> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Placebo Control Sought in Covid Vaccine Trials
- URL: https://www.fdaweb.com/placebo-control-sought-in-covid-vaccine-trials/
- Published: 2020-06-23T12:00:00.000Z
- Updated: 2026-09-14T16:19:18.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147068

The Informed Consent Action Network is petitioning FDA to require placebo controls in all Phase 2 and 3 trials of vaccines against Covid-19\. The group’s [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-1601-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the placebo should be a saline injection with nothing added. It calls for the placebo control group to be of at least equivalent size to the experimental group and says that all system adverse reactions, adverse events, serious adverse events, medically-attended adverse events, new-onset medical conditions, and any other health issue arising or exacerbated post-vaccination should be documented for each subject post-vaccination for at least 12 months for adults, 36 months for children and teens, and 60 months for infants and toddlers.

“Without a placebo-controlled trial,” the petition says, “cause and effect between a potential adverse effect and the vaccine being studied is very difficult and often impossible to establish. Hence, once licensed, studying claims of injury occurring post-licensure becomes exceedingly difficult.

According to the network, while most FDA-approved Phase 2 and 3 trial study designs for potential Covid-19 vaccine candidates appear to include a saline placebo control group, some do not.