Update: Federal Agencies Accelerate Preparations to Combat Zika Virus in the U.S.

As spring arrives and the threat of Zika virus grows in the U.S., the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are stepping up preparations to do battle against the virus. While mosquito-borne cases of Zika transmission haven’t yet been detected in the continental United States, they are found in U.S. territories including Puerto Rico and the U.S. Virgin Islands. Also, as of April 13, 2016, the CDC reports 358 cases of travel associated Zika virus cases in the United States—with New York and Florida reporting the most cases at 54 and 82 respectively and seven cases nationwide determined to result from sexual transmission.

CDC’s National Summit
April 1, 2016, the CDC hosted government representatives, health care professionals and private stakeholders at a national summit to discuss how to prepare for the Zika virus here in the U.S. “The mosquitoes that carry Zika virus are already active in U.S. territories, hundreds of travelers with Zika have already returned to the continental U.S., and we could well see clusters of Zika virus in the continental U.S. in the coming months. Urgent action is needed, especially to minimize the risk of exposure during pregnancy,” said CDC Director Tom Frieden, M.D., M.P.H. in the CDC’s release announcing the summit. In the same announcement, Amy Pope, J.D., White House Deputy Homeland Security Advisor and Deputy Assistant to the President highlighted the President’s $1.9 million funding request to “prepare for, detect, and respond to any potential Zika outbreaks” in the U.S. (See National Intelligence Report, 2/11/16, p. 7 for further discussion of federal funding requests relevant to diagnostics for the Zika virus). “The Administration is coordinating a whole-of-government effort to ensure that we are taking all available steps to pre-CDC’s National Summit April 1, 2016, the CDC hosted government representatives, health care professionals and private stakeholders at a national summit to discuss how to prepare for the Zika virus here in the U.S. “The mosquitoes that carry Zika virus are already active in U.S. territories, hundreds of travelers with Zika have already returned to the continental U.S., and we could well see clusters of Zika virus in the continental U.S. in the coming months. Urgent action is needed, especially to minimize the risk of exposure during pregnancy,” said CDC Director Tom Frieden, M.D., M.P.H. in the CDC’s release announcing the summit. In the same announcement, Amy Pope, J.D., White House Deputy Homeland Security Advisor and Deputy Assistant to the President highlighted the President’s $1.9 million funding request to “prepare for, detect, and respond to any potential Zika outbreaks” in the U.S. (See National Intelligence Report, 2/11/16, p. 7 for further discussion of federal funding requests relevant to diagnostics for the Zika virus). “The Administration is coordinating a whole-of-government effort to ensure that we are taking all available steps to pre-pare for Zika and work together with state, local, tribal, and territorial officials to protect Americans,” said Pope.

In person participants of the summit included 178 state, local and tribal representatives, representatives from 24 non-governmental organizations and representatives from 20 government agencies and departments including the FDA, National Institutes of Health, Centers for Medicare & Medicaid Services, and the Department of Health and Human Services. Additionally, the CDC indicated approximately 2,000 people registered to attend the webcast of the summit. In opening remarks, Pope noted that “we don’t have all the diagnostics we need” and thus part of the President’s funding request includes support for preparedness efforts that include “accelerating vaccine development and diagnostics.” Dr. Nicole Lurie, Assistant Secretary of Preparedness and Response, RADM, U.S. Public Health Service, similarly highlighted in her opening remarks the need for development of better diagnostics and increasing laboratory capacity. Lurie also explained that the government is active in regions with current outbreaks including Puerto Rico and the U.S. Virgin islands and using what is learned from outbreaks there to prepare the rest of the United States, including efforts to develop “better, faster, Zika diagnostic tests as quickly as possible.”

Blood donation screening
Days before the summit, the FDA announced that a screening test to detect Zika virus in blood donations was available for use under an investigational new drug application. Noting the importance of protecting the nation’s blood supply and screening blood in U.S. territories already affected by Zika transmissions, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement: “In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.” Previously, in February 2016, the FDA issued recommendations on how to reduce risk of transmission via blood transfusion. Those recommendations advised blood establishments in areas with active Zika virus transmission obtain whole blood and blood components for transfusion from areas of the U.S. without active transmission. (See National Intelligence Report, 3/10/16, p. 1).

Roche, whose cobas® Zika test was authorized for use to screen blood donations, says the “first stage” will be to use the test in Puerto Rico to reduce the need to import blood and the “second stage of deployment” for the test will be use “in the southern United States, which will most likely be impacted by any spread in the virus.” “All Testing Laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA Center for Biologics Evaluation and Research.”

Takeaway: Federal agencies increase efforts to raise awareness and prepare to combat the Zika virus in the U.S. while seeking Congressional action to fund preparedness efforts.