News about the Zika virus (ZIKV) is all around us, from scientific journals
to sports news, with athlete superstars joining in the caution
about exposure to this fast spreading epidemic.
ZIKV was identified as the cause of congenital disease during an
explosive outbreak in the Caribbean and the Americas. The infection often causes only mild symptoms in adults and is treated with rest and over
the counter medication, such as acetaminophen. However, ZIKV infections may
result in Guillain–Barré syndrome, a flaccid paralysis
bearing neurological reaction of the immune system to the virus. Further, the major threat posed by ZIKV is
that it can spread from a pregnant woman to her fetus. The transfer can result in microcephaly, severe brain
malformations, and other birth defects in the fetus. ZIKV can be transmitted
through sexual intercourse, widening the opportunities for exposure and the
number of infected individuals.
The alarming number of pregnant women in U.S. territories and the continental U.S. make this an epidemic
unlike any other to date. As of
September 15, 2016, in just Puerto Rico alone, the CDC lists 1,348 women with “laboratory evidence of possible Zika virus
infection.”
Another 749 pregnant women in the states are
infected with ZIVK. The first
wave of ZIVK exposed babies are being born in Puerto Rico and pediatricians
across the country are preparing for the resulting harm of fetal exposure to
ZIKV. Children born with microcephaly are at risk for seizures,
feeding issues, joint and bone growth issues, eye and vision problems, and developmental
delays. They require routine
neurological exams, hearing, vision and hormonal tests, and a plethora of
medical support and care. The care that
they need, however, is often unavailable in communities highly affected by this
epidemic.
A vaccine to prevent ZIKV in women of child-bearing age and
their partners is imperative. A number
of research laboratories are working hard to find the cure, including a collaboration between the Walter Reed
Army Institute of Research, the Beth Israel Deaconess Medical Centre, and
Harvard Medical School has yielded successful trials of three different
vaccines in both mice and nonhuman primate testing. The types of vaccines tested were a purified
inactivated virus vaccine, a vector
vaccine (DNA vaccine), and one that uses the ZIKV
genome inserted into a harmless adenovirus.
A Pennsylvania-based biotech company, Inovio Pharmaceutical, has
also developed a DNA-based vaccine candidate. This fully synthetic vaccine generated “robust antibody and killer T
cell responses” in Phase I Clinical Trial testing, and the company is currently
undertaking nonhuman primates testing in anticipation of human testing by the
end of the year.
Massachusetts biotech firms Moderna Therapeutics Inc. and Takeda
Pharmaceutical Co.
both won federal grants to accelerate the development
of their vaccines, $8 million, and $19.8 respectfully. These grants from the Biomedical Advanced
Research and Development Authority,
part of the Department of Health and Human Services,
will help fund initial human studies for a potential vaccine for the virus. These grants could turn into hundreds of millions of dollars in
funding based on the success of the first round of human trials.
Additionally, the Food and Drug Administration has approved investigational new drug applications for a number of bioresearch companies in
order to speed up the 5 to 10-year development and approval process for new
vaccines.
ZIKV
proved to be a trackable target due to its low mutation rate and the ability of
patients to clear the virus and recover fully thus making a vaccine a viable
option. The biggest obstacle will be getting
Congress to put aside
the partisan squabbling and pass the promised $1.1 billion funding for ZIKV
vaccine research. The funding bill,
which was blocked for a third time in early September 2016, was denied based on Democrat
objections to
Republican efforts to redirect Affordable Care Act
funds for ZIKV response funding.
The National Institute of Health’s study
of infants and pregnant women infected with ZIKV will be delayed if Congress fails to
approve new funding, as will the researchers' progress toward developing a
vaccine. The National Institute of Allergy and Infectious Diseases (NIAID)
launched a successful Phase I Clinical Trial for a DNA-based ZIKV vaccine in August 2016
and will be followed by Phase II Clinical Trial involving between 2,400 and
5,000 participants. Although the NAID notes that a safe and effective licensed
vaccine is still years away, without the federal funds from Congress the
necessary trials for the vaccine will be impossible. The federal government should follow the lead of the state officials
and the CDC
and make funding of ZIKV related illness detection and ZIKV vaccine research a
top priority.
Nesko Radovic is pursuing his law degree at DePaul University
College of Law in Chicago. He is an active member of the Mary and Michael
Jaharis Health Law Institute, a staff writer for the Institute’s online
publication, and a member of the DePaul’s Willem C. Vis International
Commercial Arbitration Moot Team. Mr. Radovic hopes to focus his career
in healthcare litigation and arbitration after graduating in May of 2017.