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Florida Blood Donations Halted In Miami-Dade & Broward Cos


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WASHINGTON—The U.S. Food and Drug Administration is calling on all blood centers in Miami-Dade County and Broward County in Florida to stop collecting blood until they can test all individual donations for the Zika virus.

The agency said it is taking this step, at least temporarily and as a precaution, because Florida authorities are investigating four cases of the Zika virus that aren't travel related. And state officials said those may therefore be the first cases of local Zika transmission by mosquitoes in the continental U.S.

The FDA recommended the two South Florida counties take this measure until they can test for the Zika virus on each blood donation or until they use a method to inactivate the virus. The FDA also recommended “adjacent and nearby counties” implement those precautions as soon as possible.

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New studies have shed light on how the Zika virus -- which can cause serious birth defects -- may be transmitted from infected mother to unborn child. Image: Dr. Indira U. Mysorekar, Dr. Bin Cao/Washington University (Originally published May 17, 2016)

Federal health experts have said they expected continental transmission of the virus in the U.S. to hit this summer. There have been 1,658 Zika cases in the U.S. and 4,750 cases in the U.S. territories as of July 27, according to the Centers for Disease Control and Prevention. The U.S. cases are almost all travel-associated; the territories’ cases are almost all locally acquired.

U.S. Surgeon General Vivek Murthy on Thursday said the possibility of local transmission in Miami-Dade and Broward counties made it all the more important that pregnant women take precautions to avoid mosquito bites and that women who were considering whether to get pregnant talk directly with their doctor. “We know each person’s situation is unique and requires a one-on-one assessment,” he said.

“At this point we are not recommending a travel restriction to South Florida,” he continued. He said the administration was working with Florida health officials to consider implications of the cases there and to watch for additional ones.

Zika has been expected to hit Florida in particular. The CDC reports it had learned of 270 cases of Zika associated with travel as of July 20.

Zika is spread by mosquitoes and can cause a birth defect in the form of an abnormally small head if women are pregnant while having the virus. It has also been linked to Guillain-Barré syndrome, a disorder that can cause permanent nerve damage.

Congress left Washington for the summer without passing legislation to provide funding to combat the spread of Zika. Democrats balked at a $1.1 billion Republican proposal that would have effectively prevented funding from going to a group that partners with Planned Parenthood in Puerto Rico, which has been hard hit by Zika. President Barack Obama in February had requested about $1.9 billion to fight the spread of the virus.

Write to Thomas M. Burton at [email protected]

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Florida Counties Asked to Stop Blood Donations Over Zika Fears

US-HEALTH-ZIKA-VIRUS
RHONA WISE—AFP/Getty ImagesMiami-Dade mosquito control worker Carlos Vargas sprays to eradicate the Aedes aegypti mosquito larvae at a home in Miami, June 8, 2016.

The FDA wants the counties to test each donation for the virus

In a statement posted on its website late Wednesday, the FDA said it was taking this precaution because the counties are investigating four cases of the Zika virus that are not related to travel and may be the first instances of transmission by local mosquitoes in the United States.

The agency recommended that the two South Florida counties halt donations until they can test each donation for Zika or until they use an approved method to inactivate the virus. The FDA also recommended that “adjacent and nearby counties” implement the precautions. For blood collection centers outside the area, the agency suggested that people who have traveled to Miami-Dade and Broward Counties in the previous four weeks be deferred.

Blood banks in the area are scheduled to begin testing for Zika on Aug. 1, the Miami Heraldreported. Experts have said they expected transmission of Zika within the continental U.S. this summer. There have been 1,658 cases of Zika in the U.S. and 4,750 cases in the U.S. territories as of July 27, according to the Centers for Disease Control and Prevention. Despite Florida’s Zika concerns, the CDC said Thursday they are not adding South Florida to the list of restricted travel areas for pregnant women.

