Download Application APP202377 - Environmental Protection Authority

Staff Assessment Report
Application APP202377: to release a live
attenuated vaccine strain of Infectious
Bronchitis Virus
February 2015
Application number
APP202377
Application type
Rapid Assessment for Release of a Qualifying Organism
Applicant
PacificVet Limited
Purpose
To release Infectious Bronchitis Virus (Massachusetts serotype, #1263 strain) as a
live attenuated vaccine for poultry.
Date formally received
4 February 2015
www.epa.govt.nz
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Staff Assessment Report: APP202377
Summary and Recommendations
This application seeks approval to introduce Infectious Bronchitis Virus (Massachusetts serotype, #1263
strain) in the form of a live attenuated vaccine for use against Infectious Bronchitis Virus (IBV) in New
Zealand poultry.
Section 38I of the HSNO Act provides for a rapid assessment of applications seeking the release of
qualifying organisms, where a qualifying organism is a new organism that is or is contained in a veterinary
medicine1. This Staff Assessment Report considers the application against the criterion set out in section 38I
of the HSNO Act.
We found that it is highly improbable that the dose and routes of administration of this vaccine will have
significant adverse effects on the health of the public or any valued species.
We also found that it is highly improbable that the vaccine could form a self-sustaining population and would
have significant adverse effects on the health of the public, or any valued species, or natural habitats, or the
environment.
We recommend that the application be approved subject to the specified controls.
1
As defined in section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997.
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Staff Assessment Report: APP202377
Table of Contents
Summary and Recommendations ........................................................................................................ 2
1.
This document ............................................................................................................................. 4
2.
The application ............................................................................................................................ 4
2.2.
3.
The organism ...................................................................................................................... 4
Background .................................................................................................................................. 4
3.1.
Infectious Bronchitis Virus ................................................................................................... 4
3.2.
IBV associated disease ....................................................................................................... 5
Impacts of IBV-associated disease ..................................................................................... 5
3.3.
IBV in New Zealand ............................................................................................................ 6
3.4.
Host range of IBV ................................................................................................................ 7
Wild birds............................................................................................................................. 7
Non-avian species ............................................................................................................... 7
3.5.
Control of IBV ...................................................................................................................... 7
IBV Vaccines ....................................................................................................................... 8
Live attenuated viruses ....................................................................................................... 8
Genetic recombination of live vaccines ............................................................................... 8
Inactivated vaccines ............................................................................................................ 8
3.6.
The Massachusetts serotype, #1263 strain vaccine ........................................................... 9
4.
Information from other Agencies ............................................................................................. 10
5.
Legislative criteria for consideration ...................................................................................... 10
5.2.
6.
Is the organism a veterinary medicine? .................................................................................. 11
6.2.
7.
Other approvals required .................................................................................................. 11
Dose and routes of administration .................................................................................... 11
Potential adverse effects of the vaccine ................................................................................. 11
7.1.
Adverse effects on the health and safety of the public ..................................................... 11
7.2.
Adverse effects on any valued species ............................................................................. 12
Through the intended dose and routes of administration ................................................. 12
Through establishment of a self-sustaining population ..................................................... 12
7.3.
Adverse effects on natural habitats and the environment ................................................. 13
8.
Recommendation ...................................................................................................................... 13
9.
References ................................................................................................................................. 14
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1.
This document
1.1.1.
This Staff Assessment Report has been prepared by EPA staff to assist the decision-maker in
considering application APP202377. It contains information from the applicant, and other readily
available sources including a range of additional publications. It also sets out the criteria for
considering the application under the Hazardous Substances and New Organisms (HSNO) Act 1996
(the Act).
2.
The application
2.1.1.
The applicant, Pacific Vet Limited, seeks approval to release Infectious Bronchitis Virus
(Massachusetts serotype, #1263 strain) in the form of a live attenuated vaccine for use against
Infectious Bronchitis Virus (IBV) in New Zealand poultry.
2.1.2.
The application was submitted on 4 February 2015, under section 34 of the Act, seeking approval to
import for release or release from containment a new organism.
