EXPOSING the FDA and the USDA - Broad Casting here the things that they would prefer us NOT to know about our FOOD & DRUGS & Farming.

Saturday, January 22, 2011

FDA Investigates Flu Vaccines (Causing Seizures in Kids)

http://www.drugwatch.com/news/2011/01/21/fda-investigates-seizure-risk-flu-vaccine/

Vaccines in Haiti Killing Folk (VDPV)

ACUTE FLACCID PARALYSIS - HAITI: REQUEST FOR INFORMATION
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A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


Date: Mon 17 Jan 2011
From: James Wilson


[ProMED-mail regrets the delay in posting. - Mod.MPP]

Subject: Haiti: Suspected VDPV Type I Cases
----------------------------
I realize many of you are waiting anxiously for the diagnostic
results of the suspected VDPV [vaccine derived poliovirus] Type I
cases that presented as reported "ascending paralysis"/Acute Flaccid
Paralysis (AFP).

Here are updates as we understand them:

1. Three adult cases were identified at a medical facility in Port de
Paix last week [week of 10 Jan 2011]. Two were fatal, and one remains
paralyzed and ventilator-dependent at an ICU in Port au Prince.
Several samples were acquired from this patient for diagnostic
testing. The surviving patient was initially diagnosed with
Guillan-Barre Syndrome.

2. An additional pediatric case was identified as having been
medivac'ed to Charlotte, North Carolina, where she remains
ventilator-dependent in an ICU. This case was found to have been ill
originally in October [2010]; she lived in Petionville. It is notable
the medical team involved in this case had diagnosed the child with
Guillan-Barre syndrome. ... Once the question of VDPV was raised,
there was concern about the safety of the Charlotte community, given
the nationwide problem of childhood vaccination compliance.

3. An anonymous HEAS [Haiti Epidemic Advisory System] partner
reported seeing a "16-18 year old from Fermate die of acute flaccid
paralysis but had no idea at that time the government reported such
things. We spent a long time trying to sort out what part of spinal
cord might have given him an ascending flaccid paralysis causing
death from respiratory failure over the course of about 24 hours and
could not come up with a medical, physiological answer except
Guillan-Barre. Polio never entered my brain. He had a fracture in his
lower leg and had a spinal anesthetic which resolved, but he came
back the next day complaining of weakness and trouble breathing."

4. Investigation by officials has uncovered multiple additional
suspect cases for diagnostic testing in both the Port de Paix and
Port au Prince areas.

As reported previously, Hispaniola (starting in Haiti, with spread to
the Dominican Republic) was the site of a large outbreak of
Vaccine-Derived PolioVirus (VDPV) Type I from 1998-2001 that debunked
the previously held belief that oral polio vaccine only caused rare
single-case reversions. Both Port de Paix and Port au Prince were
involved in the outbreak. Several environment samples provided
evidence of environmental contamination. The virus, an unstable
reverted mutant, was found to have recombined with 4 indigenous
enteroviruses. This series of mutations resulted in a novel virus now
capable of aggressive transmission, severe neurological disease, and
fatalities. It is unclear what the actual case fatality rate is when
compared to wild type polio. My personal opinion is it is likely
higher given this was/is an unstable mutant still adapting to both
the environment and the host population.

The good news is rapid emergency vaccination with OPV in 2001 was
thought to have brought the situation under control. However, the
current situation challenges the notion of whether the virus was
truly contained, hence the absolute need for definitive, credible
laboratory evaluation of both environmental and human samples.

We were dismayed to realize the number of people involved in the
initial care and transport of the Port de Paix patient cluster who
did not provide warning of the situation. They were interviewed after
discovery of a You Tube video depicting the transfer of one of the
patients by one of our astute HEAS members on [9 Jan 2011].
Potentially exposed Haitian and non-Haitian personnel included the
staff of the Port de Paix and Port au Prince facilities and 2
transport teams. We are fortunate none of the involved personnel have
reported symptoms. It is key to note that personnel vaccinated
appropriately for polio are immune; however, Haitian personnel and
the surrounding community are an entirely different matter...

Laboratory results are still pending. We hope this will turn out to
be a false alarm, but as the appearance of cholera has shown us,
complacency costs lives.

--
James M. Wilson V, MD
Haiti Epidemic Advisory System (HEAS)
Executive Director
Praecipio International
Washington-Houston-Port au Prince


[The above email is the 1st information that ProMED-mail has received
on the apparent outbreak of acute flaccid paralysis in Haiti, and we
are grateful to Dr. Wilson for sending this alert. On searching the
web, this moderator was able to find the earlier alerts related to
the identification of a "cluster" of acute flaccid paralysis cases
posted on a blog known as the Haiti Medical and Public Health
Information Sharing Environment at
.

