The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet here.
The FDA authorization of the Pfizer-BioNTech COVID-19 Vaccine for emergency use is a significant step forward in our fight against this pandemic. As we continue to distribute our vaccine, here are some key facts and answers to common questions.
1. What are the ingredients in the Pfizer-BioNTech COVID-19 Vaccine?
The ingredients are 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.1
2. How does an mRNA vaccine work?
mRNA, delivered to your body's cells by lipid nanoparticles, instructs the cells to generate the spike protein found on the surface of the novel coronavirus that initiates infection.1,2 Instructing cells to generate the spike protein spurs an immune response, including generation of antibodies specific to the SARS-CoV-2 spike protein.3
mRNA vaccines do not contain any virus particles, meaning that they don't contain weakened or dead parts of a virus or bacterium.2
3. Do mRNA vaccines change a person’s DNA?
mRNA is a transient carrier of information that does not integrate into human DNA.2,4 mRNA does not enter a cell’s nucleus, which is where our DNA is kept.2
4. What are the side effects of the Pfizer-BioNTech COVID-19 Vaccine?
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. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include1:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include1:
- Severe allergic reactions
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Injection site pain
- Muscle pain
- Joint pain
- Injection site swelling
- Injection site redness
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Arm pain
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.
5. 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 Events 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 number: 1-866-635-8337
Telephone number: 1-800-438-1985
6. What can you share about the Pfizer-BioNTech COVID-19 Vaccine in pregnant women?
Available data on the Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.1 If you are pregnant, discuss your options with your healthcare provider.
7. Does the Pfizer-BioNTech COVID-19 Vaccine cause infertility?
It has been suggested that COVID-19 vaccines will cause infertility because of a shared amino acid sequence in the spike protein of SARS-CoV-2 and a placental protein. Although the SARS-CoV-2 spike protein shares an amino acid sequence with a placental protein, the two proteins are immunologically different and distinct.5
In an animal study in which the Pfizer-BioNTech COVID-19 Vaccine was administered prior to and during gestation, no vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported.1 If you are pregnant, or planning to become pregnant, discuss your options with your healthcare provider.
8. Can your vaccine cause people to develop COVID-19?
The Pfizer-BioNTech COVID-19 Vaccine does not contain the virus and cannot give you COVID-19.2
9. How long will clinical trial participants be followed? How do we know that bad side effects can’t happen long after vaccination, if the vaccine’s only been studied for less than a year?
Pfizer and BioNTech will track participants in our Phase 3 clinical trial for two years following their second dose, in order to document the long-term effectiveness and safety of the vaccine.6
Our trial is closely monitored by Pfizer and an outside, independent group of experts called a Data Monitoring Committee, or DMC. Trial investigators also monitor participants’ health, and participants in the trial attend regular planned follow-up visits as part of the trial. The safety of patients is and always will be our number one priority.
10. Is the vaccine available for children and adolescents?
The Pfizer-BioNTech COVID-19 Vaccine is authorized for individuals 12 years of age and older. Younger children are currently being enrolled in our clinical trial.6
11. Where can I go for more information?
You can go to cvdvaccine-us.com/recipients to find a list of FAQs and other information about the Pfizer-BioNTech COVID-19 Vaccine. More information also can be found at www.cdc.gov/coronavirus.
1 Full Emergency Use Authorization (EUA) Prescribing Information. cvdvaccine-us.com. Accessed March 10, 2020. http://labeling.pfizer.com/ShowLabeling.aspx?id=14471&format=pdf&-page=…. Updated February 2021.
2 Understanding mRNA COVID-19 vaccines. CDC. Accessed January 19, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/m….
3 Understanding how COVID-19 vaccines work. CDC. Accessed January 19, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/h….
4 Schlake T, Thess A, Fotin-Mleczek M, Kallen K. Developing mRNA-vaccine technologies. RNA Biol. 2012;9(11):1319-1330. doi:10.4161/rna.22269
5 Kloc M, Uosef A, Kubiak JZ, Ghobrial RM. Exaptation of retroviral syncytin for development of syncytialized placenta, its limited homology to the SARS-CoV-2 spike protein and arguments against disturbing narrative in the context of COVID-19 vaccination. Biology. 2021;10(3):238. https://doi.org/10.3390/biology10030238
6 A phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-CoV-2 RNA vaccine candidates against COVID-19 in healthy individuals. Accessed February 4, 2021. https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-11/C4591001_Clinica….