Fact Sheet: Covid-19 Vaccine
1. Why should I get vaccinated?
• To prevent the spread of Covid 19 and protect myself, my family, the residents and my community, and to set an example for others.
2. How do we know the vaccine is safe?
• The technology used to make the vaccine has been studied for more than 10 years. COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece that looks like the “spike protein.” The spike protein is found on the surface of the COVID-19 virus. Our bodies recognize that this protein should not be there, so they build antibodies that will remember how to fight the virus that causes COVID-19. The vaccine does NOT contain any live or killed virus and cannot cause Covid 19 infection.
3. Why should we trust the vaccine?
• The FDA is using the same strict standards that it has for decades
• No steps are “skipped”
• The FDA advises a minimum of 3,000 participants to assess safety. The phase 3 trials have 30,000 to 50,000 participants. This really demonstrates how safety is a top priority for the FDA and the medical community.
• Two independent advisory committees are reviewing the results. Members and experts of these committees have no conflict of interest and are not associated with any vaccine manufacturers
I. The Vaccine and Related Biological Products Advisory Committee (VRBPAC) that advises the FDA
II. The Advisory Committee on Immunization Practices (ACIP) that advises the CDC
4. Can mRNA vaccine give me Covid-19?
• No, because the vaccine is not made of live virus.
5. Can mRNA change my DNA?
• No. mRNA stands for messenger ribonucleic acid and can most easily be described as instructions for how to make a protein or even just a piece of a protein. mRNA is not able to alter or modify a person’s genetic makeup (DNA). The mRNA from a COVID-19 vaccine never enter the nucleus of the cell, which is where our DNA are kept. This means the mRNA does not affect or interact with our DNA in any way. Instead, COVID-19 vaccines that use mRNA work with the body’s natural defenses to safely develop protection (immunity) to disease.
6. What is an EUA and what does it mean for me?
• An Emergency Use Authorization (EUA) for a vaccine is based on the need to use a vaccine quickly to save lives during a public health emergency
• EUA is a shorter process but no steps are skipped in the safety evaluation process
• The FDA will assess if the vaccine known and potential benefits outweigh the known and potential risks
• Two separate advisory boards (VRBPAC and ACIP) will also review the data and make recommendations
• An EUA does NOT imply that the authorization was done too quickly or that the vaccine is not safe
7. What is the name of the vaccine and how many doses are there?
• Pfizer (BNT162b2)
• The vaccine comprises of 2 doses, 0.3mL each, given 21 days apart (there is a 4-day grace period)
• YOU MUST GET THE SECOND DOSE because the vaccine will not protect you if only get one dose
• It is important to get the SAME VACCINE as the first dose
8. What can I expect post-vaccination?
• You may have short-term discomfort: fatigue, headache, muscle pain, chills, fever, and pain at injection site after vaccination.
• These reactions will last for 24-48 hours and are typically more pronounced after the second dose
• Side effects mean your body is doing its job and making antibodies (IT IS A GOOD THING)
• These side effects are normal, common, and expected
9. When and how long will I be protected by the Covid-19 vaccine?
• Protection occurs 1-2 weeks after the second dose
• We will most likely not know how long the vaccine will be protective once we receive it. We will know more as more time passes in the current research
• May need to have vaccine shots for COVID-19 on a regular basis (like the flu shot)
10. Is it safe to get the Covid-19 vaccine even if you have had Covid-19?
• Yes. Even if you have had COVID-19, it is important to get vaccinated. It could give you longer or better protection against the disease
• Even if you have positive antibodies, you should get the COVID-19 vaccine
11. Who should not get the vaccine?
• History of severe allergic reaction after a previous dose of the vaccine
• History of severe allergic reaction to any ingredient of the vaccine
• People with acute Covid-19 infection and still under isolation/ quarantine (can be vaccinated after resolution of infection)
American Association of Post-Acute Care Nursing (AAPACN). https://www.aapacn.org/coronavirus-resources-for-ltpac
CDC (11/2020). Benefits of Getting a Covid-19 Vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html
CDC (12/13/2020). Facts about Covid-19 Vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html
FACT SHEET FOR RECIPIENTS AND CAREGIVERS
EMERGENCY USE AUTHORIZATION (EUA) OF
THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)
IN INDIVIDUALS 16 YEARS OF AGE AND OLDER
You are being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.
The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.
Read this Fact Sheet for information about the Pfizer-BioNTech COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Pfizer-BioNTech COVID-19 Vaccine.
The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle.
The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com.
WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE?
WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.
WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA).
For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE PFIZER-BIONTECH COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if you:
• have any allergies
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that affects your immune system
• are pregnant or plan to become pregnant
• are breastfeeding
• have received another COVID-19 vaccine
WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older.
WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE?
You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine
WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?
The Pfizer BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
HOW IS THE PFIZER-BIONTECH COVID-19 VACCINE GIVEN?
The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle.
The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart.
If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.
HAS THE PFIZER-BIONTECH COVID-19 VACCINE BEEN USED BEFORE?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.
WHAT ARE THE BENEFITS OF THE PFIZER-BIONTECH COVID-19 VACCINE?
In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.
WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?
Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include:
• injection site pain
• muscle pain
• joint pain
• injection site swelling
• injection site redness
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine. Signs of a severe allergic reaction can include:
• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness
These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19 Vaccine EUA” in the first line of box #18 of the report form.
In addition, you can report side effects to Pfizer Inc. at the contact information provided below.
Fax # 1-866-635-8337
Telephone # 1-800-438-1985
WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE?
It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.
ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES PFIZER-BIONTECH COVID-19 VACCINE?
Currently, there is no approved alternative vaccine available for prevention of COVID-19. FDA may allow the emergency use of other vaccines to prevent COVID-19.
CAN I RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE WITH OTHER VACCINES?
There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?
No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.
KEEP YOUR VACCINATION CARD.
When you get your first dose, you will get a vaccination card to show you when to return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bring your card when you return.
If you have questions, visit the website or call the telephone number provided below.
To access the most recent Fact Sheets, please scan the QR code provided below.
Global website: www.cvdvaccine,com
Telephone number: 1- 877-829-2619 (1-877-VAX-CO19)
HOW CAN I LEARN MORE?
• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
• Contact your local or state public health department.
WHERE WILL MY VACCINATION INFORMATION BE RECORDED?
The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?
The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).
Questions and Answers about the COVID-19 Vaccine for PALTC Staff, Patients, Residents and Family Members.
December 1, 2020
1. How is a vaccine developed and tested?
▪ Approval of a vaccine for use in people involves multiple phases with different goals for assessing
effectiveness and safety in different populations. There are a total of 4 phases and the vaccine
must meet very intense safety criteria before completing each phase. Once a vaccine is approved
for use after phase 3, it has been tested in tens of thousands of people and if no significant
harmful side effects are noted, it is considered safe for use. Phase 4 involves continued monitoring
and gathering of safety data. This type of clinical trial has been used for decades to approve
medications and vaccines.
2. What are the Food and Drug Administration (FDA) requirements for the safety and efficacy of a COVID-19 vaccine?
▪ FDA requires 50% efficacy of a COVID-19 vaccine (the COVID-19 vaccines from Pfizer and
Moderna are showing 94-95% efficacy in preventing COVID-19 disease during this trial phase).
Many other companies are working on a vaccine and we expect that others will be approved by
▪ FDA requires 8 weeks of safety data on the COVID-19 vaccine.
3. How will we know it is safe?
▪ Safety is the most important requirement for the vaccine and is assessed in trials by independent
▪ Most adverse side effects occur within 6 weeks of vaccine administration, and the FDA has
required 8 weeks of safety monitoring so it can track any side effects.
▪ FDA advises a minimum of 3,000 participants to assess safety. The current phase 3 trials have
30,000 to 50,000 participants. This really demonstrates how safety is a top priority for the FDA
and the medical community.
4. Who else will be evaluating this vaccine to ensure it is safe and effective?
▪ There are 2 advisory committees: (1) The Vaccine and Related Biological Products Advisory
Committee (VRBPAC) that advises the FDA; (2) The Advisory Committee on Immunization
Practices (ACIP) that advises the CDC.
