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FDA's New Recommendation for Universal Zika Risk Reduction of Blood Components Includes Use of Pathogen Reduction  Fatalities Reported to FDA Following Blood Collection and Transfusion | Cerus Workshop at AABB Annual Meeting October 25, 2016: Pathogen Reduction: What's Next?  | Science Section: What We're Reading | Calendar of Events
FDA's New Recommendation for Universal Zika Risk Reduction of Blood Components Includes Use of Pathogen Reduction
On August 26, 2016, the US FDA issued a revised guidance document, titled "Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components," which extends its recommendation of appropriate blood safety measures to apply to all U.S. blood centers. Use of pathogen reduction, such as the INTERCEPT Blood System for platelets and plasma, is specified as an acceptable safety measure. In contrast to the original Zika guidance issued in February, the revised guidance now recommends that Zika risk reduction measures be implemented outside of areas with active local transmissions (currently Florida and Puerto Rico). For the 11 states considered proximate to the current areas of local transmission or at increased risk for local mosquito-borne cases due to other Zika risk factors (Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina, and Texas), implementation is required within 4 weeks. All other states have 12 weeks to comply with the revised guidance.

 Read the Revised FDA Guidance on Reducing the Risk of Zika Virus Transmission
Fatalities Reported to FDA Following Blood Collection and Transfusion
The FDA’s Center of Biologics Evaluation and Research (CBER) published reported fatalities following blood collection and transfusion for the 2015 fiscal year. Forty-one transfusion related fatalities were reported in 2015, of which 5 are attributed to bacterial contamination. Though reports of bacterial contamination over the past 13 years has been trending downward in apheresis platelet components, bacterial contamination remains a public health concern as addressed in the FDA’s draft guidance to mitigate bacterial contamination1. As per FDA draft guidance and a recent single-center study 2, it is thought that transfusion-associated sepsis reactions are grossly under-reported due to passive surveillance methods; active reporting suggests patient risk that is ~10- fold higher than passive surveillance. (Hong H et al, Blood. 2016 Jan 28)

Read Fatalities Reported to the FDA, FY 2015 
1Read the FDA Draft Guidance for Bacterial Risk Control Strategies
2 Read Hong, H et al. Blood. 2016 Jan 2016 abstract
Cerus Workshop at AABB Annual Meeting October 25, 2016: Pathogen Reduction: What’s Next?
The need for and interest in pathogen reduction technology (PRT) is evident with recent regulatory guidances that include PRT, as well as the rapid adoption of the INTERCEPT Blood System for platelets and plasma since FDA approval in 2014. Over 25 US institutions have adopted the INTERCEPT Blood System for platelets and plasma to help protect against a broad spectrum of pathogens, including bacteria and emerging pathogens. With INTERCEPT Platelets and Plasma well underway in terms of commercial adoption, Cerus continues its strive toward improved blood safety with the development of the INTERCEPT Blood System for Red Blood Cells. Recently, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), agreed to support Cerus’ clinical development program for pathogen reduction of red blood cell (RBC) components. This workshop features a US hospital’s perspective in the implementation and routine use of INTERCEPT-treated platelets for its patients. An overview of BARDA-funded activities will also be presented, including the clinical trial to assess the safety and efficacy of INTERCEPT RBCs in Puerto Rico, as well clinical development programs in support of US development, manufacturing, and licensure of the INTERCEPT Blood System for Red Blood Cells.

Cerus AABB Workshop
Science Section: What We’re Reading

Evidence of Transmission of Zika Virus by Platelet Transfusion
Motta et al, N Engl J Med, 17 August 2016
Read the letter
 
Development of a multisystem surveillance database for transfusion-transmitted infections among blood donors in the United States
Dodd et al, Transfusion. 25 August
2016
Read the abstract
 
Effect of texture of platelet bags on bacterial and platelet adhesion
Hadjesfandiari et al, Transfusion. 23 August 2016
Read the article

Culex Mosquitos are experimentally unable to transmit Zika Virus
F Amraoui et al, Eurosurveillance, Volume 21, Issue 35, 01 September 2016
Read the article

Descriptive Epidemiology of Escherichia Coli Bacteraemia In England, April 2012 to March 2014
S Bou-Antoun et al, Eurosurveillance, Volume 21, Issue 35, 01 September 2016
Read the article


Experimental Investigation of the Susceptibility of Italian Culex Pipiens mosquitoes to Zika Virus Infection
D Boccolini et al, Eurosurveillance, Volume 21, Issue 35, 01 September 2016
Read this article 
Calendar of Events

AABB (American Association of Blood Banks) Annual Meeting
October 22-25, 2016 | Orlando, FL  
Additional Information


ASA (American Society of Anesthesiologists) Annual Meeting
October 22-26, 2016 | Chicago, IL  
Additional Information

ASH (American Society of Hematology)
December 3-6, 2016 | San Diego, CA

Additional Information

BMT Tandem Meetings
February 22-26, 2016 | Orlando, FL

Additional Information
Data for pathogen reduction of ZIKA by the INTERCEPT Blood System, pathogen reduction system, has not been submitted for FDA review.
There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.

CONTRAINDICATIONS: Contraindicated for preparation of plasma and platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet and plasma components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS and PRECAUTIONS: Only INTERCEPT Processing Sets for platelets and plasma are approved for use with the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet and plasma components. No other source of UVA light may be used. Please refer to the Operator's Manual for the INT100 Illuminator. Discard any platelet or plasma components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl) phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

PLATELETS: INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.


PLASMA: Amotosalen-treated plasma may cause the following adverse reaction Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.

INTERCEPT Blood System for Red Blood Cells is in development and not available for sale.


Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-15
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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