Update: The WHO has conditionally backed human challenge trials (the conditions are that they not be the mad science of everyone’s worst nightmares). This is great and it lays out a framework for the trial design. BUT we still need FDA to either adopt these standards or issue their own in order to give vaccine manufacturers confidence to start recruiting when possible. I’ve revised my original letter to reflect this and added another version for sending as a second round.
The only way FDA will ever pre-commit to allowing human challenge trials for Covid-19 vaccines as acceptable Phase 3 trials is if there is immense public and political support. Given the nuance of this topic, politicians will have to raise the idea in public in order to shape broader public opinion. I submit to you the letter for your use that I sent to my state and federal elected officials to start to raise public support.
Find your elected officials here.
Note: Change the ALL CAPS text.
First Round Letter
Subject: Human Challenge Trials to Speed Covid Vaccine Development
Body:
Hello NAME and Team!
I urge you to publicly ask the FDA to provide encouragement and guidance on using human challenge trials for Covid-19 vaccines. The WHO has issued guidelines that are a good starting point: https://apps.who.int/iris/bitstream/handle/10665/331976/WHO-2019-nCoV-Ethics_criteria-2020.1-eng.pdf?ua=1
I am one of your constituents, I live in PLACE YOU LIVE. I think the US should lead the world in developing a Covid-19 vaccine. There is a proven way to accelerate Phase 3 trials–human challenge trials. This type of trial means that instead of waiting for the vaccinated trial group of thousands to get naturally infected over 6 or so months, you expose hundreds of volunteers on purpose as soon as the vaccine has taken effect. We would have good data in as little as 1.5 months. Human challenge trials are already used for the flu, malaria and other diseases, so structuring the trial and isolating the participants would be simple.
Again, please have your staff explore how the FDA can publicly approve of these trials and encourage them.
Over 9,000 people have already volunteered to take the risk on behalf of our fellow Americans. An organization has already compiled a list of these volunteers making it easy to recruit for trials: https://1daysooner.org/
The United States could save hundreds of thousands of lives by letting fewer than a thousand take this risk.
Here are some more resources on the topic:
https://www.nature.com/articles/d41586-020-01179-x
https://www.nytimes.com/2020/04/30/opinion/coronavirus-vaccine-covid.html
https://www.vox.com/future-perfect/2020/4/9/21209593/coronavirus-vaccine-human-trials-explained
https://www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf
Best,
YOUR NAME
Second Round Letter
Subject: WHO Supports Human Challenge Trials for Covid-19 Vaccine
Body:
Hello NAME and Team!
The WHO has issued guidelines on human challenge trial design for speeding Covid-19 vaccine development: https://apps.who.int/iris/bitstream/handle/10665/331976/WHO-2019-nCoV-Ethics_criteria-2020.1-eng.pdf?ua=1
I urge you and your staff to pressure FDA to explore this topic and issue guidance so that American manufacturers can feel confident enough to start trials as soon as possible. The US can lead on vaccine development–or as is currently the case, we can trail Oxford University. We have unrivaled pharmaceutical prowess, but without human challenge trials, we will wait years for a vaccine.
Best,
YOUR NAME