Vaccines are critical to prevent diseases that can be dangerous or even deadly. They greatly reduce the risk of contracting infections like influenza, measles, pneumonia, hepatitis, shingles and tetanus. Vaccines work with your body’s natural defenses to help you safely develop immunity to disease. This lowers your chances of getting certain diseases and suffering potential complications from them.


The FDA is responsible for making sure that, just like any other medications, any FDA-authorized or approved COVID-19 vaccines are safe and effective. Developers are required to go through a rigorous, multi-stage process including large (phase three) trials that involve tens of thousands of people participating. After the clinical trials show that the vaccine is safe and effective, a series of independent reviews and evidence is required to demonstrate efficacy and safety.


An Emergency Use Authorization (EUA) is issued by the Food and Drug Administration (FDA) during a public health emergency to allow the use of new medical products, such as a vaccine, more quickly. An EUA requires the submission of data that demonstrates a vaccine’s safety and ability to prevent the disease of interest.


These are unprecedented times. Scientists, researchers and officials have come together to move vaccine candidates through the process for preclinical and clinical assessment, including animal and human trials, under the federal government operation known as Operation Warp Speed (OWS). This has enabled researchers to advance into phase three clinical trials (testing the vaccine on large groups of people to evaluate safety and effectiveness) in six months instead of the typical two years. More information about OWS can be found here.


The COVID-19 vaccines currently approved by the FDA for Emergency Authorization Use have undergone rigorous testing and multi-phase clinical trials of more than 40,000 participants in order to determine their safety and effectiveness. The vaccines had to meet strict FDA standards before they were approved and authorized for release to the public. The vaccines have been shown to be 95% effective after both doses are received, which is much greater than anticipated.


Currently, there are two COVID-19 vaccines that have been approved for Emergency Authorization Use by the FDA – one from Pfizer and one from Moderna. All vaccines are subject to the same stringent review process to determine their safety and effectiveness before they can be approved or authorized for use. Both Pfizer’s and Moderna’s vaccines have been shown to be at least 94% effective and act in the same way. There is no notable difference in the effectiveness of the two.


Both the Pfizer and Moderna vaccine require two doses in order to achieve full protection against COVID-19 infection. The Pfizer vaccine doses are given 21 days apart, and the Moderna vaccine doses are given 28 days apart. It is important to know when you received the first dose and which vaccine you received so that you can receive the second dose of the same vaccine at the right time. North Carolina uses a secure data system to manage vaccines called the COVID-19 Vaccine Management System (CVMS). When you receive the first dose, you will be given information on making your second appointment. You will also be given a card with information about which vaccine you received and the date of your first dose.


Duke Health is following all federal, state and local guidelines for the safe, efficient and equitable distribution of the COVID-19 vaccine. It is being administered in phases over the next several months, with prioritization based on risk of exposure to and severe illness from the virus. Supplies of the vaccine are limited, with the first phase of vaccinations reserved for health care workers in high-risk COVID-19 areas and long-term care facilities’ staff and residents. We have recently begun vaccinating adults age 65 and older. In later phases, vaccinations will be offered in a variety of settings. The latest information will be updated on our COVID-19 website.


Duke Health is following North Carolina Department of Health and Human Services guidelines for COVID-19 vaccine distribution, and a breakdown of this plan is available on DukeHealth.org. We encourage all patients and community members to register for a Duke MyChart account if they do not already have one. This allows convenient communication with our team, and they will be able to schedule an appointment through MyChart when they are eligible for vaccination and an appointment is available. If patients or community members are eligible for vaccination and no appointments are currently available, we invite them to join our waitlist. They may also call the Duke COVID-19 hotline: 919-385-0429 to be placed on our waitlist. The hotline is open every day from 8:00 am to 8:00 pm. Please note that we are experiencing exceptionally high call volumes and experiencing extended wait times.


