The letter I received this week.
Dear COVE Study Volunteer:
On November 16, 2020, Moderna and the National Institutes of Health (NIH) shared some early results of our Phase 3 COVID-19 vaccine study (also called the COVE Study) in which you are participating. The study is overseen by a Data Safety Monitoring Board (DSMB) which is an independent group of experts that are separate from Moderna and not involved in running the study. They check the safety of the vaccine on an ongoing basis and at specific timepoints look to see if the vaccine is working to prevent COVID-19 infections (also called “efficacy”). When new information is available, they also make decisions in the best interest of our volunteers about whether the study should continue, be altered, or stop.
The DSMB met on Sunday, November 15, 2020 to review the information about safety and efficacy. There were no safety concerns. The information also showed that the vaccine has efficacy of 94.5% at preventing symptomatic COVID-19 disease. Of the 95 people who had symptomatic COVID-19 by the time of the meeting, 90 received the placebo and 5 received the study vaccine. Please note that cases of COVID-19 are continuing to be reported, so this efficacy number is likely to change.
For now, the DSMB recommended that we continue the study as planned while we file for an Emergency Use Authorization (EUA) with the US FDA. If and when the FDA approves an EUA, then we will inform you. Our intention is to ensure that all participants ultimately have the option of receiving the vaccine. In the coming weeks, Moderna and the research team will be discussing with expert scientists, ethics committees, and the FDA how and when to offer the study vaccine to those who received placebo. We will inform you once we have a concrete and approved plan of doing so.
Your participation in the study has enabled these initial positive results and is providing hope to millions of people. Your continued participation is enabling us to better determine the safety and efficacy of this vaccine and is supporting the application for an EUA which we hope will ultimately support broad access to a safe and effective vaccine. However, before we make any changes to the study, we will need approval from the FDA and the study IRB. We ask for your patience and continued participation in the coming weeks while we chart the path forward.
Lastly, while many are very encouraged by the preliminary data on the vaccine, it’s important to remember to follow your state and local guidance around social distancing and restrictions related to gathering in groups of people. Even if you think you got the vaccine, you still may have received the placebo. All study volunteers are strongly urged to behave as if you received the placebo, and therefore, are at risk for infection.
We are grateful for your dedication and continued participation in this trial to make it successful. You are playing a critical part in hopefully solving this pandemic. We will continue to keep you updated as the study plans progress. Feel free to contact us if you have questions.
www.worldometers.info
www.theguardian.com