2.2. The organism
2.2.1.
The organism to be considered is:
Family: Coronaviridae
Order: Nidovirales
Genus: Coronavirus
Avian infectious bronchitis virus (Massachusetts serotype, #1263 strain).
2.2.2.
This organism constitutes a live attenuated vaccine known as the Zoetis Bron-Mass vaccine, or
Poulvac IBMM.
3.
Background
3.1. Infectious Bronchitis Virus
3.1.1.
IBV is an enveloped, single stranded, positive-sense RNA virus with a genome length of
approximately 27kb, and a high mutation frequency.
3.1.2.
Genetic diversity in IBV can be generated by point mutations, insertions, and deletions in the
genome; and through genetic recombination, all of which occur naturally.
3.1.3.
Most countries are have their own indigenous IBV variants, which are well characterised. New
variants frequently emerge through spontaneous mutation or genetic recombination; many of which
are unable to replicate or survive for long, but a few emerge to become of economic importance
locally or worldwide (Awad et al, 2014).
3.1.4.
Classification of IBV varies depending on the method used for typing – functional typing
(immunotypes or protectotypes and antigenic (serotype or epitope) types) or non-functional typing
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(such as genotypes). Real time PCR (RT-PCR) genotyping methods have largely replaced
serotyping for identification of field strains (OIE, 2013). It has been found that isolates of the same
serotype or protectotype can differ substantially in some genes, while different serotypes or
protectotypes can have high genome similarity (DeWitt, 2000).
3.1.5.
IBV is temperature sensitive, and will only survive for a few days at room temperature. It is easily
inactivated by common disinfectants such as 70% ethanol, chloroform, or 1% phenol; and is more
stable at low pH than high pH (Ignjatović and Sapats, 2000).
3.2. IBV associated disease
3.2.1.
Infectious bronchitis virus (IBV) is an acute contagious viral disease. It is ubiquitous in countries
where chickens (Gallus gallus) are reared intensively, and is a major cause of economic losses in
the poultry industry.
3.2.2.
There is extensive antigenic variation, and variation in virulence and tropism between isolates of IBV
from different geographic regions. Different strains present a variety of clinical manifestations ranging
from respiratory disease and reproductive disorders, to nephritis (inflammation of kidneys) and poor
egg production and quality. In IBV-infected flocks, the morbidity rate (disease incidence) can reach
100%, but the mortality rate depends on factors including the virulence of the strain, presence of
secondary infections, flock age, immune status, management and environmental factors (Awad et al,
2014).
3.2.3.
IBV has an incubation period of 24 to 48 hours, and viral spread occurs rapidly among chickens in a
flock by aerosol and mechanical means (Awad et al, 2014; Cavanagh and Naqi, 1997). During the
acute phase of disease, the virus is shed copiously into the respiratory tract, and then shed into the
environment by coughing birds. The virus is also shed in faeces, where it can survive for long
periods. Contact with infected chickens is the most likely source of infection, along with faeces, feed
and drinking water that has been contaminated by faeces. Contaminated litter, footwear, clothing,
utensils, equipment and personnel are also potential sources for indirect transmission (Ignjatović and
Sapats, 2000).
Impacts of IBV-associated disease
3.2.4.
IBV is a significant problem for the poultry industry. It can significantly affect egg and meat
production through losses due to increased mortality, reduced egg production, and carcass
condemnation. IBV also increases flock vulnerability to secondary diseases.
3.2.5.
The symptoms of IBV include: coughing and snicking (upper respiratory clicking noise); nasal
discharge; depression; reduced quantity and quality of eggs; silent layers (layers with
underdeveloped oviducts, which appear normal but do not lay eggs); acute mortality due to gout
related kidney infection and failure; condemnation due to secondary Escherichia coli infections.
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3.2.6.