Zika is primarily spread by mosquitoes and can cause birth defects if women are pregnant while they have the virus. It has also been linked to other brain and autoimmune problems, including Guillain-Barré syndrome, a disorder that can cause nerve damage.

http://time.com/4429314/zika-fda-stop-blood-donations-florida/

 

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JULY 28, 2016 1:47 PM

FDA to South Florida blood banks: Stop donations due to possible local Zika cases

 
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FDA temporarily halts blood donation in two Florida counties over Zika fears

 
 
 
 
  

The U.S. Food and Drug Administration is asking blood centers in two Florida counties to immediately stop collections. The counties are investigating possible local transmission of Zika virus.

In a notice sent to blood centers and posted on the agency's website Wednesday evening, the FDA said it is requesting all blood centers in Miami-Dade and Broward counties to "cease collecting blood immediately" until those facilities can test individual units of blood donated in those two counties with a special investigational donor screening test for Zika virus or until the establishments implement the use of an approved or investigational pathogen-inactivation technology.

The action by the FDA comes as health officials in Florida said Thursday they were continuing to investigate two Zika cases that could have been spread by local mosquitoes, in addition to two similar cases they announced last week. Health officials have not confirmed whether any of the infected individuals acquired the virus from local mosquitoes, but it seems increasingly likely.

"These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States," the FDA said in its notice and in a media statement Thursday. It said it was making the request of blood-collection establishments "in consideration of the possibility of an emerging local outbreak of Zika virus, and as a prudent measure to help assure the safety of blood and blood products."

 

The FDA is also recommending that nearby counties also put these precautions in place as soon as possible to maintain the safety of the blood supply. For blood-collection establishments outside of this region, FDA is recommending that donors who have traveled to Miami-Dade and Broward Counties during the previous four weeks defer on donating blood.

The FDA alerted the Florida's surgeon general and the major blood collection industry organization Wednesday night. On Thursday morning, the FDA also reached out to blood collection establishments in Florida, starting with the state’s largest blood collectors, according to Tara Goodin, an FDA spokeswoman.

The FDA also said Thursday that it is working closely with companies that are making blood screening tests available to ensure that these companies are ready to expand testing as needed. Blood collection establishments in the rest of the United States may also choose now or in the future to participate in that testing, even if there is no local mosquito-borne transmission of Zika virus in their region.

The main organization collecting blood in Florida, OneBlood, said last week that it had been alerted by public health authorities about the suspected non-travel-related Zika case under investigation in South Florida. OneBlood said that if the case was confirmed, it would stop collections in the affected zip code and bring in blood from unaffected areas to supply blood needs in that region.

The organization also said it had received approval to use the investigational tool and planned to start testing donated blood for Zika virus starting Monday.

The organization did not immediately respond to a request for comment on the FDA's request for blood centers to immediately stop collection in the two counties.

Its website says it plans to test a portion of its collected blood for the Zika virus and to allow hospitals to have access to Zika-screened blood products from unaffected areas to use with their patients at high risk of Zika complications, such as pregnant women. Hospitals that want Zika-screened products will request what they need on an on-demand basis.

Additional proactive steps OneBlood implemented earlier this year to protect the local blood supply from the Zika virus remain in effect, including enacting additional donor-deferral guidelines, updating the donor history questionnaire to include Zika-specific questions and issuing educational materials to donors.

This post has been updated.

https://www.washingtonpost.com/news/to-your-health/wp/2016/07/28/fda-temporarily-halts-blood-donation-in-two-florida-counties-over-zika-fears/

 

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Fearing Zika, FDA Asks 2 Florida Counties To Halt Blood Donations

Blood donations in the U.S. aren't routinely screened for the Zika virus.

Blood donations in the U.S. aren't routinely screened for the Zika virus.

Chris O'Meara/AP

There's been a looming fear that mosquitoes would start spreading the Zika virus in the U.S. Now that possibility seems increasingly real.

On Thursday, senior officials at the Food and Drug Administration said they have asked blood donation centers in two Florida counties, Miami-Dade and Broward, to stop collecting blood for the time being.

