FDA Is In The Dark About Its Revised Zika Guidelines In New York

George Koshy, a Stony Brook senior, donates blood to help out people like his mother, who has Leukemia.

By Raghava Lakshminarayana and Yawen Tang

The FDA is in the dark about whether their revised Zika safety guidelines for blood transmission have been met by New York State hospitals as of their September 26th deadline, FDA sources said.

The guidelines established different deadlines for different states. New York was one of the 11 states that had a 4-week window to update its Zika screening practices. Other states have received up to 12 weeks to follow suit. But as of today, the FDA is uncertain whether these practices have been implemented across the state.

“Although the FDA does not currently have specific data on each State, the Agency expects that blood establishments will be able to implement testing within the timeframe in the guidance,” Paul Richards, a public affairs specialist for the FDA, said.

The revised guidelines require all donated blood to be screened for Zika, alongside the other routine tests that take place during blood testing. But, according to the Center for Disease Control and Prevention, “there is no FDA-licensed test for Zika virus (…) testing for Zika became available through two separate Investigational New Drug (IND) applications for blood collected in Puerto Rico and the continental United States.”

“The Red Cross has begun blood donor screening tests for Zika virus in the state of New York,” Patty Corvaia, the American Red Cross’ External Communications Managers, said.

According to the FDA revised guidelines: “Because of their proximity to areas with locally acquired mosquito-borne cases of ZIKV or because of other epidemiological linkage to ZIKV, such as the number of travel-associated cases reported in a state, blood establishments that collect Whole Blood and blood components in Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas should implement the recommendations as soon as feasible, but not later than 4 weeks after the guidance issue date.”

“Evidence is very compelling and therefore, ethically, we must do it in order to protect patients,” Dr. Dennis Galanakis, a doctor at the Stony Brook Hospital, in Long Island, NY, said. Galanakis said that the Stony Brook blood bank has adopted the FDA’s recommendations within the 4-week deadline.

These guidelines are also being implemented in local blood drives held by the New York Blood Center (NYBC).

“I haven’t traveled since the whole zika thing became a prevalent issue. It was a question that I answered electronically before I talked to any of the people taking blood,” Ashley Tymann, a student at a local blood drive in Stony Brook University, said.  

“Following the guidance, we added a specific question to our donor health history questionnaire concerning travel to or residence in areas with local Zika virus transmission and we continue to ask donors to self-defer, or postpone their blood donation for four weeks, if they are at risk of Zika virus exposure,” The American Red Cross stated in their press release.

“The Stony Brook hospital collects over 20,000 pints of blood in a year,” Galanakis said. “We get about 10% of our units (blood) from internal collections,” he said. The rest of the blood is collected through the American Red Cross.

Different blood organizations have different numbers on the amount of samples that have tested positive. “We do know that from March 14 – August 31 just 0.10 percent of presenting Red Cross donors were deferred due to Zika virus,” said Patty Corvaia. “We haven’t had any positive tests so far,” Andrea Garcia, a media representative of the New York Blood Center said.

“The possibility that the positive [result] is real right now is very high but we want more donors to prove it,” Galanakis said. He believes that blood samples that test positive for Zika won’t have an effect on the amount of blood donations but only time will tell, he said.