Will J&J Win the Race to Create an Ebola Virus Vaccine?
Johnson & Johnson (J&J) announced on Tuesday, Jan. 6 that it has begun testing its Ebola virus vaccine on humans and will have more than 400,000 doses available by April.
The pharma giant started a trial of its experimental Ebola vaccine in the U.K. and the first volunteers at the University of Oxford have received an initial dose. The trial aims to recruit 72 people by the end of the month, according to the New Brunswick.
Additional tests are planned for the U.S., Kenya, Uganda and Tanzania.
The vaccine uses a booster from Denmark’s Bavarian Nordic and is now the third shot to enter human testing. The commencement of this Phase I testing marks further progress in the race to develop a vaccine against the disease that has claimed the lives of more than 8,000 people in West Africa since last year and affected more than 20,000 people, according to the World Health Organization.
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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.
Just how much Ebola vaccine will be needed depends on how quickly the epidemic in Liberia, Sierra Leone and Guinea is brought under control and declines. Currently, experts project demand at anywhere between 100,000 and 12 million doses.
“As long as there are still Ebola patients, there is the risk that it will continue to go around the region,” Paul Stoffels, J&J's chief scientific officer, told reporters. “Does it come too late? That’s going to be answered when we are there. I don't think so.”
Phase I Trials
Phase I trials of the vaccine are intended to test primarily for safety but may also indicate whether vaccines produce a positive immune response.
In total, roughly 300 subjects will be involved in Phase I testing after which J&J hopes to rapidly move into larger studies, with final-stage Phase III trials planned for the second quarter of 2015.
The vaccine uses a so-called “prime-boost” approach of giving a first shot to stimulate the immune system, followed by a second booster a few weeks later.
“What we are doing with prime-boost is going for maximal protection, as well as long-term protection,” said Stoffels.
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Tests have already begun to show that the vaccine can be stored in a normal fridge for several months rather than needing special freezing, which is difficult to do in rural Africa.
The Cost of a Vaccine
Although it is too early to say how much a vaccine might cost, the GAVI global vaccines alliance announced last month it was committing up to $390 million to buy Ebola shots.
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. The investment has allowed Bavarian Nordic “to work at an unprecedented pace,” Paul Chaplin, the company’s CEO, said in a separate statement.
Shares in Bavarian Nordic, which received investment from J&J last year to accelerate production, rose 3.9 percent to their highest level in four years.
Human testing is already under way for two other vaccines, one by NewLink Genetics Corp. (NLNK) and Merck & Co. and the other by GlaxoSmithKline Plc. (GSK). 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.
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