[ACVM] Discussion topic: Pharmacovigilance

[Laurel Gershwin]

I wasn't able to attach the two documents referred to in the text. If anyone would like them, please e-mail me and I will send to you by regular e-mail.

Laurel



Laurel J. Gershwin DVM PhD Diplomate ACVM
Professor of Immunology
Dept. of Pathology, Microbiology, & Immunology
School of Veterinary Medicine, University of California, Davis

phone: (530) 752-6643
fax:  (530)  752-3349 
ljgershwin at ucdavis.edu

On Jan 11, 2016, at 7:19 PM, Laurel J. Gershwin wrote:

> Hi Tim and All:
> 
> Tim, I read your comment with interest as I am involved in studying adverse vaccine events, particularly in equine species. As the immunologist member of AVMA's COBTA I have been trying to raise awareness of the need for better reporting of adverse vaccine reactions. This is particularly important as there is an effort underway
> to increase the amount of ant
> igen (potency) in veterinary vaccines. Jim Roth hosted an excellent workshop in which we discussed the issues and a white paper (attached) was produced. My research on IgE responses to non-target antigens in equine vaccines underscores the need to NOT increase antigen loads as both target and non-target antigens will increase and already most horses have both IgG and IgE antibodies to non-target proteins in fetal bovine serum. Many of these horses develop fatal anaphylaxis upon vaccination when the levels of IgE are high (see attached paper). 
> 
> In addition the United States Equestrian Federation, who licenses all of the major equine competitions, has issued a new rule that essentially says all horses on the horse show premises must be vaccinated for Influenza and Herpes within at least 6 months of the competition. So for horses that are competing throughout the year that means those vaccines are given twice a year. There is a clause that says a vet's letter and BID temperatures for 7 days prior to the event and BID temping at the event can be used in horses deemed allergic to the vaccines. However, the combination of the increased vaccine frequency and the possible increase in antigen load in vaccines will likely produce many more sensitive horses, and sadly very likely more fatal vaccine-induced anaphylaxis.
> 
> If ACVM diplomates have issues pertaining to vaccine reactions and reporting of these adverse events, I will gladly convey comments to COBTA. We have a meeting in early February, so it is very timely to bring up this issue.
> 
> Sorry for rambling, but this issue is very close to my heart!
> 
> Best,
> Laurel
> 
> Laurel J. Gershwin DVM PhD Dipl. ACVM
> Professor of Immunology
> Dept. of Pathology, Microbiology, & Immunology
> School of Veterinary Medicine
> University of California, Davis
> Davis, CA 95616
> 
> e-mail: ljgershwin at ucdavis.edu
> phone: (530) 752-6643
> fax:  (530) 752-3349
> 
> On Jan 11, 2016, at 3:58 PM, Tim Frana wrote:
> 
> > Hi all,
> > 
> > Would like to pose the following for discussion:
> > 
> > In September 2015, the USDA APHIS published a proposed rule in the Federal
> > Register regarding standards for pharmacovigilance.  In essence, the
> > proposal would require veterinary biologics companies to record and submit
> > reports concerning adverse events associated with the use of biological
> > products, primarily vaccines. Currently, veterinary biologics companies are
> > required notify APHIS if there are indications that raise questions
> > regarding the purity, safety, potency, or efficacy of a product. However,
> > there is no specific guidance related to adverse event reports. These
> > requirements would align APHIS with guidelines outlined by the
> > International Cooperation on Harmonization of Technical Requirements for
> > Registration of Veterinary Medicinal Products (VICH). While the comment
> > period for this proposal has closed, there will likely be opportunities for
> > public input on pharmacovigilance for veterinary biological products in the
> > future. Should ACVM provide comment on the need for the proposed
> > requirements? If so, how should that be done? Examples: through AVMA
> > Council on Biologics and Therapeutic Agents (COBTA), writing a position
> > paper, supporting workshops or meeting presentations.  Issues related to
> > the proposal but not specifically addressed include how to analyze and use
> > data from adverse event reports and how to convey the information to the
> > public. Is this area of vaccinology one in which ACVM can/should be
> > involved or considered outside our area of expertise?
> > 
> > Appreciate any comments.
> > 
> > Thanks,
> > Tim Frana
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