▪ These advisory boards are independent. Their job is to monitor vaccines to ensure safety
regardless of money, politics, etc.
▪ The people on these committees are experts from academic institutions and they are vetted to
avoid a conflict of interest. Experts who may have a conflict of interest are not put on these
▪ The committees will evaluate the vaccine data for safety and efficacy, and also help to determine
how it will be distributed.
5. What are the types of potential vaccines that may be approved?
▪ Messenger RNA (mRNA) vaccines are a new type of vaccine undergoing clinical trials (see
question #6 below for more information on this). There are also other types vaccines being studied
that are similar to vaccines we have used for other diseases. None of these can give you COVID-
19! The goal is to give your body the tools it needs to fight COVID-19 effectively and/or prevent
you from getting it at all.
▪ Also, none of the proposed vaccines contain live or killed viral particles, even though some
other effective vaccines for other diseases have (see question #6 below for more information on
how these new vaccines work).
▪ Most of the vaccines that are currently being tested will require 2 doses to be effective, given
about 3-4 weeks apart.
▪ This is to make sure your body has enough antibodies to fight COVID-19. Getting 2 doses within
3-4 weeks has been shown to be safe and there are other vaccines we have been using for years
that require multiple doses without causing harm.
6. How does an mRNA vaccine work?
▪ According to the Centers for Disease Control (CDC) website, mRNA vaccines contain material
from the SARS-CoV-2 virus that causes COVID-19. This material gives our cells instructions for
how to make a harmless protein that is unique to the virus. This protein cannot build a virus or
cause infection. After our cells make copies of the protein, they destroy the genetic material from
the vaccine. Our bodies recognize that the protein should not be there and build antibodies that
will remember how to fight the virus that causes COVID-19 if we are infected in the future.
▪ While mRNA technology is new in vaccine development, this technology is being successfully
used in cancer treatments.
▪ For more information, visit the CDC website: https://www.cdc.gov/coronavirus/2019-
7. What is an Emergency Use Authorization (EUA) and if the vaccine is approved for an EUA, what does that mean?
▪ An EUA is based on the need to use a vaccine quickly to save lives during an urgent health crisis.
▪ You may be anxious about the speed with which a vaccine has been approved. While the EUA is a
shorter process, no steps are skipped in the safety evaluation process.
▪ This approval can still take weeks and the FDA will re-evaluate the numbers and data to ensure
that the calculations are correct.
▪ The FDA will assess if the vaccine’s known and potential benefits outweigh the known and
▪ Both advisory boards (VRBPAC and ACIP) will also review all the data and information.
8. How long will the vaccine protect us?
▪ It is likely that we will not know the answer to that question when a vaccine is released. That will
take more research.
▪ This vaccine may be like the annual flu vaccine, where we may need to have vaccine shots for
COVID-19 on a regular basis. More research is needed to know this and it also depends on
whether and how much the virus changes over the coming months to years.
9. When will we be protected after we get the vaccine?
▪ Even when people receive the vaccine they will not be immediately protected and will need to
continue wearing masks, social distancing and practicing frequent hand hygiene.
▪ Some vaccines will require 2 shots, with a few weeks between each shot, and protection will
usually occur about 2 weeks after the second shot.
▪ While no vaccine is 100% effective, some of the vaccines proposed are anticipated to be more than
90% effective. This will greatly reduce your risk of getting sick with COVID-19 and spreading
COVID-19 to your loved ones.
10. After I have had the second dose of the vaccine and it is 2 weeks after my second shot, do I still have to wear a mask?
▪ Yes. Even though you have received your vaccine, most of the people around you have not. We
know the vaccine prevents disease in the vaccinated person, but it still may be possible to
transmit the disease to others, until the vaccine is in widespread use.
▪ Wearing a mask, social distancing, and practicing hand hygiene protects those who have not been
vaccinated, especially our residents in long-term care.
11. What if I had COVID-19 or I took a test that showed I have antibodies? Should I get the vaccine?
▪ Yes, even if you have had COVID-19, it is safe to get the vaccine and this can add additional
protection without causing any harm.
