Experimental shots using technologies associated with Moderna and Oxford are entering first-in-human testing as public trust remains deeply damaged
By Lucretia Hughes Klucken
GENEVA — Clinical trials for two experimental Ebola vaccines are underway in Canada and the United Kingdom as researchers seek healthy adults willing to participate in first-in-human testing.
The candidates are being developed to protect against Bundibugyo ebolavirus, a rare but deadly strain responsible for the ongoing outbreak in the Democratic Republic of Congo and neighboring Uganda.
There is currently no approved vaccine specifically targeting the Bundibugyo strain.
The World Health Organization said Tuesday that laboratory and animal data connected to the experimental products appear promising but cautioned that only properly conducted clinical trials can determine whether the vaccines are safe and produce a useful immune response in people.
That means researchers need volunteers.
The public’s response, particularly across social media, has included a message researchers and public health officials may not want to hear: No thanks.
Those reactions do not represent a scientific opinion poll, but they reveal something equally important. Trust in the public health establishment has been badly damaged, and another campaign asking healthy people to test newly developed vaccines is being met with immediate skepticism.
Health Canada authorized Moderna’s Phase 1 trial of its experimental mRNA-1469 vaccine. The study is expected to enroll approximately 80 healthy adults at three Canadian locations.
The vaccine uses the same underlying messenger RNA technology associated with Moderna’s COVID-19 vaccine. Researchers will monitor participants for side effects and measure whether the shot produces an immune response against the Bundibugyo virus.
The first Canadian volunteers have already received doses.
Moderna’s project is supported by the Coalition for Epidemic Preparedness Innovations, or CEPI, which has committed up to $50 million toward early testing and manufacturing.
If the candidate advances successfully and is eventually approved, Moderna has agreed to make at least 500,000 doses available to low- and middle-income countries at what the company describes as access pricing.
A separate Phase 1 trial is underway at the University of Oxford in England.
The Oxford Vaccine Group plans to enroll 50 healthy adults between the ages of 18 and 55. Its vaccine, called ChAdOx1 BDBV, uses the same viral-vector platform used to develop the Oxford-AstraZeneca COVID-19 vaccine.
The vaccine was manufactured by the Serum Institute of India. Participants will be monitored for safety, tolerability and immune response.
Oxford says the study will not expose participants to Ebola. The investigational vaccine does not contain the complete virus capable of causing Ebola disease.
Those facts matter, but so does informed consent.
These are Phase 1 trials. Their purpose is to learn what happens when these particular experimental products are administered to people. The vaccines have not been approved for general use, and researchers do not yet know whether they will prevent infection or disease.
That uncertainty is not evidence of a secret plot. It is the reason clinical trials exist.
But asking questions about an experimental medical product is not misinformation, either.
Volunteers have every right to ask what is known, what remains unknown, what side effects occurred during preclinical research, who is financing the trial and what medical care or compensation will be available if something goes wrong.
They also have the right to decline.
The desperation to recruit volunteers should never become pressure, emotional manipulation or an attempt to shame people into participating. Clinical research depends on voluntary, informed consent. The word “volunteer” loses its meaning when people are bullied or frightened into saying yes.
Public health institutions are now confronting the consequences of their conduct during the COVID-19 pandemic.
Americans were told to trust the science even when the guidance changed. People were threatened with losing their jobs. Families were divided. Questions about natural immunity, side effects and mandates were frequently dismissed instead of answered.
Government agencies, media organizations and technology companies worked together to suppress some discussions that should have remained open. Officials often spoke with certainty when the evidence was still developing.
Now those same institutions appear surprised that the public is hesitant.
Trust cannot be demanded. It must be earned.
Ebola is a serious and often deadly disease. The ongoing Bundibugyo outbreak deserves the attention of the international medical community. According to figures cited by public health organizations, the outbreak has produced thousands of confirmed cases and more than 1,600 deaths.
Developing a safe and effective vaccine could protect health workers, families and communities living in regions where the virus is actively spreading.
But the severity of the disease does not remove the obligation to conduct ethical research or answer legitimate questions.
The risk faced by a medical worker treating Ebola patients in the Congo is not the same as the risk faced by a healthy volunteer living in Canada or England. Researchers must explain that difference honestly.
They must also be clear about what Phase 1 results can and cannot prove.
An early-stage trial involving 50 or 80 adults may identify common short-term reactions and show whether the immune system responds. It cannot establish the complete long-term safety profile of a product, and it cannot by itself demonstrate that the vaccine prevents Ebola during a real-world outbreak.
Larger trials would be necessary before regulators could consider broad approval.
There are already approved vaccines for the Zaire species of Ebola, but those products are not currently approved specifically for Bundibugyo ebolavirus. Researchers are also studying whether an existing Ebola vaccine might offer some cross-protection against this strain.
The responsible path is to allow that research to proceed transparently while protecting the rights of every potential participant.
People should not be ridiculed for volunteering. Medical progress has often depended on courageous individuals willing to participate in carefully controlled studies.
But people should not be ridiculed for refusing, either.
A healthy person considering an experimental vaccine deserves complete information, time to think, access to independent medical advice and the freedom to walk away without pressure.
Public health leaders can issue all the recruitment appeals they want. They can point to the outbreak, the death toll and the potential benefits of a successful vaccine.
What they cannot do is pretend the last several years never happened.
The public remembers the mandates. It remembers the censorship. It remembers being told that questions were dangerous.
So when researchers announce another experimental vaccine and ask for volunteers, many people are responding with two simple words:
No thanks.
That response should not be dismissed. It should be understood as a warning that medical institutions have a great deal of trust to rebuild.
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