COVID-19 mRNA Vaccine (Pfizer-Biontech)
Indications
COVID-19 mRNA Vaccine (Pfizer-Biontech) is used for:
COVID-19 disease prevention
Adult Dose
Injection
Emergency use authorization (EUA) issued by FDA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged >16 years
30 mcg/0.3mL (multiple-dose vial)
0.3 mL IM x2 doses administered 3 weeks apart
Child Dose
<16 years: Safety and efficacy not established
Renal Dose
Administration
IM Preparation
Allow vials to thaw in refrigerator (may take up to 3 hr) or at room temperature for 30 minutes
Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hr
Before dilution, invert vial gently 10 times; do NOT shake
Inspect contents; should appear white to off-white suspension and may contain white to off-white opaque amorphous particles
Do not use if discolored or if other particles observed
Dilute vial contents using 1.8 mL of 0.9% NaCl; equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe
Gently invert diluted vial contents 10 times to mix; do NOT shake
Record date and time of dilution on vial label
Store diluted vial at 2-25ºC (35-77ºF); discard any unused vaccine 6 hr after dilution
IM Administration
For IM injection only
Thawed vials before dilution
Thawed under refrigeration
Thaw and then store undiluted vials in refrigerator at 2-8ºC (35-46ºF) for up to 5 days (120 hr)
Carton of 25 vials or 195 vials may take up to 2 or 3 hr, respectively, to thaw in refrigerator; whereas, fewer number of vials will thaw in less time
Thawed at room temperature
For immediate use, thaw undiluted vials at room temperature up to 25ºC (77ºF) 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 hr
Vials after dilution
After dilution, store vials at 2-25ºC (35-77ºF) and use within 6 hr from time of dilution
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light
Discard any vaccine remaining in vials after 6 hr
Do not refreeze
Contra Indications
Known history of severe allergic reaction (eg, anaphylaxis) to any component in vaccine
Precautions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available following vaccination
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine
Vaccine may not protect all vaccine recipients
Pregnancy-Lactation
Pregnancy
Data are insufficient to inform of vaccine-associated risks in pregnancy
Lactation
Data are not available to assess effects on breastfed infants or on milk production/excretion
Interactions
Adverse Effects
Side effects of COVID-19 mRNA Vaccine (Pfizer-Biontech) :
>10%
Injection site pain (84.1%)
Fatigue (62.9%)
Headache (55.1%)
Muscle pain (38.3%)
Chills (31.9%)
Joint pain (23.6%)
Fever (14.2%)
Injection site swelling (10.5%)
1-10%
Injection site redness (9.5%)
Nausea (1.1%)
<1%
Malaise (0.5%)
Lymphadenopathy (0.3%)
Frequency Not Defined
Severe allergic reactions reported following mass vaccination outside of clinical trials
Mechanism of Action
Nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; formulated in lipid particles, which enable delivery of RNA into host cells to allow expression of the SARS-CoV-2 S antigen
Elicits an immune response to the S antigen, which protects against COVID-19