Dear Moderator, Four more infants died due to measles vaccination in Kutch on March 16 and two more died on March 18. There are deaths being reported consistantly all over the country within few minutes of vaccination but none has been attributed to vacination by the investigating agencies. The investigating agencies are at fault in a way that the open vial from which the alleged vaccine was given is not taken as sample for testing for any contamination but the new samples of the same batch are taken, and so vaccine is declared as safe. http://www.dnaindia.com/india/report_four-infants-die-after-vaccination-in-gujarat-town_1520755 http://www.dnaindia.com/india/report_fo … wn_1520755 We need to get vaccine samples tested outside the country including the left out vaccine in the vial that caused deaths as local agencies fail to establish the cause of death. How long we keep on just reading the news without any sensitivities ! Thanks, Dr. Omesh Kumar Bharti M.B.B.S.,D.H.M.,M.A.E.(Epidemiology) OSD, Emergency Medical Response and Transport, Directorate of Health, Kasumpati, SHIMLA, Himachal Pradesh, India. +91-9418120302 firstname.lastname@example.org; email@example.com
TechNet-21 - Forum
This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
Dear Moderator, The government of India closed government owned Public sector Units (PSUs) producing vaccines on account of non compliance to WHO GMPs. Since then it is a common observation that deaths after vaccination, some of them immidiatly after vaccination, have increased all over the country. This is an unusual phenomenon, as such large no. of deaths were unheard earlier when the government owned PSUs were supplying vaccines. The total number of Reported deaths due to AEFI in 7 years (2001-2007) is 136,whereas it is 355 in the post vaccine PSU closure 3 years(2008 to 2010), as per the information gathered through right to information act by Dr. Babu. Is the sudden increase in AEFI deaths due to better reporting or is due to something else. It can not be believed that suddenly after closure of PSUs, the reporting of AEFI increased andstill many deaths after vaccination are not even reported to the central reporting system.The ministry of health is not willing to include the 4 deaths in MP & 4 in Lucknow immediately after vaccination,in the list of AEFI deaths due to vaccination. This further substanciates the point that some serious lapse is there somewhere and need is to identify this lapse aand take corrective measures, simply closing our eyes saying it is due to better reporting is a bad excuse.
It is very unfortunate that 128 kids died following vaccination but we are looking at just one aspect of immunization. Vaccines, like any other medicine are not 100% safe and do carry some inherent properties that can cause some minor or very rarely serious side effects (These are called adverse events following immunization/AEFI). All medicines, even the common over the counter medicine like paracetamol has many side effects. But our system of adverse drug reaction monitoring is not that strong to pick these up in the community and report back. So we hardly see any similar news for other medicines For vaccines, the government is strengthening the system to pick up these AEFI and in turn, work to make vaccines better, health workers better trained and equipped to handle these cases. As this system will improve, we are bound to see an increase in number of cases being picked up. But we should remember that until we detect, investigate these cases we cannot bring about changes and improve the immunization program. Each day in India approximately 73,000 live births take place and approximately 3500 infants (children under one year) die. These children die because of various reasons and some of them would have received vaccines before dying, so the blame comes on the vaccines. Which may or may not be true. So the detection and proper investigation of these deaths after vaccination is very important. In most developed countries the AEFI surveillance system is functioning well and they continue to strive for making vaccines safer, based on the information gathered by this system. If we were to stop vaccination because of these rare events, we will be putting lives of 27 million infants at stake by increasing the morbidity and mortality due to vaccine preventable diseases, who will be responsible for that? We should be complementing the government’s efforts in this regards and also look at a compenasation package (as exits in developed countries) in case the deaths is actually related to vaccine. These deaths and AEFI were happening before also but only that we were not able to pick up these cases and investigate them. So the point that these were not happening when vaccines were being supplied by public sector units is not correct.