Experiencing some side effects after getting a COVID-19 vaccine is common and is a normal sign that your immune system is building protection. Common potential side effects include injection site reactions (redness, swelling and pain at the site of the shot), fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain and/or joint pain. These are side effects that may also be seen after receiving other vaccines. If you experience any side effects from the COVID-19 vaccine, it is still necessary to receive the second dose for the vaccine to be fully effective. This handout has more information about when to contact the COVID-19 hotline if you are experiencing side effects.


No. COVID-19 vaccines do not change or interact with your DNA in any way. There are currently two types of COVID-19 vaccines that have been authorized and recommended for use in the United States: messenger RNA (mRNA) vaccines and a viral vector vaccine. Both mRNA and viral vector COVID-19 vaccines deliver instructions (genetic material) to our cells to start building protection against the virus that causes COVID-19. However, the material never enters the nucleus of the cell, which is where our DNA is kept. This means the genetic material in the vaccines cannot affect or interact with our DNA in any way. All COVID-19 vaccines work with the body’s natural defenses to safely develop immunity to disease. Learn more from the CDC about how mRNA COVID-19 vaccines work and how viral vector vaccines work.


The COVID-19 vaccine will be available to everyone at no cost, regardless of whether you have health insurance.


Yes. While the vaccine has an impressive efficacy rate, it is not yet known if vaccinated people can still carry or transmit the virus. Therefore, everyone will need to continue wearing masks, practicing good hand hygiene and maintaining physical distance for some time to help reduce your chance of being exposed to or spreading the virus.


At this time, the Pfizer COVID-19 vaccine is approved for people aged 12 and older, while the Moderna COVID-19 vaccine is approved for people age 18 and older. Clinical trials continue to expand and are including younger children, but this data is not yet available.


Pregnant and breastfeeding women were not included in the vaccine clinical trials, but there are no biological or scientific reasons why it should cause harm to a pregnant woman, fetus or an infant through breast milk. Many pregnant and breastfeeding women have already received the first dose of the vaccine. Duke Health is partnering with the CDC to conduct more research on the vaccine, and we hope to have more specific data soon. Due to the increased risk of pregnant women experiencing complications from COVID-19, it is recommended that pregnant and breastfeeding women consider receiving the vaccine in order to protect them against COVID-19. However, this is a very personal decision, and pregnant and/or breastfeeding women may consult with their obstetrician.


Yes. Currently, there is not enough data available to know how long natural immunity from having the infection will last. Early evidence suggests that people who have recovered from the virus can benefit from receiving the vaccine.


The COVID-19 vaccine does not replace any other vaccine. It is a good idea to be current on vaccinations are recommended for you in addition to COVID-19. Please consult with your healthcare provider regarding which immunizations you need.


It typically takes a few weeks for the body to build immunity against COVID-19 after vaccination.


Yes. The second dose of the vaccine works (e.g., a booster) to further mount a response that would protect the recipient from contracting COVID-19.


While the vaccine has an impressive efficacy rate, it is not yet known if vaccinated people can still carry or transmit the virus. Therefore, everyone will need to continue wearing masks, using the appropriate PPE, practicing good hand hygiene and maintaining physical distance for some time to help reduce your chance of being exposed to or spreading the virus.


No. Neither of the COVID-19 vaccines that have been authorized and recommended nor those currently in clinical trials in the U.S. can cause you to test positive on viral tests. These tests are used to see if you have a current infection. The test and the vaccine do not cross-react in any way.


According to the CDC, people who are known to be infected with COVID-19 should still receive the vaccine, but should wait until they have recovered from the acute symptoms and have met the criteria to discontinue isolation. This applies to receiving the first or second dose. Current evidence suggests that it is unlikely you would become reinfected within the first 90 days after the initial infection.


Depending on the specific vaccine you get, a second dose 3-4 weeks after your first is needed to get the most protection the vaccine has to offer against this serious disease.


At this time, it is not clear how long immunity lasts after receiving the COVID-19 vaccine. We are learning more about the durability of the vaccine, and we will know more over time.


