FDA Team Completes Inspection of Chirons Liverpool Flu Vaccine Plant; None of the Vaccine is Usable
The Food and Drug Administration (FDA) announced Friday that none of the influenza vaccine manufactured by the Chiron Corporation for the U.S. market is safe for use. This determination is based on FDA's evaluation and inspection of Chiron's influenza vaccine manufacturing plant in Liverpool, England.
The purpose of the FDA inspection was both to evaluate Chiron's investigation, testing and assessment of the defects detected in nine of the one hundred lots of their finished flu vaccine (Fluvirin) manufactured for this year's flu season and also to evaluate their determination that the risk of defects was confined to those specific lots.
The safety of the vaccine supply is of the highest priority to FDA and the Department of Health and Human Services. FDA has provided Chiron with its inspectional observations and has met with the company to evaluate their response and assure that the necessary corrective actions are taken. The FDA will work with Chiron and the UK government in correcting the deficiencies in the plant.
The Department of Health and Human Services will continue to exhaust every avenue to secure more flu vaccine for this season. Literally every known manufacturer of flu vaccine in the world is being contacted and some progress is being made. Additionally, the quarantined lots of Chiron vaccine already in the United States are being ever further evaluated. We do not want to create false hope but we want to explore every option, FDA officials said.
Source: FDA
Pioneering Advances in Sterilization: The Future of Infection Control
November 28th 2024Germitec, STERIS, ASP, and Zuno Medical are pioneering sterilization advancements with groundbreaking technologies that enhance SPD workflows, improve patient safety, and redefine infection control standards.
Genomic Surveillance A New Frontier in Health Care Outbreak Detection
November 27th 2024According to new research, genomic surveillance is transforming health care-associated infection detection by identifying outbreaks earlier, enabling faster interventions, improving patient outcomes, and reducing costs.
Point-of-Care Engagement in Long-Term Care Decreasing Infections
November 26th 2024Get Well’s digital patient engagement platform decreases hospital-acquired infection rates by 31%, improves patient education, and fosters involvement in personalized care plans through real-time interaction tools.
Comprehensive Strategies in Wound Care: Insights From Madhavi Ponnapalli, MD
November 22nd 2024Madhavi Ponnapalli, MD, discusses effective wound care strategies, including debridement techniques, offloading modalities, appropriate dressing selection, compression therapy, and nutritional needs for optimal healing outcomes.
