2008 GMR 07001 genetically engineered Horse Influenza Vaccine 7-08

Publications & Resources

July 2008

The Environmental Risk Management Authority

PO Box 131

WELLINGTON 6140

Submission re Application GMR 07001 - to gain approval to import for release genetically modified vaccines (Proteqflu and Proteqflu Te) to protect horses against Equine Influenza

PSGR acknowledges the ERMA-alert regarding Application GMR 07001 and would appreciate receiving all future alerts.

PSGR recommends that ERMA declines application GMR 07001 for the following five reasons:

1. We believe there is a serious error of entry on page 42, section 4.2, of application GMR07001. Information provided in the application itself, and also information issued by NZRB in the public domain, repeatedly affirms that GMR07001 is an application for “conditional release from containment with controls” for Proteqflu and Proteqflu Te vaccines. Even though the applicants have not sought a specific expiry date, as they also formally declare on page 45 of the application, the HSNO Act (S38) will nevertheless provide a statutory default expiry date of five years (maximum) following the date of any conditional release-decision. It is therefore a serious error of contradiction for this application to have a tick for “full (unconditional) release” in the table on page 42 when the background information provided by the NZRD in the application and released to the public domain clearly supports a “conditional release from containment with controls.”

Summary: On the basis of the seriousness of the contradiction between the applicants’ background statements which clearly support “conditional release from containment with controls” and the ‘yes’ tick to ‘unconditional release’ on page 42, we recommend ERMA declines GMR07001.

2. It may be unintentional, but it is misleading for the NZRB (New Zealand Racing Board) and NZEHA (New Zealand Equine Health Association) in their Application Summary to have readers believe that Proteqflu vaccine was the sole agent responsible for the eradication and control of last year’s equine influenza outbreak in Australia. In reality, the use of this vaccine played a much less dramatic role. It was only one of several management tools used in the post-outbreak recovery process to help restore Australia to equine influenza (EI)-free status.

Professional opinion of Australian veterinarians at the time placed high significance on the reinstatement of effective quarantine procedures whose temporary collapse had allowed the virus to escape in the first place from imported vaccinated horses, probably from Japan (Dr James Gilkerson, president of Equine Veterinarians of Australia and Director of Equine Infectious Disease Lab., University of Melbourne). On the midday ‘Rural Report’ of Radio NZ on Monday 25 June 2008, Dr Gilkerson, who was in Wellington at the time, indicated that vaccination of Australian horses with Proteqflu, the vaccine named in this application to ERMA, would not be allowed to continue and would not be permitted after 30 June 2008.

< http://www.abc.net.au/pm/content/2007/s2089830.htm >

< http://www.thehorse.com/Print/Article.aspx?ID=12140 >

< http://www.horsetalk.co.nz/news/2008/06/102.shtml >

Summary: Proteqflu vaccine is likely to become known internationally as the EI vaccine withdrawn by Australia because it is no longer regarded a biosecurity tool. This is a second reason why ERMA should decline GMR07001.

3. The applicants make a further claim that they regard “vaccination with Proteqflu and Proteqflu Te as an essential tool to prevent enormous losses to the [NZ] equine industry.” Although New Zealand remains an equine influenza-free country, three other EI-vaccines are currently registered with Biosecurity NZ (MAFBNZ) for specified use in ‘emergencies.’ The most recent is a live vaccine, FluAvert I.N., which ERMA granted approval for release only a few months ago (December 2007). MAFBNZ and NZRB (with Intervet of the Netherlands) have contracted between them to supply 120,000 doses of vaccine for use ‘in emergencies’ in NZ. It is utterly presumptuous for NZRB (this application) to seek approval of a fourth “essential tool” (specifically Proteqflu and Proteqflu Te) when the existing MAFBNZ toolbox already contains three approved and registered vaccines for use in New Zealand, together with on-going contracts established to supply them.

< http://www.nzracingboard.co.nz/equineinfluenza/presentations.html >

< http://static.tab.co.nz/content/nzrb/EI_Seminar_Presentatiom_Dec%2007.pdf >

Summary: We do not believe that Proteqflu and Proteqflu Te qualify as essential biosecurity components for the MAFBNZ EI-vaccine toolbox that already contains three approved and registered-for-use EI-vaccines. This is a third reason why we recommend that ERMA declines GMR07001.

