There's A Way To Have A COVID-19 Vaccine Immediately, But Are We Willing To Take The Risk?

Scientists and researchers around the world are racing to make a SARS-CoV-2 vaccine as soon as possible. However, there have been several vaccines created, we haven’t received one because it takes a long testing process to make sure the vaccine works and safe enough for humans. One way to speed up that process is by conducting early testing on human volunteers, but this method faces ethical challenges.

If the development process is done conventionally, we will have a COVID-19 vaccine by 2036, but clearly we can’t wait that long. There is a method called human challenge trials, or controlled human infection studies (CHIs), which can help researchers speed up vaccine development. Specifically, scientists recruit a small group of human volunteers, inject the tested vaccine to them then expose them to the virus.

This way, scientists can run tests as well as collect crucial data while keeping things under control. These studies are a substitute for phase 3 trials in conventional development that involves thousands of volunteers, placebos, extended evaluation periods, special precautions, and other provisions for ensuring safety and efficacy.

While this research technique can greatly expedite the development process of a drug but is apparently ethically fraught. The new paper by Northwestern University associate professor Seema Shah and colleagues considers the ethics of human challenge trials to study the ongoing pandemic. To do that, the group came up with a “comprehensive, state-of-the-art ethical framework for CHIs that emphasizes their social value as fundamental to justifying these studies,” as in their paper.

The focus of ethical reviews for this method is on issues of informed consent and acceptable risks, but the social benefits from it are just assumed, the authors write.

“Based on our framework, we agree on the ethical conditions for conducting SARS-CoV-2 CHIs. We differ on whether the social value of such CHIs is sufficient to justify the risks at present, given uncertainty about both in a rapidly evolving situation; yet we see none of our disagreements as insurmountable. We provide ethical guidance for research sponsors, communities, participants, and the essential independent reviewers considering SARS-CoV-2 CHIs.”

With the nature of this type of research, participants would have to be quarantined at a designated facility and for a longer time while researchers monitor their symptoms and side effects closely. Key health indicators would be tracked like the appearance of virus-hunting antibodies and the level of blood oxygen. Participants would also receive special medical care and accommodations if they show other problems or get weaker by the illness.

While other authors in the Policy Forum agree with the sufficient social benefits of human challenge trials, the authors of the paper still support this method, provided that the conditions in their proposed framework are met.

The proposed framework includes considerations including agreeing on fair compensation, acquiring robust informed consent from participants, engaging with the public and stakeholders, using reasonable criteria to select participants, performing analyses between risks and benefits, and proving the research has sufficient social value.

Also, CHIs have a great shortcoming, which is the basic difference between treatments and vaccines. While a treatment drug is applied to a small number of sick people, a vaccine needs to be applied to crores of healthy people to develop herd immunity. And though a side effect influences a small proportion of those people, it could translate into a huge number on a global scale.

So, the question remained to answer is: Are scientists and us as regular people, willing to take the risk?

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