Maree Zinzley, Manager Approvals, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) that the following variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: Equivac HeV Hendra Virus Vaccine for Horses

Reference: A11122-03

Active Ingredients and Concentrations:

100µg/mL G-Protein [sG] of Hendra Virus

Formulation Type: Aqueous Solution

Current use pattern:

For primary immunisation two doses of vaccine should be administered three to six weeks apart. Effective levels of serological antibodies for the control of Hendra virus infection develops approximately 21 days after administration of the second dose of vaccine. Primary immunisation should be completed in advance of when the desired vaccination effect is needed. When horses were challenged with Hendra virus approximately six months after receiving the primary vaccination course, 100% of the horses were found to be fully protected from clinical signs of Hendra virus disease. At this stage, data to support greater than six months duration of protection is not available. Therefore, Zoetis recommends that a booster dose of the vaccine be administered six months after the completion of the primary immunisation course.

Proposed new use pattern (changes in bold):

For primary immunisation two doses of vaccine should be administered three to six weeks apart. A third dose six months after the second primary dose is also required. Booster doses are required annually (12 months) thereafter. When vaccinating foals born to mares vaccinated with Equivac HeV, it is recommended that the foal’s primary vaccination course be delayed until six months of age to ensure an effective immune response to vaccine antigen. This product has been found to be safe for administration to pregnant mares. However, in pregnant mares it is important to avoid the use of vaccines during critical stages of pregnancy. For this reason, avoid vaccinating during the first 45 days after mating and the last 14 days before the expected date of foaling.

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission;
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.

Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.

The following address is:

1. where submissions on this application are to be sent;
2. where requests for copies of the public information relating to the application can be sent;
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Zoetis New Zealand Limited, Level 4, 8 Mahuhu Crescent, Auckland Central, Auckland 1010. Postal Address: PO Box 2094, Shortland Street, Auckland 1140.

Dated at Wellington this 28th day of July 2021.

MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).