Influenza (live) vaccine side-effects

English: Avian flu vaccine development by reverse genetics technique. Français: Diagramme en anglais montrant sommairement les étapes menant à la création d'un vaccin contre la grippe aviaire par la génétique inverse. (Photo credit: Wikipedia)

From Medwatch we can read:

Influenza (live) vaccine side-effects

What are the risks from LAIV?

A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of a vaccine causing serious harm, or death, is extremely small.
Live influenza vaccine viruses very rarely spread from person to person. Even if they do, they are not likely to cause illness.
LAIV is made from weakened virus and does not cause influenza. The vaccine can cause mild symptoms in people who get it (see below).
Mild Problems
Some children and adolescents 2-17 years of age have reported:

• runny nose, nasal congestion or cough
• headache and muscle aches
• fever
• wheezing
• abdominal pain or occasional vomiting or diarrhea

Some adults 18-49 years of age have reported:

• runny nose or nasal congestion
• sore throat
• cough, chills, tiredness/weakness
• headache

Severe Problems

• Life-threatening allergic reactions from vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the vaccination.
• If rare reactions occur with any product, they may not be identified until thousands, or millions, of people have used it. Millions of doses of LAIV have been distributed since it was licensed, and the vaccine has not been associated with any serious problems.

The safety of vaccines is always being monitored. For more information, visit: Vaccine Safety Monitoring and Vaccine Safety Activities.
This information was taken directly from the LAIV VIS [PDF - 275 KB]
(This information taken from Live Influenza VIS dated 7/2/12. If the actual VIS is more recent than this date, the information on this page needs to be updated.)

In others words: the adverse effects of this vaccine is a flu-like syndrome. 

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The perfect vaccine

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Source: The Lancet, Volume 378, Issue 9802, Pages 1545 - 1546, 29 October 2011

Guillain-Barré syndrome and H1N1 influenza vaccine in UK childrendoi:10.1016/S0140-6736(11)61665-6Cite or Link Using DOI

Christopher Verity a, Lesley Stellitano a, Anne Marie Winstone a, Nick Andrews b, Julia Stowe b, Elizabeth Miller b

In 1976, the US National Influenza Immunization Programme (against swine influenza) was discontinued because of an increased risk of Guillain-Barré syndrome within 6 weeks of vaccination.1 Guillain-Barré syndrome surveillance was therefore imperative for pandemic H1N1 (swine) influenza vaccines and was fast-tracked for UK children younger than 17 years by use of the British Paediatric Surveillance Unit (BPSU) system. Fisher's syndrome is related to Guillain-Barré syndrome, so both disorders were included. Follow-up clinical questionnaires were sent to paediatricians who reported cases via the BPSU. Histories of H1N1 and seasonal influenza vaccination were obtained from general practitioners.

Between September, 2009, and August, 2010, 55 children developed symptoms of Guillain-Barré syndrome and two of Fisher's syndrome. Of these, 49 had clinical or laboratory evidence (or both) of an infection in the 3 months before the neurological symptoms started—22 had respiratory infections, 13 gastroenteritis, seven H1N1 influenza (five laboratory-confirmed), two seasonal influenza (one laboratory confirmed), two Epstein-Barr virus, one chickenpox, and two had unexplained fevers. Three children with Guillain-Barré syndrome had received H1N1 or seasonal influenza vaccines. One child had two H1N1 doses of a whole-virion unadjuvanted vaccine at 5 weeks and 10 days before onset—the only case with an interval potentially indicating a causal relation with Guillain-Barré syndrome.1 Another had received one dose of H1N1 vaccine 6 months before and the third a seasonal influenza vaccine 4 months before onset.

Between October, 2009, and March 31, 2010, an estimated 855 378 children in England received H1N1 vaccine,2 most with an AS03B adjuvanted split-virion vaccine. Additional children were vaccinated elsewhere in the UK (which our study covers). A single case of Guillain-Barré syndrome with onset within 6 weeks of H1N1 vaccination is what would be expected by chance in the vaccinated cohort given the background rate of Guillain-Barré syndrome in this age group.3

Of the 57 cases of Guillain-Barré syndrome or Fisher's syndrome, nine had influenza (six laboratory-confirmed). This finding is consistent with that of a recent study that found no association between Guillain-Barré syndrome and seasonal influenza vaccination but a 16-fold increased risk within 1 month of an influenza-like illness.4 The peak in the number of children with Guillain-Barré syndrome or Fisher's syndrome shortly after the peak of the second wave of H1N1 infection in November, 2009, might reflect this causal association (figure). Given the proven effectiveness of pandemic influenza vaccine used in UK children,5the vaccination programme might have had an overall protective effect against Guillain-Barré syndrome.

Figure Full-size image (30K) Download to PowerPoint

Children reported to our study who first developed symptoms of Guillain-Barré syndrome or Fisher's syndrome between September, 2009, and Aug 31, 2010

This study was funded by the UK Department of Health Policy Research Programme, grant numbers 019/0047 and 039/0031. The views expressed in this letter are those of the authors and not necessarily those of the Department of Health. We declare that we have no conflicts of interest.

References

1 Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. Guillain-Barré syndrome following vaccination in the National Influenza Immunization Program, United States, 1976—1977. Am J Epidemiol 1979; 110: 105. PubMed

2 Sethi M, Pebody R. Pandemic H1N1 (swine) influenza vaccine uptake amongst patient groups in primary care in England 2009/2010.http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_121014.pdf.(accessed May 16, 2011).

