GlaxoSmithKline receives FDA approval on first OSHA-compliant, all-in-one vaccine delivery system


GlaxoSmithKline (NYSE:GSK) announced today that it has received U.S. food and Drug Administration (FDA) approval for Safety Tip-LokTM: prefilled Tip-Lok® syringes packaged with BD SafetyGlideTM Needles for pediatric doses of Havrix® (Hepatitis A Vaccine, Inactivated) and Engerix-B® [Hepatitis B Vaccine (Recombinant)]. Havrix and Engerix-B are the first and only pediatric vaccines available with Safety Tip-Lok and the only vaccines to be available with an all-in-one delivery system, which meets the Occupational Safety and Health Administration's (OSHA) newly revised bloodborne pathogens standard. The OSHA standard, designed to help protect healthcare workers from needlestick injuries, went into effect April 18, 2001.

Getting stuck with a contaminated needle is a major concern for many healthcare workers, with up to 800,000 needlestick injuries and potential exposures to bloodborne pathogens occurring each year. The impact of needlestick injuries can be not only physical, but emotional and financial as well. The prevention of needlestick injuries will save costs associated with testing, diagnosing and treating needlestick injuries.

"As a nurse, I am aware of the risks and fears involved with administering injections," said Barbara Ochester, RN, Nurse Educator and Consultant for the Vaccines Business Unit at GlaxoSmithKline. "Healthcare worker safety is crucial but unfortunately often overlooked. GlaxoSmithKline is proud to provide Safety Tip-Lok on the Havrix and Engerix-B pediatric vaccines. The safety needle feature on the prefilled syringe will help protect healthcare workers from contracting dangerous diseases from needlestick injuries."

How It Works Safety Tip-Lok, a new vaccine delivery system, offers unique protection from accidental needlesticks. The BD SafetyGlide Needle has a shield that covers the needletip after activation to help protect the person administering the vaccine from an accidental needlestick. In clinical tests of the BD SafetyGlide Needle, 100 percent of clinicians were able to activate the device with one hand with no instruction; 94 percent said they were comfortable with its ease of activation. The Centers for Disease Control and Prevention estimates that by using safety devices as many as 88 percent of needlestick injuries can be avoided.

"I am comforted that nurses like myself will have the option to administer vaccines that meet the new OSHA requirements and The Needlestick Safety and Prevention Act," said Barbara DeBaun, RN, BSN, CIC, Director, Infection Control, California Pacific Medical Center, San Francisco. "Having hepatitis A and B pediatric vaccines available with the Safety Tip-Lok will improve work conditions and help alleviate fears of contracting debilitating, even deadly, diseases from needlestick injuries."

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