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LETTER to the APVMA 21/8/2019 Re:
LETTER to the APVMA 21/8/2019 Re:
LETTER to the APVMA 21/8/2019 Re:
LETTER to the APVMA 21/8/2019 Re:

APVMA REGISTERED PRODUCT: EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES  68996/103910, ZOETIS AUSTRALIA PTY LTD

UPDATE- 7/9/19 APVMA acknowledged receipt of letter and intent to reply.

No reply yet

  WEBSITE ADMINISTRATORS NOTES: 

HAS THE APVMA’S REPORTING PROCESSES PLACED THE FOX IN CHARGE OF THE HEN HOUSE?

From my reading of their website information, my interpretation is YES!

I HAVE ASKED THE AUTHORITY – See the letter following

The more I have researched the APVMA’s processing procedures for reports of alleged reactions to a registered veterinary medicine, specifically regarding Zoetis Australia Pty Ltd product Equivac HEV Hendra Virus Vaccine for Horses  68996/103910, the more alarmed I have become! I have combed the information on the APVMA’s website and unless I have seriously miss interpreted the information there, many who trusted the APVMA’s processes will be horrified!

In my opinion there are multiple issues with the procedure itself and with the APVMA’s Adverse Experience Reporting Program (AERP), The Causality Assessment Algorithm - For Veterinary Medicines, that make the process and outcome of reports far from a scientific, impartial or trustworthy register of reactions.

 

21/8/19. I sent this letter via e mail to the APVMA in an attempt to obtain concise answers to a number of questions to clarify my understanding of these issues along with a number of comments.

If / when I receive an answer from the APVMA I will publish the text on this website. 

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PAGE 1 OF 2 PAGES

page 1- This page

page 2

References and Links used in this letter

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ISSUES COVERED IN THIS LETTER:  5 PAGES

  • Seeking clarification on the APVMA processes-

  • How the APVMA deals with adverse reaction reports- assessing an adverse experience

  • Adverse Experience Reporting Program (AERP), The Causality Assessment Algorithm - For Veterinary Medicines

  • Classifying an adverse experience (Algorithm) – comments and questions on the apparent poor science, weaknesses and bias away from ‘probable’ classification in this system

  • Questions pertaining to the above and the impartiality where the registrant self-evaluates

  • Notification to the APVMA of misleading statements

  • Who pursues prosecution for the above?

  • Links/ quotes referred to in this letter

START LETTER

Re - APVMA REGISTERED PRODUCT: EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES  68996/103910, ZOETIS AUSTRALIA PTY LTD

As a concerned horse owner, I seek clarification regarding the APVMA’s processing of reported possible reactions to the above -mentioned vaccination and issues regarding claims made regarding this vaccine.

I quote from the APVMA’s  website page - (1)   https://apvma.gov.au/node/314

 

(1) “WHAT HAPPENS NEXT

ASSESSING AN ADVERSE EXPERIENCE

The APVMA assesses every adverse experience reported.

Reports made directly to the APVMA by non-registrants (voluntary reports) are copied to the product registration holder, who is then required to evaluate each report. The registration holder may contact the reporting person or the attending veterinarian to help determine if any follow-up work is required.

The product registration holder must subsequently report their findings to the APVMA, and the findings are then assessed to determine if further information is required. In some cases, additional expert opinion is sought from other government agencies such as the Office of Chemical Safety and the Department of the Environment, universities, the Australian Veterinary Association, or other appropriate authorities………..

AND excerpt from  (2) https://apvma.gov.au/sites/default/files/publication/20586-causality-assessment-algorithm.doc

 

 (2)    Adverse Experience Reporting Program (AERP), The Causality Assessment Algorithm - For Veterinary Medicines

“Each registrant should conduct a causality assessment for each adverse experience report (AER). The following algorithm has been adapted from published information and may be used as a guide by registrants to conduct causality assessments of adverse experience reports. If registrants wish to conduct causality assessment using another method, then the results of the assessment must be consistent with the APVMA’s requirements.

The APVMA will validate the registrant’s assessments using statistical random sampling techniques.”

