Second Phase Of GlaxoSmithKline's Ebola Vaccine Delayed
Published: Dec 22, 2014
December 19, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
The World Health Organization (WHO) said in a statement today 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. The countries, including Cameroon, Ghana, Mali, Nigeria and Senegal should finish the review of the information by the end of January, pending GSK’s fulfillment of the request.
“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.
GSK had expected to begin Phase 2 testing of the vaccine, which is being developed in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NAIAD), in January, BioSpace reported earlier this month.
GSK’s vaccine is not the only one to hit a snag. A clinical trial of another leading Ebola vaccine candidate, this one co-developed by Merck and NewLink Genetics, was halted in mid-December when several patients complained of joint pain. At the time of the announcement, BioSpace reported that the trials of Merck-NewLink’s vaccine were expected to continue on Jan. 5, 2015, once tests confirmed the joint pain was “benign and temporary”.
Both GSK’s and Merck-NewLink’s vaccines are scheduled to undergo Phase 2 and Phase 3 testing simultaneously, an indication of how motivated countries, companies and healthcare workers are to get vaccines to people. In the rush to vaccinate, however, all stakeholders are struggling to balance the risks and benefits of testing the vaccine in people. This has been thrown into sharp relief with the compressed timeline of the Ebola vaccine.
Vaccine development and commercialization often occurs over the course of one to two decades, but this timeline has been condensed to months in Ebola’s case, according to an article in Discover Magazine.
“I’ve been doing this kind of work for 30 years, and this is the first time I’ve encountered anything with the compressed timeline and sense of urgency,” Ripley Ballou, head of Ebola vaccine research for GlaxoSmithKline, told the magazine.
He told them that there are still many unknowns, which is “what keeps everybody up at night.”
GSK’s vaccine candidate was designed by Nancy Sullivan, chief of the Biodefense Research Section in NIAID's Vaccine Researcher Center. Sullivan collaborated with researchers at the VRC and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), as well as Okairos, a Swiss-Italian biotech company acquired by GSK in 2013.
For an up-to-date list of the companies involved in the Ebola vaccine race, refer to BioSpace’s article, “Ebola Clinical Trials: Big Name Players In The Ebola Race”.