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 The U.S. Food and Drug Administration said earlier this week that
areas with active domestic transmission of Zika virus should stop
collecting blood locally.
Puerto Rico has reported a small number of cases of local
transmission, and U.S. health officials expect many thousands of
residents to be infected once the mosquito season reaches its peak
this summer.
Local health officials fear switching to imports could undermine the
island’s voluntary donation network, which provides the bulk of its
needs. The new guidelines will require Puerto Rico to obtain its
entire supply from the continental United States at a cost of up to
$100,000 a week, said Jose O. Alsina, vice president and chief
operating officer of Puerto Rico's Banco de Sangre de Servicios
Mutuos, the island's largest blood bank.
The U.S. territory is struggling with about $70 billion in debt and
a 45 percent poverty rate. The island has already defaulted on some
debt payments and its Governor Alejandro Garcia Padilla has warned
that the government is close to running out of money.
Alsina said its eight blood banks can’t afford to buy blood and make
payroll, which includes about 400 drivers, phlebotomists, nurses and
others. Blood bank officials are asking the government to help pay
for the imports so they can maintain their infrastructure until
local collection can resume. They also have asked for extra time to
collect blood locally before having to import it all.
"Laying off people, even for a short time, would be devastating,"
Alsina said.
The FDA said that it recognized the new rules would create hardships
but stressed they were necessary to ensure safety. The Zika virus
has been found in blood, and experts are concerned about the
possibility that it could be transmitted through transfusion.
The FDA "is actively engaged in conversations with local health
authorities and blood collection establishments in Puerto Rico in
order to minimize the impact to the greatest extent possible," said
agency spokeswoman Tara Goodin.
The Zika outbreak began in Brazil last year and has spread rapidly
through the Americas. The World Health Organization declared it a
global health emergency earlier this month because the virus is
suspected of causing microcephaly, a birth defect marked by
unusually small heads that can cause developmental disabilities.
President Barack Obama has asked Congress to approve $1.8 billion in
supplemental emergency funding to help combat the virus, with $250
million designated for Puerto Rico.
Dr. Thomas Frieden, director of the U.S. Centers for Disease Control
and Prevention, has told lawmakers some of the funds should finance
the development of a blood screening test that he hoped could be
available in six to 12 months.
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TEMPORARY TEST
In the meantime, researchers at the Blood Systems Research Institute
(BSRI), a unit of the blood and transfusion services company Blood
Systems Inc, are evaluating the possibility of refining an existing
Zika test to temporarily screen blood from Puerto Rico.
The test was developed nearly a decade ago by the CDC and has been
used mainly for research purposes. Dr. Michael Busch, director of
the BSRI said he believes his institute could refine the test and
screen the Puerto Rican blood supply until a commercial test becomes
available later this year.
Busch said the institute is in discussions with the FDA and believes
it could scale up capacity to test Puerto Rican blood donations and
submit an application for approval by the end of March. The CDC test
could screen the average amount of blood Puerto Rico uses per week
but not much more, Busch said.
The U.S. Virgin Islands and American Samoa also have been identified
by CDC as areas with active Zika transmission, but both already
import their blood supply from the continental United States and
Hawaii, respectively, the FDA said.
U.S. health officials expect to see localized outbreaks in the
southeastern United States later this year.
The further the virus spreads, the greater the area that will need
to be supplied by Zika-free regions of the country, potentially
squeezing overall blood supply.
OneBlood, which collects most of the blood used in Florida, said it
will implement a screening test as soon as one is authorized by the
FDA. The organization is in "close contact" with the FDA, CDC and
Florida Department of health "should additional measures be needed,"
said spokesman Pat Michaels.
(Reporting by Toni Clarke; Editing by Michele Gershberg and Lisa
Girion)
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