Pfizer-BioNTech COVID-19 Vaccine
Vaccine Preparation and Administration Summary
Ů General Information Ů Age Indications
Vaccine: COVID-19 vaccine (Pfizer) 16 years of age and older
Diluent: 0.9% sodium chloride (normal saline, Ů Schedule
2-dose series separated by 21 days
preservative-free) Use a new vial every time.
Multidose vial: 6 doses per vial A series started with COVID-19 vaccine (Pfizer)
should be completed with this product.
Dosage: 0.3 mL
Vaccine MUST be mixed with diluent
Ů Administration
Intramuscular (IM) injection in the deltoid muscle
before administration.
Ů Thawing Frozen Vaccine
Frozen vaccine must be thawed before using. Amount of time needed to thaw vaccine varies based on
Thaw vaccine in the refrigerator or at room temperature: temperature and number of vials.
Refrigerator: Between 2°C and 8°C (36°F and 46°F) Do NOT refreeze thawed vaccine.
Unpunctured vials may be stored in the refrigerator for up to Use vials in the refrigerator before removing vials from ultra-
120 hours (5 days). cold temperature or freezer storage.
Room temperature (for immediate use): Up to 25°C (77°F) Use CDC’s beyond-use date labels for this vaccine to track
Unpunctured vials cannot be kept at room temperature for storage time at refrigerated and frozen temperatures.
more than 2 hours (including thaw time).
Ů Prepare the Vaccine
Follow aseptic technique. Perform hand hygiene
Inject 1.8 mL 0.9% sodium chloride
before vaccine preparation, between patients, (normal saline, preservative-free)
when changing gloves (if worn), and any time diluent into the vaccine vial.
hands become soiled.*
Remove vaccine from the freezer or refrigerator. Using the mixing syringe, remove
Allow vaccine to come to room temperature. Vials 1.8 mL of air from the vaccine vial to
can be held at room temperature for up to 2 hours equalize the pressure in the vaccine vial.
before mixing.
Before mixing, check the expiration dates of the Gently invert the vial containing
vaccine and diluent. NEVER use expired vaccine or vaccine and diluent 10 times. The
diluent. The expiration dates for the diluent and vaccine will be off-white in color.
the vaccine are located on the respective vials. Do not use if discolored or contains
particulate matter. Do not shake. If the
vial is shaken, contact the manufacturer.
With the vaccine at room temperature, gently invert
vial 10 times. Do not shake the vial. If the vial is
shaken, contact the manufacturer. The vaccine is
white to off-white in color and may contain opaque Note the date and time the vaccine
particles. Do not use if liquid is discolored. was mixed on the vial.
Using a new, sterile alcohol prep pad for each vial,
wipe off the stoppers of the diluent and vaccine
vials. Using a 21-gauge (or narrower) needle, Keep mixed vaccine between 2°C and
withdraw 1.8 mL of 0.9% sodium chloride 25°C (36°F to 77°F) and administer
(normal saline, preservative-free) into a mixing within 6 hours. Discard any unused
syringe. Discard diluent vial and any remaining 1.8 ml vaccine after 6 hours.
diluent every time. Do NOT use bacteriostatic Do not return to freezer storage.
normal saline or other diluents to mix the vaccine.
*Gloves are not required unless the person administering the vaccine is likely to come in contact with potentially infectious body fluids or has open lesions on the
hands. If worn, perform hand hygiene and change gloves between patients.
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Pfizer-BioNTech COVID-19 Vaccine
Vaccine Preparation and Administration Summary
Ů Administer the Vaccine
Assess recipient status: Remove any significant air bubbles with the
Screen for contraindications and precautions. needle still in the vial to avoid loss of vaccine.
Review vaccination history. Use the same needle* to withdraw and
Review medical considerations. administer the vaccine. Ensure the prepared
syringe is not cold to the touch.
Choose the correct equipment, including the
correct needle size. Bring the dose of vaccine from the designated
Use a new, sterile needle and syringe for each preparation area immediately to the patient
injection. Use low dead-volume syringes/needles treatment area for administration.
to extract 6 doses from a single vial. If sufficient
low-dead volume syringes are not available, Ensure staff has the correct PPE before
withdraw vaccine using a combination of low administering vaccines and implement policies
dead-volume syringes and non-low dead-volume for the use of face coverings for vaccine recipients
syringes per vial (e.g., 4 low dead-volume syringes older than 2 years of age (if tolerated).
and 2 non-low dead-volume syringes). Administer the vaccine immediately
by intramuscular (IM) injection in the
Cleanse the stopper on the vial of mixed vaccine
deltoid muscle.
with a new, sterile alcohol prep pad. Withdraw
0.3 mL of mixed vaccine into the syringe. Observe recipients after vaccination for an
Regardless of the type of syringe used, ensure immediate adverse reaction:
the amount of vaccine in the syringe equals 30 minutes: Persons with a:
0.3 mL. » History of an immediate allergic reaction of
If the amount of vaccine remaining in the vial any severity to a vaccine or injectable therapy
cannot provide a full 0.3 mL dose, discard the » Contraindication to Janssen COVID-19
vial and contents. Vaccine who receive Pfizer-BioNTech vaccine
Do NOT combine vaccine from multiple vials » History of anaphylaxis due to any cause
to obtain a dose. 15 minutes: All other persons
*It is not necessary to change needles between drawing vaccine from a vial and injecting it into a recipient unless the needle has been damaged or contaminated.
