/ en Tue, 29 Apr 2025 03:08:58 -0500 Fri, 24 May 19 11:49:23 -0500 /news/headline/2019-05-24-fda-authorizes-marketing-first-diagnostic-test-detecting-zika-virus <p>The U.S. Food and Drug Administration May 23 <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-diagnostic-test-detecting-zika-virus-antibodies">authorized</a> marketing of a diagnostic test for detecting Zika virus antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S. Previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—were authorized only for emergency use. The ZIKV Detect 2.0 IgM Capture ELISA – for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet the Centers for Disease Control and Prevention’s Zika virus epidemiological <a href="https://www.cdc.gov/zika/symptoms/diagnosis.html">criteria </a>– is designed to identify antibodies produced by the body's immune system in the blood. IgM antibodies indicate an early immune response. </p> Fri, 24 May 2019 11:49:23 -0500 Zika /news/headline/2018-08-24-senate-passes-857-billion-spending-package-including-hhs-funding-bill <p>The Senate last night voted 85-7 to pass an <a href="https://www.congress.gov/bill/115th-congress/house-bill/6157">$857 billion spending package</a>, which includes bills that would fund the departments of Health and Human Services, Defense and Labor for fiscal year 2019. The bill would provide a $2.3 billion increase for HHS from 2018. Among other provisions, the bill would provide $3.7 billion, an increase of $147 million, to continue combatting the opioid epidemic; $325 million, an increase of $10 million, for the Children’s Hospitals Graduate Medical Education program; $319 million, an increase of $28 million, for rural health care programs; and $3.5 billion, an increase of $113 million, to help communities prepare for, respond to, and recover from public health and medical disasters such as influenza, Ebola, Zika and natural disasters. It also would increase funding for the National Institutes of Health by $2 billion. In addition the bill includes a provision, as <a href="/news/headline/2018-08-23-aha-supports-amendment-address-out-control-cost-prescription-drugs">urged</a> by the AHA, to address the out-of-control cost of prescription drugs by providing funding to enable HHS to require disclosure of drug pricing information in direct-to-consumer advertising. The Senate and House are expected to enter into conference negotiations to reconcile their bills. Current funding runs out Sept. 30.</p> Fri, 24 Aug 2018 13:57:24 -0500 Zika /news/headline/2018-08-07-health-problems-reported-14-zika-associated-births-us-territories <p>About 14% of babies age one or older who were born in U.S. territories to pregnant women infected with Zika virus since 2016 have at least one health problem possibly caused by exposure to the virus, the Centers for Disease Control and Prevention <a href="https://www.cdc.gov/vitalsigns/zika-territories/">reported</a> today. About 6% had Zika-associated birth defects, 9% nervous system problems and 1% both. The findings are from 1,450 babies who had follow-up care reported in the U.S. Zika Pregnancy and Infant Registry. Among the recommended <a href="https://www.cdc.gov/pregnancy/zika/testing-follow-up/follow-up-care.html">follow-up care</a>, 95% received a physical exam, 76% developmental screening, 60% brain imaging, 48% a hearing test and 36% an eye exam. Most of the nearly 2,500 pregnancies in U.S. states with possible or confirmed Zika infection have been travel-associated; CDC plans to issue a follow-up report on those cases in coming months.<br />  <br /> “We are still learning about the full range of long-term health problems these babies could face,” <a href="https://www.cdc.gov/media/releases/2018/p0807-Zika-related-health-problems.html">said</a> CDC Director Robert Redfield, M.D. “We thank clinicians for their continued commitment to conduct all necessary tests and evaluations to ensure appropriate care.”<br />  <br /> Based on updated data, CDC today <a href="https://www.cdc.gov/mmwr/volumes/67/wr/mm6731e2.htm?s_cid=%20mm6731e2_w%20">recommended</a> that men with possible exposure to Zika wait at least three months before engaging in unprotected sex if they plan to conceive with their partner or want to prevent transmitting the virus through sex. The previous recommendation was six months.