▪ If you have had a test that shows you have COVID-19 antibodies, you should still get the vaccine.
It is safe and can increase your protection from future COVID-19 infections.
12. What are some of the possible side effects of the COVID-19 vaccine? Will the vaccine make me sick?
▪ The vaccines currently being tested in clinical trials can cause short-term discomfort (such as
headache, muscle pains, fatigue, chills, fever, and pain at injection site) in a percentage of the
people who receive them. This is the effect of your body developing immunity. Clinical trial
participants reported that the discomfort went away after a day, sometimes sooner. When you
receive the second dose of the vaccine, the discomfort can be more pronounced. This is a normal
reaction, so be prepared.
▪ If you experience discomfort after the first dose of the vaccine, it is very important that you still
receive the second dose a few weeks later for the vaccine to be effective.
▪ This does not mean that the vaccine has given you COVID-19. Rather, this means that the
vaccine is causing your body’s immune system to react and create antibodies to fight off the virus.
In other words, if you feel some discomfort, then the vaccine is doing its job!
▪ In some cases, a person may already be infected with COVID-19 when they get the vaccine but
are asymptomatic or pre-symptomatic. If they later have symptoms of COVID-19 or test positive
for it, it does not mean they got COVID-19 from the vaccine.
13. We should expect that vaccine recommendations will change as additional vaccines are approved.
▪ At first, we may have one vaccine, then hopefully two or three. As different vaccines become
available, some may be found to be better for different populations and different circumstances.
▪ Just like our knowledge about the virus itself changes over time, so will the recommendations
14. What can I be doing now while we wait for a vaccine to be approved and distributed?
▪ It is important to know about the process of how a vaccine is approved so you can ask questions.
▪ Listen to the VRBPAC and ACIP committees’ discussions as they are all public. Check the
websites for updates:
– VRBPAC meetings: https://www.fda.gov/advisory-committees/vaccines-and-relatedbiological-
– Here’s a link to the recorded meeting from October 22, 2020:
– ACIP meetings: https://www.cdc.gov/vaccines/acip/meetings/index.html
▪ Ask your medical director or provider about the vaccine and have them share information
and answer questions. You can talk to them about how they are planning to make their decision
to get the COVID-19 vaccine.
▪ It will be important to get your information from reliable sources, such as the CDC
(www.cdc.gov), the Immunization Action Coalition (https://www.immunize.org), your facility’s
medical director, and other providers so you can get accurate information. Social media is full
of misinformation and opinions based on that misinformation, so be careful to look to
reputable sources (such as those affiliated with academic institutions or non-profit
professional organizations like AMDA) for information.
▪ Look for specific data on potential COVID-19 vaccines and listen to/read the scientists’
evaluations of the data.
15. Is the flu vaccine also safe and effective?
▪ Yes! The flu vaccine is a good example of how vaccines can help prevent disease and be safe.
▪ It is more important this year than ever to get your flu shot so you can decrease your risk of
getting the flu (you can get both the flu and COVID-19 at the same time), and reduce the spread
of flu to others. This will also decrease the burden on healthcare staff who are caring for those
16. Who will be able to get the vaccine in a nursing home?
▪ CDC is recommending that nursing home residents and staff be among the first to get the
vaccine. Long-term care staff will often be able to get vaccinated before the residents to decrease
the risk of exposing the residents to COVID-19. Long-term care staff will include anyone who
works in a nursing home, such as those who work in environmental services, not just those who
perform direct patient care. This also includes staff who visit the nursing home, including doctors,
physician assistants, nurse practitioners, medical directors, lab technicians and consultants.
Now is the time to understand the process, ask questions and get accurate information!
Additional Resources from the CDC:
CDC: About COVID-19 vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/aboutvaccines.
CDC: Provider Resources for COVID-19 Vaccine Conversations with Patients and Answering Patients’
CDC: Understanding the Pharmacy Partnership for Long-Term Care Program and Frequently Asked
CDPH: COVID-19 Vaccine Planning Questions and Answers.
Approved by the AMDA Executive Committee. December 1, 2020