Value Through Innovation17 April 2014

CALVENZA

Equine Rhinopneumonitis + Influenza Vaccine

Calvenza™ Logo

For the vaccination of healthy, susceptible horses 6 months of age or older, including pregnant mares, as an aid in reduction of respiratory diseases caused by equine herpesvirus type 1 (EHV-1) and type 4 (EHV-4), and by equine influenza virus types A2 North American and A2 Eurasian.

CALVENZA family of vaccines:

  • CALVENZA EHV
  • CALVENZA -03 EIV
  • CALVENZA -03 EIV/EHV

This product has been tested under laboratory conditions and shown to meet all Federal standards for safety and efficacy in normal, healthy, immunocompetent animals. This level of performance may be affected by conditions such as stress, weather, nutrition, disease, parasitism, other treatments, individual idiosyncrasies or impaired immunological competency. These factors should be considered by the user when evaluating product performance or freedom from reactions.

Store at a temperature between 35° - 45° F (2° - 7° C). Protect from freezing. Shake well before using. Do not vaccinate within 21 days of slaughter.

CAUTION: Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

  • Incorporates the emerging North American EIV strain (Ohio/2003), as well as an established North American EIV strain (Kentucky/2/95).Also incorporates a relevant Eurasian EIV strain (Newmarket/2/93).
  • Also incorporates a relevant Eurasian EIV strain (Newmarket/2/93).
  • Unique EHV-1 equine respiratory origin isolate.
  • Stimulates antibody to EHV-1 & EVH-4.
  • Novel adjuvant.
  • Safe, all killed vaccine.
  • Includes innovative pliable nasal applicator.
  • Flexible dose administration.
  • No reversion to virulence concern.
  • Minimal vaccine site reactions.

Using aseptic technique inoculate horses IM with a 2 mL dose. Administer a second 2 mL dose IM in 3-4 weeks using a different injection site. Administer a third 2 mL dose in 3-4 weeks IM or IN.

  • Is there any equine rhinopneumonitis vaccine that protects against the neurological form of equine herpes?

    Currently there are no manufacturers that have a product indication offering protection against the neurological form of herpes.

  • CALVENZA has multiple studies supporting efficacy and immunity. Other flu/rhino products have similar data to support them don't they?

    Absolutely not. No other flu/rhino vaccine has as much third party data, or as many six and twelve month challenge studies as does CALVENZA. There is a difference between vaccines, and it's been proven by multiple studies.

    • Third party challenge study of three commercial killed vaccines1
    • Influenza North American and Eurasian A2 cross-protection study2
    • Influenza challenge study to demonstrate initial efficacy of two doses following two different administration protocols (IM/IM and IM/IN)2
    • Six month duration of immunity study2
    • Twelve month duration of immunity study2
    • Two EHV-1 and two EHV-4 challenge studies3
  • What makes CALVENZA different from other influenza vaccines in the U.S.?

    CALVENZA incorporates a high antigen mass, flexible administration and a relevant Eurasian A2 influenza strain. These unique features, coupled with an effective adjuvant and a relevant North American A2 influenza strain, make this a very effective influenza vaccine.

  • Does CALVENZA EHV protect mares from EHV-1 abortion?

    CALVENZA has been proven safe for use in pregnant mares and is labeled accordingly. The use of CALVENZA for the aid in prevention of abortion is considered off-label use of the vaccine.

  • Why give three initial doses of CALVENZA?

    Independent studies in recent years and experience with intensive vaccination protocols in Europe and elsewhere, have shown two-dose protocols to be less effective in producing immune responses that are consistently effective and long lasting when using killed antigens. Current AAEP vaccination guidelines recommend using a three-dose initial series for all killed vaccines.

  • Will I experience site reactions with CALVENZA?

    CALVENZA enjoys a reputation for being very smooth. Field safety trials, as well as feedback from clinical usage, indicate that a very low incidence of site reactions can be expected when CALVENZA is administered I.M.

  • Can CALVENZA be used to booster horses that have been on a regular vaccination schedule with another EIV/EHV vaccine?

    With a high antigen mass and relevant North American A2 influenza strains, CALVENZA should be an ideal vaccine to booster conventional EIV/EHV vaccines. However, the intramuscular route would be recommended for initial booster administrations following other manufacturer's vaccines. Also, the full advantages of CALVENZA may not be realized until a series of CALVENZA administrations have been completed.

  • Why were six and twelve month duration of immunity studies performed on the EIV fraction of CALVENZA?

    Boehringer Ingelheim Vetmedica is a global manufacturer of veterinary products. CALVENZA was developed to be a superior vaccine for use by veterinarians in the United States and other countries. Some of these countries require a higher standard of performance to achieve governmental approval. CALVENZA can be used with confidence knowing these additional studies have been performed to demonstrate exceptional efficacy and longer immunity.

  • Aren't all carbomer-based adjuvant systems the same?

    No. Studies presented at the 2003 annual AAEP meeting clearly showed that vaccines incorporating properly formulated carbomer-based adjuvant systems produced higher antibody titers than vaccines containing other adjuvant systems. CALVENZA outperformed other carbomer-based vaccines.1 If sufficient antigen mass is not present for the adjuvant to amplify, the immune response and overall vaccine performance will be compromised no matter what strains or adjuvants are involved.

  • Does CALVENZA have supporting studies?

    Yes, among studies available Dr. Jenny Mumford and colleagues at the Animal Health Trust in Newmarket, England performed six and twelve month post vaccination challenge studies. The results of those studies demonstrated a significant reduction of severity and incidence of clinical signs, as well as quantity and duration of viral shedding in vaccinates versus non-vaccinated controls following challenge with virulent EIV.4

  • I've heard that if a vaccine doesn't have the "latest" North American influenza strain that it's not effective. Is that true?

    Virus strains are always a topic of conversation but are frequently misunderstood. The "strain game" is not as important as you might think. Most isolates identified in the United States in recent years show little evidence of relevant antigenic drift. CALVENZA generates high levels of cross-reactive antibodies to a wide range of other relevant North American and Eurasian subtypes of EIV A2 viruses.2

  • Does CALVENZA provide effective protection against rhinopneumonitis (herpesvirus)?

    Research leading to the original approval of CALVENZA had to prove to the satisfaction of USDA/APHIS that it provides protection against both EHV-1 and EHV-4. That is why CALVENZA is approved for both types of EHV and Boehringer Ingelheim Vetmedica is allowed to state this on the label indications. All four EHV challenge studies demonstrated the ability of CALVENZA to reduce the signs of clinical disease and virus shedding in vaccinated horses following challenge as compared to non-vaccinated control horses. CALVENZA clearly demonstrated effective cross-protection against EHV-4 based on challenge.3

References

1 Townsend, H.G., et al. 49th Annual Convention of the American Association of Equine Practitioners, 2003 Proceedings. 
2 The Animal Health Trust, Newmarket, Suffolk England CB8 7UU 
3 Summit Research, Inc.
4Data on file.