</p> Tue, 07 Aug 2018 14:42:16 -0500 Zika /news/headline/2018-07-06-fda-revises-recommendations-testing-donated-blood-zika <p>The Food and Drug Administration has issued <a href="https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM518213.pdf">final guidance </a> revising its recommendations for testing donated whole blood and blood components for Zika virus. The guidance recommends that establishments collecting whole blood and blood components test all donations collected in the U.S. and its territories using minipool (MP) or individual donation nucleic acid testing, or collect and prepare blood components using pathogen reduction technology with an FDA-approved pathogen-reduction device. The guidance also recommends that establishments using MP NAT convert to ID NAT if screening identifies a Zika-reactive donation or public health authorities identify an increased risk for Zika transmission in the area. FDA previously <a href="/news/headline/2016-08-26-fda-recommends-universal-testing-donated-blood-zika">recommended </a> using ID NAT for all blood donations or pathogen reduction for indicated blood components. The agency said it expects the new recommendations “to adequately and appropriately detect early infections in an outbreak, while reducing the burden of ID NAT testing.”</p> Fri, 06 Jul 2018 14:09:38 -0500 Zika /news/headline/2018-05-01-cdc-illnesses-mosquito-tick-and-flea-bites-triple-over-13-years <p>Illnesses from mosquito, tick and flea bites more than tripled in the United States between 2004 and 2016 to more than 96,000 a year, according to a <a href="https://www.cdc.gov/vitalsigns/vector-borne/">report</a> released today by the Centers for Disease Control and Prevention. More than 642,000 cases were reported over the period. “Zika, West Nile, Lyme, and chikungunya – a growing list of diseases caused by the bite of an infected mosquito, tick, or flea – have confronted the U.S. in recent years, making a lot of people sick. And we don’t know what will threaten Americans next,” <a href="https://www.cdc.gov/media/releases/2018/p0501-vs-vector-borne.html">said</a> CDC Director Robert R. Redfield, M.D. “Our nation’s first lines of defense are state and local health departments and vector-control organizations, and we must continue to enhance our investment in their ability to fight against these diseases.”</p> Tue, 01 May 2018 14:51:49 -0500 Zika /news/headline/2018-01-25-cdc-reports-increase-us-birth-defects-areas-local-zika-transmission <p>Birth defects associated with Zika virus infection during pregnancy increased 21% in the last half of 2016 in Puerto Rico and portions of Florida and Texas where local Zika virus transmission have been reported, according to a <a href="https://www.cdc.gov/media/releases/2018/p0125-birth-defects-local-zika.html">report</a> released today by the Centers for Disease Control and Prevention. It is not known if the increase is due to local transmission of the virus alone or other contributing factors. Most of the mothers did not have laboratory evidence of Zika infection, either because they were not tested or tested at the right time or were not exposed, CDC said. The authors looked at 2016 births in all or portions of Florida, Georgia, Hawaii, Iowa, Illinois, Massachusetts, New Jersey, New York North Carolina, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, and Vermont. CDC anticipates there could be another increase in possible Zika-related birth defects when 2017 data are analyzed, because many pregnant women exposed to Zika virus in late 2016 gave birth in 2017.<br />  </p> Thu, 25 Jan 2018 15:14:59 -0600 Zika /news/headline/2017-10-23-cdc-updates-care-guidance-infants-born-mothers-possible-zika <p>The Centers for Disease Control and Prevention last week issued <a href="https://www.cdc.gov/mmwr/volumes/66/wr/mm6641a1.htm?s_cid=mm6641a1_w" target="_blank">updated guidance</a> for U.S. health care providers caring for infants born to mothers with possible Zika virus infection during pregnancy. Infection during pregnancy can cause serious damage to the brain of the developing fetus. CDC provides specific guidance for three clinical scenarios describing possible maternal Zika virus exposure, and updated information on follow-up care and interpreting laboratory test results for infants. “There’s a lot we still don’t know about Zika, so it’s very important for us to keep a close eye on these babies as they develop,” <a href="https://www.cdc.gov/media/releases/2017/p1019-zika-guidance-updated.html" target="_blank">said</a> CDC Director Brenda Fitzgerald, M.D. “Learning how best to support them will require a team approach between health care providers and families.” For more information on Zika, visit <a href="http://www.cdc.gov/zika">www.cdc.gov/zika</a> and <a href="/zika">www.aha.org/zika</a>.</p> Mon, 23 Oct 2017 09:26:00 -0500 Zika /advisory/2017-04-18-cdc-issues-guidance-managing-occupational-exposure-zika-virus-health-care Tue, 18 Apr 2017 00:00:00 -0500 Zika /news/headline/2017-01-30-cdc-issues-zika-primer-nurses <p>The Centers for Disease Control and Prevention has issued “<a href="https://www.cdc.gov/zika/pdfs/grandrounds_nursing_scriptfaq.pdf">Zika Virus: A Primer for Nurses</a>,” a slide presentation that can be used for grand rounds and other purposes. Topics include Zika basics, CDC guidance and activities, and preventing Zika and its transmission in health care settings.