Back to the West Nile Virus listserv archive.

Date: July 25, 2003
Posted by: Environmental Risk Analysis Program <envrisk@cornell.edu>

[1] WNV-L Archived Postings about the Fort Dodge Vaccine & Effects
[2] Claim that Stillborn, Aborted & Deformed Foals May Be Linked to WNV Vaccine
[3] Statement from Fort Dodge Animal Health re: Adverse Effects on 
Pregnant Mares
[4] Statement from USDA APHIS re: Adverse Effects on Pregnant Mares
[5] Pro-MED mail commentary

[1]
WESTNILEVIRUS-L ARCHIVED POSTINGS ABOUT THE FORT DODGE VACCINE & EFFECTS

The West Nile Virus listserv has discussed the use, efficacy and 
side-effects of the Fort Dodge vaccine on the following dates (and 
perhaps  others as well). Archives of WestNileVirus-L are posted to 
the web at
http://environmentalrisk.cornell.edu/WNV/WNV-LArchiveIndex.cfm.
Oct 22-23, 2002
Nov 1 2002
February 7, 2003
March 5, 25, 2003
April 17, 2003
May 4, 12, 16 2003
July 7, 2003

In addition, information about the vaccine is part of the FAQ 
response to the question "Can I be vaccinated against West Nile 
Virus? Is there a vaccine for horses? For birds? For other animals?" 
posted at
http://environmentalrisk.cornell.edu/WNV/FAQs.cfm#vaccine.  -- Lois Levitan


[2]
STILLBORN, ABORTED & DEFORMED FOALS MAY BE LINKED TO WNV VACCINE

Excerpted from  ProMED-mail  (Id: 20030724.1806)
Source: Manitowoc Herald Times Reporter, byline: Linda Willman
http://www.wisinfo.com/heraldtimes/lsc/archive/lsc_11274979.shtml
Date: July 20, 2003

Reports are coming from across the nation of troubled births, 
including a foal born with no front legs. The foal's mother received 
her first injection last year, 30 days into her pregnancy and again 2 
weeks later.

According to the USDA, there have been several dozen cases of 
deformities and stillborn foals throughout the
nation. The USDA is investigating whether a new WNV vaccine could be 
responsible for these defects. According to the USDA, they have 
received enough information to warrant an investigation.

In 2002, a WN vaccine manufactured by Fort Dodge was approved and 
distributed. Nearly 7 million doses were given to horses the first 
year. In most cases the vaccine prevented or minimized symptoms and
has saved the lives of many horses. It appears that the problem is 
showing up in the foals of mares that were vaccinated while in foal.



[3]
STATEMENT FROM FORT DODGE ANIMAL HEALTH re: ADVERSE EFFECTS ON PREGNANT MARES
Excerpted from ProMED-mail  (Id: 20030724.1806)
Source: Fort Dodge Animal Health Website [edited] 
(http://www.equinewestnile.com/vaccine.htm)

Currently, the West Nile - Innovator vaccine does not carry a claim 
for vaccination of pregnant mares. However, in pre-release safety 
trials, 32 of 649 horses were pregnant mares which were closely 
monitored following vaccination. There were no ill effects 
demonstrated in the mares, their pregnancies, or their subsequent 
foals.  Since its release, thousands of doses have been administered 
to pregnant mares. A low  number of undiagnosed abortions have been 
reported from the field following use; these reports appear to be 
associated with individual animal responses due to stress, which can 
occur with any vaccine administered to pregnant animals. The safety 
of West Nile - Innovator vaccine is similar to that of other 
routinely used killed virus vaccines such as the sleeping sickness 
combination products. For additional information contact your 
veterinarian.

[Although not provided on the Fort Dodge website, but provided 
directly by Fort Dodge, was the following information, which is 
paraphrased from the 2 reports. - Mod.TG]

In separate press releases from the University of Wyoming and from 
Colorado State University, and in conjunction with the USDA, the 
veterinarians there say there is currently no scientific proof to 
link the WNV
vaccine to aborted, stillborn, or deformed foals and that the horse 
owners should continue to vaccinate their animals to protect them 
from the deadly disease.

Concerns rose from unfounded and erroneous claims made by a Denver 
newspaper that some pregnant mares may have been adversely affected 
by the popular vaccine, according to spokespersons from the 
University of Wyoming, the Colorado State University veterinary 
diagnostic laboratories, and the Wyoming and Colorado state 
veterinary offices, because none of the horses in question has been 
scientifically tested.

The Colorado paper made reference to some anecdotal reports of 
vaccinated mares delivering stillborn or deformed foals. There is no 
proof of this, and the horses may not have been vaccinated.

According to a spokesperson from the USDA APHIS, none of the kinds of 
material that would normally be tested for veterinary diagnosis has 
been submitted. Owners are encouraged to submit aborted or stillborn 
fetuses or deformed or dead foals to veterinary diagnostic 
laboratories for necropsy and determination of the problems, whether 
or not they are related to the vaccine. Presently, there is no such 
evidence to determine [whether there is a] relationship between the 
problem and any vaccine or disease.


[4]
STATEMENT FROM USDA APHIS re: ADVERSE EFFECTS ON PREGNANT MARES

Excerpted from ProMED mail (Id: 20030724.1806)
Source: Aphis website [edited] (http://www.aphis.usda.gov), accessed 
July 23, 2003

Some recent stories have suggested that the Fort Dodge Animal Health 
WNV Vaccine approved by the USDA may cause pregnant mares to abort or 
give birth to deformed foals. The misleading information in those
articles has sparked many anxious phone calls from horse owners, 
veterinarians, and others involved with horses.

Horse owners should be assured that the vaccine is safe, and it 
should be used as protection against West Nile Virus. Millions of 
doses of the vaccine have been used since the USDA's Center for 
biologics approved its use in 2001.

The Center for Veterinary Biologics, within USDA's Animal and Plant 
Health Inspection (APHIS), maintains a toll-free telephone hotline 
(800-752-6255) and a mailbox on its web site and actively encourages 
veterinarians and other vaccine customers to report problems with 
vaccines. (http://www.aphis.usda.gov/vs/cvb)

To date, there have been a very small number of reports regarding a 
possible association between the use of WNV vaccine and abortions, 
birth defects, or other reproductive anomalies or failures. It does 
not appear that there is a relationship between WNV vaccine use and 
these reproductive problems or any other major problems. The Center 
and the vaccine manufacturer will continue to collect, monitor, and 
track the performance of this vaccine.


[5]
PRO-MED MAIL COMMENT:
from ProMED mail (Id: 20030724.1806)

The numbers cited in the vaccine trial and available on the website 
are not sufficient to detect adverse events that might be occurring 
at low rates.  The press releases from the universities cited 
indicate that no necropsies have yet been performed. However, if 
evidence or data are available, ProMED-mail would be grateful if a 
knowledgeable and authoritative source would share that information. 
­ Mod.TG

[see also ProMED-mail:
West Nile virus, equine vaccine (02): 20010808.1867
West Nile virus, equine vaccine 20010804.1533
West Nile virus surveillance 2001 - USA (15) 20010804.1532]
.....................mpp/tg/pg/mpp

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