US FDA Advises Zika Testing Of Donated Blood

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As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518218.htm

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FDA News Release

FDA advises testing for Zika virus in all donated blood and blood components in the US

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For Immediate Release

August 26, 2016

Release

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active transmission in the U.S. are currently in compliance with this guidance. The revised guidance announced today recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.

Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local or non-travel related transmission of Zika virus in the continental U.S. were reported in Miami-Dade County, Florida.

In addition to protecting the nation’s blood supply, the FDA works to protect the safety of our nation’s supply of human cells, tissues, and cellular and tissue-based products; supports the development and availability of diagnostic tests that may be useful for identifying the presence of or prior exposure to the Zika virus; works with commercial and government developers to advance the development of investigational vaccines and therapeutics; and monitors for fraudulent products and false product claims related the Zika virus.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA recommends screening all blood donations for Zika

 

 Doyle Rice, USA TODAY12:05 p.m. EDT August 26, 2016

 

 

 

 

 

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The FDA recommended expanding the screening process for all blood donations in the U.S.WIBBITZ

(Photo: CRISTOBAL HERRERA, EPA)

The Food and Drug Administration on Friday recommended expanding the screening process for all blood donations in the U.S. as a precaution against contaminating the blood supply with the mosquito-borne Zika virus.

The new recommendation expands the guidance to all U.S. states and territories. Previously, the FDA only advised screening in areas with active Zika cases, such as parts of Florida and throughout Puerto Rico.

“At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion," said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

The new order comes in the wake of the first locally acquired Zika cases in the continental U.S. More than 40 people in Miami-Dade and Palm Beach counties in Florida have been diagnosed with the virus since officials announced its appearance there earlier this month. Previously, all cases within the continental U.S. were travel-related.

The FDA updated its guidance due to the potential serious health consequences of Zika to pregnant women and children born to women exposed to the virus during pregnancy. The Zika virus is transmitted primarily by the Aedes mosquito but can also be spread by sexual contact. Although most people infected with the virus never develop symptoms, an infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes, the FDA warns.

Around 2,200 Zika cases have been reported in the continental U.S. and more than 13,000 in Puerto Rico, according to the Centers for Disease Control and Prevention. Most of the cases within the continental U.S. involved individuals who contracted the virus while traveling in another country, while most of the Puerto Rico cases were locally acquired.

http://www.usatoday.com/story/news/nation/2016/08/26/fda-blood-donations-zika-virus/89404204/

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All U.S. Blood Donations Should Be Screened For Zika, FDA Says

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August 26, 201611:06 AM ET

JOE NEEL

The FDA says that facilities that collect blood donations throughout the United States should be testing donations for Zika within 12 weeks.

Toby Talbot/AP

The Food and Drug Administration is recommending that blood banks screen all blood donations in the U.S. for the Zika virus.

It's a major expansion from a Feb. 16 advisory that limited such screening to areas with active Zika virus transmission.

In a statement released Friday, the FDA says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.

"As new scientific and epidemiological information regarding Zika virus has become available, it's clear that additional precautionary measures are necessary," the FDA's acting chief scientist, Luciana Borio, said in the statement.

The expansion of testing won't happen all at once. The FDA is advising blood establishments in 11 states to begin testing within the next four weeks. Those states include Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.

These states are in proximity to areas where Zika is actively spreading via mosquitoes or where there are a significant number of cases related to other exposures, including sexual transmission.

Within 12 weeks, blood facilities in all states should be testing donations for Zika, the FDA says.

Currently, Zika is being spread by mosquitoes in South Florida, Puerto Rico and the U.S. Virgin Islands, as well as most countries in the Caribbean and Central and South America. There is a total of 2,517 cases of Zika in the U.S. states and D.C., according to the Centers for Disease Control and Prevention, with 9,011 more in U.S. territories.

Most of the cases within the U.S. and D.C. are related to travel abroad or sexual transmission. The cases in Puerto Rico and the U.S. Virgin Islands are a mix of travel-related cases and locally acquired infections via mosquitoes or sex.

In issuing the new recommendations, the agency noted that 4 out of 5 people infected with Zika virus never develop symptoms. Thus, questions that blood banks routinely ask about the risks of disease might not catch people who have been exposed and who have been infected with the Zika virus.

Zika virus infection during pregnancy has caused serious birth defects in a few cases in the U.S. and hundreds of cases in Central and South America where infants have been born with microcephaly, a condition where the brain and skull are malformed.

There have been no cases of Zika related to blood transfusions in the U.S., according to the Centers for Disease Control and Prevention.

"There is still much uncertainty regarding the nature and extent of Zika virus transmission," says Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion."

