December 22, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
NewLink Genetics and Merck & Co. today announced today that a division of the United States Department of Health and Human Services (HHS) has awarded them a $30 million contract for the manufacturing and development of their Ebola vaccine candidate. The division, known as the Biomedical Advanced Research and Development Authority (BARDA), will partially fund a new 330-person Phase Ib study of the vaccine, known as rVSV-EBOV.
The vaccine was developed by the Public Health Agency of Canada (PHAC), which licensed the vaccine to a wholly owned subsidiary of NewLink in 2010. In November 2014, BioSpace reported that NewLink and Merck signed an agreement to develop, manufacture and distribute rVSV-EBOV.
NewLink and Merck’s vaccine is one of the leading Ebola vaccine candidates currently in clinical trials. Another is a vaccine developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline .
The U.S. National Institutes of Health (NIH) has announced plans to begin a randomized, controlled Phase II/III trial both of vaccine candidates in early 2015.
“Governments and industry are effectively collaborating in an unprecedented effort to accelerate the development of Ebola vaccine candidates,” said Mark Feinberg, chief public health and science officer of Merck Vaccines in a statement. “If we can bring an efficacious and well-tolerated vaccine to the outbreak countries, we will not only help protect people at risk in the current crisis, but also may help reduce the likelihood of such tragic events in the future,” he continued.
Both NewLink-Merck’s vaccine and GSK-NIAID’s vaccine have hit snags in recent weeks, however. A clinical trial of NewLink-Merck’s vaccine was recently halted at Geneva University Hospital in Switzerland after four of 59 participants complained of joint pain in their hands and feet, BioSpace reported in mid-December. Several other studies of the vaccine candidate are ongoing. The statement released when the trial in Geneva was paused noted that joint pain after infection or vaccination is common.
“This is a well-documented phenomenon which does not worry specialists. However, it deserves to be carefully studied in order to update the information which is provided to the volunteers. The temporary interruption of a clinical trial is a standard precautionary measure in such cases,” the statement said. The trial is expected to resume in early January 2015.
Feinberg told Discover Magazine that the trial’s dosages were higher than those that would be administered in the actual treatment. “So far the data emerging on the vaccine are very encouraging,” he was quoted as saying by Discover.
In the case GSK-NIAID’s vaccine, the World Health Organization (WHO) released a statement on Friday that countries involved in the Ebola vaccine trials have requested additional documentation from GlaxoSmithKline before they will authorize Phase 2 clinical trials of the company’s vaccine. “If these steps are completed to the satisfaction of the national authorities, Phase II trials are likely to begin in February,” the statement by WHO said.
Though these two events have slightly slowed down the Ebola vaccine development and deployment, the time frame is still light years faster than typically seen in vaccine development. Typical vaccine development can take between 10 to 20 years. “Never before has there been a push to develop a vaccine for an emerging public health threat in this short a time frame,” Feinberg told Discover Magazine.
