A multi-pronged international effort has begun to pull out all the stops to start trials of Ebola vaccines in Uganda, which declared an outbreak of the deadly disease on September 20. According to the latest World Health Organization (WHO) update, Uganda has had 18 confirmed and 18 suspected cases of Ebola, including 23 deaths – an extremely high fatality rate of 64%. A trial of a vaccine candidate that is further along in development could begin before the end of next month.
There are proven vaccines for the Zaire ebolavirus, which has led to a dozen outbreaks in neighboring Democratic Republic of Congo (DRC) and was responsible for the massive Ebola epidemic in West Africa in 2014. But those vaccines cannot control this outbreak because is being driven by a distant viral relative known as the Sudan ebolavirus, which last caused an outbreak, also in Uganda, in 2012. The Zaire and Sudan ebolaviruses “are not variants and they are not strains — they are different viruses,” says Nancy Sullivan. who directs biodefense research at the National Institute of Allergy and Infectious Diseases (NIAID) and has collaborated on Ebola vaccine studies. Researchers have long known that the world is in dire need of a vaccine against Sudan’s Ebola virus: In 2016, science published a survey of 50 leading vaccine researchers who ranked Sudan’s Ebola virus vaccine as the number one R&D priority based on feasibility and need. But vaccine makers have had little financial incentive to produce one. Even if the current trial is successful, it will be a challenge to produce enough doses quickly enough.
Three vaccines against Sudan’s ebolavirus have been tested in human studies, but because outbreaks are so rare, they have not had a real-world test. “We are moving very quickly this time and people are really willing to work to get these vaccines on the ground,” says Ana Maria Henao-Restrepo, a WHO vaccine specialist who is coordinating discussions between the government of Uganda and stakeholders anywhere in the world. including vaccine manufacturers, funders and non-governmental organizations.
The most distant is a candidate that pharmaceutical giant GlaxoSmithKline began developing during the West African outbreak; GSK donated the license to the nonprofit Sabin Vaccine Institute in 2019. The single-dose vaccine contains the gene for the virus’ surface protein stitched onto a harmless chimpanzee adenovirus (ChAd), which serves as a vessel to deliver the cargo into cells . The US government’s Biomedical Advanced Research and Development Authority in 2019 awarded Sabin a $128 million contract to develop the product, and the candidate has worked well in monkey studies and small-scale clinical trials conducted by the Vaccine Research Center of NIAID.
Henao-Restrepo says the WHO held two rounds of consultations this week with vaccine developers and others, which led to unanimous agreement that candidate Sabin should be first in line for a trial in Uganda. Ugandan health officials are now evaluating a draft proposal for this trial. If all goes well, Henao-Restrepo says a study could begin before the end of October.
NIAID’s Richard Koup, acting director of the vaccine research center, says he has 100 doses of the vaccine and has made them available to Uganda. There are another 40,000 large doses that need to be bottled. The Coalition for Epidemic Preparedness Innovations (CEPI), a nonprofit that supports vaccine R&D, is working with Sabin to find a manufacturer that can do what’s called a “fill and finish.”
Nicole Lurie, CEPI’s US director, says the current outbreak shows once again how difficult it is to produce and deploy vaccines that can help stop an outbreak. “This is a great example of all the loopholes that need to be closed,” Lurie says. “This shows that the world is not yet set up to be clear about who is responsible for what when it comes to responding to a deadly outbreak. If the virus spreads beyond Uganda and a vaccine is shown to work, Lurie says, countries could find themselves again waiting in line for it, as they did for the COVID-19 shots. “This outbreak can get really bad, and it’s not clear whose responsibility it is to produce additional doses,” she says. “The fact that we find ourselves in this situation now is upsetting.” Ideally, she says, when outbreaks occur, governments and philanthropies would fund the production of the most promising candidates to prepare for the worst.
A second candidate is not far behind. Oxford University has 71 doses of its single-shot vaccine, which aims to protect against the Sudan and Zaire viruses and is made with a different ChAd. The candidate, a variant of the widely used COVID-19 vaccine that Oxford brought to market with AstraZeneca, has yet to prove itself in a monkey study. Oxford has contracted with the Serum Institute of India to produce another 20,000 doses in the coming months, Henao-Restrepo says.
The European Commission in July 2020 approved a vaccine made by Johnson & Johnson that can protect against both Ebola viruses, but it requires two doses spaced 56 days apart, a hurdle when a virus is spreading rapidly. The company has 3,500 doses of the vaccine. Monkey studies showed it to be protective, and human trials showed its safety and ability to stimulate appropriate immune responses. Three other Sudan ebolavirus vaccine candidates are in early stages of development.
The proposed WHO trial in Uganda, which only CEPI has so far offered to help fund, will adopt the same unusual strategy as a 2015 study in Guinea that first proved the value of a measles vaccine. ebolavirus in Zaire. Instead of testing the vaccine in the general population, the researchers, led by Henao-Restrepo, gave it to contacts of known cases in what is known as a ring vaccination strategy. To circumvent the ethical dilemmas of withholding a potentially life-saving drug in a dire situation, the researchers did not compare the vaccine with a placebo vaccine, but instead gave some participants the vaccine immediately, while others were in a group ” overdue”.
Ebola outbreaks have historically ended without vaccines: Surveillance, isolation of infected people, strict hygiene efforts, and personal protective equipment for health care teams can limit the spread. But DRC has used Zaire ebolavirus vaccines half a dozen times over the past 4 years to hasten the end of outbreaks. Henao-Restrepo says vaccines also make it easier to find contacts of cases “because you’re giving something to the community,” she says. (For reasons that are not yet clear, contacts have been extremely difficult to identify in the Ugandan outbreak.) In addition, mortality tends to fall for people who receive the vaccine soon after infection, and these people are also less likely to infect others.
But Sullivan, who will soon leave NIAID to become director of the National Infectious Disease Laboratories at Boston University, worries that the world is once again finding itself unprepared to combat an outbreak of a known viral threat. for a long time. “All the pandemic preparedness we’re doing is not enough,” she says.
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