IBV is listed by the World Organisation for Animal Health/Office International des Épizooties (OIE) as
a notifiable terrestrial disease, as specified in Chapter 10.2 of the OIE Terrestrial Animal Health
Code, which sets out standards for the improvement of terrestrial animal health and welfare and
veterinary public health worldwide. The OIE consider that ill-health, regardless of the cause, is a
welfare concern, and may be exacerbated by poor environmental or husbandry management.
3.2.7.
Outbreaks of IBV-associated disease still occur in vaccinated flocks, often as a result of a virus strain
of a different seroptype from the vaccine (Cavanagh and Naqi, 1997).
3.3. IBV in New Zealand
3.3.1.
IBV is widespread in New Zealand (19% prevalence in farmed poultry), although presence of the
virus does not necessarily correlate with clinical disease (Ramneek et al, 2005; Howell, 1992). It was
first detected in New Zealand in 1967, four serotypes (A, B, C, and D) were subsequently isolated
and described as distinct from those present in other countries (Lohr, 1976 and 1977). Recent
molecular comparisons showed a high level of sequence similarity between those New Zealand
strains and the Australian strains, suggesting that the New Zealand strains may have been
introduced from Australia (McFarlane and Verma, 2008).
3.3.2.
The IBV strains found in New Zealand are considered different from those found in other countries
around the world, particularly as they are not considered to be as virulent as the “classic” or virulent
strains (Bernardi, 2008). The respiratory effects of New Zealand field strains appear to be mild,
which is consistent with the experimental observations, but severe uraemia has been observed in
chicks that were deliberately chilled following inoculation with some isolates (Howell, 1992).
3.3.3.
Molecular analysis comparing S1 genes among early IBV isolates from New Zealand and recent field
isolates showed minor differences, suggesting that there is less selection pressure for IBV mutants in
New Zealand (McFarlane and Verma, 2008). McFarlane and Verma (2008) also found similar
consistency when comparing Massachusetts serotype isolates from the 1940s with present day
strains, suggesting that not all IBV strains have a propensity for frequent mutation.
3.3.4.
The main serotypes and virulent strains that are found in many other countries are not found New
Zealand. Consequently exotic strains of IBV are listed as unwanted organisms under the Biosecurity
Act.
3.3.5.
A HSNO Act approval for the importation into containment of exotic vaccine strains of IBV was
granted in 2007 (Application NOC07004). The approval was required to fulfil Ministry for Primary
Industries (MPI) requirements to enable the live attenuated IBV vaccines to be imported into
containment in New Zealand, for export to Fiji and other Pacific nations.
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3.4. Host range of IBV
3.4.1.
There are many coronaviruses; most of these infect only one animal or species, or a small number of
closely related species. Mammalian coronaviruses belong to groups 1 and 2; while group 3
coronaviruses, including IBV, are primarily avian in origin.
3.4.2.
Chickens (Gallus gallus) are the primary and most significant hosts of IBV, and all ages of chickens
are susceptible.
3.4.3.
Farmed pheasants and turkeys have also been found to be natural hosts of IBV-like coronaviruses; it
is possible that certain strains of IBV are able to infect farmed pheasants (Ignjatović and Sapats,
2000).
Wild birds
3.4.4.
The role of wild birds in the persistence and spread of IBV is unknown. It has been suggested that
wild birds act as reservoirs and long-distance vectors of group 3 coronaviruses including IBV, and
IBV-like viruses.
3.4.5.
A three-year study of the role of wild birds as reservoirs for avian coronaviruses in Korea found
coronavirus in 14 waterfowl of 1473 individual birds tested, but concluded that the coronaviruses
they isolated were genetically distinct from IBV (Kim and Oem, 2014). A study of IBV-like
coronaviruses in wild birds in Poland found a 3.5% incidence of coronaviruses, with the virus
detected in ducks, geese, mute swans, gulls and pheasants (Domanska-Blickarz et al, 2014).
3.4.6.
A study of avian coronaviruses in wild bird populations in England examined 441 birds of 42 species;
and found coronavirus associated with wildfowl and waders, noting that the birds associated with
coronaviruses appeared healthy (Hughes et al, 2009). An investigation into the prevalence of avian
respiratory disease including IBV in Burkina Faso, and found no IBV in the small number of wild birds
studied (Tarnagda et al, 2011).
