Zika Virus


Zika, a flavivirus, is transmitted by Aedes mosquitoes, most commonly by A. aegypti. This same vector, in addition to A. albopictus, transmits dengue (another flavivirus) and chikungunya (an alphavirus). Other modes of Zika virus transmission include intrauterine, perinatal, and sexual routes. The contribution of sexual transmission to the overall Zika virus risk is unknown at this time.

Zika virus was first described in Africa and subsequently in Asia. It spread further to cause epidemics in the Pacific starting in 2007 on Yap Island, with subsequent spread in 2013 to French Polynesia and beyond. In 2015, Zika was recognized in Brazil and local (autochthonous) transmission has subsequently been reported in numerous countries and territories in the Western Hemisphere including Mexico, the Caribbean, and Central and South America. In addition, active transmission has been reported in tropical areas including several island countries in the Pacific and Cape Verde in the Atlantic. Travel-associated cases have been reported to the Centers for Disease Control and Prevention for several years, but the only vectorial transmissions in the United States have been in the Commonwealth of Puerto Rico, the US Virgin Islands, and American Samoa.

The risk posed by Zika virus to the blood supply is unclear, but the potential for transfusion transmission of Zika virus was suggested when 2.8 percent of asymptomatic blood donors tested positive for Zika viral RNA during the French Polynesian outbreak. The maximum duration of viremia is unknown, but believed to be 1-2 weeks. Although rigorous proof of transfusion transmission is lacking, there appear to be two credible cases from the epidemic in Brazil.

AABB works closely with the FDA, CDC, and the Council of State and Territorial Epidemiologists to continually assess the latest scientific information and develop appropriate tools and policies to reduce the risk of Zika virus transmission through blood transfusions.

2018 Recent Actions

AABB, America’s Blood Centers and the American Red Cross submitted joint comments presenting new information to the Food and Drug Administration (FDA) regarding the universal requirement for individual nucleic acid testing (ID-NAT) for zika virus. The joint comments, include a risk-based approach for use of Minipool (MP)-NAT, using defined triggers for conversion to ID-NAT with return to MP-NAT and request that FDA not delay in issuing final guidance.

2017 Recent Actions

AABB has updated its "Circular of Information for the Use of Human Blood and Blood Components" web page following the FDA's approval for new language to be inserted in the November 2013 Circular. The updates have been made to provide the approved statement regarding the newly licensed Zika virus (ZIKV) nucleic acid test (NAT).

On March 13th, FDA posted a statement regarding Zika Virus (ZIKV) that reflects new epidemiological information on the Centers for Disease Control and Prevention (CDC) website. A retrospective analysis identified a potential increased risk to blood and tissue safety for Broward and Palm Beach counties that dates back to June 15, 2016, associated with the movement of donors between Miami-Dade, Broward, and Palm Beach counties. FDA stopped short of recommending “lookback” activities because the potential risk of ZIKV transmission is considered very low for affected collections. However, FDA offered precautionary measures for donations made prior to testing for ZIKV.

2016 Recent Actions

Texas became the second state in the continental United States to confirm a case of mosquito-borne Zika virus (ZIKV) infection on 11/28/16, when health officials announced that a resident of Cameron County had tested positive for the virus. The county is on the Gulf Coast close to the Mexican border.

AABB, the American Red Cross, and America’s Blood Center presented a joint statement to the Food and Drug Administration’s Blood Products Advisory Committee in response to the August 2016 Zika guidance document.

Food and Drug Administration representatives clarified, during the “Ask the FDA & CMS/CLIA” education session at the AABB Annual Meeting in Orlando, that blood collectors must update their Circular regarding testing for ZIKV using the language provided by their IND sponsor. In addition, since the language in the IND has been reviewed and approved by FDA, blood collectors can report this change to the Circular in the establishment’s Annual report. The clarification was provided in response to the following question: “Following FDA’s August 2016 ZIKV guidance, does FDA continue to require that establishments use language provided in their approved IND for Zika virus testing to update their Circular, or does FDA expect AABB’s Circular of Information Task Force to develop language for the Circular?

AABB released Association Bulletin #16-07, Updated Recommendations for Zika, Dengue, and Chikungunya Viruses, pertaining to two FDA guidance documents. The first, Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components, published Aug. 26 classifies Zika virus (ZIKV) as a relevant transfusion-transmitted infection (RTTI). The second, Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus, published Feb. 16 and will remain in effect until blood establishments have implemented the recommendations contained in the August guidance. AB #16-07 supersedes both AB #16-04 and AB #16-06.

