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What Every Individual Should Know Before Providing Informed Consent to a COVID-19 Vaccine

As clinical trials for COVID-19 vaccine are initiated by the pharmaceutical industry, patients will be recruited to test the safety of a coronavirus vaccine. There are some very important questions that each individual should be asking before they enroll into a clinical trial. Human subjects should ask whether an animal study was first conducted to evaluate the efficacy and safety of that vaccine. After the SARS and MERS outbreak, there were several efforts made to evaluate the safety and efficacy of coronavirus vaccines. Vaccines were tested in mice and produced antibody responses. The FDA uses a regulatory procedure called the "Animal Rule" when a treatment is being tested for a potentially serious infection. The "Animal Rule" requires that an anti-infectious agent first be tested 2 animal models before testing in a clinical trial. Coronavirus vaccines were commonly tested in mice. However, mice have a shortcoming as a model of coronavirus because they do not mount a fever. In contrast, ferrets do mount a fever. However, when vaccines were tested in ferrets, animals developed liver toxicity ( Also, when animals were subsequently challenged with wild-type coronavirus, animals displayed a more severe pneumonia than those that did not receive the vaccine ( Thus, it is important that human subjects should ask the following questions before they consent to receive any vaccine:

1. Were animal studies conducted with the vaccine?
2. How many different animal models were tested with the vaccine?
3. Were there any evidence of toxicity with the vaccine?
4. Were the animals that received the vaccines subsequently challenged with the wild-type virus and what was the outcome of those studies?

If answers to these questions are not provided, then individuals should not provide consent. The Institute wants to ensure the public that it will conduct rigorous safety and efficacy studies in the future in animal studies before any vaccine candidate is ever tested in humans.

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