FDA Defends Universal Testing of Donated Blood for Zika Virus

Troy Brown, RN

November 21, 2016

The US Food and Drug Administration (FDA) defended its August recommendation for universal testing of donated blood for Zika virus at an informational meeting of its Blood Products Advisory Committee on Zika virus and blood safety in the United States on November 18.

Not everyone agrees with the recommendation. Susan Stramer, PhD, chair, American Association of Blood Banks Transfusion Transmitted Diseases Committee and vice president of Scientific Affairs at the American Red Cross, read a joint statement to the committee during the open public hearing. "While we support the delivery of the safest possible blood products and services, we are concerned about the processes used to develop and implement the Guidance, the balance of resource commitment to potential benefits, and the potential for future expectations for blood donation testing," Dr Stramer said.

However, the FDA says the recommendation is necessary given the disease's public health impact and the fact that some donated blood has tested positive for the virus, which often causes no symptoms. The agency anticipated the negative feedback and prepared a statement of its own.

"Zika virus is a transfusion transmitted disease which can cause potentially severe consequences including microcephaly and Guillain Barré syndrome. The requirement to test blood donations for Zika virus has already resulted in interdicting contaminated collections confirming the value of testing," Jay S. Epstein, MD, director, Office of Blood Research and Review, FDA, said in the statement.

As of November 16, 36,322 cases of laboratory-confirmed Zika virus disease have been reported in the United States or its territories; 4232 of those were travel related (4115 in the United States, 115 in Puerto Rico, and 2 in the US Virgin Islands), and 32,090 were locally acquired cases (139 in the United States, 31,294 in Puerto Rico, 603 in the US Virgin Islands, and 54 in American Samoa), according to the Centers for Disease Control and Prevention.

On February 16, 2016, the FDA issued guidance instructing US blood centers to screen donors for Zika virus disease risk and defer high-risk donors from donating blood.

As the virus continued to spread in the United States and US territories, the FDA authorized the use of the cobas Zika nucleic acid test (Roche Molecular Systems Inc) on donated blood under an investigational new drug (IND) application on March 30.

The FDA authorized the use of the Procleix (codeveloped by Hologic and Grifols) Zika nucleic acid test under an IND application on June 20.

On August 26, the FDA recommended screening of all blood and blood products in all states and US territories with a test authorized by the FDA under an IND application or a licensed test when one is approved. The agency recommended using an FDA-approved pathogen-reduction device for plasma and certain platelet products. The FDA instructed areas of active mosquito-borne transmissions, including Florida and Puerto Rico, to implement the measures immediately; 11 other states (Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina, and Texas) to implement the measures within 4 weeks; and the remainder of the country to implement them no more than 12 weeks later.

Implementation of Guidance Costly

"[W]e recognize that the current circumstances are extraordinary, with little or no precedent, but are nevertheless concerned that there has been no public quantitative assessment of the potential risks, benefits or resource usage required in the Guidance. We consider this wholly inappropriate at a time when both healthcare and public health resources are limited," Dr Stramer read from the statement.

Implementing the measures will "incur direct costs well in excess of one hundred million dollars per year," she added.

"[O]ngoing safety and quality-related projects were put on hold; laboratories were reconfigured; and we are burdening our hospitals with another IND cost recovery increase without concomitant data demonstrating efficacy."

"Exceptionally Urgent and Evolving Situation"

"We recognize the magnitude of this undertaking and we understand the concern that the guidance imposes a burden on the industry. FDA's guidance was issued to address an exceptionally urgent and evolving situation," Dr Epstein continued in the FDA statement. "The situation with Zika virus emerged very rapidly and necessitated swift action and consideration of testing throughout the United States in order to protect public health. While we agree that policymaking should not be driven by a mandate to achieve zero risk, we do believe that issuing these recommendations was warranted given the potential public health impact of the Zika virus."

As of November 12, 564,571 donations have tested positive on the cobas Zika NAT; 36 (0.006%) tested positive initially, and 13 of those were repeat reactive on index or follow-up, Lisa Lee Pate, MD, JD, director, Clinical Research for Blood Screening, Roche Molecular Systems Inc, said at the meeting. The specificity of the test is at least 99.9%, Dr Pate said.

Procleix has a sensitivity of 95% and a specificity of 99.9%, Rainer Ziermann, PhD, vice president, clinical affairs, Hologic, said.

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