Treyfish
Moderator
MEASLES VACCINE - INDIA: (MAHARASHTRA), ADVERSE EVENTS, REQUEST FOR INFORMATION
*******************************************************************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: 27 Sep 2008
Source: Sifi news [EDITED]
<http://sify.com/news/fullstory.php?id=14767455>
Measles vaccine proves fatal for 4 infants in Maharashtra
---------------------------------------------------------
A total of 4 infants died and 6 others were
gasping for life in a government hospital here on
Saturday [27 Sep 2008], a day after they were
administered a measles vaccine at a primary health centre.
The 4 dead children, all less than a year old,
were rushed to the government hospital as they
took ill following inoculation of the vaccine at
the Jategaon primary health centre in Waghola village near here.
Even as frantic efforts were on to save the lives
of the 6 seriously ill children who too were
given the vaccine from the same batch, the health
department set up a 3-man committee of
paediatricians A P Kulkarni, L S Deshpande and
A K Bindu to probe the tragic incident, hospital sources said.
While neither hospital dean Nandkumar Dravid nor
any health department officer was available to
give details like the number of children in the
district given the vaccination and the status of
their health, unconfirmed reports said all 40 000
vaccines supplied in the district are being withdrawn.
"The vaccine, kept in the cold storage, could
have got spoilt because of long hours of power
outage or something might have gone wrong while
mixing the vaccine," a hospital source said
indicating that the problem could be localised, restricted to one batch.
--
Communicated by:
HealthMap Alerts via ProMED-mail
<promed@promedmail.org>
******
[2]
Date: 27 Sep 2008
Source: ZeeNews [edited]
<http://www.zeenews.com/articles.asp?aid=472291&sid=REG>
Maharashtra: 3 children die after measles vaccination
-----------------------------------------------------
A total of 3 children have died and 7 others are
critically ill in the Aurangabad district of
Maharashtra after receiving measles vaccination.
The children were reportedly vaccinated on
Thursday evening [25 Sep 2008]. The children, who
are in a critical condition, have been admitted in a hospital.
In April this year [2008], 4 children in Tamil
Nadu's Tiruvallur district died after receiving
these vaccines. Following the incident, the
Centre had reportedly asked 10 states not to use
the measles vaccine produced by Human Biologicals
Institute (Hyderabad) for immunisation programme.
The 10 states include Maharashtra, Rajasthan,
Assam, Gujarat, Uttar Pradesh, Chhattisgarh,
Jharkhand, Madhya Pradesh, Bihar and Tamil Nadu.
This fresh incident was bound to create hurdles
on the future vaccination programmes.
The Ministry purchases 350 lakh [3.5 million]
doses of the vaccine annually for its immunisation programme.
--
Communicated by:
ProMED-mail
<promed@promedmail.org>
[The earlier cluster of deaths referred to above
that occurred in Tamil Nadu in April 2008 were
deaths reported to have occurred within a short
time of receiving vaccine (within an hour of
vaccine receipt). At the time of these reports,
the final analysis of the etiology of cause of
death was stated as due to brain hemorrhage as a
result of anaphylactic shock. (see Measles,
vaccine-related deaths - India (02): (Tamil Nadu)
20080429.1473). Cerebral hemorrhage resulting
from anaphylactic shock is not a frequent
outcome, and questions about this diagnosis were raised at that time.
Dr. T. Jacob John discussed a 1978 event with
toxic shock syndrome (TSS) following receipt of
measles vaccine. According to Dr. T. Jacob John:
"Investigation showed one vial was the source of
the problem. The leftover liquid was a heavy suspension of _S. aureus_.
"Measles vaccine is often supplied as multidose
vials. Being live virus, no preservative is
included. The rule is to discard any vaccine vial
4 hours after reconstitution of the freeze-dried
powder; _S. aureus_ clouds are known in places
where people crowd and the microbe is a common
nasal resident. If a viable organism is
introduced and the vaccine is kept several hours,
especially at icebox and outside temperatures
intermittently, the organism grows in the vial."
(for the full discussion by Dr. T. Jacob John,
please see Measles, vaccine-related deaths -
India (03): (Tamil Nadu) 20080430.1493).
The above newswire descriptions of the event
presently occurring in Maharastra is very
reminiscent of the earlier event in Tamil Nadu,
with reports of severe illness and deaths shortly
after receiving the vaccine, and apparently
clustered surrounding a single vaccination
session conducted at one primary health facility.