The move came after investigators ruled out travel as the cause of four cases of Zika virus in those counties. Florida health officials announced the cases last week. The people hadn't traveled to places where Zika is endemic and don't appear to have contracted it through sex, leaving a possibility that they got the virus from being bitten by infected mosquitoes in the U.S.

If they did acquire the virus from domestic mosquitoes, it could mean that others in the area also may have acquired Zika virus locally, and may have donated blood without knowing it was infected.

In an effort to "help ensure the safety of the nation's blood supply," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement that blood collections shouldn't resume in the area until the centers can test each incoming blood donation for Zika virus.

The agency suggested that neighboring counties do the same, and that at-risk counties across the U.S. screen donors before collecting blood.

"These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States," said the statement. The Florida Department of Health has yet to confirm how the people acquired the virus.

http://www.npr.org/sections/health-shots/2016/07/28/487802572/fearing-zika-fda-asks-2-florida-counties-to-halt-blood-donations

 

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Scientists Slam CDC For Silence On New Florida Zika Cases

Local mosquitoes may be infecting people with Zika in south Florida, prompting the FDA to halt blood donations there. But the CDC hasn’t weighed in yet.

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CDC/James Gathany

Florida health officials are now investigating four Zika virus patients who are suspected of catching the disease from local mosquitoes, raising questions about what to tell pregnant women in and around Miami, a city of 5.5 million people.

“These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States,” the FDA said in a statement requesting that all blood donation centers start screening for Zika virus in two south Florida counties, Miami-Dade and Broward, temporarily halting donations there. People who have traveled to those counties shouldn’t donate blood for four weeks afterwards, the FDA said.

Florida authorities announced the first possible case on July 19. Independent scientists are puzzled why it has taken them so long to confirm them. “Why the hold-up in making an announcement?” infectious disease expert Peter Hotez of the Baylor College of Medicine asked BuzzFeed News.

Hotez says an announcement from CDC is overdue, especially if the agency is waiting to find a mosquito with the virus in Florida, a needle in the haystack endeavor, before making a confirmation. The only reason would be “some strange political agenda,” he said by email, where they don’t want the announcement falling in the middle of the Democratic National Convention.

“This has become a chronic problem in our nation, a general wall of silence and lack of openness in terms of timely public health communication during times of epidemics,” Hotez added, citing the 2001 anthrax attacks, 2009 swine flu outbreak, and 2014 ebola cases, where inadequate public health warnings initially added to public confusion about diseases. “In my opinion, this has been an issue ever since the office of the US Surgeon General was disempowered more than 20 years ago.”

Asked by BuzzFeed News at a CDC telebriefing, Surgeon General Vivek Murthy said “it is too soon” to extend CDC travel recommendations for pregnant women to south Florida. He cited state health officials’ efforts to trap a Zika infected mosquito, and continued investigation into possible sexual transmission of the virus among the suspect case patients.

”The possibility of local transmission in Miami-Dade and Broward counties makes it all the more important that women who are pregnant, or who might potentially become pregnant, take all precautions,” Murthy added, chiefly avoiding mosquitoes.

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CDC / James Gathany

Zika infections during pregnancy are now linked to more than 1,700 cases of microcephaly, the severe shrunken skull and brain birth defect. Most of the affected infants are in Brazil, with cases in a dozen other countries.

“Our patients are very frightened,” ob-gyn Karen Harris, chairwoman of the Florida district of the American Congress of Obstetricians and Gynecologists, told BuzzFeed News. “It’s probably going to spread all the way up the state.”

The CDC has not issued any warnings for pregnant women about traveling in Florida, CDC spokesman Tom Skinner told BuzzFeed News. But the public health agency does recommend they avoid travel to 50 Zika-afflicted nations or territories, including Puerto Rico.

“Evidence is mounting to suggest local transmission via mosquitoes is going on in South Florida,” Skinner told Reuters on Wednesday, though he declined to elaborate on this evidence for BuzzFeed News. About 1,400 people in the US have been infected by the Zika virus in cases acquired through travel or sexual transmission, according to the CDC.

