With Congressional Funding, the Zika Race Could Be a Sprint

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.