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. 16advisorythat limited such screening to areas with active Zika virus transmission.
In astatementreleased 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.
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 ofZika virustransmission," 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 virusand 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.
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.
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.
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.
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All U.S. Blood Donations Should Be Screened For Zika, FDA Says
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The FDA says that facilities that collect blood donations throughout the United States should be testing donations for Zika within 12 weeks.
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
niman
FDA Advises Zika Screening for All US Blood Centers
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By MATTHEW PERRONE, AP HEALTH WRITER
WASHINGTON — Aug 26, 2016, 11:14 AM ETThe 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
niman
FDA says blood banks in 11 states, including California, must test for Zika by September
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.
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
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