The Florida Department of Health does not have a recommendation for pregnant women living in Miami, or those contemplating travel to south Florida, a popular travel destination. The department says that it has interviewed about 200 people in the investigation of the suspected local cases. A CDC investigator is assisting in the investigation.

In the meantime, Florida is reporting 381 cases of Zika in travelers, including 53 pregnant women whom the state is monitoring.

“At this stage it may be a bit premature to issue a travel advisory,” infectious disease expert Nikolaos Vasilakis of the University of Texas Medical Branch at Galveston told BuzzFeed News. Vasilakis expressed confidence that air conditioning and screened windows meant any outbreak of Zika in south Florida would remain bottled up there.

Vasilakis recommended that people in Florida follow past CDC recommendations for avoiding mosquito bites, using repellants and emptying of water containers where mosquitoes lay eggs, such as flower pots and birdbaths. Zika can also be sexually transmitted, and the CDC has recommended the use of condoms or abstaining during pregnancy.

A travel recommendation for pregnant women probably won’t stop the spread of Zika virus in Florida, Harris said. “You can’t tell people in Florida not to travel. It’s not going to happen.”

https://www.buzzfeed.com/danvergano/zika-in-florida?utm_term=.vv42ByA4Y#.lfYZrW53X

 

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July 27, 2016

The Office of the ‎Florida Department of Health State Surgeon General has announced that it is conducting an epidemiological investigation into a number of non-travel related cases of Zika virus in Miami-Dade and Broward Counties. These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States. Miami-Dade County and Broward County are adjacent counties in South Florida.

In consideration of the possibility of an emerging local outbreak of Zika virus, and as a prudent measure to help assure the safety of blood and blood products, FDA is requesting that all blood establishments in Miami-Dade County and Broward County cease collecting blood immediately until the blood establishments implement testing of each individual unit of blood collected in the two counties with an available investigational donor screening test for Zika virus RNA or until the blood establishments implement the use of an approved or investigational pathogen inactivation technology.

Additionally, FDA recommends that adjacent and nearby counties implement the precautions above to help maintain the safety of the blood supply as soon as possible.

For blood collection establishments outside of this region, FDA suggests that donors who have traveled to Miami-Dade and Broward Counties during the previous 4 weeks be deferred.

FDA will continue to monitor this potential outbreak in cooperation with the Centers for Disease Control and Prevention (CDC) and Florida State public health authorities and provide updates as additional information becomes available.

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm513583.htm

 

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July 28, 2016

Statement

The FDA is tasked with taking important steps to respond to Zika cases in the United States. One of the agency’s key public health responsibilities is to help ensure the safety of the nation’s blood supply.

Recently, the Office of the Florida Department of Health State Surgeon General announced that it is conducting an epidemiological investigation into a number of non-travel related cases of Zika virus in Miami-Dade and Broward Counties. These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States. Miami-Dade County and Broward Counties are adjacent counties in South Florida. 

In consideration of the possibility of local transmission of the Zika virus, and as a prudent measure to help assure the safety of blood and blood products, the FDA is requesting that all blood establishments in Miami-Dade County and Broward County cease collecting blood immediately until the blood establishments implement testing of each individual unit of blood collected in the two counties with an available investigational donor screening test for Zika virus RNA or until the blood establishments implement the use of an approved or investigational pathogen inactivation technology. 

Additionally, the FDA recommends that adjacent and nearby counties implement the precautions above to help maintain the safety of the blood supply as soon as possible. 

The FDA is also working closely with companies that are making blood screening tests available under an Investigational New Drug application (IND) to ensure that these companies are ready to expand testing as needed. Blood collection establishments in the rest of the United States may also choose now or in the future to participate in testing under IND, even in the absence of local mosquito-borne transmission of Zika virus. The FDA continues to support those regions of the United States at risk of local mosquito-borne Zika transmission that have already started screening their blood supply for Zika virus and encourages other areas at high risk to begin doing so.