Most people – even those with severe allergic reactions in the past – will still be able to get the vaccine. CDC recommends that people with a history of allergic reactions — to things such as food, pets, venom, environmental or latex allergies — get vaccinated. People with a history of allergies to oral medications or a family history of severe allergic reactions may also get vaccinated. If you’ve had an immediate allergic reaction to other vaccines or injectable medications, ask your doctor if you should get a COVID-19 vaccine. If you’ve ever had an immediate allergic reaction to any ingredient in a COVID-19 vaccine, CDC recommends not getting that specific vaccine. Please consult with your care provider if you have further questions about your personal situation.


This is not a live vaccine, and it is not manufactured with eggs or animals. It contains produced proteins only, so there are none of the conditions we may normally associate with some vaccines, like the flu.


Generally speaking, cancer treatment has not been identified as a contraindication for receiving the vaccine, and these patients should strongly consider getting the vaccine. The overall effectiveness of the vaccine may depend on the specific type of treatment being received. We recommend that you discuss your specific situation with your oncology team.


According to CDC, there is no evidence that the new variants affect the effectiveness of the vaccines due to the nature of the body’s immune response to the virus.


Yes, you will be able to learn which injection you received so that you can decide whether to be vaccinated if you were not given the vaccine during the trial. Reach out to your study team for more information about how they will unblind the trial and provide this information.


You can find more information about the vaccine on the Duke Health, NC DHHS and CDC websites.


 


We are following all federal, state and local guidelines for the safe, efficient and equitable distribution of the vaccine. These guidelines require the prioritization of team members with the longest exposure to COVID-19 patients to receive the vaccine first, with remaining team members, patients and members of the community receiving it in subsequent groups over the next several months. However, it is important to remember what we have learned about transmission risk. Working with infected patients does not pose the highest risk for team members as long as they follow the proper precautions (masking, appropriate PPE use, hand hygiene, etc.). The greatest risk of COVID-19 exposure for our team members occurs when they are in the community and while eating or drinking in the workplace. The most up-to-date information regarding vaccine development and our distribution plan can be found on our COVID-19 website.


According to state guidelines, the first priority group includes team members who have contact with COVID-19 positive patients. The most current details regarding distribution phases of the vaccine can be found on the team member COVID-19 vaccine webpage.


The exact quantity and timing for shipments is continuously evolving. Vaccine quantities will be determined by the state. Supply will be distributed throughout North Carolina following guidelines determined by the state to ensure equity.


No. There are currently no plans to require COVID-19 vaccination for any Duke University, Duke University Health System or PDC employees.


We are distributing the vaccine according to guidelines from the North Carolina Department of Health and Human Services (NC DHHS). When you are eligible to receive the COVID-19 vaccine, you will receive an email from NC DHHS and will be required to register through the state's COVID Vaccine Management System (CVMS). The email will come from noreply@salesforce.com on behalf of “NCCVMS” with the email address NCCVMS@dhhs.nc.gov. You will also receive an email from Duke Employee Occupational Health and Wellness with further instructions. You can register in CVMS and defer your vaccination in our Duke Health system (VaxTrax). If you choose to defer, you will not lose your eligibility and can obtain your vaccination when you are ready.


The appointment for vaccination will take approximately 30 minutes, including a 15-minute observation period after receiving the vaccine.


For your first dose of the vaccine, please bring your mobile phone, employee ID and a government-issued ID. Make sure to keep the card you are given after you receive your vaccine. Bring this card with you for your follow-up appointment.


The COVID-19 vaccine is being given by Duke Health team members who have been specially trained to administer it.


You will receive an email from Duke Employee Occupational Health and Wellness with detailed instructions for scheduling the appointment for your second dose of the vaccine.


If you choose to defer your vaccine at this time, you will not lose your eligibility or your spot in line. If you have any questions or concerns, talk to your trusted healthcare provider about your personal situation. You can also refer to the Duke Health website or other trusted resources like CDC to help you make your decision.


