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[e-drug] Lessons from measles tragedy in India (2)

E-DRUG: Lessons from measles tragedy in India (2)
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Pls see the note below. Dr Grahame Dickson of TGA drew this to my attention

Susan Walters
Australia
"Susan Walters" <susanw@netspeed.com.au>

Re measles vaccine-promed comment 
 
MEASLES, VACCINE-RELATED DEATHS - INDIA (03): (TAMIL NADU)
**********************************************************
A ProMED-mail post
< <http://www.promedmail.org/> 
ProMED-mail is a program of the
International Society for Infectious Diseases
< <http://www.isid.org/> http://www.isid.org>

Date: Wed 30 Apr 2008
From: T Jacob John < <mailto:tjacobjohn@yahoo.co.in> tjacobjohn@yahoo.co.in>

A comment on the measles vaccine-related deaths in Tamil Nadu
-------------------------------------------------------------
That the problem was limited to one day (23 Apr 2008) at one centre (or
perhaps 2 centres -- but still one day) and to only 6 children of whom 4
died, points to the extreme limitation of the problem in time and space. The
critical question as to how many vials were involved has not been clarified.
It appears that one vial in the 1st centre 
and probably another vial in another centre were the "contaminated" ones.

Anaphylaxis does not fit with either epidemiology or symptomatology and time
sequences. Measles vaccine has been notorious for toxic shock syndrome (TSS)
due to injection of preformed _Staphylococcus aureus_ exotoxin(s). This is
not widely known since TSS is usually due to infection first and toxicity
later on. Here in the vaccine situation, a bolus is injected.

My 1st encounter with this problem was in 1978, when several children fell
ill and one died. 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.

In this case, tragedy struck after vaccination in the morning -- it is
entirely possible that the vial with a few doses left, was kept overnight
and used in the morning. I do not know if another vial under similar
circumstances occurred in the afternoon in another centre. That problem was
in the afternoon and perhaps 2 children were affected and one died. Day
temperatures began to get high that week. 
If that was a factor it is worth considering.

The term TSS has been applied to this adverse event. Several cases had been
reported since 1978 in India and I recall, in Viet Nam also.

Apparently over 20 000 vials of this vaccine batch had been in use in
various places without incident -- hence a batch problem does not sound
right.

Another drug could not have been injected or used as diluent since this
happened in an "extension" clinic where the vaccine and diluent were carried
in a cold box. Moreover the nurse said that the diluent supplied was of a
manufacturer different from that of the vaccine itself; but it was measles
vaccine diluent all right.

Unless the very vial(s) involved were collected/impounded and tested, we may
never know the truth. In a few days the batch number will be known but not
the specific vial.

I say all these since I have a suspicion that my earlier note did not
contain details; experts unfamiliar with this kind of TSS may laugh it off
since TSS is a problem after tampon use, and after specific infections with
_S. aureus_ or Streptococci. Preformed _S. aureus_ toxin is well known as a
cause of food poisoning. Injected toxin is an unusual phenomenon in
low-income countries in which workers save 
left over vaccine with good intentions, but occasional disasters like this
can happen.

--
T Jacob John
Former (Retired) Prof and Head,
Depts. of Clinical Virology & Clinical Microbiology
Christian Medical College
Vellore, TN, 632 002
India
< <mailto:tjacobjohn@yahoo.co.in> tjacobjohn@yahoo.co.in>

[Professor T Jacob John has provided an intriguing analysis of the 
measles vaccine-related deaths in Tamil Nadu. We await the final 
conclusions of the investigation now in progress, and hope that the 
TSS explanation will be given careful consideration. - Mod.CP]

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