Safety, health and side effects

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.

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.

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.

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
• lethargy
• loss of appetite
• muscle stiffness and swelling in the joints (oedema)
• skin rashes (urticaria)
• colic.

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.