Last December, two vaccines to prevent severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) received Emergency Use Authorization (EUA) granting distribution in the U.S. – Pfizer/BionTech and Moderna’s messenger RNA (mRNA) vaccines. Many people can’t wait to receive one of these vaccines while others remain hesitant and skeptical. As a health care professional, you will likely be inundated with questions from your patients, family and friends. Here are some commonly asked questions and what you should know about the currently approved coronavirus disease (COVID-19) vaccines.
1. Are the vaccines safe?
The vaccines are tested in large clinical trials based on stringent scientific standards
. These trials recruit thousands of participants spanning various ages, races and ethnicities. The data collected from these studies are analyzed by the U.S. Food and Drug Administration (FDA) which determines if the vaccine is safe and effective. The FDA will only approve a vaccine if the research data shows (Biotechnology Innovation Organization [BIO], 2020):
- Safety based on the results of the randomized controlled clinical trials
- Effectiveness at preventing the disease
- Ability to be manufactured consistently, safely and at high quality
There are several independent oversight committees built into the vaccine development process. The Data Safety Monitoring Boards are comprised of medical experts that evaluate data during the clinical trial process and provide an impartial assessment to ensure the research is in compliance with the highest safety standards. The Vaccines and Related Biological Products Advisory Committee is an FDA subcommittee consisting of 15 independent immunology, infectious disease, virology and other medical experts. This advisory committee will review the data and make recommendations to the FDA on whether the vaccine should be authorized or licensed for use (BIO, 2020). The Advisory Committee on Immunization Practices (ACIP), another group of independent medical and public health experts, will review the data in real time and make recommendations to the Centers for Disease Control and Prevention
(CDC, 2020 December 22a).
Once the vaccine is approved for use, vaccine safety monitoring systems are set up to track adverse events and side effects that may not have occurred during the clinical trial. If an adverse event is reported, experts will assess whether it is a true safety concern and determine if they must alter the vaccine recommendations. In addition, the CDC has developed a new smartphone-based health checker for people who receive COVID-19 vaccines called V-safe. This tool sends text messages and web surveys to the vaccine recipients to monitor for adverse events. The CDC and FDA have also established the Vaccine Adverse Event Reporting System (VAERS) that collects adverse event reports from health care professionals, vaccine manufacturers, and the public (CDC, 2020 December 22a).
2. How do these vaccines work?
Both the Pfizer/BioNTech and Moderna vaccines utilize mRNA technology, strands of genetic material inside a special coating that helps it enter the cells (CDC, 2020 November 24). The mRNA contains instructions on how to create a piece of the “spike protein” unique to SARS-CoV-2. Once the spike protein is created, the cell is then able to break down the mRNA strand and eliminate it. The mRNA strand never enters the cell’s nucleus or affects the genetic material. The spike protein is expressed on the cell surface causing the immune system to produce antibodies to SARS-CoV-2 which protect the body from future infection (CDC, 2020 November 24).
This technology is not new and has been researched in early-stage clinical trials for influenza, Zika, rabies and cytomegalovirus (CMV) (CDC, 2020 November 24). In addition, mRNA is also being studied to target cancer cells. There are several benefits of mRNA technology in that it does not include infectious material, it can be manufactured faster and has the potential to target multiple diseases (CDC, 2020 November 24).
3. Can I get the virus from the vaccine? Can the vaccine make me ill with COVID-19?
Since these vaccines don’t contain “infectious material” or live virus, you can’t contract the disease from the vaccine and therefore will not make you sick with COVID-19 (CDC, 2021 January 4).
4. How is the vaccine administered?
The mRNA COVID-19 vaccines consist of two doses administered by injection into the muscle, typically the deltoid.
- Pfizer-BioNTech (30 ug, 0.3 mL): three weeks (21 days) apart
- Moderna (100 ug, 0.5 mL): one month (28 days) apart
Second doses should be administered as close to the recommended interval as possible but may be administered within a grace period of less than 4 days (CDC, 2020 December 30).
