Novartis Voluntarily Withdraws Five Lots of Flu Vaccine
Fluvirin Lost 'Minimal' Amount of Potency
Novartis Vaccines & Diagnostics Inc. has initiated a voluntary withdrawal of five lots of its seasonal influenza vaccine Fluvirin in Luer-Lok prefilled syringes. The vaccine manufacturer is asking health care providers to immediately discontinue use of affected vaccine and return any remaining doses.
According to information posted Feb. 4 on the FDA Web site, routine stability testing of the vaccine product revealed a "minor deviation in the potency of the A/Brisbane (H1N1) component of the vaccine."
Beth Birke, Novartis' director of global vaccines communications, told AAFP News Now that the market withdrawal applies only to Fluvirin shipped in the Luer-Lok prefilled syringes. She said the affected lots account for only one-tenth of 1 percent of flu vaccine doses in the United States.
The vaccine met required specifications at the time of its release, according to the FDA, but a monthly check in January identified a minimal decrease in H1N1 antigen content. However, the FDA, the CDC and the manufacturer have agreed that no public health impact is expected, and revaccination of patients who were vaccinated with the affected lots is not necessary.
The affected lots are 878771P, 878772P, 878773P, 878775P and 878776P. All five lots carry May expiration dates.
Novartis sells Fluvirin directly to physicians and through vaccine distributors. Birke said doctors with remaining doses from the affected lots can call the company's customer service department at (800) 244-7668 for information on returning the doses.
Beth Birke, Novartis' director of global vaccines communications, told AAFP News Now that the market withdrawal applies only to Fluvirin shipped in the Luer-Lok prefilled syringes. She said the affected lots account for only one-tenth of 1 percent of flu vaccine doses in the United States.
The vaccine met required specifications at the time of its release, according to the FDA, but a monthly check in January identified a minimal decrease in H1N1 antigen content. However, the FDA, the CDC and the manufacturer have agreed that no public health impact is expected, and revaccination of patients who were vaccinated with the affected lots is not necessary.
The affected lots are 878771P, 878772P, 878773P, 878775P and 878776P. All five lots carry May expiration dates.
Novartis sells Fluvirin directly to physicians and through vaccine distributors. Birke said doctors with remaining doses from the affected lots can call the company's customer service department at (800) 244-7668 for information on returning the doses.
