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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

https://www.fda.gov/media/144414/download

COVID-19 Vaccination Questions and Answers

GENERAL INFORMATION

  • The FDA has authorized the emergency use of the Pfizer-BioNTech (Pfizer) COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA).

EUA Fact Sheet

  • Yes!  The vaccine is available to all consenting residents and team members at Carespring locations.
  • Patients and team members in nursing homes are part of a high risk category and have been prioritized to receive the vaccine.  It is highly recommended that we all take the vaccine.
  • Help to end the Pandemic – Vaccination along with masking, social distancing and proper hand washing will be the best way for us to get back to normal inside and outside of the facilities.
  • Protect Yourself – the vaccinated person is protected from contracting COVID-19.
  • Protect Others – the vaccinated person is protected from infecting others with COVID-19.
  • Decrease the Risk of Serious Illness and Death to Self and Others.
  • Overall Safety – COVID-19 Vaccination is a safer more effective way to be protected from COVID-19.
  • 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 potential risks.
  • Both advisory boards (VRBPAC and ACIP) will also review all the data and information.
  • The Pfizer COVID-19 Vaccine is administered as a 2-dose series that are 3 weeks apart.
  • The FDA has authorized the emergency use of the Pfizer COVID-19 vaccine in individuals ages 16 and older.
  • A person who has had a severe allergic reaction after a previous dose of this vaccine.
  • A person who has had a severe allergic reaction to any ingredient of this vaccine.
  • The Centers for Disease Control and Prevention on Sunday, 12/13/2020, said people who have experienced severe reactions to prior vaccines or injectable drugs can still get the Pfizer/BioNTech vaccine for Covid-19, but should discuss the risks with their doctors and be monitored for 30 minutes afterward. 
  • Severe allergic reactions to vaccines are extremely rare and were also rare during the Pfizer/BioNTech trial, which excluded people with a history of anaphylaxis. The FDA has released data indicating .63% of participants who received the vaccine experienced serious adverse reactions, compared to .51% of people who received a placebo.
  • The Pfizer COVID-19 Vaccine includes the following ingredients:
    • mRNA
    • Ingredients to hold the mRNA vaccine together:
      • lipids (fat molecule)
      • monobasic potassium phosphate (an ingredient commonly used in beverages, cheese and other products we consume daily)
      • sodium chloride (salt molecule)
      • dibasic sodium phosphate dihydrate
      • sucrose (sugar molecule)

Click here to view the EUA document which includes detailed information:  Emergency Use Authorization Fact Sheet

  • The Pfizer COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.
  • 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 about vaccines.
  • 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:
  • 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.

SAFETY AND POTENTIAL SIDE EFFECTS

  • Similar side effects to the flu vaccine:
    • injection site pain, swelling and/or redness
    • muscle or joint pain
    • tiredness
    • headache
    • fever or chills
    • nausea or feeling unwell
    • swollen lymph nodes (lymphadenopathy)
  • There is a remote chance that the 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. 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
  • Severe allergic reactions to vaccines are extremely rare and were also rare during the Pfizer/BioNTech trial, which excluded people with a history of anaphylaxis. The FDA has released data indicating .63% of participants who received the vaccine experienced serious adverse reactions, compared to .51% of people who received a placebo.
  • Side Effects (aches or pains) 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!
  • This is 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.
  • 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.
  • Currently, there are limited data available on the safety of COVID-19 vaccines for people who are pregnant. Animal developmental and reproductive toxicity (DART) studies are ongoing and studies in people who are pregnant are planned. CDC and the Food and Drug Administration (FDA) have safety monitoring systems in place to capture information about vaccination during pregnancy and will closely monitor reports.
  • While studies have not yet been done, based on how mRNA vaccines work, experts believe they are unlikely to pose a risk for people who are pregnant. mRNA vaccines do not contain the live virus that causes COVID-19 and therefore cannot give someone COVID-19. Additionally, mRNA vaccines do not interact with genetic material DNA because the mRNA does not enter the nucleus of the cell. Cells break apart the mRNA quickly. However, the potential risks of mRNA vaccines to the pregnant person and her fetus are unknown because these vaccines have not been studied in pregnant women.
  • Observational data demonstrate that, while the chances for these severe health effects are infrequent, pregnant people with COVID-19 have an increased risk of severe illness, including illness that results in ICU admission, mechanical ventilation, and death. Additionally, pregnant people with COVID-19 might be at increased risk of adverse pregnancy outcomes, such as preterm births.
  • American Society for Reproductive Medicine Statement on Vaccines
  • The American College of Obstetricians and Gynecologists Vaccine Information
  • Safety is the most important requirement for the vaccine and is assessed in trials by independent experts.
  • COVID-19 vaccines were tested in large clinical trials across the US and the world to make sure they meet safety standards. In the US, many people were recruited to participate in these trials to see how the vaccines offers protection to people of different ages, races, and ethnicities, as well as those with different medical conditions
  • 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.
  • COVID -19 is a worldwide pandemic.  Thus the resources of the world were united to assure that there were abundant resources of time, money and personnel to research and develop a safe vaccine.
  • Typically, when a new vaccine or medical treatment is developed, the time from development to approval is not extraordinary.  What takes the most time is from approval to production of the actual product for mass distribution.
  • The COVID-19 vaccine was the first time that we produced a vaccine simultaneously while going through clinical trials and approval process.  Thus, the vaccine was ready for widespread distribution when approved.
  • 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 the FDA.
  • FDA requires 8 weeks of safety data on the COVID-19 vaccine.
  • 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.
  • 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 committees.
  • The committees evaluated the vaccine data for safety and efficacy, and also help to determine how it will be distributed.
  • 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 committees.
  • The committees will evaluate the vaccine data for safety and efficacy, and also help to determine how it will be distributed.
  • 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.
  • 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- ncov/vaccines/about-vaccines/how-they-work.html
  • mRNA is not able to alter or modify a person’s genetic makeup (DNA). The mRNA from a COVID-19 vaccine never enters 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.

LIFE AFTER VACCINATION

  • Yes, you may work as long as you have consulted with facility leadership for evaluation of symptoms and it has been determined that the symptoms you are experiencing have known correlation with vaccination.
  • 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.
  • 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.
  • 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.
  • We know, as more people get vaccinated in the facility and the surrounding community, this will lead to significant decreases in cases in our communities.   This in itself will provide us all greater flexibilities with visitation/group activities/full communal dining
  • As we go into early next year, we will aim for guidance from public health as to what vaccination means for visitation.  We feel resident vaccination should provide the resident flexibility with visitation (while still wearing a mask and being socially distant).    We will need guidance before this flexibility can start.
  • 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.
  • 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 about vaccines.