• Most of the reports of reactions to vaccines are mild and resolve quickly. These range from fever, rashes or injection site soreness and nearly all reactions are associated with complete recovery. ²

 

 

• All vaccines are extensively tested by the manufacturers for quality, safety, immunogenicity and efficacy before a product licence can be granted.³
• In addition, the manufacturers must submit samples of each batch together with the results of their own potency, safety and purity tests for independent assessment before the batch can be released for general use in the UK.⁴

HOW IS THE SAFETY OF VACCINES MONITORED?

 

• The Vigilance Risk Management of Medicines Division of the Medicines and Healthcare Products Regulatory Agency (MHRA) has responsibility for monitoring the safety of all medicines including vaccines³
• The MHRA also uses a variety of methods of collecting information on medicines. Healthcare professionals, as well as patients, are encouraged to report suspected adverse drug reactions and there is a legal requirement for companies to report such reactions to their products to the MHRA⁵
• When a vaccine is first marketed, it undergoes intensive monitoring and all adverse events must be reported to the MHRA. Such products are indicated by a black triangle⁶
• Reports of suspected adverse reactions are classified and entered into a national computer database operated by the MHRA³
• The number, pattern and severity of reported reactions are regularly reviewed and appropriate investigation and action is initiated if a possible problem is identified³
• Important information on vaccine safety is routinely collected through spontaneous adverse drug reaction reporting schemes such as the Yellow Card scheme, from clinical and epidemiological studies, worldwide medical literature, information from pharmaceutical companies, information from worldwide regulatory authorities and morbidity and mortality databases⁵
• All vaccine companies produce regular global summaries of all adverse events. This Periodic Safety Update Report (PSUR) is sent to all local regulatory authorities¹⁰

 

ARE THERE ANY INDEPENDENT COMMITTEES?

 

• The Joint Committee on Vaccination and Immunisation (JCVI) and the Commission on Human medicines (CHM) are independent committees which provide expert advice on immunisation policy and on the quality, safety and efficacy of vaccines respectively.
• The JCVI’s aim is ‘to advise the Secretaries of State for Health, Scotland, Wales and Northern Ireland on matters relating to communicable diseases, preventable and potentially preventable through immunisation.’ In addition to their work on the Committee, members may be called upon by the Secretariat to give advice when matters arise on which the members' particular expertise may be of assistance to the public service.⁸

 

THE MANAGEMENT OF ADVERSE EVENTS
FOLLOWING IMMUNISATION2

 

• Vaccines provide protection by stimulating the body’s immune system. Some adverse reactions (side effects) can be predictable, and these can be mild and resolved quickly. However, it is not always possible to predict which individuals may have mild or serious reactions to a vaccine.
• Adverse events following immunisation (AEFIs) may be caused by the way the vaccine is administered, or may be related to an underlying condition in the recipient. Other AEFIs may have occurred regardless of vaccination. These are classified under categories:
  
  
  • Vaccine induced reactions: Reactions in individuals specifically caused by a particular vaccine or its component parts. They may be due to an underlying medical condition or an unusual response in the recipient.
  • Programme related reactions: Adverse events resulting from inappropriate practices in the provision of vaccination, including but not limited to administering the wrong dose of vaccine, using vaccines beyond expiry date, using vaccines at inappropriate intervals.
  • Co-incidental reactions: not a true adverse reaction to an immunisation or vaccination, and linked only because of the timing of their occurrence. For example, flu vaccine does not prevent the common cold and colds are common in the winter when people are receiving flu vaccine.

   

 

CONCLUSION

• In general, the risk of serious illness following natural infection far outweighs any possible risks from the relevant vaccine. For further information consult chapter 8 Vaccine safety and the management of adverse events following immunisation in "Immunisation against infectious disease – The Green Book" London, HMSO. 2006 or visit http://www.dh.gov.uk/assetRoot/04/13/78/98/04137898.pdf

 

 

1. Health Protection Agency. Health Topics: Vaccination. http://www.hpa.org.uk/infections/topics_az/vaccination/vacc_menu.htm Accessed October 2006

2. Immunisation against Infectious Disease. Vaccine safety and the management of adverse events following immunisation Chapter updated August 2006. Department of Health. http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Greenbook/fs/en Accessed October 2006

3. Immunisation against Infectious Disease. Surveillance and monitoring for vaccine safety Chapter updated August 2006. Department of Health. http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Greenbook/fs/en Accessed October 2006

4. Health Scotland. Ready Steady Baby. The MMR Discussion pack http://www.hebs.co.uk/readysteadybaby/moreinfo/hebs_pub4.cfm?TxtTCode=1172 Accessed October 2006

5. MHRA Safety Information. How we monitor the safety of products. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=273 Accessed October 2006

6. MHRA. Safety Information. Black triangle scheme http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON024119 Accessed October 2006

7. MHRA How we regulate. Periodic Safety Update reports http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=686 Accessed October 2006