A variety of vaccines are available to prevent corona virus infection. The Pfizer vaccine is one of them. Many people who are vaccinated develop myocarditis. This was revealed by the Israeli Ministry of Health.
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.
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 include:
- 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.
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. If you are pregnant, or planning to become pregnant, discuss your options with your healthcare provider.