DOCUMENT: Complete Disclosure Of Moderna 94.5% Effective COVID-19 Vaccine With Side Effects And Demographics
- November 16, 2020
- Posted by: Craig Chamberlin
- Category: Social Media
Another great story broke today as Moderna announced a new vaccine with a 94.5% Efficacy rating passing stage 3 clinical trials. This story follows a previous announcement from Pfizer last week who reported their recent vaccine with a 90% efficacy rating passed stage 3 clinical trials.
The full disclosure from Moderna can be found on their website and it includes the efficacy ratings as well as details regarding side effects and demographics. Here is a summary.
Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, knownModerna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
as the COVE study, enrolled more than 30,000 participants in the U.S.
Further down the study you can review the side effects and their severities.
The majority of adverse events were mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived.Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
Additional information is provided in regards to the demographics tested, showing a strong range of age groups and ethnicities.
The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study.
The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African AmericanModerna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
Donald Trump weighed in on the announcement earlier in the day as well
All of this is good news for those concerned over the long term impacts of COVID-19. This news comes amidst growing concerns over Joe Biden’s campaign pushing for harsher lockdowns and restrictions in cities due to the increased cases loads. Many schools are in the process of shutting down temporarily until the numbers drop.