GENEVA (Reuters) – Both GlaxoSmithKline and NewLink Genetics are working to boost their capacity to make Ebola vaccines, with a goal of a “very significant increase in scale during the first half of 2015”, the World Health Organization said on Wednesday.
Even under the best conditions, if the experimental vaccines are proven to be safe and confer protection in clinical trials, a significant number of doses will not be available until late in the first quarter of 2015, the WHO said.
GSK and NewLink are conducting phase 1 trials in healthy volunteers currently or soon in more than 10 sites in Africa, Europe and North America, the WHO said in a statement after hosting a two-day meeting of 70 experts.
Initial safety data was expected by year-end, with phase II trials early next year to generate more data.
“Both companies are working to augment their manufacturing capacity. The goal is a very significant increase in scale during the first half of 2015,” the U.N. agency said.
“The next step is to make these vaccines available as soon as possible – and in sufficient quantities – to protect critical frontline workers and to make a difference in the epidemic’s future evolution,” it said.
At least 3,091 people have died from Ebola in the worst outbreak on record of the haemorrhagic disease that has been ravaging Liberia, Sierra Leone and Guinea in West Africa.
More than 6,500 cases have been diagnosed, and the U.S. Centers for Disease Control has warned that the number of infections could rise to up to 1.4 million people by early next year without a massive global intervention to contain the virus.
Some 800 vials of the NewLink vaccine, donated by the government of Canada, could yield from 1,500 to 2,000 doses, and priority should be given to consenting health workers, WHO said. The vaccine was developed by Canada’s Public Health Agency but the commercial license is held by Iowa-based NewLink.
The overall challenge is to achieve clinical and regulatory work that normally takes from two to four years “within a matter of months” without compromising safety and efficacy standards, it said.
“All agreed on the ultimate goal: to have a fully tested and licensed product that can be scaled up for use in mass vaccination campaigns,” it said.