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FDA seeks US-wide Zika blood screening; sexual transmission concerns grow
Filed Under:
Zika
Lisa Schnirring | News Editor | CIDRAP News
| Aug 26, 2016
The US Food and Drug Administration (FDA) today expanded its recommendation for testing blood donations and blood components for Zika virus beyond Puerto Rico and Florida to include all of the United States and its territories.
In other developments, a report documenting a case of Zika sexual transmission involving an asymptomatically infected traveler shed more light on exposure risks, while other reports revealed new information on virus complications, including patterns in Puerto Rico's Guillain-Barre syndrome cases and heart-wrenching findings on health problems that surface in infected babies during their first few months.
FDA: Blood screening cuts Zika transmission
According to the FDA's new guidance, all states and territories should screen donated blood and blood components with a test authorized for emergency use by the FDA or use a licensed test when available. Also, the FDA said facilities can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.
Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said there's still much uncertainty about the nature and extent of Zika virus transmission. "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 made its first blood screening recommendation in February for areas with active Zika transmission and stepped up its advice in July for Florida when the state detected its first local cases. All areas of the United States that have seen active transmission have complied with the FDA's guidance.
Screening has proved helpful for curbing the Zika transmission risk, and expanding the recommendation should reduce the risk even more, the FDA said. The measure will remain in effect until the risk of transfusion-related Zika transmission subsides.
No new local cases in Florida
No new locally acquired Zika infections were reported in Florida today for a second day in a row, though the state continued to pile up more travel-related cases, according to an update from the Florida Department of Health (Florida Health).
Further investigation found that one of the earlier reported local patients from Miami-Dade County's Wynwood neighborhood had recently traveled outside the United States to an area with widespread transmission, so the number of local cases declined by one, to 42, Florida Health said.
Fifteen new travel-related cases were reported, plus five more in pregnant women. The developments put the state's totals at 545 and 75, respectively.
First clear sexual transmission involving asymptomatic Zika
Though experts have suspected that people with asymptomatic Zika infections can pass the virus to their sex partners, no clear-cut cases have been reported in the literature until today, when researchers from Maryland and their partners at the Centers for Disease Control and Prevention reported the results of an investigation into a Maryland woman's infection. The team described the case in an early online report in Morbidity and Mortality Weekly Report (MMWR).
In June, the Maryland woman, who wasn't pregnant, sought care for a fever and itchy rash. Tests confirmed Zika virus infection. The woman said she had recently had unprotected sex twice with a man who had recently returned from the Dominican Republic.
During an interview, the man told clinicians he had experienced no symptoms consistent with Zika infection, though he had felt tired, which he assumed was related to travel.
The woman sought care 3 days after she started feeling sick, and reverse-transcription polymerase chain reaction (RT-PCR) tests on blood and urine revealed Zika RNA only in the urine sample. Serologic tests for Zika, as well as for chikungunya and dengue, were negative. However, plaque-reduction neutralization testing at the CDC confirmed recent Zika virus infection.
To assess evidence of recent infection in the man, officials collected serum, plasma, and urine samples. RT-PCR tests were negative for Zika in serum and plasma, but equivocal for the urine specimen. Serologic testing was positive for both Zika and dengueantibodies. A semen sample collected a few days later was negative for Zika RNA.
The authors said only one other report has described possible Zika transmission from an asymptomatic man to a woman, but in that instance, investigators weren't able to rule out mosquito-sourced infection of the woman during travel.
The Maryland case is a reminder of the Zika sexual transmission risk from people who aren't sick after being in active transmission areas, though more studies are needed to assess the risk, the authors said. They also noted that unprotected sex with an asymptomatic person who has returned from a Zika-affected area should be considered as another form of exposure to the virus.
Puerto Rico GBS cases show tilt toward women
An analysis of cases reported through Puerto Rico's Guillain-Barre syndrome (GBS) surveillance system has identified 56 cases since the first of the year, 34 of them with confirmed flavivirus infection, including 10 with confirmed Zika virus infections, researchers from the CDC and Puerto Rico said today in an early online MMWR report.
Surveillance also found turned up 26 patients with other neurologic conditions, 7 of whom had evidence of Zika or another flavivirus infection.
Most of the GBS patients were older than 50, which is consistent with past GBS reports. However, investigators noted some unusual patterns, such as more cases in women than men, which they said suggests the Zika burden in Puerto Rico might be higher in women.
Also, they found that the acute inflammatory demyelinating polyneuropathy type of GBS was most common in those who underwent electrophysiological testing. In contrast, similar testing in French Polynesian patients with Zika-linked GBS showed that the acute motor axonal neuropathy subtype was more common.
Follow-up of Zika babies shows emerging problems
A follow-up study of growth and neurologic outcomes in 48 babies born in Brazil with congenital Zika infections revealed that the most common clinical signs were irritability and sleep problems, with many of the infants difficult to calm, even during feeding. Researchers reported 1- to 8-month follow-up findings on babies who are being treated at a rehabilitation center in Sao Luis, Brazil. They described the findings yesterday in Emerging Infectious Diseases.
Neurologic difficulties that seemed to emerge in the second and third month included seizures and swallowing problems. Head growth continued to be severely compromised, "suggesting a very disruptive brain insult," the group wrote.
Of six affected babies born without obvious microcephaly, three went on to develop the condition after birth, which the researchers said is a further reminder that microcephaly at birth is only one of the symptoms of congenital Zika infection and that screening should also be based on signs of fetal brain disruption sequence and cranial computed tomography findings.
