- Side Effects
- Dosing Schedule
- Drug Interactions
- Pregnancy and Nursing
What is the Pfizer-BioNTech COVID-19 vaccine?
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, 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.
The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.
What are the side effects of the Pfizer-BioNTech COVID 19 Vaccine?
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.
Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy.
Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine.
What is the dosage for the Pfizer-BioNTech COVID-19 Vaccine?
The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart.
Storage and Handling
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Frozen Vials Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and store in an ultra-low temperature freezer between -80°C to -60°C (-112°F to -76°F). Vials must be kept frozen between -80°C to -60°C (-112°F to -76°F) and protected from light until ready to use. If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90°C to -60°C (-130°F to -76°F). Storage within this temperature range is not considered an excursion from the recommended storage condition.
Thawed Vials Before Dilution
Thawed Under Refrigeration
Thaw and then store undiluted vials in the refrigerator [2°C to 8°C (35°F to 46°F)] for up to 5 days (120 hours). A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time.
Thawed at Room Temperature
For immediate use, thaw undiluted vials at room temperature [up to 25°C (77°F)] for 30 minutes. Thawed vials can be handled in room light conditions. Vials must reach room temperature before dilution.
Undiluted vials may be stored at room temperature for no more than 2 hours. After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution.
- During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
- Any vaccine remaining in vials must be discarded after 6 hours.
- Do not refreeze.
Dosing and Schedule
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) 3 weeks apart.
There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.
What drugs interact with the Pfizer-BioNTech COVID-19 Vaccine?
There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
Is the Pfizer-BioNTech COVID-19 Vaccine safe to use while pregnant or breastfeeding?
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% , respectively.
Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
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The Pfizer-BioNTech COVID 19 vaccine uses RNA -- a type of genetic coding molecule -- to get the body to produce its own copies of a certain coronavirus protein. Harmless by themselves, the protein molecules spur the immune system to develop antibodies. These antibodies protect you against COVID-19 (or at least, the most severe symptoms). The vaccine is not approved, but authorized for emergency use to combat the coronavirus pandemic.
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How Long Is COVID-19 Patient Contagious for?
People infected with COVID-19 can still be contagious even when they stop feeling sick, so precautionary measures should continue for at least 2 weeks after symptoms disappear and until the COVID-19 test result is negative. Ideally, patients should be quarantined at home or an institution for 2 weeks after the symptoms completely disappear.
COVID-19 (Coronavirus, 2019-nCoV)
Infection with COVID-19 (2019 novel coronavirus, 2019-nCoV) causes respiratory problems in humans. Transmission of COVID-19 occurs mainly through contact with respiratory sections from an infected person, however, fecal contamination may also spread the virus. Symptoms start off flu-like and progress to coughing, fever, shortness of breath, shaking chills, headache, loss of sense of taste and/or smell, muscle pain, and sore throat. Treatment focuses on supportive care and symptom relief. COVID-19 vaccines are available.
COVID-19 vs. Flu vs. Cold
When you're feeling sick, it can be difficult to distinguish the symptoms of a COVID-19 infection from the symptoms of the common cold or the flu (influenza). While fever is common with the flu and COVID-19, sneezing is typically only associated with colds. Though sore throats are typical with colds, they are uncommon with COVID-19 infections and the flu.
COVID-19 (Coronavirus) Prevention Tips
COVID-19 is a novel coronavirus that spreads from person to person via infected respiratory droplets. The main symptoms of COVID-19 infection include cough, fever, and shortness of breath. Occasionally, people infected with COVID-19 may experience diarrhea, a sore throat, a runny or stuffy nose, or aches and pains. Avoiding contact with infected people, social distancing, not touching your face, frequent hand washing, cleaning, and disinfecting of frequently touched surfaces can help to reduce your risk of contracting the 2019 novel coronavirus.
COVID-19 vs. Allergies
Though there is some overlap in allergy and COVID-19 signs and symptoms there are also significant differences. Symptoms that they have in common include headache, fatigue, tiredness, shortness of breath, wheezing, and sore throat. Fever does not occur with allergies but is one of the defining symptoms of COVID-19 infections.
Does COVID-19 Affect My Heart?
As per the American Heart Association, COVID-19 may have a long-term effect on the heart. Having a heart condition doesn't make a person more likely to catch COVID-19, but an individual with heart disease or a serious heart condition is more likely to become severely ill from COVID-19 and has a higher risk of death.
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