Flu Vaccine Approved in Prefilled Syringe
The Tip-Lok syringe reduces administration steps.
FDA has approved Fluarix, a new influenza vaccine from GlaxoSmithKline (GSK), in time for the 2005–2006 flu season. Cleared for U.S. marketing under accelerated approval regulations, Fluarix is packaged in 0.5-ml single-dose prefilled glass syringes made by BD Medical-Pharmaceutical Systems (Franklin Lakes, NJ). GSK is shipping about 8 million doses this season.
Marketed by GSK under the brand name Tip-Lok, the prefilled syringes are used for GSK’s family of vaccines, which in addition to Fluarix includes Boostrix, Engerix-B, Havrix, Infanrix, Pediarix, and Twinrix. “The biggest advantage of the prefilled syringe is that it streamlines the vaccination process,” explains Johnny Im, senior product manager, vaccine marketing, for GSK. “We’ve cut the process from 12 steps to three. All nurses need to do is uncap the syringe, put a needle on it, and deliver the vaccine.”
GSK applies labels to the Tip-Lok syringes that include peel-off stickers for affixing to patient charts. “Medication errors are a major concern. With brand name, vaccine type, lot number, and expiration date printed on the peel-off labels, nurses do not need to write these details down, eliminating the chance for error,” says Im. GSK also recently redesigned these labels to add a bar code with the National Drug Code. Im ads, “GSK is always seeking improvements to its delivery system for vaccines and most recently has added separate color bands around the syringes for easier product identification.”
Im says that GSK is also considering adding tamper evidence to the syringes.
To help nurses get used to administering vaccines with prefilled syringes, GSK has produced demonstration kits with dummy syringes. The company has also created comprehensive sales materials and brochures to explain the benefits of the Tip-Lok syringe to vaccine administrators.
Submitted for review on May 25, 2005, Fluarix was approved August 31, 2005. Indicated for adults 18 and older against influenza disease, Fluarix is currently distributed in 79 countries in prefilled Tip-Lok syringes.