5. Do I really need 2 doses?
Two doses are required to obtain the highest level of protection from COVID-19. The first dose prepares the immune system and helps it to recognize the virus while the second dose increases the immune response (CDC, 2020 November 2).
6. When I get the 2nd dose, does it have to be the from the same manufacturer as the 1st dose?
The mRNA COVID-19 vaccines are not interchangeable with one another or with other vaccine products. Both doses of the series should be completed with the same vaccine.
7. Will I experience side effects and if so, what are they?
Minor side effects from vaccines are common and a sign that your body is building immunity to the virus. These side effects may make you feel mildly ill in the short term but should resolve in a few days. Side effects include (CDC, 2020 December 19):
- Pain and swelling on the arm where you received the shot; apply a clean, cool, wet washcloth over the area and exercise your arm.
- Fever; drink fluids.
- Headache; ibuprofen or acetaminophen may be taken for pain or discomfort.
- Anaphylactic reactions have been reported after vaccination with mRNA COVID-19 vaccines; if you experience difficulty breathing, seek medical help right away.
Advise patients to contact their health care provider if the redness or tenderness at the injection site increases after 24 hours or if other side effects do not improve or resolve after a few days.
8. Who can receive the vaccine? Who will get priority? When can I expect to get the vaccine?
While supply is limited, vaccines will be administered in a phased approach and will be coordinated at the state and local level (CDC, 2020 December 22b).
- Phase 1a: health care personnel and residents of long-term care facilities
- Phase 1b: individuals 75 years and older and frontline essential workers (non-health care) including firefighters and police officers, corrections officers, food and agricultural workers, U.S. Postal Service workers, manufacturing workers, grocery store workers, public transit workers, teachers and support staff members and childcare workers
- Phase 1c: individuals 65-74 years, individuals 16-64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b such as those working in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety, and public health
- Phase 2: all other individuals 16 years and older (Pfizer-BioNTech vaccine) or 18 years and older (Moderna vaccine) not already recommended for vaccination in Phases 1a-c. If you do not fall into one of the above categories, you can expect access to vaccination this summer.
9. What about pregnant women? Can they be vaccinated?
Studies to date have not included women who are pregnant and therefore the safety of COVID-19 vaccines is limited. Individuals who are pregnant and part of one of the Phase 1a-c groups listed above, may choose to be vaccinated (CDC, 2020 December 28).
10. Is it safe for individuals with underlying medical conditions or weakened immune systems?
The mRNA COVID-19 vaccines may be administered to individuals with underlying medical conditions as long as they have not had a severe allergic reaction to any of the components of the vaccine (CDC, 2020 December 29a).
- Individuals with HIV or weakened immune systems from other illnesses may receive an mRNA COVID-19 vaccine, however safety data is limited, and they may experience a decreased immune response to the vaccine (CDC, 2020 December 29a).
- Individuals with autoimmune conditions may receive an mRNA COVID-19 vaccine, however safety data is not available.
11. Who should not get the vaccine? What are the contraindications?
Individual who have a history of the following should not receive the mRNA vaccines at this time:
- Severe allergic reaction (i.e., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
- Immediate allergic reaction (of any severity) to a previous dose of an mRNA COVID-19 vaccine or any component (including polyethylene glycol [PEG]) may be at higher risk for anaphylaxis upon re-exposure
- An immediate allergic reaction is defined as any hypersensitivity-related sign or symptom such as urticaria, angioedema, respiratory distress (i.e., wheezing, stridor), or anaphylaxis within four hours following administration (CDC, 2020 December 30).
- Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
*Note: allergic reactions not
related to vaccines such as food, pet, venom or environmental allergies or allergies to oral medications are not
a contraindication or precaution to vaccination with either mRNA COVID-19 vaccine.
Studies are being conducted in adolescents under the age of 16. Until data is obtained and analyzed for this population, children should not receive the vaccine at this time.