Ů Scheduling Doses
Vaccination History†‡ And Then Next Dose Due
Give dose 2 at least
0 doses Give dose 1 today
21 days after dose 1§
It has been at least 21 days since Series complete;
Give dose 2 today
dose 1 no additional doses needed
1 dose (Pfizer COVID-19 Vaccine)
It has not been at least 21 days Give dose 2 at least
No dose today
from dose 1 21 days after dose 1§
2 doses (Pfizer COVID-19 Vaccine) Series complete;
at least 21 days apart§ no additional doses needed
2 doses (1 product unknown) Series complete;
at least 28 days apart ‡ no additional doses needed
†mRNA COVID-19 vaccines should not be administered at the same time as other vaccines. Separate mRNA COVID-19 vaccines from other vaccines by 14 days before
or after the administration of mRNA COVID-19 vaccine. However, mRNA COVID-19 and other vaccines may be administered within a shorter period in situations
where the benefits of vaccination are deemed to outweigh the potential unknown risks of vaccine coadministration (e.g., tetanus-toxoid-containing vaccination
as part of wound management, rabies vaccination for post-exposure prophylaxis, measles or hepatitis A vaccination during an outbreak) or to avoid barriers to or
delays in mRNA COVID-19 vaccination.
‡ Every effort should be made to determine which vaccine product was received as the first dose. In exceptional situations in which the vaccine product given for the first dose
vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at least 28 days after the first dose.
§Administer the second dose as close to the recommended interval (21 days) as possible. If the second dose is not administered within 42 days of the first dose,
the series does not need to be restarted. Doses inadvertently administered less than 21 days apart do not need to be repeated.
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Pfizer-BioNTech COVID-19 Vaccine
Vaccine Preparation and Administration Summary
Ů Contraindications and Precautions Document each recipient's vaccine administration information
in the:
Contraindications:
Medical record:
Severe allergic reaction (e.g., anaphylaxis) after a previous dose
or to a component of an mRNA COVID-19 vaccine (Moderna or Vaccine and the date it was administered
Pfizer-BioNTech) Manufacturer and lot number
Immediate allergic reaction* of any severity to a previous dose Vaccination site and route
or known (see Table 1 for a list of ingredients in COVID-19
Name and title of the person administering the vaccine
vaccine products)
Personal vaccination record card (shot card):
Note: Persons who have a contraindication to an mRNA COVID-19
Date of vaccination, product name/manufacturer, lot number,
vaccine (Moderna or Pfizer-BioNTech) may be able to receive the
and name/location of the administering clinic or healthcare
Janssen COVID-19 Vaccine (see footnote).† professional. Give to the vaccine recipient.
Precautions: Immunization information system (IIS) or “registry”: Report
History of an immediate allergic reaction* to any other vaccine the vaccination to the appropriate state/local IIS.
or injectable therapy (i.e., intramuscular, intravenous, or
subcutaneous vaccines or therapies) Ů Reporting Adverse Events
This includes people with a reaction to a vaccine or injectable Healthcare professionals are required to report to the Vaccine
therapy that contains multiple components, one of which Adverse Event Reporting System (VAERS):
is a vaccine component, but for whom it is unknown which Vaccine administration errors (whether associated with an
component elicited the immediate allergic reaction. adverse event [AE] or not)
People with a contraindication to Janssen COVID-19 Vaccine Serious AEs (irrespective of attribution to vaccination)
have a precaution to both mRNA vaccines (see footnote).†
Multisystem inflammatory syndrome (MIS) in adults or children
Moderate to severe acute illness
Cases of COVID-19 that result in hospitalization or death
For more information, please see Interim Clinical Considerations
for Use of COVID-19 Vaccines Currently Authorized in the United Any additional AEs and revised safety reporting requirements
States at [Link]/vaccines/covid-19/info-by-product/ per the Food and Drug Administration’s conditions for use of an
[Link]. authorized vaccine throughout the duration of the EUA
Adverse events should be reported even if the cause is uncertain.