Non-avian species
3.4.7.
Non-avian species are not considered to be susceptible to natural infection with IBV, and there is no
record of IBV infecting a non-avian species naturally. Under experimental conditions, suckling mice,
rabbits and guinea-pigs have been infected through intra-cerebral inoculation (Ignjatović and Sapats,
2000).
3.5. Control of IBV
3.5.1.
Vaccination is considered to be the only practical means of controlling IBV, and it is used around the
world in the intensive poultry industry.
3.5.2.
Other control methods such as exclusion have not been successful, however flock management
methods such as ‘all-in/all-out’ operations, cleaning and disinfection between batches are actively
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used to minimise infection rates. In addition, breeding to increase resistance is not practiced,
although infection outcomes may differ between different chicken lines (Ignjatović and Sapats, 2000).
IBV Vaccines
3.5.3.
IBV-associated disease is controlled by the use of live attenuated and inactivated virus vaccines.
The generally accepted strategy for control of IBV is to use vaccine strains that are similar to those
found in a particular area or farm. However this is not always possible as there may not be vaccines
available for the prevalent strains (Awad et al, 2014).
3.5.4.
In broilers, vaccines are used to prevent respiratory problems, and reduce the economic costs of
secondary infections. In layers and breeders, vaccination is used to prevent economic losses from
decreased egg production and poor egg quality.
Live attenuated viruses
3.5.5.
Live vaccines represent IBV strains that have been passaged in embryonated chicken eggs, or
thermally treated, to achieve a reduction in virulence for the respiratory tract; the resulting vaccine
can be mild or virulent depending on the level of attenuation (OIE, 2013). Vaccines with low virulence
are generally given to day-old chicks; however the immune response to a low virulence vaccine is
lower, and only sufficient to protect the respiratory tract. Conversely vaccines with high residual
virulence can result in increased airsacculitis (inflamed air sacs, and accumulation of purulent or
caseous (cheese-like) material in respiratory cavity) (Ignjatović and Sapats, 2000).
3.5.6.
The emergence of variant strains of IBV, through mutation and recombination, means that
vaccination programmes employed by the poultry industry have not eliminated the disease. There
are a range of vaccines available. The most frequently used vaccines are based on Massachusetts
(Mass) strains (Ignjatović and Sapats, 2000), and many countries only allow live vaccine strains of
the Massachusetts type (OIE, 2013). However new vaccines are becoming available as new variant
strains become predominant, and in some cases vaccines containing multiple IBV serotypes are
used.
Genetic recombination of live vaccines
3.5.7.
Genetic recombination of vaccine strains and wild-type strains can occur (Wang et al, 1993).
Therefore it is best practice to mass-immunise all chicks in a flock concurrently, to minimise ‘back
passaging’ of the vaccine virus, thus reducing the potential for recombination (Ignjatović and Sapats,
2000; OIE, 2013). In addition, vaccination using the manufacturer’s recommended dosage will help
reduce the potential for back-passage reversion that can result from fractional dose application (OIE,
2013).
Inactivated vaccines
3.5.8.
Inactivated vaccines are usually given after “priming” with a live vaccine. They are used in layers and
breeders, administered by subcutaneous inoculation at 13 to 18 weeks of age, and in pullets that
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have been previously primed with a live vaccine. They provide high and uniform levels of antibodies
that persist for a longer time, and protect against a reduction in egg production (Ignjatović and
Sapats, 2000).
3.5.9.
The inactivated IBV vaccine used in New Zealand is a Massachusetts serotype.
3.6. The Massachusetts serotype, #1263 strain vaccine
3.6.1.
Pacific Vet is proposing the introduction of this live attenuated vaccine for use by the poultry industry
in New Zealand, as they are currently unable to source the live attenuated vaccine previously used in
New Zealand (see section 2.3 of the application).
3.6.2.