AABB posted an analysis of "Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry” published by the Food and Drug Administration on August 26, superseding both the February 2016 Zika guidance and the March 2016 Zika guidance.

AABB published Association Bulletin #16-06, which supplements Association Bulletin #16-04 and provides additional information about Zika virus infection. Included in the bulletin are recommendations for 1) the availability and use of investigational blood donation screening tests for Zika virus, 2) the use of licensed or investigational pathogen reduction technologies for inactivating Zika virus, 3) actions following the recognition of local transmission as a result of voluntary investigational blood donation testing programs, and 4) posting of data to the AABB Zika Virus Biovigilance Network. The bulletin contains minimal information for HCT/Ps.

AABB posted the table, Tracking Zika Travel Notices, to assist with postdonation information, donor eligibility and inventory management decisions.

FDA approved the Procleix Zika virus blood donor screening assay on the Procleix Panther system under the agency's investigational new drug protocol. The test system is manufactured by Hologic and Grifols.

The Centers for Disease Control and Prevention has posted its Draft Interim Zika Response Plan on Tuesday. The document describes CDC’s response plan for the first locally acquired cases of Zika virus infection in the continental U.S. and Hawaii.

AABB hosted a Zika Virus Symposium on June 10, 2016 in Washington D.C., that addressed the current knowledge of mosquito-borne Zika Virus (ZIKV) and risks facing the continental U.S. Sessions updated the public health and blood safety implications of ZIKV, including FDA recommendations on protecting blood and HCT/P safety and current research on ZIKV screening tests, pathogen inactivation technologies and other blood safety initiatives. Presentations from the symposium are available for purchase on the AABB Marketplace.

AABB, ABC and ARC submitted comments to FDA in response to the agency’s February guidance, “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus.”

The CSTE posted a consensus proposal that State and local health departments can use to identify local vector-borne Zika virus transmissions. It includes steps for forwarding the information to the CDC so it can be used by blood establishments to activate blood safety interventions as described in the current FDA guidance.

AABB, America’s Blood Centers and the American Red Cross expressed concern in a joint letter to Food and Drug Administration officials about the ability of blood establishments to comply with specific recommendations in the February 2016 FDA guidance on reducing the risk of transfusion transmission of Zika virus (ZIKV).

The Centers for Disease Control and Prevention and the Occupational Safety and Health Administration (OSHA) issued an interim guidance to help protect health care and laboratory professionals, outdoor and mosquito control workers, and business travelers from occupational exposure to Zika virus. The guidance contains steps employers can take to protect their workers and methods employees can take to protect themselves.

The FDA published an announcement on the availability of an investigational test, manufactured by Roche, to screen blood donations for Zika virus. Initially, the Roche Zika test, which is the first of its kind, will be deployed to screen blood donations collected in Puerto Rico. The second stage will be to prepare for screening of blood donations collected by blood services in the southern US, which will most likely be impacted by any spread in the virus (Roche Media Release, March 30, 2016).

AABB posted an analysis of "Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus” published by the Food and Drug Administration on February 16 for immediate implementation, and “Question and Answers Regarding Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus” published by the FDA on March 14 to answer common questions received since the publication of the first guidance.

AABB released Association Bulletin #16-04 “Zika, Dengue, and Chikungunya Viruses,” superseding Association Bulletin #16-03 of the same name, following publication of the FDA final guidance, “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus.”

AABB Donor History Task Force posted Zika Additional Questions, compliant with the FDA guidance document, for use with screening blood donors.

AABB Zika Audioconference
Members of the AABB TTD Committee as well as representatives from the CDC and FDA provided an audioconference with updated information on Zika, the FDA recommendations for Zika as explained in the final guidance published the day before, and AABB Association Bulletin #16-03.

The FDA publishes an FDA final guidance, “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus,” with recommendations for blood collections in areas with active Zika virus transmission and areas without active Zika virus transmission. The recommendations can be implemented with ta combination of self-deferral and donor history questions.

AABB releases Association Bulletin #16-03 “Zika, Dengue, and Chikungunya Viruses” recommending self-deferral of blood donors for travel to Zika-affected areas, and use of postdonation information sheets for symptoms related Zika, dengue, and chikungunya following travel to identified tropical areas.