This content is current only at the time of printing. This document was printed on 11 September 2020. A current copy is located at http://www.xlg888.com/node/12871
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Hendra virus vaccine
Hendra virus can transfer from animals to people.
Hendra virus can cause disease in horses and rarely in humans. The Hendra virus naturally occurs in flying foxes and it can be transmitted from flying fox to horse, horse to horse, and horse to human.
The Hendra virus vaccine was registered on 4 August 2015. Details about the registered product, including the approved label are on the APVMA chemicals database.?The product number is 68996.
Prior to its registration the vaccine was made available for use in Australia in 2012 under an APVMA permit. The permit was issued as an additional tool to biosecurity measures in response to the increase in Hendra virus cases at the time. This permit is no longer in use as the product is now registered.
1. About the Hendra virus vaccine product
Equivac? HeV virus vaccine is a 1mL vaccine that is injected intramuscularly in horses. Equivac? HeV virus vaccine is a ‘subunit’ vaccine, meaning it contains only a small part of the protein from the virus surface. It does not contain the virus.?The active constituent is the G-Protein (sG) of Hendra virus.
2. Duration of immunity
The previously approved instructions for the product indicated that a booster dose of the vaccine is required every 6 months. The APVMA has now approved a variation application to extend the duration of immunity to 12 months. The data provided with the variation application demonstrated that horses vaccinated with the product developed immunity for up to 12 months.
3. Mandatory vaccination
Mandatory vaccination requirements put in place in the equine industry, event organisers and by some veterinarians are outside the scope and jurisdiction of the APVMA—they are not requirements of the APVMA.
The APVMA’s role is very specific in terms of assessing whether the vaccine is safe to use and is effective.
4. Safety considerations
Before granting registration of the product the APVMA was satisfied that the vaccine—used in accordance with the approved instructions—would:
- not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues
- not be likely to have an effect that is harmful to human beings
- not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
The instructions included in the approved label for the product include specific directions for use, advice to people administering the vaccine, as well as precautions and health warnings.
5. Effectiveness of the vaccine
Before granting registration of the product, the APVMA was satisfied that the product—when used as instructed—would be effective as an aid in the prevention of clinical symptoms of the disease caused by Hendra virus. That is when it is administered with a booster dose every 12 months after the primary vaccination course.
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.
Detailed practical advice on the appropriate precautions to take is available from:
- Queensland Government Department of Agriculture, Fisheries and Forestry
- NSW Department of Primary Industries.
6. Animal safety warnings
The approved instructions include specific safety warnings such as:
- the product should not be used in sick or immunocompromised horses
- the potential for interactions when administered with other vaccines and veterinary medicines is not known.
Horse owners considering having the vaccine administered to a horse in any of these circumstances should seek the advice of their veterinarian.
7. Potential side effects of the Hendra virus vaccine
The approved label lists potential side effects, including:
- swelling and soreness at the site of vaccination
- increase in body temperature
- loss of appetite
- muscle stiffness and swelling in the joints (oedema)
- skin rashes (urticaria)
These symptoms are generally short-lived and are typical of many vaccines. As with all vaccines, side effect symptoms may vary in severity and on some occasions may require veterinary intervention.
Although some side effects may be expected, it is important that people who observe an adverse effect report them to the veterinarian who administered the vaccine, the registration holder, or the APVMA.