Day 2: Tuesday 19 April 2011

When you arrive in your office, two items are waiting for your attention.

A parcel has been delivered, which contains samples of Klinigen measles vaccine and diluent from affected centres in Karoomana province. It has been sent by Dr Ramon Cajal, who is investigating the cases. The samples have been transported on ice. You give instructions that they should immediately be sent to the national reference laboratory, which is also in Freeport, not too far from your office. You document the process of collection of specimens, the mode of shipment and the tests to be carried out on them. You make a mental note that such samples should not be sent directly to you since you do not have facilities to store them properly or to examine them – if this happens again, they should go directly to the reference laboratory.

There is one AEFI report from Trent Province, indicating an AEFI following MMR immunization, in a child aged 9 months. She had a severe local reaction at the vaccine site.

Since nothing else requires your urgent attention, you decide to

  • Find out more information about the appropriate use of the Klinigen measles vaccine, to ensure that it is being administered correctly to the appropriate group of children,
  • Establish the correct way to categorize and report the symptoms seen in the affected children.

Select the activities that you will do next.

Look up information from the Brighton Collaboration.

You carry out an online search for definitions of the symptoms described in the AEFI reports and find the following publications:

Kohl KS, et al The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine 2007; 25(31):5671–5674.

Sejvar JJ et al. Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 2007;25(31):5771–5792.

  • This is a relevant activity, as using standardized case definitions is crucial to keep information comparable.
  • These publications provide agreed definitions of reactions. Reading these papers will allow you to categorize the AEFI reports you have received.

Phone the national reference laboratory.

You phone the senior laboratory manager at the national reference laboratory.

He says:

"A large parcel arrived containing vials of vaccine. What is it and what do you want me to do with it?"

You explain that the batch of vaccine is suspected of causing convulsions and fever in young children.

The lab decides to test for sterility, toxicity and potency. The remaining vaccine will be stored appropriately, in case it has to be shipped to the manufacturer or to another laboratory for further tests.

  • In this case, this action is important to ensure the appropriate storing of vaccines.
  • If you had not contacted the national reference laboratory, the cold chain may be broken, and any results from analysis of this batch of vaccine would be invalid.

Contact the Ministry of Health.

You telephone the secretary to the Minister of Health, to say that you would like to speak to her.

  • Contact the ministry of health after doing a thorough research and having compiled relevant information.

The secretary says:

"Dr Swahami is opening a new hospital in Mantus today, and will not be back until this evening. Do you want me to give her a message? Or you could call her at 4:30 tomorrow afternoon. She has a slot in her diary then"

You say that she may expect a written report on a matter associated with immunization and you would like it placed on her desk as soon as it arrives.

  • Avoid sharing complex information with the Minister via her secretary. By sending a written report, you ensure that accurate information gets across.

Consult the Global Advisory Committee on Vaccine Safety (GACVS) website for any reports on measles immunization.

You search for reports on measles vaccine on the GACVS website.

  • This is a relevant activity, as it may provide you with information on adverse events and the vaccine.

Most of the information is concerned with measles immunization as a component of MMR. There is nothing pointing at previous issues with Klinigen measles vaccine.

  • You have checked the main global advisory body for information that may be related to the observed adverse event with measles vaccine.

However, there is a paper concerning measles immunization in HIV-positive children which confirms that:

"The evidence does not demonstrate a serious risk in using measles vaccine in HIV-positive children. Although millions of doses of measles vaccine have been administered to HIV-positive children, only 1 case report was identified that suggested possible severe adverse events following immunization."

You also check the report of the Institute of Medicine "Adverse Effects of Vaccines: Evidence and Causality" (Page 118 Conclusion 4.2) on the internet, which states: "The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and encephalitis".

  • There is no indication that the vaccine itself is inappropriate for the children who have received it, even if they were HIV positive.

Visit the WHO website providing scientific advice from other scientifically reliable websites.

You search for additional informations on Vaccine Safety Net, a WHO website compiling website containing useful information on vaccine safety.

There is no indication pointing at previous issues with Klinigen measles vaccine, or at an inappropriate use of the vaccine itself.

  • This is a relevant activity, as it may provide you with information on adverse events and the vaccine.

    You have now checked reliable sources of information for potentially known issues with the vaccine.