Are the COVID-19 vaccines safe?
There are many strict protections in place and steps taken during vaccine development to ensure that any vaccine authorized for use is proven to be safe and effective. Vaccine developers are required to go through a rigorous, multi-stage process including large (phase III) trials that involve tens of thousands of participants.
More than 70,000 people from diverse backgrounds and ethnicities participated in the COVID-19 vaccine clinical trials. Clinical trials for the three vaccines included White, Hispanic/Latino, Black, Asian, and other races/ethnicities.
After the clinical trials show that the vaccines are safe and effective, a series of independent reviews and evidence is required to demonstrate efficacy and safety. The FDA is responsible for making sure that FDA-authorized or approved COVID-19 vaccines are safe and effective. Duke experts in vaccine science reviewed all available safety and efficacy data for any authorized vaccine to ensure the evidence supports its broad use.
What ingredients are in the COVID-19 vaccines?
The Pfizer vaccine and the Moderna vaccine use mRNA to instruct the cells in your body to make a harmless piece of the “spike protein” found on the surface of COVID-19. Your immune system is tricked into thinking this is a virus and makes antibodies. A live virus is not included in the vaccine. Your body destroys the mRNA and gets rid of it. It doesn’t stay in your body or alter any DNA. The other ingredients in the Pfizer and Moderna vaccines are salt, sugar, and fat.
The Janssen COVID-19 (Johnson and Johnson) uses a harmless inactivated cold virus as the carrier for the genetic material that codes for a piece of the “spike protein” of COVID-19 to help the body build an immune response against the coronavirus that causes COVID-19. These types of vaccines are generally safe for large populations of people.
None of the vaccines contain eggs, preservatives, fetal tissue, stem cells, mercury, or latex.
Are the vaccines safe for children?
As of now, none of the vaccines are approved for children under 16 years of age. Only non-pregnant adults at least 16 years of age participated in early COVID-19 vaccine clinical trials. However, clinical trials of the COVID-19 vaccines have expanded to include children. More information will be available from the vaccine manufacturers as these trials progress.
Are the vaccines safe for pregnant people?
The approved COVID-19 vaccines have not been studied in pregnancy. However, we know that pregnant people are at an increased risk for complications from COVID-19. That's why we encourage all pregnant people to ask questions and discuss their concerns with their care providers.
So far, there have been no significant adverse events seen in pregnant women receiving the Pfizer or Moderna vaccines. Duke Health will offer pregnant people the option to get vaccinated according to North Carolina guidelines for vaccine distribution.
Should I get the vaccine if I am breastfeeding?
The approved COVID-19 vaccines were not studied in people who are breastfeeding. However, according to the Centers for Disease Control, there is no data indicating that the vaccines would be a risk to infants who are breastfeeding. If you are breastfeeding, discuss your concerns with your care providers. Duke Health will offer breastfeeding people the option to get vaccinated in accordance with North Carolina guidelines for vaccine distribution.
Can the COVID-19 vaccine make me infertile/sterile?
No. There is no evidence to suggest the vaccines cause infertility or affects your ability to become pregnant. A rumor on the Internet claims a protein created by the body after vaccination is similar to a protein that is needed for placental formation. This is not true. The proteins are not similar nor do they impact fertility or affect a pregnancy. The vaccine manufacturers are monitoring people in the clinical trials who became pregnant.
Do the vaccines cause side effects?
There is a potential for injection site reactions (redness, swelling, and pain) as well as fever, fatigue, headache, chills, nausea, vomiting, diarrhea, muscle pain, and/or joint pain. These are adverse reactions commonly seen with other vaccines. There may be other reactions that are not currently known. If you are receiving a two-dose vaccine, it is important that you receive the second dose to ensure the vaccine is effective, even if you experience side effects after the first dose.
If you have a severe allergic reaction following the first dose of a two-dose vaccine course, such as anaphylaxis, you should not receive the second dose. The incidence of this occurring is low, about one in six per million doses.
Should I get the vaccine if I have allergies?
You can receive the vaccine if you have allergies to injectable medicines, antibiotics, pets, environmental substances, or foods. The three approved COVID-19 vaccines do not contain egg protein, and are safe for people who have egg allergies. If you have questions about allergies, your doctor can help you determine if the benefits of the vaccine outweigh the risks.
Who determines who will receive the vaccine and when?
The North Carolina Institute of Medicine convened an independent COVID Vaccine Advisory Committee, which created a priority plan for North Carolina. It provides guidelines for the equitable distribution of the vaccine. The prioritization plan is based on the risk of exposure to and severe illness from COVID-19. You can view the guidelines for distribution of the vaccine in North Carolina on the North Carolina Health and Human Services website.
Can non-U.S. citizens receive the vaccine and will receiving the vaccine affect my immigration status?
The COVID-19 vaccine is free and available to everyone regardless of citizenship or immigration status.
Receiving the vaccine will not negatively affect your immigration status or be used in “public charge” determinations. Data gathered during the vaccination is kept confidential and will not be used for immigration enforcement. The Department of Homeland Security said in a statement that it will not be present at vaccination sites for immigration enforcement.
If I had COVID-19 and recovered, should I get the vaccine?
