J&J Ebola Shot Languishes, Making Merck Vaccine Only Option
Johnson & Johnson Shot Languishes Amid Deadly Ebola Outbreak
(Bloomberg) -- Johnson & Johnson’s experimental Ebola vaccine sits idle in a Dutch warehouse, ready to help counter the international crisis erupting in Africa -- if authorities decide to use it.
The Ebola epidemic that began a year ago has already killed more than 1,700 people and was declared a global public health emergency on Wednesday. World Health Organization officials have said that they have about 245,000 doses of an experimental vaccine from Merck & Co. that’s already in use, and that there’s a need for additional options.
Health leaders in the Democratic Republic of Congo are reluctant to roll out J&J’s vaccine alongside Merck’s because their differing regimens may lead to confusion in the conflict-riven region of the outbreak. Both products are experimental and are yet to be licensed. Still, as the virus continues to spread, health experts and the humanitarian group Medecins Sans Frontieres say it’s imperative that vaccination coverage in the region be extended.
“We must use all of the tools and approaches at our disposal, including the coordinated use of both the Merck and Johnson & Johnson vaccines,” Peter Piot, director of the London School of Hygiene & Tropical Medicine, said in a statement Wednesday. Piot was among the team who discovered Ebola. “WHO has sounded the global alarm. Now, it is up to the world to act.”
The Merck vaccine has already been given to at least 143,000 people in the latest outbreak, according to a report from Congo’s Ministry of Health on a series of late-June meetings with the WHO and other health groups on stopping the outbreak. The remaining supply could be doubled to about 500,000 by splitting doses in half, an approach that was shown to be effective when used in Guinea, the report said.
Merck also plans to make about 100,000 more doses by January, which could also be doubled, according to the report. Overall, Merck plans to supply 900,000 doses over the next six to 18 months that will be produced in Germany and in the U.S., the company said in an email.
Sole Shot
“There is no ‘crisis’ so far,” regarding availability of Merck’s vaccine, the June report said. The shot remains, “the only vaccine to be used as part of the response.”
J&J’s is one of four other experimental vaccines that officials have discussed using in or around the outbreak. The company has been working on the product, which also includes a shot developed by Bavarian Nordic SA, for more than a decade, according to Paul Stoffels, chief scientific officer of the U.S. health-care giant. While it still hasn’t gained approval from health officials, studies in humans and animals suggest that it’s safe, effective, and gives long-lasting immunity to Ebola.
But there are important differences from Merck’s vaccine that have to be taken into account, he said. Made from a live, replicating virus, Merck’s vaccine mounts protection against Ebola in about 10 days. While the J&J immunization appears to raise the body’s defenses for the long-term, it’s administered in two shots about two months apart.
“We have developed a vaccine for a time of peace,” said Stoffels, who worked in clinics in poor African communities in Congo and elsewhere for years before coming to the company.
How much, if any, protection a person gets from the first shot before getting the second isn’t clear. Ensuring people are fully vaccinated with the two-shot regimen would be challenging among mobile populations, especially in people fleeing conflict, and could stoke suspicions.
Vaccine Dilemma
Introducing a second vaccine production “on the face of it, scientifically, may make perfect sense,” said Michael Ryan, head of the WHO’s emergencies program. However, those in the middle of the outbreak may ask “why is one being used one in one place, another in another place?”
Moving ahead with the J&J vaccine in Congo is still an important priority, if only to make sure that it will be tested and available later if it’s needed, said Ryan, who first joined WHO in 1996 and has helped manage outbreaks and other health emergencies for about 25 years.
The June meetings concluded that J&J’s vaccine should be tested in the country, but in areas outside the epidemic “hot zone” to reduce the chance that erroneous perceptions about the differing shots will lead people to refuse vaccination, the report said. Usage would also have to be closely monitored as part of a clinical study.
“The Johnson & Johnson vaccine should be tested for what role it can play” in prevention of Ebola, said Marie-Paule Kieny, a director of research at French biomedical institute Inserm. J&J and its partners in research “might look at whether a protocol would be accepted to start with a feasibility pilot phase outside the hot zone,” said Kieny, who was previously WHO’s assistant director-general for health systems and innovation.
Ebola is a contagious and deadly virus that can cause massive internal bleeding from multi-organ failure and shock; about half of infected people die. Merck’s vaccine was tested in a massive outbreak in West Africa that killed about 11,000 people and spread outside the continent for the first time. From 2014 to 2016, Ebola spread from Guinea, Liberia and Sierra Leone to Nigeria, Senegal and Mali.
Health Emergency
The Congo outbreak is the worst since the 2014-2016 epidemic, and more than 2,500 people have already been infected. There is a very high risk that the virus will spread within Congo and around the region, WHO Director-General Tedros Adhanom Ghebreyesus said Wednesday, when the emergency was declared.
Congo’s health minister, Oly Ilunga, resigned on Monday after being replaced as the head of the country’s Ebola response team, according to reports.
People in the afflicted region understand the usefulness of vaccination and are asking to be immunized, said Anne-Marie Pegg, clinical lead for epidemic response and vaccination with Medecins Sans Frontieres, also known as Doctors Without Borders.
While “optimal use” of a second vaccine remains under review, one strategy could be to use the J&J vaccine on the periphery of the epidemic zone, where people remain at high risk due to population movement and re-seeding of cases, she said in an email Monday.
A second potential strategy would be to offer it in high-risk areas to those not identified as eligible according to recommendations made by a WHO expert panel, Pegg said, adding that any strategy “needs to remain open to evaluation and adaptation according to the dynamics of the epidemic.”
While the WHO says there are 600,000 doses of the Merck vaccine available, logistical issues are creating bottlenecks. The country’s supply is sporadic and stocks usually number fewer than 1,000 doses where they are urgently needed, Isabelle Defourny, Medecins Sans Frontieres’ director of operations, said in an email Friday. Testing other vaccines in an epidemic zone would aid preparations should the outbreak spread, she said.
The J&J vaccine is tested regularly for stability, is in good condition, and will probably remain usable for another five or 10 years, Stoffels said.
“If the epidemic gets under control quickly and there’s no need for it, we’ll happily store it for the next one,” he said. “As a company, we stand by with 1.5 million doses of vaccine when people want to deploy them.”
--With assistance from James Paton, Kristen V. Brown and Marthe Fourcade.
To contact the reporter on this story: John Lauerman in London at jlauerman@bloomberg.net
To contact the editors responsible for this story: Eric Pfanner at epfanner1@bloomberg.net, ;Shamim Adam at sadam2@bloomberg.net, Jason Gale
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