Ingelvac Provenza®: FAQs

About Ingelvac Provenza®

GENERAL

What is the composition of Ingelvac Provenza®?

Ingelvac Provenza® is a live attenuated influenza vaccine (LAIV), of H1N1 and H3N2 viruses. The vaccine has demonstrated cross-protection against relevant circulating IAV-S strains, and shown a reduction in viral shedding when administered to pigs as early as day one.¹
What are the advantages of a live attenuated influenza vaccine (LAIV) administered intranasally?

An LAIV administered intranasally stimulates a rapid onset of immunity (cell mediated immunity, as well as respiratory mucosal immunity)² at the site of influenza A virus infection.³ In addition, an LAIV administered intranasally may be less stressful to the animals and present less risk of injury for workers.
Why does Ingelvac Provenza® have a single-tier label in the United States?

In September 2015, the US Department of Agriculture/Animal Plant and Health Inspection Service (USDA APHIS) introduced an amended Virus‑Serum‑Toxin Act regulation. The purpose of the change was to replace the existing multi-tier vaccine label system with a single, uniform format. The updated requirements for a simpler label claim system are intended to clearly communicate product effectiveness to veterinarians. Instead of the 'tiered' label claims that manufacturers previously have used to describe the level of efficacy provided, vaccines will all use the same labelling claim:

‘This product has been shown to be effective for the vaccination of healthy <insert name of species> <insert number> weeks of age or older against <insert name of disease>.’

The new label format is accompanied by a standardized summary of the efficacy and safety data, which will be available on a publicly accessible website. Additionally, removal of the previous 4-tier system aims to simplify the APHIS evaluation of efficacy studies by focusing on a basic claim of effectiveness. The change should enable better understanding of product efficacy and safety and the results of the studies conducted.⁴
Download more information on the new Ingelvac Provenza® single-tier label
How will this vaccine change the health of the swine population?

Ingelvac Provenza® demonstrates cross-protection against relevant circulating IAV-S strains and reduces viral shedding if pigs become infected later with a wild type influenza A virus (IAV).¹ Reducing IAV circulation in the population can help decrease the burden of the disease in a swine operation and help producers capture unrealized potential.^5,6
Where can I find more information on influenza A virus in swine?

Visit www.aboutswineinfluenza.com for information about the disease, its transmission, and its impact on production.

References: 1. BIAH studies #2013200, 2013232, and 2014001 published on http://productdata.aphis.usda.gov. 2. Vincent AL, Ma W, Lager KM, et al. Efficacy of intranasal administration of a truncated NS1 modified live influenza virus vaccine in swine. Vaccine. 2007;25:7999–8009. 3. Vincent AL, Ma W, Lager KM, et al. Live attenuated influenza vaccine provides superior protection from heterologous infection in pigs with maternal antibodies without inducing vaccine-associated enhanced respiratory disease. J Virol. 2012;86(19):10597–10605. doi:10.1007/s12250-014-3471-5. 4. Department of Agriculture. Federal Register. Viruses, serums, toxins, and analogous products; single label claim for veterinary biological products. https://www.federalregister.gov/documents/2015/07/10/2015-16898/viruses-serums-toxins-and-analogous-products-single-label-claim-for-veterinary-biological-products. Published July 10, 2015. Accessed May 14, 2017. 5. Donovan T. The role of influenza on growing pig performance. In: Proceedings of Allen D. Leman Conference, September 17–20, 2005; St. Paul, MN. 6. Dykhuis Haden C, Painter T, Fangman T, Holtkamp D. Assessing production parameters and economic impact of swine in influenza, PRRS and Mycoplasma hyopneumoniae on finishing pigs in a large production system. In: Proceedings of the 43rd American Association of Swine Veterinarians Annual Meeting; March 10–13, 2012; Denver, CO: 75–76.