One can't help but wonder if a similar etiology
to the April 2008 event occurred, suggesting
there may be either periodic contamination of
vaccine vials at the production site, or perhaps
periodic distribution of inappropriate or
contaminated diluents (the vaccines are
lyophilized -- freeze dried attenuated virus
vaccines -- that are packaged in either single
dose or multiple dose vials, the latter being
more cost effective, that must be reconstituted
with the addition of a diluent that is
distributed with the vials), or similar local
events (use of inappropriate diluent not supplied
by the manufacturer, use of "left over" vaccine
doses on the following day after the vial was
reconstituted) that are occurring in the vaccination clinics.
Investigations into the event in Tamil Nadu
suggested the problem was a local event, rather
than a manufacturer event, that was related to
insufficient training and monitoring of
vaccinators (see Thirumalaikolundusubramanian P.
Measles Vaccination And Deaths: Analysis Of Lay
Press Reports. The Internet J. of World Health & Soc. Politics available at:
<http://www.ispub.com/ostia/index.php?xmlFilePath=journals/ijwh/vol5n2/measles.xml>)
There is an interesting discussion on the April
2008 event in Y K Amdekar YK, Singhal T, Measles
Vaccine Deaths -- The IAP-COI Stand (Committee on
Immunization, Indian Academy of Pediatrics),
Editorial; Indian Pediatrics 2008; 45:479-480, available at:
<http://www.indianpediatrics.net/june2008/june-479-480.htm>.
In this discussion are references to other
reports of interest related to possible TSS following receipt of the vaccine:
1. Sood DK, Kumar S, Singh S, Sokhey J. Adverse
reactions after measles vaccination in India.
Natl Med J India 1995; 8: 208-210.
2. WHO. Information for health-care workers
managing adverse events. Real-life case histories from the field. Available at:
<http://www.who.int/immunization_safety/aefi/managing_AEFIs/en/index4.html>
(see Case 3).
More information from knowledgeable sources on
results of investigations on the actual vaccines
used would be appreciated as well as results on
autopsies of the fatal cases with determination of cause of death.
For a map of India with States see:
<http://www.lib.utexas.edu/maps/middle_east_and_asia/india_pol01.jpg>.
For the interactive HealthMap/ProMED map of India
with links to other recent ProMED-mail postings
in India and surrounding areas, see:
<http://healthmap.org/promed?v=22.9,79.6,5>. - Mod.MPP]
:tiphat:http://www.promedmail.org/pls/otn/f..._BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,74154
*******************************************************************************
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>
[1]
Date: 27 Sep 2008
Source: Sifi news [EDITED]
<http://sify.com/news/fullstory.php?id=14767455>
Measles vaccine proves fatal for 4 infants in Maharashtra
---------------------------------------------------------
A total of 4 infants died and 6 others were
gasping for life in a government hospital here on
Saturday [27 Sep 2008], a day after they were
administered a measles vaccine at a primary health centre.
The 4 dead children, all less than a year old,
were rushed to the government hospital as they
took ill following inoculation of the vaccine at
the Jategaon primary health centre in Waghola village near here.
Even as frantic efforts were on to save the lives
of the 6 seriously ill children who too were
given the vaccine from the same batch, the health
department set up a 3-man committee of
paediatricians A P Kulkarni, L S Deshpande and
A K Bindu to probe the tragic incident, hospital sources said.
While neither hospital dean Nandkumar Dravid nor
any health department officer was available to
give details like the number of children in the
district given the vaccination and the status of
their health, unconfirmed reports said all 40 000
vaccines supplied in the district are being withdrawn.
"The vaccine, kept in the cold storage, could
have got spoilt because of long hours of power
outage or something might have gone wrong while
mixing the vaccine," a hospital source said
indicating that the problem could be localised, restricted to one batch.
--
Communicated by:
HealthMap Alerts via ProMED-mail
<promed@promedmail.org>
******
[2]
Date: 27 Sep 2008
Source: ZeeNews [edited]
<http://www.zeenews.com/articles.asp?aid=472291&sid=REG>
Maharashtra: 3 children die after measles vaccination
-----------------------------------------------------
A total of 3 children have died and 7 others are
critically ill in the Aurangabad district of
Maharashtra after receiving measles vaccination.
The children were reportedly vaccinated on
Thursday evening [25 Sep 2008]. The children, who
are in a critical condition, have been admitted in a hospital.
In April this year [2008], 4 children in Tamil
Nadu's Tiruvallur district died after receiving
these vaccines. Following the incident, the
Centre had reportedly asked 10 states not to use
the measles vaccine produced by Human Biologicals
Institute (Hyderabad) for immunisation programme.
