BREAKTHROUGHS BLOG

October 14, 2019

Research Roundup: Global Fund replenishment, FDA allows marketing of first rapid Ebola test, and NIH to launch influenza vaccine research centers

Ansley Kahn
Senior Program Assistant
GHTC
PATH/Satvir Malhotra

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At its sixth replenishment conference, the Global Fund to Fight AIDS, Tuberculosis and Malaria received commitments of more than US$14 billion for the next three years to wipe out three of the world’s deadliest diseases. The Global Fund is the world’s largest backer of programs to combat tuberculosis (TB) and malaria and the second largest funder of programs to fight HIV/AIDS. The $14 billion pledged, a 15 percent increase from its previous fundraising round in 2016, will cover the Global Fund’s work from 2020 to 2022 and is the largest amount of money ever raised by a health organization. Since the Global Fund’s establishment in 2002, it has helped save the lives of 32 million people and has cut deaths from TB, malaria, and AIDS by 40 percent in the countries in which it invests.

For the first time, the US Food and Drug Administration (FDA) has granted marketing authorization for a rapid diagnostic test to identify the Ebola virus. The test, known as the OraQuick Ebola Rapid Antigen Test, detects Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals. The FDA reviewed the test under the De Novo premarket review pathway, a regulatory pathway for new types of devices considered low-to-moderate risk, following considerations of data from many clinical studies. The FDA also granted Breakthrough Device designation to the OraQuick Ebola Test and worked closely with OraSure Technologies, the device’s manufacturer, to improve device development and facilitate the generation of evidence, as well as expedite FDA's review of the device.

The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, will provide up to $51 million in funding to launch a network of research centers that will work to develop more broadly effective influenza vaccines, including a universal flu vaccine that offers long-lasting protection against multiple viral strains. The allocation for this initiative, dubbed the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, is designed to support the program for more than seven years. The CIVICs program will consist of three vaccine centers: one vaccine manufacturing and toxicology center, two clinical centers, and one statistical, data management and coordination center.

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