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Published: March 2002
ADR update

Reassuring News on Suspected Vaccine Adverse Reactions

Prescriber Update 23(1): 4-5
March 2002

Medsafe Editorial Team

Recent studies have confirmed that there is no association between infant immunisation and sudden infant death syndrome, between MMR vaccine and either autism or bowel disease, and between hepatitis B vaccine and multiple sclerosis.

The Medicines Adverse Reactions Committee (MARC) has reviewed recent studies of some suspected vaccine adverse reactions.  This article reflects the views of the Committee and updates advice in earlier Prescriber Update articles.1-4

DTPH AND ORAL POLIO VACCINES AND SIDS

SIDS is associated with illness but not infant immunisation

Studies,5 including one6 conducted in New Zealand, have found no association between sudden infant death syndrome (SIDS) and childhood vaccination.  SIDS occurs in infants at the age at which they are receiving their immunisations.  Hence, close temporal relationships with vaccination are inevitable in some cases.

A recent case control study conducted in the United Kingdom7 included a base cohort of 470,000 births and identified 303 deaths attributed to SIDS.  The odds ratio for SIDS with vaccination uptake (DTPH and oral polio vaccines) after adjusting for matching and the infants' sleeping environment was 0.67 (95% confidence interval 0.31-1.43).  Five percent of SIDS deaths and reference sleeps (the reference sleep for each control infant occurred in the period of the day in which the matched case infant had died) occurred within 48 hours following vaccination.  Babies who died of SIDS were more likely to have needed medical attention in the 24 hours before death than their matched controls (21% and 7%, respectively).  The results of this study7 are consistent with there being no association between DTPH and oral polio vaccination and SIDS.

MMR VACCINE, AUTISM AND BOWEL DISEASE

No association between MMR vaccine and autism

The assertion that there was an association between MMR vaccine and autism, as a result of bowel abnormalities, was made by Wakefield et al8 in 1998 on the basis of a case series.  However, subsequent evidence has not supported this alleged association.3,9  Two recent studies have compared the rate of uptake of vaccination with the rate of diagnosis of autism over time using United Kingdom10 and Californian11 data.  Both studies found steep rises (5- to 7-fold) in the number of cases of autism occurring over periods for which the uptake of MMR vaccine was almost static (about 97%) in one study10 or increased by a small percentage (10%) in the other.11  The increase in uptake of MMR vaccine could not account for the rise in diagnosis of autism in either study.  A further study12 found no association between MMR vaccine and a distinct syndrome of autism involving regression or autism coupled with gastrointestinal symptoms.  A recent review13 has summarised the evidence regarding MMR vaccine and autism.

Bowel disease not linked to measles infection or vaccine

Initial findings of an association between exposure to measles in utero or measles infection in early childhood and inflammatory bowel disease later in life have not been confirmed.3,14  A recent case control study15 of 142 persons with inflammatory bowel disease found no association with MMR or other measles-containing vaccine.  However, the authors considered that a small increase in risk would not have been detected in their study.  The MARC considers that the overall balance of evidence is not consistent with an association between MMR vaccine and bowel disease.

Recently the American Academy of Pediatrics16 published its conclusions that the available evidence does not support an association between MMR vaccine, autism and bowel disease.  The American Institute of Medicine17 reached a similar conclusion with regard to autism.

HEPATITIS B VACCINE AND MULTIPLE SCLEROSIS

No association between hepatitis B vaccine and multiple sclerosis

Three recent studies have examined the possibility of an association between hepatitis B vaccine and demyelinating disease, specifically multiple sclerosis.  One study18 conducted in adolescents in British Columbia found no difference in incidence of multiple sclerosis before and after initiation of the hepatitis B vaccination programme.

Hepatitis B vaccine not associated with new onset multiple sclerosis in women

Another study19 using the cohort of women in the US Nurses' Health Study identified 192 women with multiple sclerosis and matched these to 534 healthy controls.  After adjustment for age, the relative risk of multiple sclerosis in women vaccinated with hepatitis B vaccine compared with unvaccinated women was 0.9 (95% CI 0.5-1.6).  Restricting the analysis to those vaccinated within two years of the onset of disease did not increase the association.

