BREAKTHROUGHS BLOG

May 13, 2019

Research Roundup: Warning to address drug-resistant TB, a new Ebola vaccine strategy in DRC, and FDA takes step to bolster research on pregnant and lactating women

Ansley Kahn
Senior Program Assistant
GHTC
PATH/Georgina Goodwin

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A report released by the Economist Intelligence Unit warns that the fight against drug-resistant tuberculosis (DR-TB) lags behind that of other diseases in terms of money and public attention. Deaths from DR-TB will cost the world economy nearly US$20 billion annually; however, international funding for TB is approximately one-eighth that of HIV/AIDS and about half that of malaria. The report calls for TB to be treated as a public health emergency and states that $9 billion is needed by 2020 to develop new drugs, diagnostics, and vaccines to address this disease—the world’s number one infectious disease killer. DR-TB can develop when patients fail to adhere to the notoriously grueling treatment regimen, which includes thousands of pills and painful injections, or because of poor-quality drugs. Last year, the United Nations held the first-ever High-Level Meeting on TB, determining that ending TB is a global priority after progress against the disease has stalled in recent years.

The World Health Organization (WHO) announced plans last Tuesday to change its vaccination strategy in the Democratic Republic of Congo (DRC) in an attempt to better confront the country’s current Ebola outbreak, which has lasted nine months and claimed more than 1,000 lives. As part of the new vaccination strategy, WHO intends to launch “pop-up” vaccination campaigns in safe communities and shift to immunizing as many people in each target area as possible instead of relying solely on its current tactic of ring vaccinating health workers and the immediate contacts of each known case. To extend vaccine supplies, WHO also recommended offering smaller doses of the vaccine—developed by Merck—to those at high risk and low risk respectively, and eventually introducing a second vaccine made by Johnson and Johnson. A consortium, including the Coalition for Epidemic Preparedness Innovations and the London School of Hygiene and Tropical Medicine, is planning how to safely roll out the new vaccine.

On Wednesday, the US Food and Drug Administration (FDA) released two new draft documents which provide guidance about how to study drug safety and efficacy in pregnant and lactating women. The draft documents provide insight to drug makers into the FDA’s thinking on when they should study a medicine in lactating women and how they can better monitor health outcomes in pregnant women who are taking medications that have already been FDA-approved. These documents follow 2018 recommendations made by a federal task force formed by Congress to study the lack of research involving pregnant and lactating women. Historically, the drug industry has excluded pregnant women from research out of concern that an experimental medication might harm a fetus. There is a similarly small amount of research on medications safety in lactating women. Once finalized, the documents will help companies collect more high-quality safety information about drugs used in pregnant and lactating women.

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