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 U.S. concerns over Zika, which is spreading rapidly in the Americas
and has hit Brazil the hardest, have risen since Florida authorities
last week reported the first signs of local transmission in the
continental United States in a Miami neighborhood.
There is no approved vaccine or drug for Zika, a virus spreading
rapidly in the Americas that can cause the birth defect microcephaly,
marked by small head size that can lead to severe developmental
problems in babies.
A number of companies and academic groups are racing to develop a
Zika vaccine, which is not expected to be ready for widespread use
for at least two to three years.
The National Institute of Allergy and Infectious Diseases (NIAID),
part of the National Institutes of Health federal research agency,
said its early-stage clinical trial will involve at least 80 healthy
volunteers ages 18 to 35 at three study sites. It said the trial
will evaluate the experimental DNA-based vaccine's safety and
ability to elicit an immune system response.
"A safe and effective vaccine to prevent Zika virus infection and
the devastating birth defects it causes is a public health
imperative," NIAID Director Dr. Anthony Fauci said in a statement.
U.S. vaccine maker Inovio Pharmaceuticals <INO.O> in June won U.S.
Food and Drug Administration approval to begin testing its Zika
vaccine in humans. It began its clinical trial last month, aiming to
enroll 40 healthy adult volunteers in Miami, Philadelphia and Quebec
City.
President Barack Obama in February asked the Republican-led Congress
for about $1.9 billion in emergency funds to combat Zika
domestically and abroad, but lawmakers have not passed funding
legislation.
A $1.1 billion compromise failed after House of Representatives
Republicans attached language that would place restrictions on
abortion and defund part of Obama's signature 2010 healthcare law.
The administration has redirected $374 million from other health
initiatives including combating the Ebola virus for stopgap Zika
funding.
Obama's health and human services secretary, Sylvia Burwell, told
top congressional appropriators in a letter that the NIH will
exhaust $47 million in repurposed funding by the end of the month.
She said without additional funding, the second phase of the NIH
vaccine clinical trial would have to be delayed, which could prolong
the development process.
"In addition, research and development of other vaccine candidates,
diagnostics, therapeutics and (mosquito) vector control technologies
may be constrained," Burwell wrote.
She said the component within her department that provides funding
to private-sector partners to develop medicines and vaccines will
exhaust its $85 million in repurposed funding by the end of August.
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She said the U.S. Centers for Disease Control and Prevention would
virtually exhaust its $222 million in repurposed funds for its
domestic Zika response by the end of September.
TEXAS ON HIGH ALERT
Public health officials have said small, localized outbreaks are
likely in southern U.S. states already vulnerable to mosquito-borne
disease. Florida said it would make Zika testing available to all
pregnant women at county health departments statewide at no cost.
Texas health officials said they were on high alert for local Zika
transmission and urged residents to follow precautions against
mosquito bites.
"It's the perfect mix - local transmission in Florida, travel to
Brazil, and we're at the height of mosquito season in Texas," said
John Hellerstedt, Texas Department of State Health Services
commissioner, referring to the Olympic Games beginning this week in
Rio.
Fauci said that while it will "take some time" before a vaccine
against Zika is commercially available, the launch of the study
marked an important step forward.
The study sites for the NIH vaccine trial were: NIH facilities in
Bethesda, Maryland; the University of Maryland School of Medicine in
Baltimore; and Emory University in Atlanta.
The Zika vaccine includes a piece of DNA that has been engineered to
contain genes for proteins of the Zika virus. Such DNA vaccines do
not contain infectious material so they cannot cause a person to
become infected with Zika, the NIAID said.
New York Attorney General Eric Schneiderman said his office has sent
cease-and-desist letters to seven companies accused of deceptively
marketing ineffective Zika-protection products. Schneiderman also
issued an alert warning consumers against the companies'
advertisements, which mainly promote ultrasonic and botanical
oil-based mosquito repellants.
(Reporting by Will Dunham, Additional reporting by Jessica Dye and
Anthony Lin in New York and Doina Chiacu in Washington; Editing by
Michele Gershberg and Bernard Orr)
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