Novartis Replacing Flu Vaccine Syringes with Fixed Needle

Novartis has agreed to replace syringes pre-filled with Fluvirin 2008/2009 influenza vaccine with syringes that have a connection allowing safety needles to be attached, the California Department of Public Health announced. Novartis, which makes the vaccine in Rosia, Italy, and Liverpool, England, facilities and has FDA approval to distribute it in pre-filled syringes, agreed to the modification after CDPH learned that syringes distributed nationwide have a permanently affixed 5/8-inch needle and lack a safety device to protect the user from needlesticks. Cal/OSHA requires employers to use syringes and needles with built-in engineered sharps injury protection, and most employers in other states are required by OSHA standards to provide this protection, the agency noted.

Novartis announced Aug. 7 that it had begun shipping the products to the United States and would have at least 20 million doses available by the end of September 2008. The announcement said the company, which is based in Basel, Switzerland, planned to produce up to 40 million doses of Fluvirin.

Beth Birke, director of Global Vaccines Communications for Novartis Vaccines and Diagnostics, Inc. of Cambridge, Mass., said Fluvirin was available in three ways: a multidose vial (majority of doses), a pre-filled syringe with a fixed 5/8 inch needle and a pre-filled syringe with a Luer Lock. Less than 5 percent of Fluvirin doses produced are in the fixed 5/8-inch needle presentation, she said in an Oct. 28 e-mailed message. Birke said Novartis Vaccines has stopped shipping Fluvirin vaccine in pre-filled syringes with 5/8-inch fixed needles unless specifically requested and is not distributing the vaccine with fixed needles in the state of California; she also said 21 states have adopted some level of federal OSHA needle standards, but "only a limited number require attached safety devices. California has the strictest standards in the country."

Novartis has agreed to replace the non-compliant pre-filled syringes with other available Fluvirin product presentations (not necessarily Luer Lock) that meet California regulations, Birke said.

The CDPH notice links to a photo of the syringe. Novartis has agreed to replace the pre-filled syringes that lack safety devices with syringes with a "luer" connection so safety needles can be attached, the agency said. The Cal/OSHA Consultation Service safe needles fact sheet, says the Cal/OSHA rule has been in effect since July 1999. The Novartis influenza vaccine online ordering portal has new announcements and information about its vaccine development.

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