Ethical Concerns With Vaccine Testing
By Mohini Haque
During the COVID-19 pandemic, we were able to have a sneak peak at the race for producing the COVID-19 vaccine through the news. The news even covered some of the people who were participating in the process as test subjects. Now what risks were these people taking? Over the years, ethics regarding vaccine testing have been changing in order to decrease risks while not decreasing the quality of science. As scientists would say, good science is itself an ethical requirement.
One concern on how well a vaccine production team follows ethics is how well they are able to consult with involved parties. Involved parties would include the government, local community, and human test subjects. Such need for clarification is stated by the ethical principle of Respect for Persons and Communities.
Then there’s the consent required from test subjects to test the vaccine on them. This involves proper delivery of information and there being no coercion to get consent. This had actually been a problem in regards to the study of the meningococcal A vaccine. The team were testing the vaccine with people in West Africa. The problem was that some of the local languages there were spoken but not written. With that, a paper consent form and information sheet wasn't able to be in these languages. They weren’t able to officialize some people’s consent to be tested on, especially with the candidates not being able to fully know what they’re engaging with. However, the team was able to solve the problem with relaying information by using pictures, diagrams, and objects to explain what the team will be doing. A one-on-one discussion can then be used to get the informed consent. Overall, both sides were able to establish a proper sense of trust in each other.
Now in regards to the COVID-19, some new ethical concerns came into light. One of such concerns would be speeding up the vaccine production process. It makes sense to speed up the process with it being a pandemic and there being a sense of urgency to save as many lives as possible. The disease was spreading fast and the death count was increasing. Research and testing had to happen almost in a tandem and the FDA had to expedite the process. However, this can influence how the team and FDA make judgements on vaccine safety. Part of the concern with producing the COVID-19 vaccine is the immune response it gives. There is the possibility of causing strong inflammation and autoimmune conditions by accident. Nobody wants that to happen. So while we wanted the vaccine to be dished out to the public as fast as possible, we also wanted it to be safe.
And then there’s the animal testing models that goes on during the pre-clinical trial. It’s done before testing a vaccine on human subjects. This trial is not only ethically controversial for its animal testing but also for its reliability. The disease may not affect the animal subject like it would with a human subject. Drug testing can be comparable to this aspect as according to the National Institutes of Health, 95 percent of drugs tested on animals failed in human trials as they were either proven to be detrimental or inefficient to humans. Pre-clinical trials can assume the vaccine to be low-risk when it actually causes quite a deal of damage to a human subject’s health. With that, there is a recommendation for scientists to use human cells, computer modeling, 3D printing, and robots for experiments as they can be more accurate, less expensive, and faster than animal testing.
However, animal testing had been proven useful for the production of the COVID-19 vaccine. A couple of labs had used mice by trying to infect them with SARS-CoV-2. The weird thing was that the mice didn’t get infected. The ACE2 protein that gets affected by SARS-CoV-2 is different in mice and humans. To overcome this, scientists had made mice to have the human ACE2 protein. Once infected, the mice with human ACE2 expressed about the same symptoms as humans have with COVID-19. Now with that obstacle out of the way, the team could now work towards developing a vaccine properly. One of the important milestones in the testing process was when the team had mice given a small dose of Moderna’s mRNA vaccine. This produced a highly effective antibody response against SARS-CoV-2 once. Same thing happened when testing the vaccine on nonhuman primates except they had exhibited fast protection in the upper and lower airways, which similarly happened in the phase I human clinical trials. These animal experiments led to COVID-19 being an mRNA vaccine, a new type.
Now, there are people who suggest human challenge testing as a replacement for animal testing.
Although, this involves intentionally giving subjects the disease we’re trying to fight. As many people can tell, this raises concerns as well. This puts the subject’s health at risk in ways that can go beyond symptoms. It sounds absurd, especially with the number of deaths the disease was causing. However, this infection was being monitored closely by the team doing this. Human challenge testing has a participant get infected with a pathogen and get closely monitored. They had done this in the case of COVID-19 as well. Participants had agreed and consented to participating in such a trial. They were to be monitored, swabbed twice a day, have blood tests taken, and taken care of over 14 days. Scientists were able to learn about COVID-19 in a way that’s a lot more relative to humans than when using animal testing.
The vaccine production process for the COVID-19 vaccine was no simple matter. It’s no simple matter for any vaccine in fact. While there is still room for improvement, much was done by the scientists involved to compensate for problems that raised such ethical concerns.