The vaccine was selected by Pacific Vet because it is widely used, and continuing supply is unlikely
to be an issue. The vaccine is currently produced by Zoetis, under the names Bron Mass and
Poulvac IBMM. It is registered for use in the following countries: Argentina, Bangladesh, Bolivia,
Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia,
Lebanon, Malaysia, Mexico, Morocco, Namibia, Nicaragua, Pakistan, Paraguay, Peru, Philippines,
Saudi Arabia, South Africa, Sri Lanka, Turkey, the United States of America, Uruguay, and
Venezuela (in litt. Dr Karen Booth, Regulatory Affairs Manager, Zoetis New Zealand. 15 November
2014).
3.6.3.
The vaccine is also considered to be a low virulence strain, so it considered safer for the treated
birds than a vaccine with higher residual virulence. Live IBV vaccines are required to pass the safety
test set out by the OIE, requiring chickens to be inoculated with 10 times the recommended dosage,
and observed for 21 days, with no serious clinical signs or deaths from causes attributable to the
vaccine (OIE, 2013).
3.6.4.
In addition, while the vaccine is a Massachusetts serotype, rather than being a derivative of New
Zealand specific serotypes, Pacific Vet believes it will provide some immunity to the New Zealand
specific strains of IBV. Bengelsdorff and Lohr (1975) found that the New Zealand IBV isolate N.Z.103
antigen is almost completely covered by the Massachusetts antibody. They also demonstrated that a
live attenuated Massachusetts serotype vaccine resulted in substantial protection from four New
Zealand field isolates of IBV, using vaccination trials under experimental conditions (Bengelsdorff
and Lohr, 1975). The effectiveness of a Massachusetts serotype vaccine in providing immunity to
New Zealand strains of IBV has not been demonstrated under field conditions.
3.6.5.
The introduction of this mild Massachusetts type IBV vaccine is supported by the Poultry Industry
Association of New Zealand (Inc) (PIANZ), in particular by their veterinarian member who believe the
availability of a live vaccine is essential for animal welfare and production (in litt Michael Brooks,
Executive Director, PIANZ, 29 January 2015).
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4.
Information from other Agencies
4.1.1.
The Department of Conservation (DOC) and the Ministry for Primary Industries (MPI) were given the
opportunity to comment on the application.
4.1.2.
DOC noted that they did not have the have the capacity to comment on whether there are any
potential or actual significant adverse effects of this new vaccine on valued species, natural habitats,
or the environment” particularly given the statutory timeframe.
4.1.3.
MPI noted that Ignjatović and Sapats (2000) recommended that “strong considerations should be
given to measures to restrict the introduction of exotic IBV variants” as an incursion of unrelated IBV
strains would impact on the vaccines needed to control the disease. Introduction of new IBV variants
would also increase the pool of genetically different viruses that circulate on a site, increasing “the
likelihood of generating new and more variable strains through processes such as recombination
(Ignjatović and Sapats, 2000).
4.1.4.
MPI is also reviewing the vaccine as required by their responsibilities under the Agricultural
Compounds and Veterinary Medicines (ACVM) Act 1997, and the Biosecurity Act 1993.
5.
Legislative criteria for consideration
5.1.1.
Section 38I of the Act provides for a rapid assessment of applications seeking the release of
qualifying organisms, where a qualifying organism is a new organism that is or is contained in a
veterinary medicine2.
5.1.2.
In order to be approved for release as a qualifying organism, section 38I(3) of the Act requires that
the decision maker be satisfied that, taking into account all the controls that will be imposed (if any),
it is highly improbable that:
(a) the dose and routes of administration of the veterinary medicine would have significant adverse
effects on(i)
the health of the public; or
(ii)
any valued species; and
(b) the qualifying organism could form an undesirable self-sustaining population and would have
significant adverse effects on(i)
the health and safety of the public; or
(ii)
any valued species; or
(iii) natural habitats; or
(iv) the environment.
5.1.3.
In the first instance we have assessed the organism against these criteria, this assessment is set out
in the following sections of this report.
2
As defined in section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997.
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5.1.4.
If the organism does not meet these criteria, the applicant may request that the application be
considered under section 38, or section 38A.
