Zika Update-October 2016: Congress Finally Appropriates Funds but Vaccine Still a Long Way Off
Ending a nearly seven months long political stalemate, Congress appropriated $1.1 billion to fund international and domestic activities related to the spread and effect of the Zika virus on September 28. The funding, which became available on October 1 with the beginning of the 2017 fiscal year, generally aligns with the World Health Organization’s coordinated strategy for addressing Zika through coordinated detection, prevention, care and support, and research.
Supporting Zika Vaccine Research and Clinical Trials
The appropriation bill includes $152 million to the National Institute of Allergy and Infectious Diseases (NIAID) for vaccine and medical countermeasure development. Developing a vaccine for the Zika virus has been a priority for public health officials for months as the links between Zika and devastating birth defects solidified. Before Congressional appropriations were finalized, NIAID announced three sites to test one potential vaccine in humans: Emory University, the National Institutes of Health Clinical Center, and the University of Maryland School of Medicine’s Center for Vaccine Development.
While announcing testing sites indicate strong progress toward developing a Zika vaccine, it is unclear when a vaccine will become commercially available. The three announced sites are conducting Phase I trials, which focuses on a small group of research subjects to determine the general safety of a vaccine. Should Phase I of these studies be successful, researchers hope to move onto Phase II in early 2017. Phase II starts to evaluate a vaccine for general effectiveness and further explores its safety, with Phases III and IV providing escalated efficacy and safety evaluations. This process often takes years. Even with President Obama authorizing the vaccine development to be fast tracked in April 2016, it is highly unlikely that a Zika vaccine will finish clinical trials before 2018. Including an expedited FDA regulatory review after all phases of the clinical trial are complete, a Zika vaccine may not be available for use in the United States until 2019.
Although Florida is the only state in the continental United States with locally acquired, mosquito-transmitted infections, New York currently has the highest total number of Zika infections in the continental United States with 811 reported the week of September 28. Currently, every state in the continental United States has at least one travel-acquired case of Zika. Looking forward to 2017 and 2018, it is likely that Zika transmission will continue in the future with a possible increase in the number of Zika infections.
Continuing Concerns in Domestic Zika Response
State and local public health officials nationwide have been advocating for federal funding to support domestic Zika detection and prevention efforts since February 2016, anticipating the Zika infections seen during the 2016 mosquito season. Many states, particularly those with known Aedes aegypti or Aedes albopictus mosquitos, have increased mosquito control efforts as a way to prevent Zika transmission. Mosquito control, which is important to a comprehensive Zika prevention effort, is typically a local government undertaking. Many states in the Gulf Coast, which has a high population of Aedes mosquitos, usually maintain local mosquito control efforts.
States outside the Gulf Coast, however, may not have had any mosquito control or surveillance infrastructure. For example, several jurisdictions in Maryland—such as Baltimore City and Montgomery County—had not had mosquito control or surveillance programs for several years before 2016. Because these efforts were new in 2016 and resources were scarce, the mosquito control and surveillance activities in many Maryland jurisdictions relied heavily on the state during the 2016 mosquito season, which was also under resourced.
In addition to mosquito vector control efforts, many states are struggling to meet the demand from pregnant women for Zika testing. For example, some pregnant women in Florida reported up to a five week wait for test results. With Florida state law prohibiting abortion after 24 weeks’ gestation, unless the mother’s life is threatened, such a long delay in testing not only increases anxiety, it could essentially eliminate a woman’s choice of whether or not to continue a pregnancy after exposure to Zika. Florida recently received $2.5 million from the Centers for Disease Control and Prevention to expand Zika testing capabilities in the state to, hopefully, shorten the testing delay.
Although the Zika funding passed by Congress last week includes $394 million for the Centers for Disease Control and Prevention to prepare, prevent, and respond to Zika and other vector-borne diseases, it is still unclear how much of that funding will be allocated to assist local mosquito control efforts. To fund 2016 Zika efforts during the Congressional stalemate, the CDC reprogramed $44.25 million from the Public Health Emergency Preparedness grant that generally funds local public health emergency efforts. This funding cut—on top of several years of reduced funding—reduced the capabilities of many local health departments to prepare for and respond to public health threats. Additionally, the Zika funding provides $387 million to the United States Department of Health and Human Services to support its Public Health Emergency Fund. However, this will likely only help offset the $428 million HHS had to reallocate from Ebola response and internal operations.
Preparing for 2017 and Beyond
With a Zika vaccine likely years off and public health officials anticipating continued Zika transmission over the next few summers, it is important to continue support of local detection and prevention efforts. The Zika funding signed into law by President Obama on September 29 provides much needed financial support to address this growing public health epidemic. But the funding, which is limited to one year, will not be sufficient on its own because it is backfilling funds already drawn away from other programs. State and local governments will need to continue to support Zika prevention and response efforts, particularly in areas of education and community outreach.
One major concern is that public knowledge of the disease is still very low. Many Americans are unware that up to 80% of people with Zika never show symptoms, that Zika can be sexually transmitted, or the newly learned possibility of transmitting the virus through skin-to-skin contact of an individual with active symptoms. Moving forward, there will need to be a large effort to educate the public about the disease and how a person can prevent transmission.
As we learn more about the effects of Zika infants that were exposed to the disease in utero will need continued support. The CDC has already reported 21 live born infants with Zika-related birth defects and 5 reported pregnancy losses with birth defects in the continental United States and that number will likely increase over the next several months. Beyond the reported birth defects, some physicians have noted additional developmental delays for infants exposed to Zika that appeared healthy at birth.
Overall, the Zika funding enacted into law last week was long overdue. However, the initial funding in itself will likely be insufficient to cover the entire costs of this public health crisis. In addition to state and local governments continuing to support Zika prevention and response efforts, it is likely that the 115th Congress will need to once again find the political will to provide the necessary financial support to respond to Zika.