The FDA will continue to monitor this potential outbreak in cooperation with the Centers for Disease Control and Prevention (CDC) and Florida State public health authorities, and will provide updates as additional information becomes available.  

In addition to protecting the nation’s blood supply, the FDA is prioritizing the development of diagnostic tests that may be useful for identifying infection with the virus, helping to facilitate the development and evaluation of investigational vaccines and therapeutics, and reviewing technology that may help suppress populations of the mosquitoes that can spread the virus.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm513792.htm

 

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FDA Halts Florida Blood Donations in 2 Counties Over Concerns of Zika Outbreak

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Blood donations have been halted in two Florida counties being investigated as the epicenter of a possible outbreak of locally transmitted Zika virus, according to the U.S. Food and Drug Administration.

At least four cases of Zika infections in Miami-Dade and Broward counties are being investigated by the Florida Health Department as a possible outbreak of locally transmitted Zika. Yesterday, the FDA asked all blood donation centers in both Miami-Dade and Broward counties to cease collecting blood until they can implement tests to check donor blood for signs of the Zika virus. The FDA also recommended that adjacent and nearby counties adhere to these requirements as well.

"These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States," FDA officials said in a statement. "In consideration of the possibility of an emerging local outbreak of Zika virus, and as a prudent measure to help assure the safety of blood and blood products, FDA is requesting that all blood establishments in Miami-Dade County and Broward County cease collecting blood immediately until" officials can implement tests for Zika.

 

 

 

 

 

 

More than 1,650 people have been diagnosed with Zika within the U.S., but the vast majority have been people who contracted the virus while abroad. A small number of people contracted the Zika virus through sexual transmission within the U.S.

 

http://abcnews.go.com/Health/fda-halts-florida-blood-donations-counties-concerns-zika/story?id=40964482

 

 

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OneBlood to begin screening all donations for Zika

All blood donations will be screened for Zika in Broward, Miami-Dade

South Florida's largest blood supplier will begin screening all donations for the Zika virus on Friday, two days after federal regulators asked for collections to stop immediately. They cited concerns about four mysterious Zika virus cases being investigated in Miami-Dade and Broward counties.

The Food and Drug Administration on Wednesday requested all blood donations in the two counties be immediately stopped until approved Zika screenings for every unit collected, or the use of technologies that kill pathogens, could be implemented. FDA officials recommended nearby counties do the same "to help maintain the safety of the blood supply."

The FDA also urged travelers who had visited the Miami and Fort Lauderdale areas over the last month to not donate blood for the time being, according to the Associated Press.

State and federal public health officials are continuing their probe, in its second week, of two Zika cases in Broward and two in Miami-Dade that may not have been brought here by travelers. If confirmed, South Florida could become the first place in the continental United States to have Zika infections transmitted by local mosquitoes.

OneBlood, the blood bank supplying most of Florida's largest hospitals, will begin using a new Zika investigational donor screening test on 100 percent of its donations beginning Friday, said spokeswoman Susan Forbes.

No donations were interrupted and it's anticipated none will need to be discarded because of the FDA request, Forbes said.

An earlier written statement from OneBlood said it had suspended collections in parts of South Florida earlier this week, in cooperation with state health officials, due to the ongoing investigations.

OneBlood supplies more than 200 hospitals in Florida as well as parts of Georgia, Alabama and South Carolina. Forbes said the blood bank added questions about Zika to its donor history query and deferral guidelines earlier this year, and issued educational materials to donors "to protect the blood supply."

Mara Gambineri, spokeswoman for the Florida Department of Health, said smaller blood banks were working toward implementing Zika screens as well.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement Thursday that some U.S regions that, like Florida, are at high risk of developing local Zika outbreaks already have started screening their blood supplies. The FDA is working with companies under its Investigational New Drug application, Marks said, to develop and expand accurate Zika blood supply screening even for areas not facing local transmission.

