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**Treyfish** · October 17, 2008, 11:08 PM

Re: Promed: Undiagnosed Fatal Illness - India (02): (uttar Pradesh), Request For Information

JAPANESE ENCEPHALITIS - INDIA (06): UTTAR PRADESH
[2] Uttar Pradesh
Date: Thu 16 Oct 2008 17:19:51 -0700
From: Deborah Phillips
<dphillips@path.org>

Subject: Response to RFI on Japanese encephalitis in India
----------------------------------------------------------
With regard to reports on Japanese encephalitis cases and vaccines in
Uttar Pradesh, the situation has been confusing and reports somewhat
conflicting. In response to the moderator's request for further
details (ProMED post 20081014.3260), we would like to provide the
following information.

MOD: "If one understands the ongoing situation in Uttar Pradesh,
there has been a major outbreak of Japanese encephalitis this year,
with a large proportion of cases with a history of adequate
vaccination, and probably data that demonstrated a much lower than
expected vaccine efficacy in the state.... Further investigations in
the state revealed that many of the vaccine vial temperature monitors
had changed color, confirming that the vaccines had been exposed to
high temperatures for a period of time known to be associated with
significant potency loss."

* The encephalitis outbreak in Uttar Pradesh (UP) this year has not
actually been linked to JE infection. As of September 2008, as noted
in Dr T. Jacob John's posting (ProMED post 20080901.2738), the
outbreak was not thought by the Government Medical Officers to be JE.
Due to the similarity of symptoms between JE and other acute
encephalitis infections, clinical diagnosis is not reliable and
therefore laboratory confirmation is needed. While a small proportion
of samples have tested positive for JE (5 percent mentioned in ProMED
post 20080828.2697), there has been no confirmation at this point
that it is the cause of the larger outbreak. It was noted in a
previous posting (ProMED post 20080830.2718) that a team including
doctors from the Union Government, as well 2 from the US Centers for
Disease Control and Prevention, Atlanta, were visiting UP in late
August to investigate possible causes of the outbreak.

* Physicians in Uttar Pradesh have noted a substantial decrease in JE
cases admitted to hospitals since mass vaccination campaigns were
initiated in 2006 (ProMED post 20080901.2738)

* We are not aware of any data that demonstrate diminished vaccine
efficacy in UP in 2008.

* It is important to note there has been no evidence of any vaccines
with expired vaccine vial monitors (VVMs) reaching health centers or
being administered to any children. Changed vaccine vial monitors
(VVMs) were spotted immediately upon the states' receipt of shipments
at the cold stores, and appropriate officials were promptly notified.

MOD: "If the entire shipment is being deemed unworthy of use in Uttar
Pradesh as is suggested in the above newswire, it is hard to
understand why it will be okay to use in another state....
Clarification of the rationale here would be greatly appreciated --
but what is the definition of good vials -- stage II color indicator change."

* As noted in the article, officials have determined in accordance
with WHO guidelines that the vaccines in Stage II can still be used
and are viable for up to 2 months, so therefore will still be
suitable for use in states with campaigns to be completed within that
timeframe.

* One value of having different stages of heat exposure is to guide
vaccine management. Vials with heat exposure that causes VVMs to
change to Stage II are still well within the potency levels needed
but should be used sooner than those with little or no heat exposure.

* Also noted in the news article, a replacement shipment of JE
vaccines that have not had substantial heat exposure and therefore
have a longer time frame for use will be sent to the states for use
in routine immunization over the coming year (ProMED post 20081014.3260).

--
Deborah Phillips
PATH, USA
<dphillips@path.org>

[ProMED-mail would like to thank Deborah Phillips from PATH, an
organization that is collaborating with the Ministry of Health in
India in their control of Japanese encephalitis program, for
responding to our RFI with a more detailed explanation of the
circumstances not well covered in the original newswire. She has
clarified the timing of the various vaccination activities in India
as well as the time frame implications for utilization of the JE
vaccine based on current status of the vaccine vial monitors (VVMs).
A well thought out strategy optimizes the use of good vaccine before
the shelf life expiration date. The original newswire of the posting
was misleading in its presentation of the rationale for use or
non-use of the JE vaccine in distribution, suggesting a different
rationale: "Following the controversy over the vaccine in the state,
the Centre has decided to withdraw the supply and replace it with the
fresh stock. The previous stock will be used for the JE vaccination
campaign rather than the routine immunisation programme.

"We will not use this supply in any case for the children in the
state. The vaccine sent by the Centre was to be used under the
routine immunisation in the most sensitive areas for JE. Thus, any
reduction in the potency could be lethal for the children," said Dr.
M L Khatloiya, the Director General, Medical and Health Uttar Pradesh."

As Deborah Phillips suggests, there has been significant confusion as
to the etiology of the acute encephalitis picture that has been seen
in Uttar Pradesh (UP) this year, especially with a very low rate of
JE seroconfirmation (in one report, of 100 acute encephalitis
syndrome patients tested, only 5 (5 percent) were positive for recent
JE infection). In Dr. T. Jacob John's excellent discussion on the
situation in UP [Undiagnosed fatal illness - India (07): (UP)
20080901.2738], he made the disquieting observation that "Testing for
JE virus infection [by the] health system in Uttar Pradesh leaves
much to be desired from quality and equity angles." If there are
questions concerning the reliability of the serological tests being
employed on which the JEV diagnosis is based, it would be prudent to
have duplicate serological samples tested in 2 different reference
laboratories. The results of parallel tests and other tests that the
article indicates are being carried out may provide more solid
information on which to exclude or include JEV infection as the major
cause of the encephalitis being observed, or implicate another
etiological agent.

ProMED-mail looks forward to hearing the results of further studies
on the acute encephalitis syndrome cases in UP, and hopefully for the
identification of the etiologic agent. - Mod.MPP]

http://www.promedmail.org/pls/otn/f?..._ID:1000,74416

Announcement

Promed: Undiagnosed Fatal Illness - India (02): (uttar Pradesh), Request For Information

Promed: Undiagnosed Fatal Illness - India (02): (uttar Pradesh), Request For Information

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