Archive · 5 Jun 2025
Moderna to Test New Covid Shot Against Placebo
Moderna is going to test its new Covid vaccine in a study where some people get the real vaccine and others get a fake one (placebo).
This is happening because the FDA, the US government agency that checks medicines, made it a requirement for the new shot.
The new vaccine is approved for older adults and those with health issues.
The FDA will carefully watch the trial for any problems.
Some people have questions about giving a placebo when a vaccine is available because some people might get sick.
The older Moderna shot had previously been approved for anyone over 12 years of age.
US health officials are limiting who can get Covid vaccines, saying there isn't enough proof for extra doses.
Moderna will conduct a placebo-controlled trial of its new Covid vaccine, mNexspike.
The FDA required the trial as a condition for approving the new shot.
The trial will involve adults aged 50-64 without high-risk conditions.
The FDA will monitor data and scrutinize every aspect of the trial.
The new vaccine is approved for adults 65+ and those 12+ with risk factors.
- Who
- Moderna and the FDA
- What
- Moderna will test its new COVID-19 vaccine, mNexspike, against a placebo.
- When
- The trial will be conducted in the future.
- Where
- United States
- Why
- The FDA required a placebo-controlled trial as a condition for approving the vaccine.
Concerns over Placebo Use
Support for Placebo-Controlled Trials
Ethical Concerns
Concerns over Placebo Use
Giving people an inert substance (placebo) when a vaccine exists raises ethical concerns.
Support for Placebo-Controlled Trials
Placebo-controlled trials are important to assess new vaccines.
- Company
- Moderna
- Vaccine Name
- mNexspike
- Trial Type
- Placebo-controlled
- FDA Requirement
- Placebo trial
- Target Group
- Adults 50-64 without high-risk conditions