included in the Pandemrix product information reads as follows: “Preliminary reports form epidemiological studies in two countries (Sweden and Finland) have indicated a 4-9-fold risk increase of narcolepsy in vaccinated as compared with unvaccinated children/adolescents, corresponding to an absolute risk increase of about three to four additional cases in 100,000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). Similar epidemiological studies have not yet been conducted in other countries. The relationship between Pandemrix and narcolepsy is still under investigation. When considering the use of Pandemrix in children and adolescents, an individual benefit risk assessment should be performed taking this information into account.”
21 Jul 2011: European Medicines Agency recommends restricting use of Pandemrix
In persons under 20 years of age Pandemrix to be used only in the absence of seasonal trivalent influenza vaccines, following link to very rare cases of narcolepsy in young people. Overall benefit-risk remains positive.
More on the discussion - some EMA members favoured restriction to adults only
Full report: http://www.ecdc.europa.eu/en/publications/Publications/Vaesco%20report%20FINAL%20with%20cover.pdf
The case–control study found an association between vaccination with Pandemrix® and an increased risk of narcolepsy in children and adolescents (5 to 19 years of age) in Sweden and Finland – countries which reported the initial signal (signalling countries). Pandemrix® was the only pandemic vaccine used in these countries. No such association was found in adults in these countries. The overall number of new cases of narcolepsy being reported after September 2009 was much higher in Sweden and Finland (significantly increased incidence rates) compared with the other countries participating in the study. In the Netherlands, the United Kingdom and Italy, no increase in narcolepsy incidence was noted. However, vaccination coverage among the reported affected age group (5–19 years of age) was low in all these other countries.
In the non-signalling countries (Denmark, France, Italy, the Netherlands, Norway and the UK), the strictest primary analysis, the kind of assessment designed to avoid most biases like media and diagnostic awareness biases, found no significant risk to children and adolescents.
However, sensitivity analyses that assess the robustness of the results from the primary analysis, have highlighted the importance of several time-related factors that affect the strength of association between influenza pandemic vaccines and narcolepsy. An example of a time-related factor shown to influence results is the length of the chosen study period, eg the inclusion of cases occurring before and after the period of media attention would give a different outcome.
One such sensitivity analysis was based on the date of onset of excessive daytime sleepiness before media attention. This identified an increased risk for narcolepsy for children and adolescents following influenza A(H1N1)pdm09 vaccination in both signalling and non-signalling countries.
A similar sensitivity analysis also addressed date of onset of excessive daytime sleepiness and showed an association in adults in non-signalling countries before awareness increased.
To further inform the regulatory actions and the public, the report recommends increasing the statistical power by:
- ensuring completeness of the case–control study through an exhaustive case inclusion in the primary study period before increased awareness in the countries that are currently part of the VAESCO study;
- including further European countries with significant vaccine coverage among the affected age groups that were unable to be part of the current study (e.g. Ireland);
- pooling all available data from national studies that were not included in VAESCO (Ireland, the United Kingdom (studies based in sleep centres) and Germany).
Another conclusion from the report is that it would be important to extend the investigation beyond Europe, where there was no regulatory or media attention. In particular, countries such as Canada and Brazil used AS03-adjuvanted Arepanrix®, a vaccine very similar to Pandemrix®. The experience of countries where children and adolescents where vaccinated with other pandemic vaccines (adjuvanted and unadjuvanted) is also very important.
Conclusions from the epidemiological studies
- Pandemrix vaccination is significantly associated with an abrupt increase in narcolepsy-cataplexy among children and teens, and possibly also in adults
- The relative risk varies between 3 to 14 / 100 000 in the susceptible age group
- The vaccine attributable absolute risk is small (<7 /100 000 vaccinated) but consistently seen in different populations where Pandemrix was used in large numbers in susceptible age group
- In most countries, the postlicensure safety surveillance did not pick up the signal
- Most likely such a rare event would not have been picked up even in large prelicensure trials
Gaps in knowledge – significance to vaccine development and NVPs
- What is the biologically plausible mechanism ?
- Would the affected patients become narcoleptic later on in their life anyhow; i.e. did vaccine trigger the disease in advance ?
- What does this incident mean to the future development of adjuvanted influenza / pandemic vaccines ?
- What does the finding mean to the future seasonal influenza vaccination of those Pandemrix exposed ?
- How to contain the negative safety messages and impact to influenza vaccination / vaccinations in general ?
Case notes for 245 children and young people were reviewed; 75 had narcolepsy (56 with cataplexy) and onset after 1 January 2008. Eleven had been vaccinated before onset; seven within six months. In those with a diagnosis by July 2011 the odds ratio was 14.4 (95% confidence interval 4.3 to 48.5) for vaccination at any time before onset and 16.2 (3.1 to 84.5) for vaccination within six months before onset. The relative incidence from the self controlled cases series analysis in those with a diagnosis by July 2011 with onset from October 2008 to December 2010 was 9.9 (2.1 to 47.9). The attributable risk was estimated as between 1 in 57 500 and 1 in 52 000 doses.
Conclusion: The increased risk of narcolepsy after vaccination with ASO3 adjuvanted pandemic A/H1N1 2009 vaccine indicates a causal association, consistent with findings from Finland. Because of variable delay in diagnosis, however, the risk might be overestimated by more rapid referral of vaccinated children.
27 Feb 2013: HPA Announcement: Pandemic flu vaccination linked to narcolepsy in UK children
In collaboration with researchers from Papworth and Addenbrooke’s hospitals in Cambridge, the study looked at 75 children aged between four and 18 who were diagnosed with narcolepsy from January 2008 and who attended sleep centres across England. Eleven of these children had been vaccinated with Pandemrix before their symptoms began, seven of these within six months. This suggests a risk of narcolepsy following vaccination with Pandemrix of around one in every 55,000 doses of the vaccine.
Narcolepsy.co.uk: Is this the beginning of the end for the Pandemrix story?
GSK have been saying for some time that studies in Canada (where they offered a vaccine called Arepanrix to immunise against H1N1) showed no increase in narcolepsy. Arepanrix is similar to Pandemrix and contains the adjuvant ASO3. GSK themselves have admitted the two products have some minor formulation differences because they were manufactured at different sites. Pandemrix was produced in Dresden, Germany; Arepanrix in Canada.
Dr Outi Vaarala works for at Finland's National Institute for Health and Welfare and has been studying Pandemrix since cases of narcolepsy first appeared in 2010. She informed reporters earlier this year that she had found differences in the way antibodies bind to the antigen in the German made vaccine and the way they do in the Canadian version.
We must point out these findings have not yet been published or peer reviewed but she has gone on record as saying; "Our findings of the immunological differences between Pandemrix and Arepanrix virus antigen are important clues to the mechanism of Pandemrix-related narcolepsy." GSK meanwhile continue to say that they can find no indication that the manufacturing process is one of the causes of Pandemrix and narcolepsy.
19 Sep 2013: Swine flu vaccine can trigger narcolepsy, UK government concedes (Guardian)
The government is to reverse its stance on the safety of a swine flu vaccine given to 6 million people in Britain and accept that on rare occasions the jab can trigger the devastating sleep disorder narcolepsy.
The Department for Work and Pensions (DWP) has contacted people turned down for compensation last year to explain that, after a review of fresh evidence, it now accepts the vaccine can cause the condition. The move leaves the government open to compensation claims from around 100 people in Britain, and substantial legal fees if a group action drawn up by solicitors is successful.