DIY vaccines are a landmine of public health concerns

By The Science Advisory Board staff writers

September 18, 2020 -- A new Science article describes the legal and ethical implications of do-it-yourself (DIY) COVID-19 vaccines.

According to the article, in July 2020, a group reported administering themselves with a homemade vaccine against SARS-CoV-2. The group of "citizen scientists," a concept which invites public participation in scientific activities, developed a vaccine with an evolving protocol and unclear plans for collecting data and analyzing outcomes.

This is in contrast with traditional vaccine development, which utilizes randomized controlled trials and well-established protocols to collect and analyze data to establish safety and determine immune responses.

Despite the misperception that a DIY vaccine is permissible and that self-experimentation cannot be regulated by the U.S. Food and Drug Administration (FDA), that belief is legally and factually incorrect, said Jacob S. Sherkow, a professor of law at the University of Illinois. The FDA authorizes investigational new drug applications that permit unapproved drugs to legally cross state lines and be investigated in humans. These drugs are subject to review by external entities including institutional review boards (IRBs). IRBs help verify that the risks of an experiment are reasonable and ensure participants provide voluntary, informed consent.

DIY vaccines pose risks to the users themselves and to the general public who may injure themselves in the process of trying to administer an unauthorized vaccine due to improper preparation, incorrect administration, or heightened allergic or other reactions. Moreover, DIY vaccines do not have safety and efficacy profiles established through randomized controlled trials, which could make them unethical, according to the authors.

"Although many citizen scientists appear to take seriously the ethical responsibilities associated with their activities, it is important to recognize that those responsibilities expand when public health is at stake, such as with COVID-19 vaccine development," Sherkow said. "But just because there's a list of instructions on the internet created by a lot of well-respected and well-trained scientists doesn't mean that something can't go wrong."

Biopharma CEOs pledge commitment to safe vaccines
The CEOs from nine biopharmaceutical companies have pledged to remain committed to upholding the integrity of the scientific process as they work toward...
Experts draw lessons from FDA's hydroxychloroquine EUA controversy
Public health and regulatory experts advocated for changes to the U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) process in...
FDA issues guidance on COVID-19 vaccine licensure
The U.S. Food and Drug Administration (FDA) has provided new regulatory guidance for developers of vaccines for COVID-19. The guidance lays out the agency's...
FDA issues guidance to accelerate COVID-19 therapy trials
With over 140 clinical trials of potential COVID-19-related drugs and biological products underway, the U.S. Food and Drug Administration (FDA) issued...
COVID-19 vaccine candidates show progress amid challenges
As the COVID-19 outbreak advances worldwide, companies are stepping up to the challenge to develop a potential vaccine. There are over 75 confirmed COVID-19...

Copyright © 2020

Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter