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Zika Public Health Issue Alert

AHIP is staying abreast of the latest notifications from trusted government sources related to the Zika virus. We are committed to providing timely information to help our members to proactively engage on this and other key issues.

Zika Virus

Zika virus is a mosquito-borne flavivirus primarily transmitted by Aedes aegypti mosquitoes. Zika virus infections have also been documented through sexual transmission, intrauterine transmission resulting in congenital infection and intrapartum transmission from a viremic mother to her newborn. Zika virus RNA has been detected in breast milk, but Zika virus transmission through breastfeeding has not been documented. The most common symptoms of Zika virus disease are fever, rash, joint pain, and conjunctivitis (red eyes). The illness is usually mild with symptoms lasting from several days to a week. Severe disease requiring hospitalization is uncommon. The virus has been linked to microcephaly, a serious birth defect.

The World Health Organization has declared the Zika virus epidemic a public health emergency. Hundreds of thousands of cases are suspected in countries across Central and South America and the Caribbean.

At an emergency meeting convened by the World Health Organization, concern was raised that sexual transmission of the virus is easier than previously thought.  The Zika virus has infected individuals without known mosquito carriers, and has been seen in asymptomatic individuals.  Researchers continue to explore the link between Zika and microcephaly in infants and acute myelitis.

In April, the Centers for Disease Control and Prevention (CDC) will convene a one-day summit with state and local officials ahead of the Zika virus’ anticipated arrival in the USA later this year. Zita continues to spread domestically and as the weather warms, is expected to impact Puerto Rico and southern states most significantly. Miami, New Orleans and Charleston, S.C. are among the US cities identified at highest risk for the Zika virus to be established locally.

There have been close to 200 people with confirmed Zika infections in the US, but no known mosquito-borne transmission in the continental US.

The Administration announced that it is asking Congress for more than $1.8 billion in emergency funding to enhance its ongoing efforts to prepare for and respond to the Zika virus, both domestically and internationally.

The Centers for Disease Control and Prevention announced that its emergency operations center has been put on a “Level 1” status, its highest level of activation. The CDC website (http://www.cdc.gov/zika) has the most up-to-date advisories for health care providers and pregnant women, and travel advisories for areas with Zika.

On February 5, 2016, the CDC issued Interim Guidelines for Prevention of Sexual Transmission of Zika Virus. detailing how to prevent the sexual transmission of Zika, and offered recommendations for health care providers preparing to treat patients infected with the virus.

As more information becomes available, AHIP will update this section of our webpage.


Updates

August 18, 2016

CDC has updated its interim guidance for U.S. health care providers caring for infants born to mothers with possible Zika virus infection during pregnancy. Laboratory testing is recommended for:

1) Infants born to mothers with laboratory evidence of Zika virus infection during pregnancy, and

2) Infants who have abnormal clinical or neuroimaging findings suggestive of congenital Zika syndrome and a maternal epidemiologic link suggesting possible transmission, regardless of maternal Zika virus test results.

Congenital Zika syndrome is a recently recognized pattern of congenital anomalies associated with Zika virus infection during pregnancy that includes microcephaly, intracranial calcifications or other brain anomalies, or eye anomalies, among others.

Recommended infant laboratory evaluation includes both molecular (real-time reverse transcription–polymerase chain reaction [rRT-PCR]) and serologic (immunoglobulin M [IgM]) testing. Initial samples should be collected directly from the infant in the first 2 days of life, if possible; testing of cord blood is not recommended. A positive infant serum or urine rRT-PCR test result confirms congenital Zika virus infection. Positive Zika virus IgM testing, with a negative rRT-PCR result, indicates probable congenital Zika virus infection.

In addition to infant Zika virus testing, initial evaluation of all infants born to mothers with laboratory evidence of Zika virus infection during pregnancy should include a comprehensive physical examination, including a neurologic examination, postnatal head ultrasound, and standard newborn hearing screen. Infants with laboratory evidence of congenital Zika virus infection should have a comprehensive ophthalmologic exam and hearing assessment by auditory brainstem response (ABR) testing before 1 month of age.  Recommendations for follow-up of infants with laboratory evidence of congenital Zika virus infection depend on whether abnormalities consistent with congenital Zika syndrome are present.

Currently there are > 1,000 pregnant women with laboratory evidence of possible Zika virus infection in the U.S. and U.S. territories.  Pediatric health care providers need information to guide appropriate laboratory testing and clinical evaluation and management of infants born to these mothers.  CDC, in collaboration with the American Academy of Pediatrics, convened a meeting to obtain input from experts to inform development of this guidance.

The detailed updated interim guidance is available here:  http://www.cdc.gov/mmwr/volumes/65/wr/mm6533e2.htm?s_cid=mm6533e2_w


Updated CDC Interim Guidance for Health Care Providers Caring for Pregnant Women with Possible Zika Virus Exposure

CDC has updated its interim guidance for U.S. health care providers caring for pregnant women with possible Zika virus exposure.  The new recommendations expand real-time Reverse Transcriptase Polymerase Chain Reaction rRT-PCR laboratory testing for Zika RNA with the goal of increasing the number of pregnant women with Zika virus infection who receive definitive diagnosis.  In addition, the new guidance includes clinical management recommendations to help healthcare providers better care for their pregnant patients with confirmed or possible Zika virus infection.

More specifically, the updated interim guidelines:

  • Extend the rRT-PCR testing window from <1 week to <2 weeks from symptom onset in symptomatic pregnant women
  • Add a new recommendation to implement Zika-specific rRT-PCR testing of serum and urine among asymptomatic pregnant women with possible exposure
  • Add a new recommendation for immediate rRT-PCR testing after a pregnant woman has a positive or equivocal Zika IgM antibody test
  • Update the guidelines to emphasize testing of infant blood rather than “infant blood or cord blood”

A table summarizing CDC’s updated interim pregnancy guidance is available here:

http://www.cdc.gov/zika/pdfs/testing_algorithm.pdf

The detailed updated interim guidance is available here:

http://www.cdc.gov/mmwr/volumes/65/wr/mm6529e1.htm?s_cid=mm6529e1_e


Update on Zika Virus from CDC on May 11

Cases of Zika continue to increase – as of April 27, there were 426 travel-associated cases reported in US states, and 600 locally acquired cases in Puerto Rico, the US Virgin Islands, and American Samoa. New travel notices were posted for Belize, Saint Lucia, Fiji, and Kosrae (Micronesia), bringing the total number of affected countries and territories to 43.


In an article(http://www.cdc.gov/ncezid/pdf/nejmsr1604338.pdf) published this month in the New England Journal of Medicine, CDC scientists made a significant contribution to Zika research. After a rigorous review of existing evidence, the authors concluded that Zika virus is a cause of microcephaly and other severe fetal brain defects.

On April 25, 2016, public officials with the Centers for Disease Control and Prevention (CDC) issued new guidelines to protect workers caring for patients who have been exposed to the Zika virus.  The guidelines recommend that healthcare workers use standard precautions such as full hand-hygiene compliance and use of personal protective equipment during contact with potentially hazardous materials such as blood or laboratory samples. Healthcare workers should also properly dispose of potentially-contaminated sharps, reporting needle sticks or lacerations.

Additional Information Regarding the Zika Test

The Centers for Disease Control and Prevention (CDC) announced that the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a real-time diagnostic test for the Zika Virus.

CDC provided the following additional information:

  • In response to a request from the CDC, the FDA issued an EUA for the Trioplex Real-time RT-PCR (Trioplex rRT-PCR) assay on March 17, 2016.
  • CDC will begin distributing the test during the next two weeks to qualified laboratories in the Laboratory Response Network, an integrated network of domestic and international laboratories that respond to public health emergencies.
  • CDC is currently producing 750 rRT-PCR test kits with 500 reactions each, which is a total of 375,000 tests.
  • There are currently 28 laboratories in 21 states, DC and Puerto Rico that have validated the rRT-PCR assays for Zika virus, meaning they have the capacity to test for Zika virus.
    • These laboratories are located in the following states/territories: Arkansas; California; Connecticut;  District of Columbia; Florida; Hawaii; Kentucky; Louisiana; Maryland; Massachusetts; Maine; Minnesota; Nebraska; New Hampshire; New York; New Mexico; Nevada; Ohio; Oklahoma; Puerto Rico; South Carolina; Tennessee; Texas
  • The test will not be available in U.S. hospitals or other primary care settings.  Clinicians should contact their state or local health department to facilitate testing.

Questions and additional information can be accessed by emailing the CDC Zika Virus Policy Unit at eocPUCC@cdc.gov.


FDA Clears Zika Test for CDC, Labs

We wanted to make you aware that today the Centers for Disease Control and Prevention (CDC) announced that the Food and Drug Administration (FDA) issued an emergency use authorization for a real-time diagnostic test for the Zika Virus.  This one test shows whether an individual is infected with chikungunya, Zika or dengue, rather than requiring separate tests for the three viruses.

The authorization allows qualified laboratories to use the test despite the lack of official FDA clearance.  This will permit quick detection of Zika infections and help public health efforts to stop the spread of the virus.


On February 19, 2016, CDC released updated guidelines for U.S. health care providers caring for infants born to mothers who traveled to or resided in areas with Zika virus transmission during pregnancy and expanded guidelines to include infants and children with possible acute Zika virus disease.


On February 16, 2016, the FDA released new guidelines including recommending that individuals at risk of Zika infection avoid donating blood for four weeks.  Individuals at risk of Zika include people who have had Zika symptoms during the past four weeks, traveled to areas with active Zika transmission in the past four weeks, or had sexual contact with a person who has traveled to or resided in an area with active Zika transmission during the prior three months.

While there have been no reports of Zika virus entering the U.S. blood supply, FDA said the risk of Zika being transmitted via blood is considered likely given the scientific evidence of how Zika and similar viruses are spread and reports of transfusion-associated infection outside of the U.S.


GOVERNMENTS, MEDICAL GROUPS PLEDGE TO SHARE ZIKA DATA: More than two dozen government organizations, medical journals and non-governmental organizations have signed a declaration to share data related to the Zika virus, as soon as possible and free of charge. The CDC, NIH, Doctors Without Borders, the Bill and Melinda Gates Foundation, government groups in South Africa, Japan, and India are just a handful that signed on the pledge. http://bit.ly/1WeYrtb


On February 9, the Virginia Department of Health confirmed one case of Zika Virus in an adult who had recently traveled to a Zika-affected area.  In addition, the Virginia Department of Health disseminated the latest guidance from the Centers for Disease Control and Prevention (CDC) including interim guidance for pregnant women and women of reproductive age and interim guidance for sexual transmission of the Zika Virus.  Pregnant women are advised to avoid travel to Zika-affected areas.  If they have traveled to areas with ongoing Zika Virus transmission they can be tested regardless of whether they have symptoms.  Sexual transmission of the Zika Virus is possible.  Men who have traveled to Zika-affected areas who have a pregnant partner are advised to abstain from sex or use condoms.


The New York Times reported on a study in Brazil links Zika virus to eye abnormalities in babies.  The article also notes that in China, health authorities announced the country’s first known case of Zika on February 9, a man who had recently returned from a trip to Venezuela.


The Zika virus, thought to be responsible for a surge in birth defects in Brazil, has been found inside the abnormally small brain of an aborted fetus at roughly 29 weeks of gestation, a team of researchers reported Wednesday in the New England Journal of Medicine. An autopsy of the aborted fetus revealed a brain that had virtually none of the folds and convolutions that would usually be seen on the brain’s surface in a fetus at that point in its development. Calcium deposits were evident throughout the brain’s white matter–the tissue that connects neurons and brain regions to one another. And in several places, those calcifications displaced developing cortical matter. The case, described by a team of pathologists, microbiologists and maternal-fetal medicine specialists at Slovenia’s University of Ljubljana, is the first published finding of Zika virus directly in brain tissue. Other, unpublished, findings have suggested scientists have found Zika in cerebrospinal fluid.