Dear Duke Health and Duke University colleagues and staff:
The FDA is planning to review the interim safety and efficacy data for the Pfizer/BioNTech COVID-19 vaccine on December 10th and the Moderna vaccine on December 17th as part of the process to consider COVID-19 vaccines for an emergency use authorization. We anticipate that the FDA could move quickly so we are preparing for an expected early shipment of the Pfizer vaccine to Duke, along with final guidance from the FDA, later this month.
Based on guidelines developed by the state, Duke healthcare workers who are most likely to be exposed to COVID-19 (also known as SARS-CoV-2) in the course of fulfilling their job responsibilities will be among the first group eligible to receive a vaccine. This includes employees in both clinical and research areas. It is important to note that:
- Eligible faculty and staff in clinical and research areas will be contacted in the coming weeks with additional information.
- Initial supplies will be limited.
- Currently, there are no plans to require COVID-19 vaccination.
- The vaccine will be provided at no cost.
Before we administer any authorized vaccine, Duke experts will review all available safety and efficacy data to ensure the science supports its use. While we expect to learn more during the FDA review process, here are answers to some of the most frequently asked questions:
- The initial safety and efficacy data released by Pfizer for this first vaccine are very promising. Unlike traditional vaccines that use inactive parts of the virus to trigger the immune system, the Pfizer vaccine uses messenger RNA, or mRNA, to produce protective antibodies.
- While this type of vaccine is new and will represent a medical breakthrough if authorized for emergency use, the approach of using mRNA to trigger the immune system has already been shown to be safe and effective in peer-reviewed medical research.
- The Pfizer vaccine requires ultra-cold storage and precise handling, and we are fortunate at Duke to have the equipment and expertise to administer it safely and effectively.
- The vaccine will initially be available at Duke University Hospital, Duke Regional Hospital and Duke Raleigh Hospital, as well as through county health departments. In later months, as the vaccine becomes more widely available, we expect to expand to additional vaccination sites in the Duke system.
- The Pfizer vaccine requires two doses administered three weeks apart to be effective.
- After receiving each dose of the vaccination, team members will need to wait under observation for a short period of time. Some individuals will experience side effects, similar to most of our current vaccines.
- Regardless of your vaccination status, we will all need to be vigilant about wearing masks, observing physical distancing and washing hands until the pandemic subsides. We are still months away from vaccines being available widely to our community.
- Over time, the more people who are vaccinated, the less likely it is that any of us will develop COVID-19 disease. Vaccinations are an important way we take care of ourselves and of each other.
Thank you for all you are doing to keep yourself, your family and our community safe.
Vice President, Administration
Carol Epling, MD, MSPH
Director, Employee Occupational Health and Wellness
Gail Shulby, RN, MA, CPPS
Chief of Staff to the Executive Vice President, Duke Health
Cameron R. Wolfe, MBBS (Hons), MPH, FIDSA
Associate Professor of Medicine, Infectious Diseases, Duke Health
Co-Leaders of the Duke COVID Vaccination Work Group