NIH Funds Zika Research on US Olympic Team While US Army Collaborates on Vaccine Development

Concerns over Zika have been ongoing since it’s spread in South America in 2015; yet, there is still much we don’t know about the virus, and what infection entails. Because protection against this mysterious virus is essential, as is a need to understand it, researchers have been using the resources that are available to learn more about Zika and how to prevent infection.

Zika Vaccine Development

Recent testing guidelines for Zika have raised concern among healthcare professionals; therefore, preventing initial infection is of the utmost importance.

In a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR), vaccines global business unit of Sanofi, Sanofi Pasteur, will begin co-development of a vaccine candidate for the Zika virus. The agreement* states that WRAIR will provide Sanofi Pasteur with its Zika purified inactivated virus (ZPIV) vaccine technology, as well as present the company with several key materials for vaccine development:

• Immunologic assay development data which will aid in measuring neutralizing antibody responses after an individual has been naturally infected with the virus and subsequently received ZPIV vaccination
• Biologic samples collected during primate studies
• Biologic samples collected using ZPIV during studies measuring human safety and immunogenicity

The pharmaceutical company is tasked with creating a clinical development and regulatory strategy, as well as producing clinical material, which complies with Good Manufacturing Practices, “to support phase II testing, optimization of the upstream process to improve production yields, and characterization of the vaccine product.” Sanofi Pasteur will be conducting studies using the WRAIR technology while simultaneously using vaccine technologies which were successfully used for Dengue and Japanese encephalitis in pre-clinical studies.

While this is the first collaboration between United States government and private sector on a Zika vaccine, it is not the first attempt to develop a Zika vaccine. Last month, Inovio Pharmaceuticals partnered with GeneOne Life Science to begin human testing of a DNA vaccine (GLS-5700) in a phase I trial. Trial results will be announced later this year.

Zika Funding in the United States

In what has been a prolonged debate between Republican and Democrat representatives, a Zika funding bill is due for a re-vote, before Congress’ impending summer recess. The proposed bill aims to repurpose funds from both the Ebola and Obamacare programs, and hinder the use of such funds by any family planning organizations, such as Planned Parenthood. Although there is a possibility that the bill will be passed, President Obama has stated that he will veto the funding plan. The outcome is yet to be seen.

Regarding the government funding, Stephen Redd, MD, director of the Office of Public Health Preparedness and Response (OPHPR) at the Centers for Disease Control and Prevention (CDC) told Contagion in an exclusive interview, “There are scientific questions that really won’t get answered unless we have the funding. We really won’t be able to protect the American people to the extent that we can, from the technology standpoint, without that funding.”

In the meantime, the CDC has decided to provide US states and territories with $25 million in funds in order to help them prepare for a possible Zika outbreak. The CDC has provided the aforementioned amount to 53 state, city, and territorial health departments. The funds were made available for Fiscal Year 2016 starting July 1, 2016 through June 2017.

Zika Cases in the United States

In addition to providing some funds, and in an effort to “increase the public’s trust that [they] are providing facts [the public] can use to make informed decisions” in compliance with item 11 under the Clear Communication Index, the CDC published a bulletin explaining the uncertainties surrounding Zika.

On their website, the CDC has made available two maps of the United States depicting the estimated range of Aedes aegypti and Aedes albopictus mosquitos (the two vectors which can carry the Zika virus) within the 50 states. According to the bulletin, the maps show areas where the mosquitos are either currently found or have been found in the past. However, the maps are “not meant to represent risk of spread of disease,” nor do they imply that the mosquitos in those areas are infected with the Zika virus.

Updates on Zika in Pregnancy

In terms of the risk of Zika in pregnant women and their fetuses, the CDC has clarified the following: women can either be infected through the bite of an infected mosquito, or through (several forms of) sexual contact with an infected male. However, whether the mode of infection affects the risks associated with Zika or not is yet to be determined.

The CDC confirms that a fetus can be infected during pregnancy or at the time of delivery. Nonetheless, there are several factors which are still unclear. For example, the probability of a woman (or any individual) to become infected upon exposure to the virus is still uncertain, as is how the virus will affect the mother, her pregnancy, and her unborn child (if at all). Not only this, but the probability of an infected fetus to develop neurological or other birth defects is still to be determined, as well. Although some healthcare providers can agree that the first trimester and the beginning of the second trimester of pregnancy are likely the time during which a Zika infection is to cause the most harm to a fetus, it is not certain.

Recent Zika Research

In an effort to better understand the effects of a Zika infection, the National Institute of Health’s (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will fund a research initiative that aims to study viral exposure in athletes, coaches, and staff from the US Olympic Committee (USOC) who will be attending the 2016 games in Rio de Janeiro, Brazil, where there is active Zika transmission.

With this study, researchers hope to better understand not only the dynamics of Zika, but also the risk factors for infection, the reproductive outcomes of those participants infected with the virus, as well as where and for how long the virus remains in the body. Carrie L. Byington, MD, from the University of Utah in Salt Lake City, UT will lead the study.

In order to overcome the fear that Zika has instilled in healthcare providers and families alike, the threats posed by the effects of Zika should not be taken lightly. Zika vaccine developments are finally underway after much stalling, as are research efforts. However, in order for states to better protect their citizens from initial infection, government funding is needed.

*According to the press release, “WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID)—part of the U.S. National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA)—part of the Health & Human Services (HHS) Office of the Assistant Secretary of Preparedness and Response–have been coordinating pre-clinical development of the candidate encouraged by new, pre-clinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center. NIAID will sponsor a series of phase 1 ZPIV trials while the technology transfer process is occurring.”