Yes. Early findings suggest natural immunity from COVID-19 may not last long. More studies are needed. We generally recommend getting vaccinated three months after recovering from COVID-19 infection. Your natural immunity should protect you during this and it may allow non-immune people to get the vaccine sooner. There is no harm in getting vaccinated before 90 days as long as you are beyond your isolation period.
How much vaccine does Duke Health receive?
The exact quantity and timing for shipments continue to evolve. Vaccine quantities are determined by the state. Supplies are distributed throughout North Carolina according to state distribution guidelines.
How many doses will I need?
The Pfizer and Moderna vaccines require two doses. Pfizer’s vaccine requires two doses of the vaccine 21 days apart. Moderna's second dose is administered one month after the first. The Janssen vaccine (Johnson & Johnson) requires one dose.
If I get my first dose at a location outside of Duke Health, can I get my second dose at a Duke Health location?
No. Due to how first and second doses are distributed by the state, you cannot get your second dose at a Duke location if you received your first dose at a non-Duke location.
Am I required to present identification to be vaccinated?
Duke Health will ask for a form of identification in order to confirm your identity (name, date of birth, etc.) and make sure we are vaccinating the right person. However, Duke Health will not withhold vaccinations or appointments for vaccinations if you cannot supply a form of identification.
Duke Health collects name, address, date of birth, location at which the vaccine was given, when the vaccine was given, the person who administered the vaccine, information about the specific vaccine vial, and how the vaccine was given (ex. in the right arm muscle). This information is required by the state and by Duke Health in order to contact the patient after the visit to schedule additional visits. Information about race and ethnicity is also collected, which helps support North Carolina’s efforts for the equitable distribution of the COVID-19 vaccine.
North Carolina is required to submit vaccination data to the CDC to meet federal requirements. Data submitted to the CDC will not be used to market commercial services to individual patients or nonpatients, assist in bill collecting services, or civil or criminal prosecution or enforcement, including but not limited to immigration enforcement.
Will there be interpreting services at my vaccine appointment?
Yes, there are interpreting services at all of our vaccine sites.
How much does the vaccine cost?
The COVID-19 vaccine is available at no cost to you regardless of if you have health insurance. If you do have insurance, your insurance will be billed, but you will not be charged.
Can I choose which vaccine I want?
When you are invited to schedule your appointment, the vaccine brand will be indicated in the appointment time. You may have a choice depending on what is available. Supply is still limited which may limit the options available.
What are the differences between the Moderna, Pfizer and Janssen (Johnson & Johnson) vaccines?
Clinical trial data show the FDA-approved Moderna and Pfizer COVID-19 vaccines are equally effective after vaccination -- 95% for Pfizer and 94.1% for Moderna -- and are safe for most adults and across different ethnic and racial groups. The vaccines were studied extensively and tested successfully in 30,000 people before receiving FDA approval. Since approval, they have been safely administered to tens of millions of people.
The Janssen vaccine (Johnson & Johnson) is 67% effective at preventing moderate to severe disease from COVID-19 and 85% effective at preventing severe disease. The clinical trial also found the vaccine to be 100% effective at preventing hospitalization and deaths.
Pfizer and Moderna Vaccines Use mRNA Technology
Neither vaccine uses a live virus to help the body develop immunity, as some traditional vaccines do. Instead, both vaccines are messenger RNA vaccines (mRNA). This new vaccine technology teaches the body how to make a harmless piece of protein, called a spike protein, that triggers an immune response that protects you from COVID-19. Although this is a newer type of vaccine, researchers have been studying and working with mRNA vaccines for decades. Both COVID-19 vaccines were thoroughly tested before approval. The mRNA vaccines do not manipulate your DNA as they never enter the cell. More information is available on the CDC website.
The Janssen vaccine (Johnson & Johnson) does not use mRNA technology. Instead, it uses a harmless inactivated cold virus to help the body build an immune response against the coronavirus that causes COVID-19.
Differences between the Vaccines
- Population Approved for Use
The Moderna vaccine and the Janssen vaccine (Johnson & Johnson) are approved for use in people 18 and older. The Pfizer vaccine is approved for use in people age 16 and older.
- Dosage Timing
Both vaccines require two doses, however, the timing for the second dose differs. The second Moderna dose is given 28 days after the initial dose; the second Pfizer dose is given 21 days after the initial dose. The Janssen vaccine (Johnson & Johnson) requires one dose.
- Side Effects
The vaccines may cause similar side effects including redness, swelling, and pain at the injection site, fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain, and/or joint pain. These are signs that your immune system is building protection against the virus. There have been rare cases of a severe allergic reaction after the Pfizer vaccine, but not after the Moderna vaccine. This was not seen in the clinical trials.
- Vaccine Storage
Both vaccines require cold storage, however, not to the same degree. Moderna’s can be stored in a refrigerator freezer while Pfizer’s requires ultracold freezers. This makes the Moderna vaccine easier to distribute. The Janssen vaccine (Johnson & Johnson) does not require cold storage.
If I get the vaccine, do I still need to wear a mask and practice social distancing?
Yes. Vaccines may boost your immune system so it is ready to fight the virus if you are exposed, but it is not yet fully understood whether vaccinated people might still be able to transmit the virus. Initially, we will not have enough vaccines to vaccinate everyone who wants it, and the virus will still be in the community. Therefore, wearing a mask, practicing social distancing, and frequently washing your hands will help reduce your chance of being exposed to and spreading the virus.