</p> Mon, 30 Jan 2017 15:54:00 -0600 Zika /websites/2017-01-03-clinician-zika-resources <ul> <li><a href="/advocacy-issues/tools-resources/advisory/2017/170418-readiness-adv.pdf">AHA Advisory: CDC Issues Guidance for Managing Occupational Exposure to Zika Virus for Health Care Personnel, April 18, 2017</a></li> <li><a href="https://www.cdc.gov/zika/hc-providers/infection-control/managing-occupational-exposures.html" target="_blank">CDC Interim Guidance for Managing Occupational Exposures to Zika Virus for Healthcare Personnel, April 2017</a></li> <li><a href="/advocacy-issues/tools-resources/advisory/2016/160824-readiness-adv-zika.pdf">CDC Updates Zika Considerations for Health Care Settings, August 2016</a></li> <li> <p><a href="https://www.cdc.gov/mmwr/volumes/65/wr/mm6533e2.htm?s_cid=mm6533e2_w">Update: Interim Guidance for the Evaluation and Management of Infants with Possible Congenital Zika Virus Infection — United States, August 2016</a></p> </li> <li><a href="https://content.govdelivery.com/accounts/USCDC/bulletins/15a3b55">CDC Health Alert Network (HAN) Health Advisory: CDC Guidance for Travel and Testing of Pregnant Women and Women of Reproductive Age for Zika Virus Infection Related to the Investigation for Local Mosquito-borne Zika Virus Transmission in Miami-Dade and Broward Counties, Florida</a></li> <li><a href="http://www.cdc.gov/zika/pdfs/clinicianppt.pdf">Zika Virus: Information for Clinicians Slide Set</a></li> <li><a href="http://www.cdc.gov/mmwr/volumes/65/wr/mm6518e1.htm">Interim Guidance for Zika Virus Testing of Urine — United States, 2016</a></li> <li><a href="http://www.cdc.gov/mmwr/volumes/65/wr/mm6512e1er.htm?s_cid=mm6512e1er_w">CDC Morbidity and Mortality Weekly Report: 65 Estimating Contraceptive Needs and Increasing Access to Contraception in Response to the Zika Virus Disease Outbreak — Puerto Rico, 2016</a></li> <li><a href="http://www.cdc.gov/mmwr/volumes/65/wr/mm6512e2er.htm?s_cid=mm6512e2er_w">Update: Interim Guidelines for Health Care Providers Caring for Pregnant Women and Women of Reproductive Age with Possible Zika Virus Exposure — United States, March 25, 2016</a></li> <li><a href="http://www.cdc.gov/mmwr/volumes/65/wr/mm6512e3er.htm?s_cid=mm6512e3er.htm_w" target="_blank">Update: Interim Guidance for Prevention of Sexual Transmission of Zika Virus — United States, March 25, 2016</a></li> <li><a href="http://www.cdc.gov/mmwr/volumes/65/wr/pdfs/mm6511e3er.pdf">CDC Morbidity and Mortality Weekly Report: Preventing Transmission of Zika Virus in Labor and Delivery Settings Through Implementation of Standard Precautions — United States, March 22, 2016</a></li> <li><a href="https://asprtracie.hhs.gov/documents/ASPR-TRACIE-Zika-Virus-Disease-Resources-At-Your-Fingertips.pdf">ASPR TRACIE: Zika: Resources at Your Fingertips</a></li> <li><a href="http://www.cdc.gov/mmwr/volumes/65/wr/mm6507e1er.htm?s_cid=mm6507e1er_e">Update: Interim Guidelines for Health Care Providers Caring for Infants and Children with Possible Zika Virus Infection — United States, February 2016</a></li> <li><a href="http://www.cdc.gov/zika/hc-providers/qa-pregnant-women.html">Questions and Answers for Healthcare Providers Caring for Pregnant Women and Women of Reproductive Age with Possible Zika Virus Exposure</a></li> <li><a href="http://www.aabb.org/programs/publications/bulletins/Documents/ab16-03.pdf">AABB Transfusion-Transmitted Diseases (TTD) Committee Response to the Ongoing Outbreaks of Zika Virus Disease in Mexico, the Caribbean, and Central and South America</a></li> <li><a href="http://www.redcross.org/news/press-release/Red-Cross-to-Implement-Blood-Donor-Self-Deferral-Over-Zika-Concerns">Red Cross Statement on the Zika Virus</a></li> <li><a href="http://www.cdc.gov/mmwr/volumes/65/wr/mm6505e1er.htm?s_cid=mm6505e1.htm_w">Interim Guidelines for Prevention of Sexual Transmission of Zika Virus — United States, 2016</a></li> <li><a href="http://emergency.cdc.gov/coca/calls/2016/callinfo_012616.asp">CDC Emergency Preparedness and Response: Zika Virus- What Clinicians Need to Know presentation with slides, webcast and audio transcript</a></li> <li><a href="http://www.cdc.gov/zika/hc-providers/clinicalevaluation.html">Clinical Evaluation and Disease</a></li> <li><a href="http://www.cdc.gov/zika/hc-providers/diagnostic.html">Diagnostic Testing</a></li> <li><a href="http://dx.doi.org/10.1017/dmp.2016.116">Development and Implementation of a Zika Virus Disease Response Protocol at a Large Academic Medical Center</a></li> </ul> Tue, 03 Jan 2017 16:19:27 -0600 Zika