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Tuesday, Jun 21 2016

Full Issue

Federal Officials Approve Testing Zika Vaccine In Humans

The early tests, in 40 adults, will look at safety concerns first. In other developments, health officials from around the world examined the Zika threat at a U.N. meeting, U.S. officials seek to ensure the safety of blood donations and a look at the virus' effect on children.

An experimental vaccine for the Zika virus is due to begin human testing in coming weeks, after getting the green light from U.S. health officials. Inovio Pharmaceuticals said Monday it received clearance from the Food and Drug Administration to begin early-stage safety tests of its DNA-based vaccine against the mosquito-borne virus. That puts the company ahead of researchers at the National Institutes of Health, who have said they expect to begin testing their own DNA-based Zika vaccine by early fall. (Perrone, 6/20)

Pennsylvania vaccine maker Inovio Pharmaceuticals and South Korea鈥檚 GeneOne Life Sciences said Monday that they had received approval from U.S. regulators to start testing a DNA vaccine, known as GLS-5700, on humans. The early-stage study will include 40 healthy subjects. It is primarily designed to assess the safety of the vaccine but will also measure the immune response generated by the injection. (Cha, 6/20)

Interim results from the trial, which will involve 40 healthy adults, are expected later this year. Testing in mice and monkeys has shown the vaccine triggered what Inovio called a robust antibody response. Gary Kobinger, whose team at Canada鈥檚 National Microbiology Laboratory in Winnipeg did the mouse testing, said the Inovio team decided late last year to try to develop a Zika vaccine in the shortest time it could. (Branswell, 6/20)

The tests will be done at three U.S. locations, including Philadelphia, and will evaluate safety, tolerability, and immunogenicity of the vaccine against the mosquito-borne virus. Test results from the study are expected this year, said Inovio president and CEO Joseph Kim. (Loyd, 6/21)

Even though the explosive spread of the Zika virus has been met with a new level of international response, thanks to lessons learned from the Ebola crisis, experts warn they are only beginning to grasp the damage the mosquito-borne virus can do. Doctors speaking at a U.N. meeting on Global Health Crises said Monday that the Zika virus has already affected 60 countries on four continents, and a major outbreak on the Atlantic Ocean island nation of Cape Verde suggests the disease is now poised to enter continental Africa. Zika has already become epidemic in Latin America and the Caribbean. (Astor, 6/20)

The U.S. government said on Monday it has agreed to help fund two pathogen reduction technologies to help reduce the risk of Zika virus and other infections from being transmitted through the blood supply. (6/20)

By now we know that Zika is dangerous for pregnant women and their future babies. The virus can cause devastating birth defects. But what about for infections after babies are born? Or in older children? Is Zika a danger for them? So far, all the evidence suggests probably not. But there are a few caveats. (Doucleff, 6/20)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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