5.2. Other approvals required
5.2.1.
Section 38I(5) of the Act specifies that an approval granted under section 38I is not an approval to
use a qualifying veterinary medicine until the veterinary medicine has been approved for use under
the Agricultural Compounds and Veterinary Medicines Act 1997. MPI are currently processing an
application from Pacific Vet for an interim ‘Special Circumstances’ approval for the vaccine, which
would enable the vaccine to be used in New Zealand under strict control for a specified period.
Pacific Vet have indicated their intention to apply for full registration in the near future.
5.2.2.
We also note that the vaccine may trigger requirements under the hazardous substance provisions
of the HSNO Act, and the Biosecurity Act.
6.
Is the organism a veterinary medicine?
6.1.1.
The organism is the main constituent part of a vaccine called Zoetis™ Bron-Mass or Poulvac IBMM
vaccine, produced by Zoetis™. This product is a veterinary medicine as defined in section 2(1) of the
Agricultural Compounds and Veterinary Medicines Act 1997, as it is a biological compound intended
for use in the direct management of poultry.
6.2. Dose and routes of administration
6.2.1.
The vaccine can be administered to birds from one day in age by intranasal (inhaled into nasal
cavity), intraocular (drops into eye) or by spray (directly above the birds) methods. It can also be
administered in drinking water for birds from two weeks of age.
6.2.2.
It is recommended that a control be imposed requiring that the vaccine only be administered at the
dose rate recommended by the manufacturer, and that all chicks in a flock, or on a farm, be
vaccinated simultaneously/concurrently. This will reduce the potential for the vaccine strain to spread
to unvaccinated chickens, and reduce potential for mutation or recombination with wild-type strains
of IBV, and will cement current best practice in New Zealand.
7.
Potential adverse effects of the vaccine
7.1. Adverse effects on the health and safety of the public
7.1.1.
IBV is not known to pose any human health risk, and there have been no reports of human infection
with IBV (OIE, 2013). Ignjatović and Sapats (2000) report that no evidence exists to suggest that
humans act as a reservoir for active replication of IBV and no evidence has been found of
transmission from human to human or human to animal.
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7.1.2.
The manufacturer’s instructions recommend that when applying by spraying, the operator should
wear eye and respiratory protection (conforming to relevant Standards for the country of use) or a
helmet with filtered air circulation; and that the operator wash and disinfect hands on completion.
This recommendation is based on good hygiene practices and to prevent inhalation of foreign
particulates, rather than concern about infection or toxicity to humans.
7.1.3.
It is highly improbable that the dose and routes of administration of the vaccine would have
significant adverse effects on the health and safety of the public.
7.1.4.
It is highly improbable that the vaccine could form an undesirable self-sustaining population and
would have significant adverse effects on the health and safety of the public.
7.2. Adverse effects on any valued species
Through the intended dose and routes of administration
7.2.1.
IBV-associated disease has only been recorded in chickens, and no adverse effects have been
reported from the intended use of this vaccine.
7.2.2.
The vaccine is intended to be administered to poultry in the form of a vaccine to protect against IBVassociated disease. This vaccine has a strong safety record, with acknowledged potential for mild
and transitory reactions in inoculated chickens including gasping, snicking and railing lasting up to
three days, and sneezing and coughing for up to 10 days.
7.2.3.
Vaccination of commercial poultry for IBV using a combination of live attenuated and inactivated
vaccines is standard practice in New Zealand (Bernardi, 2008).
7.2.4.
It is highly improbable that the dose and routes of administration of this vaccine will have significant
adverse effects on any valued species.
Through establishment of a self-sustaining population
7.2.5.
Chickens are a valued species in New Zealand; they are reared commercially for meat and egg
production, and domestically in ‘backyard flocks’. As noted above, chickens are the only known
natural, susceptible host of IBV, and it is highly improbable that the intended use of the vaccine will
result in adverse effects to those chickens treated with the vaccine.
7.2.6.