AND

I quote from the APVMA’s website page - (1)  https://apvma.gov.au/node/314

 

(1)  Classifying an adverse experience

The APVMA classifies the relationship between exposure to or use of a registered product and a reported adverse experience in terms of ‘probable’, ‘possible’, ‘probable or possible off-label’, ‘unlikely’ and ‘unknown’. “

 

My interpretation of this procedure with regard to this specific vaccine is that the APVMA assesses every adverse experience reported AFTER Zoetis (the product registration holder) has evaluated the information using the APVMA   (2) Adverse Experience Reporting Program (AERP), The Causality Assessment Algorithm - For Veterinary Medicines.

The specific steps in this process as I understand it are:

The APVMA receives the initial report from the vaccine end user and sends the report to Zoetis, who processes the information (plus any additional information sought) through the APVMA   (2)  Adverse Experience Reporting Program (AERP)

The product registration holder sends their AERP report back to the APVMA.

(2)   The APVMA will validate some (not all) registrant’s assessments using statistical random sampling techniques.  Not all assessments are checked

 

Then the   (1) APVMA classifies a reported adverse experience in terms of ‘probable’, ‘possible’, ‘probable or possible off-label’, ‘unlikely’ and ‘unknown’; based on the AERP report returned by the product registration holder

Your information strongly indicates that the APVMA does not see/process the full information in the adverse experience reported by the end user; but rather the findings reported by the product registration holder, in this case Zoetis, after Zoetis has  (2)  processed the initial report.  This report does not include the full detailed content of the adverse experience reported, therefore the APVMA does not work with the full adverse experience report made initially by the end-user.

1    QUESTION - Is my interpretation correct? If not, could you please clarify this process.

2    QUESTION - If my interpretation is correct- the product registration holder would have strong financial motivation to report ‘findings’ that support the efficacy and safety of their product to the APVMA. How can the APVMA see this process as impartial, safe or thorough? What is the APVMA’s rationale regarding this process?

 

AND Regarding:

    (2)   Adverse Experience Reporting Program (AERP), The Causality Assessment Algorithm - Causality Assessment Algorithm - For Veterinary Medicines

https://apvma.gov.au/sites/default/files/publication/20586-causality-assessment-algorithm.doc

Specifically, the statements highlighted in lime green - 

(2)   1 PREVIOUS EXPERIENCE WITH PRODUCT

 

(2)

 

a

b

c

1AERP - Copy.jpg

Comment – As I understand it Equivac HEV Hendra Virus Vaccine for Horses 68996/103910, Zoetis Australia Pty Ltd had very limited trials and testing on horses before its final registration.

In the case of this vaccination, in my opinion using the APVMA’s  AERP  (2)   is un-scientific because statement #1c (and subsequent numeric allocation) refers to the ‘unknown’ component. The assessment criteria/statements in #1a to c are not appropriate for such a ‘young’ vaccination where data/trials are limited, the score will most probably be 0 regardless of the information in the reported reaction, this represents an unacceptable bias.

My comment regarding this specific vaccination  is supported by the statements included in the

       product information sheet (4)  http://websvr.infopest.com.au/labelrouter/label?productcode=68996&labeltype=L&Mode=1

 

 (4) Precautions:

The effectiveness of Equivac HeV vaccine in the face of Hendra virus disease outbreak has not been studied.

While all horses receiving the recommended vaccine course and booster vaccination at 6 months were antibody positive, the potential for vaccinated horses to shed virus if exposed to and infected with the Hendra virus cannot be ruled out.

The compatibility of Equivac HeV Hendra virus vaccine with other vaccines and veterinary chemical products has not been studied.

                           

              AND

 

 

           (4)   https://apvma.gov.au/node/12881

Effectiveness of the vaccine

The potential for a vaccinated horse to pass on the Hendra virus cannot be ruled out. As a precaution, it is recommended people take the same steps to protect vaccinated horses from exposure to infection—and to prevent humans being infected by horses—as are recommended for unvaccinated horses. Personal protective equipment should be worn whenever infection is suspected even in vaccinated horses.

PAGE 2 OF THIS LETTER

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