In a news conference Friday, Marks said that there had been one case in Florida where a unit of donated blood was tested and taken out of the blood supply. Other units where Zika is suspected are currently under investigation, he said.

http://www.npr.org/sections/health-shots/2016/08/26/491484838/all-u-s-blood-donations-should-be-screened-for-zika-fda-says

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FDA Advises Zika Screening for All US Blood Centers

• By MATTHEW PERRONE, AP HEALTH WRITER

WASHINGTON — Aug 26, 2016, 11:14 AM ET

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ABCNews.com

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The Food and Drug Administration wants all U.S. blood centers to start screening for Zika, a major expansion intended to protect the nation's blood supply from the mosquito-borne virus.

The new advisory means all U.S. states and territories will need to begin testing blood donations for Zika. Previously, the FDA had limited the requirement to Puerto Rico and two Florida counties.

"There is still much uncertainty regarding the nature and extent of Zika virus transmission," said Dr. Peter Marks, director of the FDA's biologic products center, in an agency release. "At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion."

Blood collection sites already test donations for HIV, hepatitis, West Nile virus and other blood-borne viruses.

FDA officials said Zika testing is already underway in Puerto Rico and parts of Florida, where "it has shown to be beneficial in identifying donations infected with Zika virus."

The FDA has authorized use of two experimental blood-screening tests for Zika, one made by Roche and another from Hologic Inc. Several testing sites are already voluntarily using the technology, including blood centers in Texas. The cost of adding Zika testing to the blood screening process is less than $10, according to officials at South Texas Blood and Tissue Center.

Since February, U.S. blood centers have been turning away people who have recently traveled to areas with Zika outbreaks, under a previous FDA directive.

Zika is spread primarily by mosquito bites, as well as sex. There have been cases of Zika transmission through blood transfusion in Brazil.

The FDA works with other federal agencies to set standards for screening, testing and handling blood donations.

Last month, blood centers in Miami and Fort Lauderdale had to halt donations until they could begin screening each unit of blood. The order followed now-confirmed reports of local Zika transmission in the Miami area — the first in the continental U.S.

Puerto Rico suspended blood donations and imported blood products in March until the island began screening its blood.

Friday's announcement follows recent pressure from members of Congress urging the FDA to expand Zika screening.

"We must implement widespread universal screening now to prevent any further contamination of the blood supply before it occurs and to pre-empt a widespread shortfall in the blood supply," stated Reps. Lloyd Doggett, D-Texas, Patrick Murphy, D-Fla. and a half-dozen other House members, in a letter to the FDA earlier this month.

The Zika virus causes only a mild illness in most people, but scientists have confirmed that infection during pregnancy can lead to severe brain-related birth defects.

The tropical mosquito that spreads Zika and other viruses is found in the southern U.S. While health officials have predicted that mosquitoes in the continental U.S. would begin spreading Zika this summer, they also have said they expect only isolated clusters of infections and not widespread outbreaks. So far, there have been about 40 cases of homegrown Zika in Florida.

http://abcnews.go.com/US/wireStory/fda-advises-zika-screening-us-blood-centers-41670193

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FDA says blood banks in 11 states, including California, must test for Zika by September

The battle to contain the Zika virus is now expanding to protect the nation's blood supply. The U.S. Food and Drug Administration announced new blood bank guidelines Friday nationwide.

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POSTED:AUG 26 2016 10:54PM PDT

UPDATED:AUG 26 2016 10:54PM PDT

SAN FRANCISCO (KTVU) - The federal government is taking action to prevent the Zika virus from entering the nation's blood supply.

The U.S. Food and Drug Administration announced Friday that blood banks nationwide should begin screening all donated blood units for the Zika virus within three months.

 

"We're recommending testing of donated blood throughout the United States and its territories. We're taking this step to further enhance the safety of the blood supply," said Dr. Peter Marks,  a U.S. Food and Drug Administration spokesman.

FDA says blood banks in 11 states, including California, must test for Zika by September

California is one of eleven states facing an earlier deadline to implement testing by the end of September.

Those states are Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.

Most of those states are close to Florida or Mexico where the Zika virus has been spread by mosquitoes.

Some states on the list have had a large number of Zika cases related to travel or sexual transmission. California has 170 such Zika cases.

Doctors say the concern is that blood donors might be carrying the Zika virus without knowing it.

"About 80% of people who are infected with Zika will never develop any symptoms and that's one reason why it's a risk to a unit of blood," said Dr. Suchitra Pandey, the Chief Medical Officer at the Blood Centers of the Pacific, which has donation centers throughout the Bay Area.

http://www.ktvu.com/news/196321366-story