Florida has 328 confirmed Zika cases as of Thursday, the most of any state and about 18 percent of the national total. About half of Florida's cases are in Miami-Dade and Broward counties.

There are an additional 55 Florida cases involving pregnant women, including two new ones on Thursday. These patients are considered high risk, as Zika infections can cause severe birth defects among newborns.

U.S. Surgeon General Vivek Murthy, during a Thursday press briefing in Washington, D.C., on Zika and the 2016 Rio Summer Olympics, advised pregnant women against traveling to the Games, as the virus is endemic in Brazil. He stopped short, however, of telling them not to travel to South Florida -- although he did say couples considering starting a family should talk to their doctors about timing their pregnancies if concerned.

"At this point, we are not recommending travel restrictions to South Florida," Murthy said. "What we are going to do is work closely with Florida [on] identifying any local cases."

[email protected] or 954-356-4295

http://www.sun-sentinel.com/health/fl-zika-stops-blood-donations-broward-miami-20160728-story.html

 

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FDA: No Miami-area blood donations during Zika investigation

 
 

 

MIAMI (AP) — Federal authorities have told blood centers in two Florida counties to suspend collections amid investigations into four mysterious cases of Zika infection that may be the first spread by mosquitoes on the U.S. mainland.

 

 

Blood centers in the Miami and Fort Lauderdale areas were asked to immediately stop collecting blood until they can screen each unit of blood for the Zika virus with authorized tests, according to a statement on the U.S. Food and Drug Administration website.

 

 

Florida health officials have said the infections in Miami-Dade and Broward counties may not be linked to travel outside the U.S., but they have not confirmed how the virus spread.

 

 

Investigators are going door-to-door in the affected areas to talk with residents and collect samples. No mosquitoes collected from those areas so far have tested positive for Zika, said Jennifer Meale, spokeswoman for the state's Department of Agriculture and Consumer Services.

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The FDA recommends that neighboring counties also implement the same precautions "to help maintain the safety of the blood supply as soon as possible."

 

 

Visitors to South Florida in the last month are being urged to defer donations as well.

 

 

The FDA previously advised U.S. blood banks to refuse donations from people who recently travelled to areas outside the country that have Zika outbreaks.

 

 

Florida's main supplier of blood said it was working as quickly as possible to comply with the FDA's "unanticipated" request and would start testing all its collections for Zika on Friday.

 

 

OneBlood suspended collections earlier this week in the areas of Miami-Dade and Broward counties that are being investigated, according to a statement released Thursday.

 

 

The FDA is working with companies making the blood screening tests available to expand their operations, and blood centers nationwide can do this testing even without the transmission of Zika by local mosquitoes, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement Thursday.

 

 

Blood banks in Texas and Hawaii have begun or soon will start testing blood donations for the Zika virus. Puerto Rico suspended blood donations and imported blood products for the month of March until U.S. health officials approved the use of an experimental test to screen blood donations for the virus.

 

 

Messages left Thursday for officials at the Florida Department of Health were not immediately returned. Miami-Dade County's Department of Solid Waste Management released a statement saying mosquito control inspectors are spraying pesticides and eliminating mosquito breeding sites in response to both to residents' complaints and health department requests.

 

 

Residents are reminded that they are the first line of defense against the spread of mosquito-borne viruses. Residents can help by draining any standing water outside their homes, covering areas where standing water is likely to accumulate, and using mosquito repellent outdoors.

 

 

Zika is mainly spread by mosquitoes, as well as sex. So far, the 1,400 infections reported in the U.S. — including 383 in Florida — have been linked to travel to countries in Latin America or the Caribbean with Zika outbreaks.

 

 

There have been no reports of the virus in the country's blood supply, though FDA officials have said Zika transmission through blood is possible.

 

 

The 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.

 

http://www.orovillemr.com/business/20160728/fda-no-miami-area-blood-donations-during-zika-investigation

 

 

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