Dear Sir, I agree that GOI has strenghthen the system for reporting AEFI, but my concern is lack of proper investigation. Non of the AEFI has been linked to vaccine, that shows we are hiding more than we are revealing. As you said there are always reaction to any substance, so we need not panic but yes, we need to investigate to conclude that the death was not actually due to vaccine and for that we need a transparent mechanism to operate without any fear or repremand,. Thanks and regards,
A transparent, robust system to report, investigate, analyze and give feedback to parents, community and scientific community should not be a luxury but a necessity for any immunization program. We should remember that the so called actual serious adverse effects (not events) due to vaccines are rare (for e.g., anaphylaxis due to DPT/Measles etc may be seen in one case out of one million doses administered). These are really not preventable but need to be investigated thoroughly to look at trends and also signals which can help us to improve quality of vaccines. Thinking that these will not occur at all or blaming every event to be related to vaccines will not be correct. Yes, we need to report, investigate cases thoroughly and provide feedback on these cases. What is more important is program errors, which should not exist in the immunization program and should not be tolerated. These cases point where we are failing in delivering quality vaccines to beneficiaries and where the program requires strengthening (planning, cold chain, injection safety, waste disposal or capacity of workers). The government should have well trained experts to investigate and provide causality assessment of all cases of AEFI.
Thank you, Dr Sagar, for a thoughtful posting. It is heartbreaking for all concerned, if one does find that a life-saving preventative intervention such as immunization in very rare cases is the cause of a serious or even fatal reaction. The investigation of these cases in India has actually markedly improved in the last few years, and the statistics quoted in your email have subsequently been updated and a public newspaper report can be found here: http://articles.timesofindia.indiatimes.com/2011-06-01/india/29608245_1_vaccination-programme-doses-aefi What is clear is that all serious incidents that occur at the time of vaccination should be investigated, and your call to improve and complement the existing AEFI reporting is wholeheartedly supported. When such investigations are honestly and comprehensively conducted, they benefit both the victim and their family, as well as the immunization programme which is then either able to correct the rare genuine programmatic mistakes or be exonerated from AEFIs that are not caused by vaccinations but are only co-incidental. Your comment on national compensation schemes for true victims of vaccine injury are valid and depend on national decisions and funding. At the same time it needs to be acknowledged that vaccines cause very, very few serious or fatal incidents, and the likelihood of serious or fatal disease when not vaccinated is much higher.
Am sure Karan, who was the first person responsible for AEFI reporting in India knows the updated government reports on AEFI. The question is how much transparency there is. Unlike AFP reporting- which is available and up to date every Friday on the NPSP website (http://www.npspindia.org) the data for AEFI and for Measles surveillance tend to take a lot of time to be announced. Newspaper reports are nice- but no substitute for a good surveillance report.
Dear Prabir, I agree that the current AEFI surveillance system in India is still developing and we should aim at having a system as robust as the AFP surevillance system, but this will require resolve, time, effort, and resources and support of all stakeholders. I am sure GoI is making efforts in this direction. Efforts are on to create a investiagtion and causality assessment mechanism at district, state and national level. Once this is in place the reports, causality assessments etc can be made available on regular aned timely manner.
Dear Dr Karan and Dr Prabir, The question is which definition we are using to determine causality criteria ? Regards,
Case definitions can be seen on page 13-15 of the revised AEFI operational guidelines. You will note that these are not in line with the Brighton collaboration definitions. But since it is work in progress, India can adopt the Brighton collaboration definitions in due course of time. For Causality assessment, WHO categorization of Very likely/ Certain, Probable, Possible, Unlikely, Unrelated and Unclassifiable are used.
Dear Dr. Karan, I appreciate the fact that we in India are progressing towards a better reporting system but I would insist to have a uniform system of investigating AEFI. Brington classification later, should not be the line of action. We should decide whether to use Brington Classification or not or only Indian classification, so that we donot compare reports tested based on different classifications suited to us. I am giving a link below to bring home the point and to say it is really difficult to effectively investigate AEFI as have been after deaths due to Pentavalent in Sri Lanka, http://jacob.puliyel.com/download.php?id=213 http://jacob.puliyel.com/download.php?id=213 http://jacob.puliyel.com/download.php?id=213 Thanks,
Based on the discussions in the forum, I had informed GoI and they have agreed to include Brigton Definitions in AEFI guidelines, so the next version of the guidelines will include these and it is going to be very soon.
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