BREAKTHROUGHS BLOG

November 18, 2019

Research Roundup: the threat of antibiotic resistant infections, J&J Ebola vaccine roll out in DRC, and Merck Ebola vaccine granted marketing approval by European Commission

Ansley Kahn
Senior Program Assistant
GHTC
PATH/Felix Masi

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. 

Drug-resistant germs sicken about three million people every year in the United States and kill about 35,000, representing a much larger public health threat than previously understood, according to an updated report released last Wednesday from the Centers for Disease Control and Prevention (CDC). The CDC previously estimated in a 2013 report that about two million antibiotic resistant infections occur every year, causing 23,000 deaths. Using previously unavailable data and by applying new methods, the CDC calculated that the 2013 estimate missed about half of the yearly cases and deaths caused by antibiotic resistant infections. Infectious disease experts say that the new numbers, though still conservative, underscore the magnitude of the problem and establish a new national baseline of infections and deaths that will help prioritize resources to address the most pressing threats.

Health authorities in eastern Democratic Republic of the Congo (DRC) have introduced a new Ebola vaccine produced by Johnson & Johnson (J&J) in an effort to combat the world’s second-worst outbreak of the virus on record. The new vaccine—which has completed phase 1 and 2 clinical trials and has been endorsed by the World Health Organization (WHO) —will be administered to 50,000 people in the city of Goma, on the Rwandan border. The experimental vaccine, which requires two injections eight weeks apart, will be rolled out alongside Merck’s single-dose Ebola vaccine. Merck’s vaccine has been administered to over 250,000 people since the start of the current outbreak in August 2018 through a strategy known as ring vaccination, offering the vaccine to contacts of those likely to be infected. The J&J vaccine will be provided to “targeted at-risk populations” in areas where the virus is not yet being actively transmitted, according to WHO.

The European Commission granted marketing authorization to Merck’s Ebola vaccine, known as Ervebo, last Monday, making it the world’s first approved Ebola vaccine. This authorization comes less than one month after the European Medicines Agency recommended it to be licensed. A few days following this approval, Merck also received WHO prequalification, a process in which WHO assesses vaccines and other medical products in order to assure member countries that they are safe and effective. Merck said it will also continue to work with the US Food and Drug Administration and regulatory agencies in African countries to license the vaccine. Ervebo is currently being used in the DRC under a “compassionate use” or research protocol similar to a clinical trial. Merck expects the licensed doses will become available during the third quarter of 2020 and has made a commitment to make the vaccine available to countries eligible for purchasing assistance through Gavi, the Vaccine Alliance, at the lowest possible price.

back