Johnson & Johnson started a trial of its experimental Ebola vaccine in the U.K. and said it will produce 2 million courses of the shot this year.
The first volunteers in Oxford have received an initial dose, and the trial aims to recruit 72 people by the end of January, the New Brunswick, New Jersey-based company said in a statement today. Other tests are planned for the U.S., Kenya, Uganda and Tanzania. J&J has produced more than 400,000 courses of vaccine for use in large-scale trials by April, and could produce as many as 5 million courses over 12 to 18 months.
Drugmakers are racing to develop a protective vaccine against Ebola to curb the outbreak that has struck more than 20,000 people and killed more than 8,000, according to the World Health Organization. While the epidemic has stabilized in Liberia and Guinea, transmission remains intense in Sierra Leone, where more than 300 new infections were diagnosed in the last week of the year.
“As long as there are still patients, there is a risk that it will continue,” Paul Stoffels, J&J’s chief scientific officer, said on a call with reporters today. “Does it come too late? That’s going to be answered when we are there. I don’t think so.”
As many as 12 million doses of vaccine may be needed to bring the outbreak under control, J&J said, citing the London School of Hygiene and Tropical Medicine. Previously, the company aimed to manufacture more than 1 million by the end of 2015, with 250,000 available for clinical trials by May.
If the vaccine is shown to be safe in the initial studies, J&J plans larger tests involving about 2,000 people as early as mid-February, followed by a third round of trials in the Ebola-affected countries, Stoffels said.
The vaccine combines a shot from J&J’s Janssen unit in the Netherlands with one developed by Danish biotechnology company Bavarian Nordic A/S in a so-called prime-boost vaccine, in which recipients are given an initial shot to stimulate the immune system, followed by a boost several weeks later to enhance the body’s defenses.
The ideal interval between the two shots is still being determined, though a greater gap is associated with better long-term protection, according to Stoffels. Tests in monkeys showed the vaccine protected six animals, while others not given the shot died.
Human testing is already under way for two other vaccines, one by NewLink Genetics Corp. and Merck & Co. and the other by GlaxoSmithKline Plc. Both involve a single shot, though Stoffels said he’s confident that people who receive the first J&J shot will return for the second.
It’s too early to comment on the vaccine’s expected price, Stoffels said. The shot “will be available for anyone who needs it,” he said. The GAVI Alliance, a Geneva-based funder of vaccines, said last month it will commit as much as $390 million to buy Ebola vaccines.
J&J said in October it was committing as much as $200 million to accelerate and expand production of the vaccine, and buy new shares in Bavarian Nordic. That investment has allowed Bavarian Nordic “to work at an unprecedented pace,” Paul Chaplin, the company’s CEO, said in a separate statement today.
Bavarian Nordic rose 2.2 percent to a four-year intraday high of 211.50 Danish kroner as of 10:35 a.m. in Copenhagen, giving the company a market value of 5.85 billion kroner ($939 million).