The 10 states include Maharashtra, Rajasthan,
Assam, Gujarat, Uttar Pradesh, Chhattisgarh,
Jharkhand, Madhya Pradesh, Bihar and Tamil Nadu.
This fresh incident was bound to create hurdles
on the future vaccination programmes.
The Ministry purchases 350 lakh [3.5 million]
doses of the vaccine annually for its immunisation programme.
--
Communicated by:
ProMED-mail
<promed@promedmail.org>
[The earlier cluster of deaths referred to above
that occurred in Tamil Nadu in April 2008 were
deaths reported to have occurred within a short
time of receiving vaccine (within an hour of
vaccine receipt). At the time of these reports,
the final analysis of the etiology of cause of
death was stated as due to brain hemorrhage as a
result of anaphylactic shock. (see Measles,
vaccine-related deaths - India (02): (Tamil Nadu)
20080429.1473). Cerebral hemorrhage resulting
from anaphylactic shock is not a frequent
outcome, and questions about this diagnosis were raised at that time.
Dr. T. Jacob John discussed a 1978 event with
toxic shock syndrome (TSS) following receipt of
measles vaccine. According to Dr. T. Jacob John:
"Investigation showed one vial was the source of
the problem. The leftover liquid was a heavy suspension of _S. aureus_.
"Measles vaccine is often supplied as multidose
vials. Being live virus, no preservative is
included. The rule is to discard any vaccine vial
4 hours after reconstitution of the freeze-dried
powder; _S. aureus_ clouds are known in places
where people crowd and the microbe is a common
nasal resident. If a viable organism is
introduced and the vaccine is kept several hours,
especially at icebox and outside temperatures
intermittently, the organism grows in the vial."
(for the full discussion by Dr. T. Jacob John,
please see Measles, vaccine-related deaths -
India (03): (Tamil Nadu) 20080430.1493).
The above newswire descriptions of the event
presently occurring in Maharastra is very
reminiscent of the earlier event in Tamil Nadu,
with reports of severe illness and deaths shortly
after receiving the vaccine, and apparently
clustered surrounding a single vaccination
session conducted at one primary health facility.
One can't help but wonder if a similar etiology
to the April 2008 event occurred, suggesting
there may be either periodic contamination of
vaccine vials at the production site, or perhaps
periodic distribution of inappropriate or
contaminated diluents (the vaccines are
lyophilized -- freeze dried attenuated virus
vaccines -- that are packaged in either single
dose or multiple dose vials, the latter being
more cost effective, that must be reconstituted
with the addition of a diluent that is
distributed with the vials), or similar local
events (use of inappropriate diluent not supplied
by the manufacturer, use of "left over" vaccine
doses on the following day after the vial was
reconstituted) that are occurring in the vaccination clinics.
Investigations into the event in Tamil Nadu
suggested the problem was a local event, rather
than a manufacturer event, that was related to
insufficient training and monitoring of
vaccinators (see Thirumalaikolundusubramanian P.
Measles Vaccination And Deaths: Analysis Of Lay
Press Reports. The Internet J. of World Health & Soc. Politics available at:
<http://www.ispub.com/ostia/index.php?xmlFilePath=journals/ijwh/vol5n2/measles.xml>)
There is an interesting discussion on the April
2008 event in Y K Amdekar YK, Singhal T, Measles
Vaccine Deaths -- The IAP-COI Stand (Committee on
Immunization, Indian Academy of Pediatrics),
Editorial; Indian Pediatrics 2008; 45:479-480, available at:
<http://www.indianpediatrics.net/june2008/june-479-480.htm>.
In this discussion are references to other
reports of interest related to possible TSS following receipt of the vaccine:
1. Sood DK, Kumar S, Singh S, Sokhey J. Adverse
reactions after measles vaccination in India.
Natl Med J India 1995; 8: 208-210.
2. WHO. Information for health-care workers
managing adverse events. Real-life case histories from the field. Available at:
<http://www.who.int/immunization_safety/aefi/managing_AEFIs/en/index4.html>
(see Case 3).
More information from knowledgeable sources on
results of investigations on the actual vaccines
used would be appreciated as well as results on
autopsies of the fatal cases with determination of cause of death.
For a map of India with States see:
<http://www.lib.utexas.edu/maps/middle_east_and_asia/india_pol01.jpg>.
For the interactive HealthMap/ProMED map of India
with links to other recent ProMED-mail postings
in India and surrounding areas, see:
<http://healthmap.org/promed?v=22.9,79.6,5>. - Mod.MPP]
:tiphat:http://www.promedmail.org/pls/otn/f..._BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,74154
