Some clinical trials get much more publicity than others, and for very understandable reasons, trials for various COVID-19 vaccines throughout 2020 and into 2021 received enormous attention. Worldwide efforts toward a vaccine for this novel virus were unprecedented, and the result was the creation of multiple effective vaccines in a very short period of time, a major scientific achievement to be commemorated.
At AGA Clinical Trials, we’re proud to carry out a number of clinical research studies, including those for various viruses and related conditions and those meant to help develop vaccines or other treatments. Using the vaccine developed by Moderna as our example, let’s look at the basic clinical trials that were run, their demographics and data summaries, and the results they showed for one of the most successful vaccines in recent memory.
For the Moderna vaccine, a Phase 3 randomized, placebo-controlled, observer-blind clinical trial was used and remains ongoing in the United States. Randomization was stratified by age and health risk: 18 to 65 without comorbidities, 18 to 65 comorbidities, and 65 or older with or without comorbidities.
At the time of vaccination, the mean age of the trial population was 52 years of age. Over 75% (75.2%, to be precise) of participants were in the 18 to 64 age range (22,831 in total), while 24.8% (7,520 total) were ages 65 and older.
Of the total population, 52.7% were male and 47.3% were female. Ethnic breakdowns were as follows (some people checked more than one group):
- White: 79.2%
- Hispanic or Latino: 20.5%
- African American: 10.2%
- Asian: 4.6%
- American Indian or Alaska Native: 0.8%
- Native Hawaiian or Pacific Islander: 0.2%
- Multiracial: 2.1%
- Other: 2.1%
Demographic characteristics were kept similar among those who received the actual Moderna vaccine and those who received a placebo as part of the control group.
As noted above, the final count was 28,207 participants who received two doses of the vaccine or a placebo and had a negative baseline COVID-19 status. Median length of follow-up for efficacy among participants was nine weeks past dose two.
The study showed 11 COVID-19 cases in the vaccine group, with 185 cases in the placebo group. There was a vaccine efficacy of 94.1%, with a 95% confidence interval of 89.3% to 96.8%. Not a single severe case of COVID-19 was reported among the vaccine group, compared to 30 cases among the placebo group. At the time of analysis, one PCR-positive case of severe COVID-19 in the vaccine group was awaiting adjudication.
For more on the clinical trials that took place for the Moderna COVID-19 vaccine, or to learn about any of our medical research studies or other services, speak to the staff at AGA Clinical Trials today.