There is potential for the vaccine strain of IBV to mutate, or recombine with circulating field strains of
IBV. Mutation of the vaccine strain, similarly with mutation of wild-type field strains, could result in a
more virulent variant of IBV. There is also potential for the vaccine strain to spread to non-vaccinated
birds, providing an environment where mutation or recombination is more likely to occur.
7.2.7.
A more virulent strain could cause adverse effects on commercial and domestic chicken, such as
clinical disease which has animal welfare consequences.
7.2.8.
Proposed control 2 requires that the vaccine only be used in accordance with OIE best practice
including concurrently vaccinating all animals on site at the dosage recommended by the
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manufacturer. These precautions reduce the potential for back-passaging of the virus, and the
subsequent potential for mutation or recombination.
7.2.9.
There is also potential for the vaccine to spread to wild birds, who could act as vectors or reservoirs
for the virus, or as a source of genetic material for recombination. There is no evidence to indicate
that acting as a reservoir results in significant adverse effects on wild birds. In addition, proposed
control 2 reduces the potential for spread to wild birds.
7.2.10. Given that IBV-associated disease is not known in non-avian species, we have not identified any
potential adverse effects on valued species of the non-avian variety.
7.2.11. Taking into account the proposed controls, it is highly improbable that the vaccine could form a selfsustaining population and would have significant adverse effects on valued species.
7.3. Adverse effects on natural habitats and the environment
7.3.1.
IBV has only been recorded as causing disease in chickens; there is no known potential impact from
these diseases on natural habitats or the wider environment.
7.3.2.
It is highly improbable that the vaccine could form a self-sustaining population and would have
significant adverse effects on natural habitats or the environment.
8.
Recommendation
8.1.1.
We recommend that this application to release from containment and/or import for release Avian
infectious bronchitis virus (Massachusetts serotype, #1263 strain) be approved subject to the
following controls:
Control 1
The organism may only be released in the form of the vaccine known as Poulvac IB MM
or Zoetis Bron-Mass vaccine.
Control 2
The vaccine must be used in accordance with OIE best practice including concurrent
vaccination of all animals on site, at the dosage recommended by the manufacturer.
8.1.2.
We have consulted with the applicant on the proposed controls, and they indicated that the controls
are consistent with current practice.
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9.
References
Awad F, Chhabra R, Baylis M, Ganapathy K, 2014. An overview of infectious bronchitis virus in chickens.
World’s Poultry Science Journal 70: 375-383.
Bengelsdorff HJ, Lohr JE, 1975. Vaccination of young chickens with live vaccine against some New Zealand
isolates of infectious bronchitis virus. New Zealand Veterinary Journal 23: 85-92.
Bernardi E, 2008. Impact and control of Infectious Bronchitis in layers and breeders. Pacific Vet Technical
Bulletin, Winter 2008.
Cavanagh D, Naqi SA, 1997. Chapter 18: Infectious Bronchitis. In Calnek BW, Barnes HJ, Beard CW, Reid
th
WM, McDougald LR, Saif YM (Eds.), Diseases of Poultry, 10 Edition, The Iowa State University
Press, Ames, Iowa, pp511-525.
Domanska-Blicharz K, Jacukowicz A, Lisowska A, Wyrostek K, Minta Z, 2014. Detection and molecular
characterisation of infectious bronchitis-like viruses in wild bird populations. Avian Pathology 43(5):
406-413.
Ignjatović J and Sapats S, 2000. Avian infectious bronchitis virus. Re Revue Scientifique et Technique 19:
493-508.
Howell J, 1992. Viral diseases and the New Zealand poultry industry. Surveillance 19(2):15-17.
Hughes LA, Savage C, Naylor C, Bennett M, Chantrey J, Jones R, 2009. Genetically Diverse Coronaviruses
in Wild Bird Populations of Northern England. Emerging Infectious Diseases 51(7): 1091-1094.
Kim H-R, Oem J-K, 2014. Surveillance of Avian Coronaviruses in Wild Bird Populations of Korea. Journal of
Wildlife Diseases 50(4): 964-968.
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