The outbreak of VDPV in Hispanola was covered by ProMED and can be
reviewed through reading the prior posts referenced below. At the
time of this outbreak (2000-2001), there was a total of 21 cases of
VDPV-associated paralysis on Hispanola (Haiti 8 and the Dominican
Republic 13), of which 12 cases were reported in 2000 and 9 cases
were reported in 2001.
().
Kew et al demonstrated that the viruses responsible for the paralytic
poliomyelitis outbreak in the Dominican Republic and Haiti were
derivatives from an attenuated poliovirus vaccine (OPV) in use during
1998-1999. (See Kew O, et al. Outbreak of Poliomyelitis in Hispaniola
Associated with Circulating Type 1 Vaccine-Derived Poliovirus.
Science 12 Apr 2002: 356-359. Abstract available at
.) Kew mentions that it
is common for vaccine viruses to "back mutate" (revert to wild
poliovirus-like neurovirulence), but the concerns arise in areas with
low vaccination coverage and, therefore, low herd immunity, so that
these reverted viruses are in an environment favorable for
circulation and propagation of an outbreak of paralytic disease. (See
prior ProMED postings on other events associated with VDPVs.)

As part of the global polio eradication initiative activities, all
cases of acute flaccid paralysis (AFP) in individuals less than 15
years of age are to be reported and investigated. A benchmark
indicator of adequate surveillance activities is a reported AFP rate
of at least 1 per 100 000 population annually. According to
monitoring data available on the WHO immunization monitoring website,
during the period 1996 through 2010, non-polio AFP rates reported in
Haiti were less than 1 per 100 000 population under age 15 years for
all years during this period, including 2000 and 2001, the 2 years
during which there were cVDPV (circulating vaccine derived
poliovirus) associated paralytic cases, and AFP surveillance was
significantly increased (from rates of 0.0/0.1 up to 0.6 and 0.8 in
2000/2001 respectively) (data available through an interactive page
at:
).
These figures suggest that surveillance for paralytic disease in
Haiti has been suboptimal and may well not rule out the possibility
of having had some "below the radar" circulation of poliovirus,
either wild poliovirus (WPV) or vaccine derived poliovirus (VDPV). In
addition, as seen with the recent experience with cholera in Haiti,
the possibility of introduction of WPV is there, as there has been
significant influx of international workers in the post earthquake
relief activities.

Unfortunately, laboratory confirmation at this point in time may be
challenged as 2 of the identified cases were fatal cases, one had
onset of illness in October 2010, so a negative virus isolation study
will not definitively rule out a viral infection, leaving the one
case presently hospitalized in Haiti on a respirator as the only case
in which there is a reasonable likelihood of successful virus
isolation studies. That being said, the possibility of a several
cases of Guillain-Barre syndrome (GBS) occurring in close temporal
proximity also exists. GBS has been associated with gastrointestinal
and respiratory infections (both viral as well as bacterial), and
following vaccination, all 3 pre-disposing events/conditions have
been coexisting in the present environment in Haiti.

ProMED-mail awaits further information on the results of
investigations and laboratory studies.

For the interactive HealthMap/ProMED map of Haiti, see
. - Mod.MPP]

[see also:
2010
----
Poliomyelitis, vaccine derived - India: (TN) 20101026.3880
Polioviruses, vaccine-derived - Finland 20100514.1567
2009
----
Polioviruses, vaccine-derived - worldwide: 2008-2009 20090922.3333
2007
----
Poliomyelitis, vaccine-derived strains - worldwide 20071012.3350
2005
----
Poliomyelitis, vaccine derived - Madagascar: RFI 20050717.2043
2002
----
Poliomyelitis - Dominican Republic & Haiti: Notice 20020401.3861
Poliomyelitis - Dominican Republic & Haiti 20020331.3848
Poliomyelitis, vaccine-derived - Madagascar 20020719.4809
2001
----
Poliomyelitis - Dominican Republic & Haiti 20011005.2415
Poliomyelitis - Dominican Republic & Haiti (02) 20010122.0167
Poliomyelitis - Dominican Republic & Haiti 20010117.0133
Polio, circulation of vaccine-derived virus 20010129.0205
Poliomyelitis, vaccine-derived - Philippines: 2001 20011013.2506
2000
----
Poliomyelitis - Dominican Republic & Haiti: update 20001208.2149
Poliomyelitis - Dominican Republic & Haiti: comment 20001204.2110
Poliomyelitis - Dominican Republic & Haiti: background 20001203.2102
Poliomyelitis - Dominican Republic & Haiti: ALERT 20001202.2098
Poliomyelitis - Dominican Rep.: control measures 20001218.2212
Poliomyelitis - Dominican Republic: visitor advice 20001215.2195]
..............................................................mpp/msp/dk

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