Swine producers have a new conditionally licensed vaccine from Pfizer Animal Health to help protect their herds from the pandemic H1N1 (pH1N1) strain of Swine Influenza Virus (SIV).

Pfizer Animal Health today announced that its Swine Influenza Vaccine, pH1N1 – Killed Virus, has been approved by the US Department of Agriculture (USDA) for vaccination of healthy swine, including pregnant sows and gilts, three weeks of age or older against SIV subtype H1N1.

Pfizer Animal Health became the first US biologics manufacturer to receive a USDA conditional licence for this new vaccine. Earlier this year, the USDA provided a master seed of the pH1N1 strain to multiple manufacturers in anticipation of potential transmission in swine herds. Producers today have not detected widespread transmission of the pH1N1 strain within swine herds.

Gloria Basse, senior director of the US swine business for Pfizer Animal Health, said: "This gives us hope that this pH1N1 strain can be managed by producers like any other seasonal swine flu strain in pigs."

Producers are advised to consult their veterinarian on the use of this new conditionally-licensed vaccine, as well as continue to follow American Association of Swine Veterinarians and National Pork Producers Council recommendations for routine flu preventive measures.

Pfizer Animal Health has built an adequate inventory of this new vaccine to ensure supply in key pork-producing states. Local use of the new pH1N1 vaccine requires the approval of state veterinarians and Pfizer Animal Health is working to achieve state-by-state approvals.

Steve Sornsen, DVM, MS, director of veterinary services for Pfizer Animal Health, commented: "Our new conditionally licensed pH1N1 vaccine adds another valuable swine influenza management tool to Pfizer Animal Health's FluSure XP^TM Defense System toolbox.

"This new vaccine was developed from the USDA master seed virus and helps protect pigs against current pH1N1 strains circulating in humans and pigs. Serologic studies in pigs vaccinated with this vaccine showed an increase in antibody titres against the pandemic H1N1 strain."

Pfizer Animal Health's new vaccine is a freeze-dried preparation containing the A/California/04/2009 (H1N1) isolate and requires a 2-mL dose and a booster after three weeks. The new vaccine is available in 50-dose and 250-dose sizes.

It also contains Amphigen® to help stimulate immune responses, using the animal's natural defense system to rapidly fight disease. Amphigen was developed for excellent syringeability at any temperature, making vaccination easier.

For more information about this new vaccine, producers should talk with their veterinarian or local Pfizer Animal Health representative, or visit the dedicated web site [click here].

USDA explains conditional licensing

“USDA and its partners in animal health have worked hard to expedite the development of a vaccine for the 2009 pandemic H1N1 influenza virus,” said Cindy Smith, Administrator of the US Department of Agriculture Animal and Plant Health Inspection Service. “This vaccine will help producers protect their swine herds and protect themselves from economic losses in the event that their herds contract this virus.”

On 2 June 2009, the Center for Veterinary Biologics informed interested parties that the agency would provide pre-approved Master Seed Viruses to be used for development of a conditionally licensed pandemic H1N1 vaccine to protect swine. In the event that the pandemic H1N1 virus would become an emerging disease in swine, the availability of pre-approved Master Seed Viruses would facilitate a more rapid response should vaccine production be warranted. On 10 September 2009, Secretary Vilsack announced that USDA was expediting development of the H1N1 vaccine to protect swine.

USDA's Animal and Plant Health Inspection Service (APHIS) issues conditional licences for veterinary biologics products to meet an emergency situation, limited market, local situation or special circumstance. The special circumstance addressed here is the need for a product to vaccinate pigs against the 2009 pandemic H1N1 virus. Under these regulations, a product that is shown to be pure and safe and that demonstrates a reasonable expectation of efficacy may be licensed while data to establish efficacy and potency are still being obtained.

Conditional licences are generally issued with restrictions and for a limited period of time. In this, case, the product has been issued a conditional licence for one year. At the end of the conditional licence period, data obtained in support of the product’s performance will be evaluated to determine if the conditional licence should be renewed or if a regular product licence may be issued. The product is restricted to use by a veterinarian in those states where use of the product has been approved by the appropriate state regulatory authorities.

Further Reading

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Find out more information on influenza in pigs by clicking here.