Day 3: Wednesday 20 April 2011

You arrive early on Wednesday morning. Your assistant, Shara, draws your attention to several reports that she has just put onto your desk. There are seven more AEFI reports, four from Karoomana and three from Weston provinces that have been investigated. A line list of the details of these cases has been drafted. The cases include two deaths but the remaining five children have recovered completely. All of the events are related to the Klinigen measles vaccine and all the children showed symptoms of convulsions with high fever within 48 hours of immunization.

There is also a fax of a pathology report from Hinandi hospital.

Select the activities that you will do next.

Direct regional health officers to stop using the suspect batch of measles vaccine.

You pick up contact with the NIP that sends out an e-mail to the five regional health officers in Reganda instructing them to stop using the Klinigen measles batch U-5773, and requesting that they acknowledge receipt of the e-mail and that they are taking appropriate action.

  • Taking this decision is a mishandling of the situation: There is no indication of an increased number of cases apart from a suspected batch. You should limit this decision to the Karoomana and Weston provinces that received the concerned batch.

During the day, you receive acknowledgement of your e-mail from all of the regional health officers.

The regional health officers in Kyogo, Ashi and Trent Provinces say that they do not have any of that batch of vaccine.

The regional health officers in Karoom and Weston say that they have some of the batch, but could not find out (given the short amount of time) exactly which centres had the batch.

Contact the director of the national immunization programme.

You telephone Dr Maia Rayon, who has reviewed the latest AEFI reports from Karoomana and Weston Provinces. She agrees with you that the problem may be related to vaccine batch U-5773. You tell her that the vaccine has been distributed in Karoomana and Weston.

  • This is an important activity, as you involve the relevant actors at national level to collaborate with you.

She says:

“I am going to send immediate instructions to the programme managers in Weston and Karoomana to stop the use of the vaccine batch. Could you please ensure that no further U-5773 batch is distributed?

For the programme as a whole I see no evidence that another batch is affected. We should therefore continue with the programme and just stop using batch U-5773.

We also have to make sure that all programme officers are aware of what is happening so that they can manage information requests adequately. We will also prepare communication to the public and at ministerial level. You assure Dr Rayon that you will provide clear guidance for the Minister of Health, Dr Meeta Swahami."

  • The NIP controls immunization programmes in Reganda. If you want something to be stopped quickly and in the right areas, this is the correct way to do it.

Consult the AEFI review committee.

You contact Professor Urumono with the latest information on the cluster of reactions in the Karoomana and Weston provinces, where 10 cases of convulsions in the past week (three children have died) occurred. You also inform him of the one case in the remainder of the country.

  • Running an investigation in close collaboration with the AEFI review committee will ensure that you receive important and independent expert input.

After taking into account all the information available and checking the background rate of convulsions, Professor Urumono responds: "There are five million people in those two provinces and perhaps 400,000 children in the age group that is being vaccinated. I have calculated that the immunization campaign will extend over 16 weeks, so we can estimate that about 25,000 children are immunized each week. Not all of them will have that batch of the vaccine, but most of them will. So I estimate an incidence of 10 serious AEFIs in 20,000 immunizations – that is 500 serious AEFIs per million immunizations (with that batch). That is higher than we expect from a measles vaccination, and higher than the incidence in other provinces and the background rate of convulsions. Given these figures, the batch of vaccine should be recalled."

You thank him and ask him to send his written calculations.

  • This confirms what you have suspected. The batch of vaccine must be withdrawn.
  • Note down the incidence figure for your report.

Contact the vaccine manufacturer.

You contact the vaccine manufacturer Klinigen. First you post a note on their safety site alerting them to the 10 AEFIs that you have recorded following immunization with their measles vaccine. You then contact them by phone, and ask to speak to the person in charge of safety and post-licensure monitoring. You are transferred to Mr Gunther Stiegman.

  • Transparent rules of engagement secure good collaboration with vaccine manufacturers who can provide helpful information and action to respond to an adverse event.

You restate your findings and explain that you are recommending to the NIP director to suspend use of the batch of the measles vaccine.

He says:

"We will investigate the problem immediately, and we will send out an alert to UNICEF to check for other locations where this batch may have been distributed. We will do everything we can to stop its use and will recheck the sterility and quality."

You ask whether they require samples of the vials held at your national reference laboratory.

He says:

"We keep reserve vials of all batches at our own laboratories, and will test those vials first. We may require your samples if we can find no defect in the reserve vials. I will contact you if we need the samples, and I will in each case send our results to you as soon as we have them."

You thank him and give him your e-mail address.

  • Checking the samples Klinigen has available may help to identify whether there is a problem with the batch itself, or whether there was a problem with the transport/supply of the vaccine to Reganda.

Send an e-mail directly to all immunization centres with instructions on temporarily suspending the non selective mass immunization campaign.

You request the e-mail list of all vaccine centres from your assistant Shara, and say that you want to suspend the measles immunization programme.

  • This action is not in the remit of the NRA. In addition, suspending the entire measles immunization campaign may impact the public trust in the programme. At this point you may take more specific action, e.g. by withdrawing the suspect batch only.

She says:

"We don’t have that type of e-mail list. We would have to ask the NIP for it, and in any case, they decide whether the programme should be suspended or not. If you really think that it is essential to stop the programme, you should contact Dr Maia Rayon, the NIP Director."

  • Always make sure to go through the correct channels, in this case the NIP.

Read the pathology report.

You look over the post mortem report of Ahmed Alabi, who died in Hinandi hospital. The report is dated 18 April and is signed by the senior pathologist. It contains a considerable amount of detail, but the key finding concerns the histology of the brain.

Severe encephalitis (no sign of infection).

The haematology report also detected no infection.

  • This information is relevant. These findings help to exclude infection as the cause of death.

Contact the Ministry of Health.

At 16:30 you have a short phone call booked to the Minister of Health, Dr Meeta Swahami. You tell her that you will be sending a report on a possible cluster of vaccine reactions, and briefly explain the circumstances. You tell her that you have consulted with the director of the NIP, and that a single vaccine batch seems to be affected.

  • Providing appropriate and timely information to the Ministry of Health is highly important to ensure a proper handling of vaccine safety issues at all levels.

She says:

"Should I make an announcement on national television? I am booked to appear on ‘Good Morning Reganda’ on Friday."

Upon her request, you suggest that she should not make any statements until she has received your report, which will arrive within 2 days. You also tell her that if a statement is made, then it would be better to come from an expert on the AEFI review committee.

  • The minister and you agree on the importance of maintaining the public confidence in the immunization programme, and to continue further investigations based on scientific statements. Such statements should best be made by independent experts as their opinion will help to increase the quality and power of your messages to the public.

Request an update on the map of AEFI locations.

Shara, your personal assistant, quickly updates the map on your wall with the latest data.

  • Mapping out the cases of AEFI may be helpful to see a local pattern of the occurring events.
  • The map confirms the clustering of cases in the area in the South of Karoomana and the East of Weston provinces.

Contact the vaccine distributor.

You telephone Mr Yen at Yuchong Medical Supplies, and ask him to stop distribution of vaccine batch U-5773, immediately.

He says:

"I told you already that we have distributed all of that batch. Do you want me to stop distribution of the current batches, U-5889 and V-1119?"

You tell him that he should continue with the distribution.

  • It is now too late to stop the distribution of batch U-5773. It must be stopped at the immunization centres.