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Pfizer’s H1N1 Vaccine for Swine Flu Receives Conditional Approval

Posted: Monday, Dec. 14, 2009, 6:29 p.m., EST

Pfizer’s H1N1 Vaccine for Swine Flu Receives Conditional ApprovalPfizer Animal Health has received a conditional product license for its Swine Influenza Vaccine, designed to protect swine herds from the H1N1 strain of swine influenza virus.

The vaccine has been approved by the U.S. Department of Agriculture for vaccination of healthy swine, including pregnant sows and gilts, three weeks of age or older.

Earlier this year, the USDA provided a master seed of the H1N1 strain to multiple manufacturers in anticipation of potential transmission in swine herds. Pfizer Animal Health reported that it is the first U.S. biologics manufacturer to receive a USDA conditional license for this new vaccine.

“This new vaccine was developed from the USDA master seed virus and helps protect pigs against current H1N1 strains circulating in humans and pigs,” said Steve Sornsen, DVM, director of veterinary services for the New York-based company. “Serologic studies in pigs vaccinated with this vaccine showed an increase in antibody titers against the pandemic H1N1 strain.”

Local use of the new vaccine requires the approval of state veterinarians. Pfizer Animal Health reported that it’s working to achieve state-by-state approvals.

The vaccine, available in 50-dose and 250-dose sizes, 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 vaccine also contains Amphigen to help stimulate immune responses, using the animal’s natural defense system to rapidly fight disease, according to Pfizer Animal Health.

Dr. Sornsen said that the new vaccine adds another valuable swine influenza management tool to the company’s FluSure XP Defense System toolbox. <HOME>

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