Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure

[Shiloh]

Source: https://academic.oup.com/jid/article/doi/10.1093/infdis/jiaa152/5814216

Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure

Nir Eyal, Marc Lipsitch, Peter G Smith

The Journal of Infectious Diseases, jiaa152, https://doi.org/10.1093/infdis/jiaa152

Published:
31 March 2020


Abstract

Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care...

 

[Shiloh]

Source: https://www.vox.com/future-perfect/2020/4/9/21209593/coronavirus-vaccine-human-trials-explained

“Human challenge trials,” where healthy volunteers would be exposed to Covid-19, explained
Advocates say human trials could speed up the development of a coronavirus vaccine.
By Dylan Matthews@dylanmattdylan@vox.com Apr 9, 2020, 2:00pm

As a journalist who covers philanthropy, one of the most frequent questions I get about the coronavirus crisis is how ordinary people can help.

A couple things leap to mind. GiveDirectly is giving money to poor Americans struggling with unemployment and other hardships; you can also donate money to other public health charities helping poor countries handle a sudden surge in demand for doctors and hospitals.

Now, a bioethicist and two epidemiologists are proposing a bolder option: You can volunteer to get infected yourself...

 

[Shiloh]

Source: https://www.theatlantic.com/ideas/a...=twitter&utm_medium=social&utm_campaign=share

Let Volunteers Take the COVID Challenge
Young, healthy, informed people should be allowed to participate in vaccine trials.
April 21, 2020
Conor Friedersdorf
Staff writer at The Atlantic

Until scientists discover a treatment or vaccine for COVID-19, the disease will inflict mass suffering. And experts say that safely developing, producing, and delivering a vaccine will likely take at least 18 months. That’s in part because, in the final phase of testing, researchers inject thousands or tens of thousands of subjects with the vaccine while others get a placebo, then they wait to see if the vaccinated group avoids infection. What if they instead gave a vaccine candidate to a smaller group of volunteers, then deliberately exposed them to the virus to more quickly learn if the vaccine works?

A recent article in The Journal of Infectious Diseases suggests a “human challenge trial” of that sort. “Challenging volunteers with this live virus risks inducing severe disease and possibly even death,” the authors acknowledge. However, hastening deployment of a vaccine could significantly reduce death and disease, they argue––and the risk to volunteers could be acceptable if the volunteers are young and healthy, and get excellent care.

To learn more, I interviewed the head of a health-care nonprofit that is collecting the names of possible volunteers for a human challenge trial. Then I spoke with some of those prospective participants....