No. Once you are notified that you are eligible to receive the vaccine, you will continue to remain active and eligible for vaccination. Be sure to keep the email notification so that you have the information about registering and scheduling your first dose of the vaccine when you are ready.


The COVID-19 vaccine is being administered to team members at all three hospitals at the following locations. Please remember that you must have an appointment in order to be vaccinated. • Duke University Hospital – Trent Semans Center – 8 Searle Center Dr. Durham, NC 27710 • Duke Regional Hospital – First Level Classroom – 3643 N. Roxboro St. Durham, NC 27704 • Duke Raleigh Hospital – Medical Office Building 9 – 3300 Executive Dr. Raleigh, NC 27609


You may experience some side effects after receiving the COVID-19 vaccine. This is common and is a normal sign that your immune system is building protection. Common side effects include injection site reactions (redness, swelling or pain), fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain and/or joint pain. If this occurs, it is still necessary to receive the second dose for the vaccine to be fully effective. Some people report having more intense side effects after their second dose of vaccine. Please keep this in mind and aim to schedule your vaccinations when you will be off of work for 1-2 days. This handout may help you decide if you should contact the employee COVID-19 Hotline for advice after receiving your vaccination.


If you begin to experience symptoms after receiving the first dose of the COVID-19 vaccine, you should reach out to Employee Occupational Health and Wellness. Based on the symptoms you are experiencing, refer to this handout to determine if you should call the COVID hotline.


Our COVID-19 vaccine page on the Duke Health website includes up-to-date information for patients and the general public. As our Duke Health patients become eligible, we are notifying them by email with instructions on how to schedule an appointment for vaccination, if they so desire. This talking points handout can be used to help answer questions from patients and the community.


Unless your family member is also a healthcare worker, they will fall in the same category as patients and the community. We realize that many of our team members are also caregivers for family members. Remember that the greatest risk of team member infection is not at work when they follow appropriate protocols and use the proper PPE. The majority of team member infections can be traced to community activity or while unmasked and eating with others.


We are coordinating with federal, state and local partners to ensure sufficient quantities of the vaccine. We are also ensuring that we continue to maintain capacity to receive, store and distribute the vaccine to team members, patients and the community. Of course, the demand for the vaccine is high, but we are working to provide it as quickly, efficiently and equitably as possible.


Yes. We are currently working to open additional offsite clinics as soon as possible.


We maintain strong relationships with the health department and other community organizations. We have been working with these partners since the beginning of the pandemic and are currently collaborating with them to identify those populations and how to reach them to distribute the vaccine. We realize that a significant number of people will not be able to travel to a specific location and are working to develop an operational plan to reach these populations.


We have begun receiving supplies of the Moderna vaccine. When you get your first dose, you will receive a card that lets you know which vaccine you received. Your second dose will be the same type of vaccine. It’s important to remember that there is virtually no difference in the safety or efficacy of the two vaccines.


No. EOHW and IP will continue to work together on contact tracing and exposure notifications regardless of vaccination status at this time.


Yes. Team members who have been classified as essential for on-site work required to maintain normal Health System operations may present to work after a high-risk COVID-19 exposure only if the following conditions are met:

1. The team member received both doses of the COVID-19 vaccine.

2. 14 days have elapsed since the second dose of the vaccine and prior to the exposure.

3. The team member is asymptomatic and agrees to symptom monitoring and testing should symptoms develop.

4. The team member agrees to being tested day 5-7 post-exposure.

5. The team member continues to do their best to isolate from the infected individual in their home.


No. Team members who develop signs or symptoms of COVID-19 should not report to work and should call the COVID-19 hotline to notify EOHW and arrange testing regardless of receiving the COVID-19 vaccine series.


Our goal is to continue with all COVID-19 infection prevention bundle elements until we see sustained decreases in the following metrics:

1. Community COVID-19 prevalence rates

2. The number of COVID-19 hospitalizations

3. The number of COVID-19 cases among DUHS team members

By continuing testing and contact tracing/notification post-exposure we will have local data on vaccine efficacy and durability to help inform when we can roll back some of the elements.