FDA Clears GlaxoSmithKline's New Safe Syringe For Vaccine Delivery

WASHINGTON (Reuters Health) Jun 18 - GlaxoSmithKline said on Monday that it has received clearance from the US Food and Drug Administration (FDA) to market its Safety Tip-Lock syringes for administering vaccines to pediatric patients.

The syringes, which comply with the US Occupational Safety and Health Administration's (OSHA) newly revised blood-borne pathogens standard, will we be available loaded with Becton Dickinson & Co.'s SafetyGlide Needles for pediatric does of Havrix (hepatitis A vaccine, inactivated) and Engerix-B (hepatitis B vaccine, recombinant).

The two products are now the only pediatric vaccines with the Safety Tip-Lock feature and the first to be administered in an all-in-one delivery system, Glaxo said in a news release.

The US-based drug giant is co-marketing the Safety Tip-Lock system, launched on Monday, with Becton Dickinson & Co., Glaxo's exclusive supplier of safety needles and prefillable syringes used in the system, a spokeswoman for GaxoSmithKline told Reuters Health.

The system was designed to comply with the OSHA guidelines, which are intended to help prevent healthcare workers from experiencing needlestick injuries. The OSHA guidelines took effect in April.

One of the safety features of the Safety Tip-Lock is a shield that covers the tip of the needle after it is activated, according to GlaxoSmithKline.

The company estimates that up to 800,000 needlestick injuries and potential exposures to infectious diseases occur each year in the healthcare field. The prevention of this mishap saves costs associated with testing, diagnosing and treating needlestick injuries, the company noted.

Galxo shares were up 0.02 to 55.05 at the close of trading on the New York Stock Exchange on Monday.