3 Black S, Eskola J, Siegrist CA, et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet 2009; 374: 2115-2122. Summary | Full Text | PDF(113KB) |CrossRef | PubMed

4 Stowe J, Andrews N, Wise L, Miller E. Investigation of the temporal association of Guillain-Barré syndrome with influenza vaccine and influenza-like illness using the United Kingdom General Practice Research Database. Am J Epidemiol 2009; 169: 382-388. CrossRef | PubMed

5 Andrews N, Waight P, Yung CF, Miller E. Age-specific effectiveness of an oil-in-water adjuvanted pandemic (H1N1) 2009 vaccine against confirmed infection in high risk groups in England. J Infect Dis 2011; 203: 32-39. CrossRef | PubMed

a PIND/GBS Research Group, Box 267, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK

b Health Protection Agency, London, UK

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Vaccines for preventing influenza in healthy adults

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Clinical Summary

Influenza is an acute respiratory viral infection. Its symptoms include fever, aches and pains, tiredness, headache and cough. Complications of influenza include otitis media (an ear infection), pneumonia, secondary bacterial pneumonia, exacerbations of chronic respiratory disease and bronchiolitis in children. Efforts to prevent or minimise the impact of seasonal influenza from the second part of the 20th century have centred on the use of vaccines. Due to the yearly changes in viral antigenic configuration and the lack of carry-over protection from year to year, annual vaccination campaigns require a huge scientific and logistic effort to ensure production and delivery of that year's vaccines for high population coverage.
In 2006, the US Advisory Committee on Immunization Practices (ACIP) published a document where 11 categories of people were listed as being at high risk of complications from influenza. These included healthy adults, 50 to 65 years of age, and healthcare workers.
This Cochrane review, focusing on the effects of influenza vaccines in healthy adults aged 16 to 65, was first published in 1999 and was updated in 2004 and 2007. It has now been updated again and is able to draw on 40 trials with more than 70,000 participants and 8 non-randomised studies of harms. It provides the most robust evidence base of all of the Cochrane reviews of influenza. The main findings are based on 26 clinical trials of the effectiveness of inactivated vaccines and ten studies of the harms of the same vaccines.

Expand   

To place the findings of the review in context, it is important to understand the background risk of developing influenza (which might be effected by the vaccine) and influenza-like symptoms due to other viruses (which will not be effected by the vaccine). Data to help with this comes from the control groups in 274 influenza vaccines studies published up to 2007 and 13 ad hoc studies, which include a total of more than 3 million observations. All of these studies had virological confirmation and defined denominators, which provides more reliable estimates than public surveillance data which are biased and incomplete. The data reveal that, on average, there are seven cases or episodes of influenza-like illness (ILI) in a year among 100 people. But, only one of these is caused by influenza.

This means that influenza is a relatively rare cause of ILI. In these circumstances, influenza vaccines have a low probability of hitting such a target and producing sizeable benefits. This needs to contrasted with the large costs and time involved in vaccinating whole populations.
The findings of the Cochrane review confirm the relatively small effects of vaccination on influenza. When expressed in absolute terms, the low background risk for influenza means that you would need to vaccinate 100 people to avoid one set of influenza symptoms in real world situations, or 33 people if it had been possible to create a perfect match between the vaccine and antigens and circulating viruses. The authors of the Cochrane review are also cautious about the size of these benefits, given the potential for selective reporting biases and the relationship between the source of funding and the findings of trials. These might mean that the true effects are smaller than those found by their review, and that the numbers needed to vaccinate would be larger. The review did not find any evidence that vaccines prevent viral transmission or complications. Harms were rarely studied and the comparative safety of vaccines seems to be taken for granted.
Large studies encompassing several influenza seasons are required to allow the reliable assessment of the effect of the vaccines on rare outcomes such as complications and death. However, the authors of the review conclude that it is unlikely that these will be done because influenza vaccines are centre stage in an “industry” upon which government departments, pharmaceutical giants, the media and researchers depend.

Acknowledgements

The authors of the Cochrane review would like to thank the following for their help with the review and its interpretation: Fiona Godlee and Deborah Cohen (BMJ); Tom Clarke, Jon Snow and Phil Carter (ITN C4 News); Stephane Horel (La Canard Enchane) ; Serena Tinari (Falo’ RSI, Swiss State TV); Mark Jones, Maryann and Richard Napoli (The Cochrane Collaboration); Jeanne Lenzer (Atlantic Magazine); Francesca Nava (La7 TV); Manuela Perrone (Il Sole 24Ore); Catherine Mark (Al Jazeera English); Imogen Foulkes (BBC World Service); Eben Harrel (Time Magazine); Veronika Hackenbrock (Der Spiegel); Per Hermanrud (TV4Se); Frank Konopatzki (ARD Frontal 21); Elsa LePeutrec (Canal Plus); Ronan Lawlor (The Last Word Today FM, Irish BC); Amrita Tripathi (CNN-CNBC India) and Mike Clarke (UK Cochrane Centre). The original review was funded by the UK Ministry of Defence, the 2004 update was supported by the two Italian Local Health Authorities in which two of the review authors were employed, and the 2007 update was funded by the same Local Health Authorities and the UK's Department of Health Cochrane Incentive Scheme. The 2010 update was not funded

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Vaccines for-preventing-influenza-clinical

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