An aggressive push to use a second experimental Ebola vaccine to try to help stop the nearly yearlong outbreak in the Democratic Republic of the Congo may have backfired, with the DRC’s health minister insisting the country will not allow use of the vaccine, made by pharmaceutical giant Johnson & Johnson (JNJ).
The health minister, Dr. Oly Ilunga, had previously suggested a consortium made up of the London School of Hygiene and Tropical Medicine, Doctors Without Borders, and others might be permitted to conduct a clinical trial of J&J’s Ebola vaccine in the country, although not in the outbreak zone, where Merck’s experimental vaccine is being used.
Late last week he rescinded that option, saying the country would not approve a trial of another experimental vaccine during the ongoing outbreak, which has infected more than 2,500 people and killed nearly 1,670.
“There’s a whole debate raging around vaccinations. And we need to close down this debate,” Ilunga said Monday at a World Health Organization meeting called to share updates on the outbreak with partners in the response and donor countries. “We have an effective weapon. … Let’s focus on that.”
That remark seemed to be a rebuttal to Dr. Josie Golding, epidemics lead at the Wellcome Trust, who moments earlier had urged the DRC to reconsider its decision to block use of other vaccines at this time. The Wellcome Trust is part of the consortium.
Golding said the Wellcome Trust strongly believes there is an urgent need to deploy and test the second experimental vaccine, of which there are over a million doses available. “We regret the recent announcement against the use of the J&J vaccine and ask for this to be reconsidered. The lives of the people in North Kivu, across DRC and the region, depend on it,” she said.
Peter Piot, dean of the London School of Hygiene and Tropical Medicine, issued a statement Monday questioning the DRC’s decision, saying his institution trusts “the Minister’s decision [will] be reconsidered.”
But in an interview with STAT, Ilunga appeared unswayed. He criticized the actions of some who want to add the J&J vaccine to the outbreak response arsenal.
“We are in the presence of a very, very dangerous situation. We have people who don’t want to discuss [their plans] with the government. People who have no respect for ethics. And they are ready to introduce a new vaccine and to create new communications problems and trust problems with the community,” he said. “So I just made the decision to say no. We are not going to start a discussion again.”
J&J was more circumspect in its response to Ilunga’s announcement. “We respect the decision of the DRC minister of health regarding Ebola vaccine studies in the country,” Dr. Paul Stoffels, chief scientific officer and the main driver of J&J’s Ebola vaccine effort, said in a statement. “We remain ready to mobilize our resources if we are called on to help with outbreak response efforts.”
Talks have been underway for months among partners in the response about how to use the current outbreak to test unlicensed Ebola vaccines and whether additional unlicensed vaccines could help contain the outbreak.
No Ebola vaccines have yet been licensed in Western countries, though Merck has started the approvals process with the Food and Drug Administration. Russia and China have licensed vaccines, but both countries licensed the products without human effectiveness data to support their use.
Ebola vaccines and therapies have been hindered for years by an unfortunate reality. The only way to test if they actually work is to conduct clinical trials during an Ebola outbreak — a highly challenging time in which to do research.
The unprecedentedly large West African outbreak of 2014-2016 allowed for some clinical trials to take place. But only one — testing the Merck vaccine in Guinea — was able to generate results. The outbreak ended before trials could determine if other experimental vaccines or any of the experimental Ebola drugs worked.
Based on the Guinea trial results, the WHO advised that the Merck vaccine — which is given in a single dose and generates a protective response in about 10 days — should be used in future outbreaks until there is a licensed vaccine. But organizations involved in funding the development of these vaccines such as the Wellcome Trust and CEPI — the Coalition for Epidemic Preparedness Innovations — have been pressing for others to be deployed as well to determine if they work.
In April, the WHO’s vaccines advisory committee, the Strategic Advisory Group of Experts on Immunization, strongly urged that trials of other vaccines be conducted in DRC.
While there has been discussion about whether to test the Chinese or the two Russian vaccines, none of these vaccines is currently available in mass quantities. The only other vaccine for which there is a large supply is the J&J vaccine. And for months discussions have been underway about how and where to use the vaccine.
In late June, it appeared the DRC would be open to the testing of other vaccines. After a two-day meeting in Kinshasa, Ilunga said the country would consider approving applications for vaccine trials so long as Congolese scientists were involved and the vaccines were tested in other parts of the country, not near where Ebola is spreading.
Those pushing for the use of the J&J vaccine had proposed using the vaccine to create a firewall, vaccinating people near but outside the outbreak zone to prevent the virus from spreading into new territory.
But there have been serious concerns raised about the communications and logistical challenges a trial of another vaccine would pose, especially the J&J product, which was designed to be used to prevent outbreaks, not stop them. It must be administered in two doses given nearly two months apart.
Some DRC and NGO officials worried it might be difficult to communicate why some people were getting a one-dose vaccine while others got one requiring two shots, and that the different schedules might give rise to rumors that would erode confidence in and acceptance of the vaccines.
The dosing schedule would be difficult to implement in northeastern DRC, where there are large numbers of displaced people and the population moves about over long distances, Ilunga said.
“How can you, in an environment where people are traveling a lot, where people have no identity card, how can you organize a two-dosage vaccination in rural areas?” he asked. “You vaccinate somebody today and say, ‘Come back two months later.’ … Even from a logistical point of view, it’s not feasible.”
Ilunga said that, instead of modifying the study protocol to take into account the conditions the DRC had set, those designing the study of the J&J vaccine continued to plan for a trial that would also serve as a firewall, citing confidential emails that had been shared with him.
“So they were deliberately ignoring the conclusion of the forum and the decision made by the minister of health,” Ilunga said. “This for me is unacceptable.”
Word of the possible introduction of another vaccine was starting to spread, Ilunga said, with some community leaders asking about it.
He also disputed one of the arguments made to support use of the J&J vaccine — the concern that supplies of the Merck vaccine will may run out before the outbreak is over. Since the vaccination began early last August, more than 162,000 people have been vaccinated with the Merck vaccine.
As of June, there were roughly 500,000 doses currently available, with another 200,000 doses currently in production that should be available next January.
“We are in a very critical outbreak in a very complex environment,” Ilunga said. “We want to have all the human resources dedicated to the outbreak. We don’t want people to be diverted in another clinical trial elsewhere in the country.”