Relapse of multiple sclerosis did not follow vaccination

The third study20 looked for an association between relapse and vaccination with any vaccine in 643 patients diagnosed with multiple sclerosis who had been relapse-free in the 12 months preceding the relapse.  In this study exposure to vaccination in the 2-month period immediately preceding the relapse was compared with exposure in the preceding relapse-free 2-month periods.  The relative risk for relapse with hepatitis B vaccine was 0.67 (95% CI 0.20-2.17).

None of these studies found evidence for an association between hepatitis B vaccine and multiple sclerosis or relapse of multiple sclerosis.

Competing interests (authors): none declared.

References
  1. Medsafe Editorial Team. Current evidence - no link between vaccination and type I diabetes mellitus. Prescriber Update February 2000(19):25-27 www.medsafe.govt.nz/Profs/PUarticles/IDDM.htm
  2. Mansoor O. MMR vaccine, bowel disease and autism. Prescriber Update April 1998(16):41-42 www.medsafe.govt.nz/Profs/PUarticles/11.htm
  3. Medsafe Editorial Team. MMR vaccine not associated with bowel disease and autism. Prescriber Update February 2000(19):37-39 www.medsafe.govt.nz/Profs/PUarticles/MMR.htm
  4. Vaccine adverse reactions: separating fact from speculation. Prescriber Update December 1998(17):20-24 www.medsafe.govt.nz/Profs/PUarticles/vaccine.htm
  5. Dwyer T, Ponsonby A-L, Blizzard L, et al. The contribution of changes in the prevalence of prone sleeping position to the decline in sudden infant death syndrome in Tasmania. JAMA 1995;273:783-789.
  6. Mitchell EA, Stewart AW, Clements M, et al. Immunisation and the sudden infant death syndrome. Arch Dis Child 1995;73:498-501.
  7. Flemming PJ, Blair PS, Ward Platt M, et al. The UK accelerated immunisation programme and sudden unexpected death in infancy: case-control study. BMJ 2001;322:822-825.
  8. Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis and pervasive development disorder in children. Lancet 1998;351:637-641.
  9. Taylor B, Miller E, Farrington CP, et al. Autism and measles, mumps and rubella vaccine: no epidemiological evidence for a causal association. Lancet 1999;353:2016-2029.
  10. Kaye JA, Del Mar Melaro-Montes M, Jick H. Measles, mumps and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis. BMJ 2001;322:460-463.
  11. Dales L, Hammer SJ, Smith NJ. Time trends in autism and in MMR immunization coverage in California. JAMA 2001;285:1183-1185.
  12. Fombonne E, Chakrabarti S. No evidence for a new variant of measles-mumps-rubella-induced autism. Pediatrics 2001;108:e58 www.pediatrics.org/cgi/content/full/108/4/e58
  13. DeStefano F, Chen RT. Autism and measles-mumps-rubella vaccination. Controversy laid to rest? CNS Drugs 2001;15:831-837.
  14. Davis RL, Bohlke K. Measles vaccination and inflammatory bowel disease. Controversy laid to rest? Drug Safety 2001;24:939-946.
  15. Davis RL, Kramarz P, Bohlke K, et al. Measles-mumps-rubella and other measles-containing vaccines do not increase the risk for inflammatory bowel disease: a case-control study from the Vaccine Safety Datalink Project. Arch Pediatr Adolesc Med 2001;155:354-359.
  16. Halsey N, Hyman SL and the Conference Writing Panel. Measles-mumps-rubella vaccine and the autistic spectrum disorder: report from the New Challenges in Childhood Immunization Conference convened in Oak Brook, Illinois, 12-13 June 2000.  Pediatrics 2001;107(5) http://www.aap.org/mrt/mmrv.htm
  17. Stratton K, Gable A, Shetty P, et al, on behalf of the Immunization Review Committee, eds. Measles-mumps-rubella vaccine and autism. Washington, DC: Institute of Medicine, National Academy Press, 2001.  http://www.nap.edu/catalog/10101.html?se_side
  18. Sadovnick AD, Scheifele DW. School-based hepatitis B vaccination programme and adolescent multiple sclerosis. Lancet 2000;355:549-550.
  19. Ascherio A, Zhang SM, HernĂ¡n MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med 2001;344:327-332.
  20. Confavreux C, Suissa S, Saddier P, et al. Vaccinations and the risk of relapse in multiple sclerosis. N Engl J Med 2001;344:319-326.