Ů Management of Anaphylaxis Healthcare professionals are also encouraged to report any
clinically significant AEs that occur after vaccine administration.
Be prepared to manage medical emergencies.
Submit reports to [Link].
Have a written protocol to manage medical emergencies
following vaccination, as well as equipment and medications, For additional information, see the vaccine manufacturer’s
including at least 3 doses of epinephrine, H1 antihistamine, product information at [Link].
blood pressure monitor, and timing device to assess pulse. For additional information on preventing, reporting, and
Healthcare personnel who are trained and qualified to managing mRNA COVID-19 vaccine administration errors, see
recognize the signs and symptoms of anaphylaxis as well as [Link]
administer intramuscular epinephrine should be available at [Link]#Appendix-A
the vaccination location at all times. *For the purpose of this guidance, an immediate allergic reaction is defined as any
hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory
For more information, please see Interim Considerations: distress (e.g., wheezing, stridor), or anaphylaxis that occur within 4 hours following
Preparing for the Potential Management of Anaphylaxis after exposure to a vaccine or medication.
COVID-19 Vaccination at [Link]/vaccines/covid-19/info-by- †Consider consultation with an allergist-immunologist to help determine if the patient can
product/pfizer/[Link]. safely receive vaccination. Healthcare providers and health departments may also request
a consultation from the Clinical Immunization Safety Assessment COVIDvax Project https://
[Link]/vaccinesafety/ensuringsafety/monitoring/cisa/[Link]. Vaccination of these
Ů Document the Vaccination individuals should only be done in an appropriate setting under the supervision of a healthcare
provider experienced in the management of severe allergic reactions.
COVID-19 vaccination providers must document vaccine • People with a contraindication to mRNA COVID-19 vaccines (including due to a known
administration in their medical record systems within 24 hours of PEG allergy) have a precaution to Janssen COVID-19 vaccination. People who have
previously received an mRNA COVID-19 vaccine dose should wait at least 28 days to
administration and use their best efforts to report administration receive Janssen COVID-19 vaccine.
data to the relevant system (i.e., immunization information
• People with a contraindication to Janssen COVID-19 vaccine (including due to a known
system) for the jurisdiction as soon as practicable and no later polysorbate allergy) have a precaution to mRNA COVID-19 vaccination.
than 72 hours after administration.
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Pfizer-BioNTech COVID-19 Vaccine
Vaccine Preparation and Administration Summary
Ů Table 1: Ingredients included in COVID-19 vaccines
The following is a list of ingredients for the Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccines reported in the prescribing
information for each vaccine.
Description Pfizer-BioNTech (mRNA) Moderna (mRNA) Janssen (viral vector)
Nucleoside-modified mRNA encoding Nucleoside-modified mRNA Recombinant, replication-
Active the viral spike (S) glycoprotein of encoding the viral spike (S) incompetent Ad26 vector,
ingredient SARS-CoV-2 glycoprotein of SARS-CoV-2 encoding a stabilized variant of
the SARS-CoV-2 Spike (S) protein
2[(polyethylene glycol)-2000]-N, PEG2000-DMG: 1,
N-ditetradecylacetamide 2-dimyristoyl-rac-glycerol, Polysorbate-80
methoxypolyethylene glycol
1,2-distearoyl-sn-glycero-3- 1,2-distearoyl-sn-glycero-3- 2-hydroxypropyl-β-cyclodextrin
phosphocholine phosphocholine
Cholesterol Cholesterol Citric acid monohydrate
SM-102: heptadecane-9-yl
(4-hydroxybutyl)azanediyl)bis(hexane-6,1- 8-((2-hydroxyethyl) Trisodium citrate dihydrate
Inactive diyl)bis(2-hexyldecanoate) (6-oxo-6-(undecyloxy) hexyl)
ingredients amino) octanoate
Sodium chloride Tromethamine Sodium chloride
Monobasic potassium phosphate Tromethamine hydrochloride Ethanol
Potassium chloride Acetic acid
Dibasic sodium phosphate dihydrate Sodium acetate
Sucrose Sucrose
*None of the vaccines contain eggs, gelatin, latex, or preservatives.
Note: Both the Pfizer-BioNTech and Moderna COVID-19 vaccines contain polyethylene glycol (PEG). PEG is a primary ingredient in osmotic laxatives and oral
bowel preparations for colonoscopy procedures, an inactive ingredient or excipient in many medications, and is used in a process called "pegylation" to improve
the therapeutic activity of some medications (including certain chemotherapeutics). Additionally, cross-reactive hypersensitivity between PEG and polysorbates
(included as an excipient in some vaccines and other therapeutic agents) can occur. Information on active or inactive ingredients in vaccines and medications can
be found in the package insert. CDC's vaccine excipient summary and the National Institutes of Health DailyMed database can also be used as resources.
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