Concern about deaths following Pentavalent Vaccine – making each death count.. Letter to Health Secretary and Corrections
To
The Health Secretary
Ministry of Health and Family Welfare
Nirman Bhawan
New Delhi
January 15, 2013
Sir
Subject: Concern about deaths following Pentavalent Vaccine – making each death count.
We, a group of academicians, professors and teachers of public health and pediatrics, would like to draw your attention to the pattern of adverse events and deaths from the newly introduced Pentavalent vaccine (DPT+ Hib + Hep B).
Pentavalent vaccine was introduced in Kerala and Tamil Nadu on the recommendation of the National Technical Advisory Group on Immunization. There were concerns about the safety of Pentavalent vaccine and therefore, the NTAGI mandated it was to be introduced in Immunization programme in just two states (of Tamil Nadu and Kerala) - to monitor the vaccine’s safety. “Thereafter,” according to the minutes of the NTAGI meeting, “data was to be reviewed after 1 year of introduction, before expanding the vaccine to other states.” (1)
We are concerned that well before data from Kerala and Tamil Nadu has been analyzed, it has been introduced in Haryana at the end of last year. (2)
In the last three weeks, 3 more infants died in Kerala after receiving the vaccine. On the face of it there seems to have been no 'alternate cause' for these deaths. (Post-mortems have been done). One baby has died in Harayana this week. (3)
In November there were three deaths in Vietnam and this led to the program being stopped immediately in the province. (4) Similar deaths have occurred in Sri Lanka and Bhutan and Pakistan after the use of Pentavalent vaccine. When each death is seen in isolation, it is reasonable to consider them as mere coincidences – but that is not acceptable when it happens repeatedly.
In Pakistan it was said to be ‘sudden death’. This unfortunately is mistakenly confused with the Sudden Infant Death Syndrome (SIDS - which is diagnosed only in case of unexplained deaths) which clearly it was not. (5)
Bhutan had 8 deaths and it was said that the deaths were due to encephalitis, although there was no CSF evidence of infection. It has been noted subsequently, that after the vaccination was stopped for a year, that there were no more such ‘encephalitis’ deaths - without CSF changes in infants. (6)
In Sri Lanka the expert group investigating the deaths following Pentavalent vaccine, reported that they could find no alternate cause for death other than the use of the vaccine (and so should have had to conclude the deaths were probably related to the vaccine). That they wrote in their report that the vaccine was unrelated to the deaths is another story. (7)
It is for us as experts and the Government of India, to look at all these seemingly isolated instances of deaths after Pentavalent vaccine in a comprehensive manner, to see the underlying pattern and act if needed, to protect lives. Considering that vaccines are given to a large number of children who are well, it is crucial that they be completely safe.
The crucial question then is - how many deaths following vaccination would we ignore or consider as acceptable.
As doctors, we are aware that most medicines have some side effects but repeated instances of death as side effect from a vaccination programme for a disease that itself can be treated with antibiotics cannot be acceptable. (Please see box for a calculation on deaths from Hib disease for comparison)
The deaths from Pentavalent are sporadic, meaning that thousands receive the vaccine with no reactions, but a few have died. All anaphylaxis reactions are like that - only a very few people react adversely. However when a drug is known to cause this form of fatal reactions, it is no longer permissible to give the medication to anyone without first testing to see if the person will react adversely. We do that with penicillin skin test for example, and doctors are liable for negligence if they administer penicillin without testing.
Pentavalent deaths have now been reported in different countries with use of Pentavalent vaccine from different manufacturers. It cannot therefore be explained on defects in some specific batch of the vaccine, nor can it be blamed on some programmatic error - because of incorrect storage or administration. There is no test available to identify the child who is going to react and die. We, as public health experts, understand it is our responsibility to inform you of this pattern of reactions seen with this vaccine.
Yours faithfully,
1. Professor BM Hegde, MD, PhD (Hon. Causa), FRCP (London), FRCP (Edinburgh), FRCP (Glasgow), FRCPI (Dublin), FACC, FAMS.
Former Vice Chancellor, Manipal University, Manipal.
Former Director-Professor of Medicine and Dean. Kasturba Medical College, Mangalore.
Visiting Professor of Cardiology, University of London between 1982 and 2005,
Affiliate Professor of Human Health, University of Northern Colorado, USA.
2. Vikas Bajpai PhD
Centre for Social Medicine and Community Health, Jawaharlal Nehru University, Delhi
3. Professor Amitav Banerjee
Professor Community Medicine, Dr D Y Patil Medical College, Poona
4. J P Dadhich MD
Consultant Pediatrician, New Delhi.
5. Arun Gupta MD FIAP
Pediatrician, Member, Prime Minister's Council on India's Nutrition Challenges,
Convener, Alliance Against Conflict of Interest(AACI)
6. Professor K P Kushwaha
Professor & Head of Pediatrics, BRD Medical College, Gorakhpur. UP.
7. R Lodha
Associate Professor, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
8. Professor S K Mittal
Formerly Professor of Pediatrics, MAMC Delhi,
Head of Pediatrics, Pushpanjali Crosslay Hospital, Delhi
9. Professor Ritu Priya,
Professor
Centre of Social Medicine and Community Health
Jawaharlal Nehru University
New Delhi-110067
10. Jacob Puliyel MD MRCP M Phil
Head of Pediatrics, St Stephens Hospital, Delhi
Member National Technical Advisory Group on Immunization (NTAGI)
11. Dhiraj Shah MD
Reader in Pediatrics, University College of Medical Sciences, Delhi.
12. Professor S Srinivasan MD
Formerly Director-Professor of Pediatrics, JIPMER, Pondicherry
References
1. https://docs.google.com/viewer?a=v&q=cache:8ThPBFubBOsJ:healthadvisor.co.in/wp-content/uploads/2011/06/Minutes-of-NTAGI-260810.pdf+&hl=en&gl=in&pid=bl&srcid=ADGEEShBKh0ARk9XCWS7nTqtgLnJ9O-7DTsQrIc1SHNZS2KVGTao76yfpOt8atuR26qA_n2LQUDWC3goNbdM_2QAfq0DgNm9c1tGosOjPEAULEut4Z8_rJx10-1ciEOf2HDrQMy4apcZ&sig=AHIEtbRoH1yjSQDOp-7PuJAwN60oPr-85A
2. http://articles.timesofindia.indiatimes.com/2012-12-20/chandigarh/35932951_1_pentavalent-vaccine-pneumonia-and-meningitis-hib
3. http://articles.timesofindia.indiatimes.com/2013-01-12/chandigarh/36295667_1_pentavalent-vaccine-vaccination-programme-jhajjar#inbox
4. http://talkvietnam.com/2012/12/vaccinated-child-deaths-seek-verification/#.UPBPmaxcHz8
5. http://www.bmj.com/rapid-response/2011/11/02/sudden-deaths-after-pentavalent-vaccination-vaccine-really-safe
6. http://bhutannews.blogspot.in/2010/07/pentavalent-killer-is-back.html
7. http://www.bmj.com/content/341/bmj.c4001
Correction letter sent 20 Jan 2013
Dear Sir
In our last letter to you, with regards Vietnam, we had written that Pentavalent vaccine has been stopped in the country. I am sorry that should read "it has been stopped in the 'province'."
The letter was sent on the 17th not the 15th.
I apologize for the inaccuracies.
Jacob Puliyel