4. Only a few months ago (20 December 2007), ERMA approved an application (from MAFBNZ) for the controlled release of FluAvert I.N., (a live intranasal vaccine) as a biosecurity tool to control possible equine influenza (EI) in New Zealand. Only two months earlier (October), the NZRB was briefed by MAFBNZ that one of the currently registered EI-vaccines (Equilis IPA by Intervet) was undergoing replacement with Prequenza, a sterile EI vaccine preparation administered by intramuscular (IM) injection. Prequenza is described as having vaccine characteristics and performance almost identical with Proteqflu, the vaccine named in the present application (GMR 07001). Biosecurity NZ has clearly established it already has three “essential” biosecurity tools against EI registered previously for use in NZ, none of which is based on a transgenic viral platform that is the basis of Proteqflu now withdrawn in Australia.

< http://www.ermanz.govt.nz/resources/publications/word/Equine%20Flu%20Vacine.doc >

< http://www.nzracingboard.co.nz/equineinfluenza/presentations.html >

Summary: At least one of the currently registered EI-vaccines in MAFBNZ’s tool box, Prequenza, has features that are at least the equal of Proteqflu. We recommend that ERMA decline this application.

5. Application GMR07001 claims that horses vaccinated with Proteqflu show an immunising effect that is reduced to a “third of the time of any other vaccine.“ Our reading of the technical data for Proteqflu, is that low levels of haemaglutinin-antibodies that appear a few days following vaccination have been mistakenly interpreted by the applicants to be an “immunising effect.” Such responses may not genuinely indicate that such animals have acquired sufficient immunity to withstand live EI viral-challenge.

In contrast, the technical data for Prequenza (a vaccine that supersedes Equilis IPA, and whose details are well known to MAFBNZ) indicates that actual viral protection (not just detection of antibodies) determined by strain specific EI-challenge procedures can be observed by 14 days, with full protection after 4 weeks lasting for up to 12 months. This is the sort of ‘essential tool’ characteristic that should be desired by the applicant.

Any vaccination schedule involving horses for export, or temporary export, is likely to fall well within the time-frame normally set aside for customary pre-export animal preparation. In any event, for NZ horses specifically being lined up for export to Australia, vaccination with Proteqflu as a requirement of entry is no longer presumed to be necessary.

< http://www.emea.europa.eu/PDFs/EPAR/equiliaPrequenza?20510005en6.pdf >

Summary: For several reasons, such as the five outlined above, there appear to be no substantial grounds for ERMA to conclude it should approve Proteqflu as the ‘essential tool’ for emergencies as claimed by NZRB and NZEHA, or even that it has the desirable features of a biosecurity tool. These reasons underscore our recommendation that ERMA declines approval of application GMR07001.

PSGR will not speak to this submission.

Compiled by A Neil Macgregor PhD on behalf of PSGR.

Dr A Neil Macgregor is a biological scientist with primary expertise in soil biology and biochemistry, soil microbial ecology, and microbial genetics. He graduated BSc and MSc from the University of Otago in 1961, and PhD from Cornell University (USA) in 1968. He has held teaching and research positions at universities in several countries and Massey University, Palmerston North (Tiritea Campus) from 1991 until his retirement in1999. His specific research interests and on-going major interests include work on vaccines and animal health.

Signed by the Trustees of Physicians and Scientists for Global Responsibility

Paul G Butler, BSc, MB, ChB, Dip. Obst. (Auckland), FRNZCGP

General Practitioner, AUCKLAND

Bernard J Conlon, MB, BCh, BAO, DCH, DRCOG, DGM, MRCGP (UK), FRNZCGP

General Practitioner, MURUPARA

Elvira Dommisse BSc (Hons), PhD, Mus.B, LTCL, AIRMTNZ

Scientist, Crop & Food Research Institute (1985-1993), working on GE onion programme.

CHRISTCHURCH

Michael E Godfrey, MBBS, FACAM, FACNEM

Director, Bay of Plenty Environmental Health Clinic, TAURANGA

Neil Macgregor, BSc, MSc, PhD

Soil Microbiologist, formerly of the Institute of Natural Resources, Massey University,

PALMERSTON NORTH

Peter R Wills, BSc, PhD

Associate Professor, University of Auckland, AUCKLAND

Robert G Anderson, BSc, PhD

Lecturer retired, TAURANGA

Jean Anderson

Businesswoman retired, TAURANGA.

Ends