Can COVID-19 vaccine trials continue ethically once an efficacious candidate is found?

December 03, 2020

In a Perspective, David Wendler and colleagues propose guidance on when it can be ethical to continue placebo-controlled COVID-19 vaccine trials after an effective and safe candidate is found - a topic that is particularly relevant given the recent announcements of success in several late-stage clinical trials. Currently, more than 180 COVID-19 vaccines are in development, with at least 12 undergoing phase 3 trials. Given this unprecedented effort, it's likely that one or more candidates will be found safe and efficacious while many others are still being tested. However, discovering a vaccine in a placebo-controlled trial raises several yet-unanswered ethical questions. Should researchers continue that trial as designed? Should trials for other vaccine candidates continue? "With careful planning and systematic assessment of social value and risk, we believe it can be ethical to conduct some placebo-controlled trials of vaccine candidates for COVID-19, even after we have an efficacious vaccine," write Wendler et al. "Doing so may be necessary to effectively address a pandemic that is causing so much harm around the world." According to the authors, some argue that decisions to continue placebo-based trials are unethical as it's in an individual's best interest to receive an effective vaccine rather than participate in clinical studies where they might instead receive a placebo or ineffective candidate. On the other hand, manufacturing and supply challenges suggest that several vaccines may be needed to meet the global need, highlighting the urgency in conducting additional trials. The risks of serious harm that individuals face from COVID-19 vary widely across groups. Wendler et al. argue that by excluding those at high risk from ongoing COVID-19 vaccine trials, the authors suggest that researchers can continue to collect valuable data from participants who are at low risk of experiencing serious harm.
-end-


American Association for the Advancement of Science

Related Vaccines Articles from Brightsurf:

Comprehensive safety testing of COVID-19 vaccines based on experience with prior vaccines
'The urgent need for COVID-19 vaccines must be balanced with the imperative of ensuring safety and public confidence in vaccines by following the established clinical safety testing protocols throughout vaccine development, including both pre- and post-deployment,' write David M.

Safety of HPV vaccines in males
A new analysis published in the British Journal of Clinical Pharmacology shows that HPV vaccines are safe and well tolerated in the male population, and the side effects that may occur after immunization are similar in both sexes.

Model could improve design of vaccines, immunotherapies
Researchers have discovered a general property for understanding how immune cell receptors sense and respond to microbial signals, which could lead to more effective vaccines for both existing and novel viruses.

Better vaccines are in our blood
Red blood cells don't just shuttle oxygen from our lungs to our organs: they also help the body fight off infections by capturing pathogens in the blood and presenting them to immune cells in the spleen.

Challenges in evaluating SARS-CoV-2 vaccines
With more than 140 SARS-CoV-2 vaccines in development, the race is on for a successful candidate to help prevent COVID-19.

Designing vaccines from artificial proteins
EPFL scientists have developed a new computational approach to create artificial proteins, which showed promising results in vivo as functional vaccines.

Misinformation on vaccines readily available online
Parents researching childhood vaccinations online are likely to encounter significant levels of negative information, researchers at the University of Otago, Wellington, have found.

Battle with the cancer: New avenues from childhood vaccines
A new research from the University of Helsinki showed for the first time how the pre-immunization acquired through common childhood vaccines can be used to enhance therapeutic cancer treatment.

Personalized cancer vaccines
The only therapeutic cancer vaccine available on the market has so far showed very limited efficacy in clinical trials.

Doubts raised about effectiveness of HPV vaccines
A new analysis of the clinical trials of HPV vaccines to prevent cervical cancer raises doubts about the vaccines' effectiveness.

Read More: Vaccines News and Vaccines Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.