What vaccine was authorized by the Food and Drug Administration?
The FDA authorized the emergency use of the Pfizer-BioNTech (Pfizer) COVID-19 Vaccine to prevent COVID-19 in individuals ages 16 and older under an Emergency Use Authorization (EUA). The Moderna mRNA-1273 COVID-19 Vaccine was similarly approved. This page focuses on information about the Pfizer vaccine. Visit the CDC’s website to learn more about the Moderna vaccine.
Is the vaccine available to all consenting patients and team members?
Is the vaccine mandatory?
Older patients and team members are part of a higher-risk category and have been prioritized to receive the vaccine. It is HIGHLY RECOMMENDED that all patients and team members get the vaccine.
Why is it important for patients and team members to get vaccinated?
- Help 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”.
- Protect Yourself: the vaccinated person is protected from contracting COVID-19.
- Protect Others: the vaccinated person is protected from infecting others with COVID-19.
- Decreased Risk: From serious illness and death for self and others.
- Overall Safety: COVID-19 Vaccination is a safe, effective way to be protected from COVID-19.
What is an Emergency Use Authorization (EUA) and since the vaccine is approved for an EUA, what does that mean?
An EUA is based on the need to quickly use a vaccine 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 had a shorter process, no steps were skipped in evaluating the safety of the vaccine.
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 Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Advisory Committee on Immunization Practices (ACIP) advisory boards will also review all the data and information.
How many doses need to be given?
The Pfizer COVID-19 Vaccine is administered as a 2-dose series scheduled 3 weeks apart.
Who should get the Pfizer COVID-19 Vaccine?
The FDA has authorized the emergency use of the Pfizer COVID-19 Vaccine in individuals ages 16 and older.
Who should not get the Pfizer COVID-19 Vaccine?
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.
Should I get the vaccine if I have had a severe allergic reaction to injectable vaccines in the past?
The Centers for Disease Control and Prevention stated 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 released data indicating .63% of participants who received the vaccine experienced serious adverse reactions, compared to .51% of people who received a placebo.
What are the ingredients in the Pfizer COVID-19 Vaccine?
The Pfizer COVID-19 Vaccine includes the following ingredients:
- Ingredients to hold the mRNA vaccine together:
- Lipids (fat molecules)
- 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)
Can the Pfizer COVID-19 Vaccine give me COVID-19?
The Pfizer COVID-19 Vaccine DOES NOT contain SARS-CoV-2 and CANNOT give you COVID-19.
What are some of the possible side effects of the COVID-19 vaccine?
Similar side effects to the flu vaccine:
- Injection site pain, swelling and/or redness
- Muscle or joint pain
- Injection site pain, swelling and/or redness
- 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 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.
Why do side effects occur? Does it mean it’s working?
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, the vaccine is doing its job!
This is your body developing immunity. Clinical trial participants report 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.
What is the risk if I am pregnant or breast feeding?
Currently, there is 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 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 an increased risk of adverse pregnancy outcomes, such as preterm birth.
How do we know it is safe?
Safety is the most important requirement for the vaccine and assessed in trials by independent experts. COVID-19 vaccines were tested in large clinical trials across the U.S. and the world to make sure they meet safety standards. In the U.S., many people were recruited to participate in these trials to see how the vaccines offer 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.
The FDA advises a minimum of 3,000 participants to assess safety. The current phase 3 trials have 30,000 to 50,000 participants. This demonstrates how safety is a top priority for the FDA and the medical community.
How was the vaccine approved so quickly?
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 the clinical trials and approval process. Thus, the vaccine was ready for widespread distribution when approved.
What are the Food and Drug Administration (FDA) requirements for the safety and efficacy of a COVID-19 vaccine?
The FDA requires 50% efficacy of a COVID-19 vaccine. The COVID-19 vaccine from Pfizer is showing 94-95% efficacy in preventing COVID-19 during the trial phase.
The FDA requires 8 weeks of safety data on the COVID-19 vaccine.
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 is 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.
Who evaluated this vaccine to ensure it is safe and effective?
There are 2 advisory committees:
- The Vaccine and Related Biological Products Advisory Committee (VRBPAC) that advises the FDA
- 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 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 help to determine how it will be distributed.
What are the types of potential vaccines that may be approved?
Messenger RNA (mRNA) vaccines are a new type of vaccine undergoing clinical trials. There are also other types of vaccines being studied that are like 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.
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.
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.
Can the mRNA vaccine change or impact my DNA?
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.