12. What can I expect and how long does the vaccination process take?
You will be asked to complete an initial screening questionnaire prior to vaccination. After you receive the shot, you will be observed for 15 minutes to monitor for immediate adverse events. If you have an allergy unrelated to the vaccine or its components, you will be observed for 30 minutes (CDC, 2020 December 30). You should receive a vaccination card or printout that tells you which COVID-19 vaccine you received, the date, and where you received it.
13. Where can I get the vaccine?
The vaccines will be available at a variety of locations based on your state and local public health department roll-out. Vaccinations may be available at hospitals, clinics, provider offices, assisted living facilities, pharmacies, schools and community centers. Check your local public health department website for locations near you.
14. What will it cost?
To start, vaccines that have been purchased with taxpayer funds will be provided at no cost. However, vaccination providers may charge administration fees. Providers may be able to get this fee reimbursed by the patient’s public or private insurance company (CDC, 2020 December 22c).
15. If I had COVID-19 and recovered, should I still get the vaccine?
Following infection, you may have developed antibodies to COVID-19, however researchers have not determined how much immunity you have after recovering from the illness or how long natural immunity will last. According to the CDC (2020, December 30), data from clinical trials indicate that the mRNA COVID-19 vaccines are safe for individuals who have had a prior SARS-CoV-2 infection and vaccines should be offered regardless of a history of prior symptomatic or asymptomatic infection. According to the CDC, individuals with a current SARS-CoV-2 infection should wait until they have recovered from the acute illness.
16. Can I stop wearing a mask after I get vaccinated?
While the vaccine will help protect you from becoming seriously ill from COVID-19, scientists have not determined whether the vaccine decreases an individual’s spread of the disease and you may still be contagious to others (BIO, 2020). The CDC (2020, December 29b) does not have enough information as to how much protection the COVID-19 vaccine will provide and therefore cannot recommend that people stop wearing masks at this time.
17. I heard there is a new strain of the virus that is highly transmissible. Will the vaccine protect me from this strain as well?
It is common for viruses to mutate and evolve gradually over time resulting in new strains. The latest strain was detected in the United Kingdom in December and appears to be more contagious. However, there are no indications that the new virus causes more severe COVID-19 disease and there’s no evidence that the mRNA vaccines would not work against the new strain (Bollinger & Ray, 2020).
18. What should I do to protect myself until I can get the COVID-19 vaccine?
Until we have an adequate supply of the vaccine for the general population, it is important that you continue to cover your mouth and nose with a mask when around others, avoid close contact with individuals who are ill, maintain 6 feet of distance from others, avoid crowds, and wash your hands often (2020, December 29b).
The CDC has compiled a list of commonly asked questions
with examples of how you can respond to your patients. Encourage your patients, family and friends to continue to follow public health guidelines until the vaccine becomes more widely available.
The following is a quick reference for health care providers outlining the basic differences between the current mRNA vaccines.
|COVID-19 mRNA Vaccine Quick Reference for Health Care Providers
(CDC, 2020 December 20)
||Ultra-cold freezer between -112°F and -76°F (-80°C and -60°C)
Thawed vaccine cannot be refrozen.
|Between -13° F and 5° F
(-25°C and -15°C)
Thawed vaccine cannot be refrozen.
||Before mixing, may refrigerate between 36°F and 46°F (2°C and 8°C) for up to 120 hours (5 days)
||Before vials are punctured, may refrigerate between 36°F and 46°F (2°C and 8°C) for up to 30 days
||16 years and older
||18 years and older
||30 ug (0.3 mL)
||100 ug (0.5 mL)
|Doses per vial
||Yes – MUST be diluted with 0.9% sodium chloride (normal saline, preservative-free) before administration.
||No – Do NOT mix with diluent. Discard vial when there is not enough vaccine to obtain a complete dose. Do not combine residual vaccine from multiple vials.
||2-dose series separated by 21 days
||2-dose series separated by 28 days
||Intramuscular (IM) injection into the deltoid muscle