See also:
Aug 26 FDA press release
Aug 26 Florida Health daily Zika report
Aug 26 MMWR report on asymptomatic sexual transmission case
Aug 26 MMWR report on GBS in Puerto Rico
Aug 25 Emerg Infect Dis report
FDA seeks US-wide Zika blood screening; sexual transmission concerns grow
Filed Under:
Zika
Lisa Schnirring | News Editor | CIDRAP News
| Aug 26, 2016
The US Food and Drug Administration (FDA) today expanded its recommendation for testing blood donations and blood components for Zika virus beyond Puerto Rico and Florida to include all of the United States and its territories.
In other developments, a report documenting a case of Zika sexual transmission involving an asymptomatically infected traveler shed more light on exposure risks, while other reports revealed new information on virus complications, including patterns in Puerto Rico's Guillain-Barre syndrome cases and heart-wrenching findings on health problems that surface in infected babies during their first few months.
FDA: Blood screening cuts Zika transmission
According to the FDA's new guidance, all states and territories should screen donated blood and blood components with a test authorized for emergency use by the FDA or use a licensed test when available. Also, the FDA said facilities can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.
Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said there's still much uncertainty about the nature and extent of Zika virus transmission. "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 made its first blood screening recommendation in February for areas with active Zika transmission and stepped up its advice in July for Florida when the state detected its first local cases. All areas of the United States that have seen active transmission have complied with the FDA's guidance.
Screening has proved helpful for curbing the Zika transmission risk, and expanding the recommendation should reduce the risk even more, the FDA said. The measure will remain in effect until the risk of transfusion-related Zika transmission subsides.
No new local cases in Florida
No new locally acquired Zika infections were reported in Florida today for a second day in a row, though the state continued to pile up more travel-related cases, according to an update from the Florida Department of Health (Florida Health).
Further investigation found that one of the earlier reported local patients from Miami-Dade County's Wynwood neighborhood had recently traveled outside the United States to an area with widespread transmission, so the number of local cases declined by one, to 42, Florida Health said.
Fifteen new travel-related cases were reported, plus five more in pregnant women. The developments put the state's totals at 545 and 75, respectively.
First clear sexual transmission involving asymptomatic Zika
Though experts have suspected that people with asymptomatic Zika infections can pass the virus to their sex partners, no clear-cut cases have been reported in the literature until today, when researchers from Maryland and their partners at the Centers for Disease Control and Prevention reported the results of an investigation into a Maryland woman's infection. The team described the case in an early online report in Morbidity and Mortality Weekly Report (MMWR).
In June, the Maryland woman, who wasn't pregnant, sought care for a fever and itchy rash. Tests confirmed Zika virus infection. The woman said she had recently had unprotected sex twice with a man who had recently returned from the Dominican Republic.
During an interview, the man told clinicians he had experienced no symptoms consistent with Zika infection, though he had felt tired, which he assumed was related to travel.
The woman sought care 3 days after she started feeling sick, and reverse-transcription polymerase chain reaction (RT-PCR) tests on blood and urine revealed Zika RNA only in the urine sample. Serologic tests for Zika, as well as for chikungunya and dengue, were negative. However, plaque-reduction neutralization testing at the CDC confirmed recent Zika virus infection.
To assess evidence of recent infection in the man, officials collected serum, plasma, and urine samples. RT-PCR tests were negative for Zika in serum and plasma, but equivocal for the urine specimen. Serologic testing was positive for both Zika and dengueantibodies. A semen sample collected a few days later was negative for Zika RNA.
The authors said only one other report has described possible Zika transmission from an asymptomatic man to a woman, but in that instance, investigators weren't able to rule out mosquito-sourced infection of the woman during travel.
The Maryland case is a reminder of the Zika sexual transmission risk from people who aren't sick after being in active transmission areas, though more studies are needed to assess the risk, the authors said. They also noted that unprotected sex with an asymptomatic person who has returned from a Zika-affected area should be considered as another form of exposure to the virus.
Puerto Rico GBS cases show tilt toward women
An analysis of cases reported through Puerto Rico's Guillain-Barre syndrome (GBS) surveillance system has identified 56 cases since the first of the year, 34 of them with confirmed flavivirus infection, including 10 with confirmed Zika virus infections, researchers from the CDC and Puerto Rico said today in an early online MMWR report.
Surveillance also found turned up 26 patients with other neurologic conditions, 7 of whom had evidence of Zika or another flavivirus infection.
Most of the GBS patients were older than 50, which is consistent with past GBS reports. However, investigators noted some unusual patterns, such as more cases in women than men, which they said suggests the Zika burden in Puerto Rico might be higher in women.
Also, they found that the acute inflammatory demyelinating polyneuropathy type of GBS was most common in those who underwent electrophysiological testing. In contrast, similar testing in French Polynesian patients with Zika-linked GBS showed that the acute motor axonal neuropathy subtype was more common.
Follow-up of Zika babies shows emerging problems
A follow-up study of growth and neurologic outcomes in 48 babies born in Brazil with congenital Zika infections revealed that the most common clinical signs were irritability and sleep problems, with many of the infants difficult to calm, even during feeding. Researchers reported 1- to 8-month follow-up findings on babies who are being treated at a rehabilitation center in Sao Luis, Brazil. They described the findings yesterday in Emerging Infectious Diseases.
Neurologic difficulties that seemed to emerge in the second and third month included seizures and swallowing problems. Head growth continued to be severely compromised, "suggesting a very disruptive brain insult," the group wrote.
Of six affected babies born without obvious microcephaly, three went on to develop the condition after birth, which the researchers said is a further reminder that microcephaly at birth is only one of the symptoms of congenital Zika infection and that screening should also be based on signs of fetal brain disruption sequence and cranial computed tomography findings.
See also:
Aug 26 FDA press release
Aug 26 Florida Health daily Zika report
Aug 26 MMWR report on asymptomatic sexual transmission case
Aug 26 MMWR report on GBS in Puerto Rico
Aug 25 Emerg Infect Dis report