Pfizer-BioNTech COVID-19 Vaccine, Vaccine Preparation and Administration Summary

Pfizer-BioNTech COVID-19 Vaccine

Vaccine Preparation and Administration Summary

General Information ofย Pfizer-BioNTech COVID-19 Vaccine

Vaccine: COVID-19 vaccine (Pfizer)

Diluent: 0.9% sodium chloride (normal saline,ย preservative-free) Use a new vial every time.ย Multidose vial: 6 doses per vial

Dosage: 0.3 mL

Vaccine MUST be mixed with diluentย before administration.

Age Indications

16 years of age and older

Schedule ofย COVID-19 vaccine (Pfizer)

2-dose series separated by 21 days

A series started with COVID-19 vaccine (Pfizer)ย should be completed with this product.

Administration ofย COVID-19 vaccine (Pfizer)

Intramuscular (IM) injection in the deltoid muscle

Thawing Frozen Vaccine

Frozen vaccine must be thawed before using.

Thaw vaccine in the refrigerator or at room temperature:

Refrigerator: Between 2ยฐC and 8ยฐC (36ยฐF and 46ยฐF)ย Unpunctured vials may be stored in the refrigerator for up toย 120 hours (5 days).

Room temperature (for immediate use): Up to 25ยฐC (77ยฐF)ย Unpunctured vials cannot be kept at room temperature forย more than 2 hours (including thaw time).

Amount of time needed to thaw vaccine varies based onย temperature and number of vials.

Do NOT refreeze thawed vaccine.

Use vials in the refrigerator before removing vials from ultracoldย temperature or freezer storage.

Use CDCโ€™s beyond-use date labels for this vaccine to trackย storage time at refrigerated and frozen temperatures.ย 

Prepare the Vaccineย COVID-19 vaccine (Pfizer)

Follow aseptic technique. Perform hand hygieneย before vaccine preparation, between patients,ย when changing gloves (if worn), and any timeย hands become soiled.

Remove vaccine from the freezer or refrigerator.ย Allow vaccine to come to room temperature. Vialsย can be held at room temperature for up to 2 hoursย before mixing.ย 

Before mixing, check the expiration dates of theย vaccine and diluent. NEVER use expired vaccine orย diluent. The expiration dates for the diluent andย the vaccine are located on the respective vials.

With the vaccine at room temperature, gently invertย vial 10 times. Do not shake the vial. If the vial isย shaken, contact the manufacturer. The vaccine isย white to off-white in color and may contain opaqueย particles. Do not use if liquid is discolored.

Using a new, sterile alcohol prep pad for each vial,ย wipe off the stoppers of the diluent and vaccineย vials. Using a 21-gauge (or narrower) needle,ย withdraw 1.8 mL of 0.9% sodium chlorideย (normal saline, preservative-free) into a mixingย syringe. Discard diluent vial and any remainingย diluent every time. Do NOT use bacteriostaticย normal saline or other diluents to mix the vaccine.

Inject 1.8 mL 0.9% sodium chlorideย (normal saline, preservative-free)ย diluent into the vaccine vial.

Using the mixing syringe, removeย 1.8 mL of air from the vaccine vial toย equalize the pressure in the vaccine vial.

Gently invert the vial containingย vaccine and diluent 10 times. Theย vaccine will be off-white in color.ย Do not use if discolored or containsย particulate matter. Do not shake. If theย vial is shaken, contact the manufacturer.ย 

Note the date and time the vaccineย was mixed on the vial.ย 

Using a new, sterile alcohol prep pad for each vial,ย wipe off the stoppers of the diluent and vaccineย vials. Using a 21-gauge (or narrower) needle,ย withdraw 1.8 mL of 0.9% sodium chlorideย (normal saline, preservative-free) into a mixingย syringe. Discard diluent vial and any remainingย diluent every time. Do NOT use bacteriostaticย normal saline or other diluents to mix the vaccine.

Keep mixed vaccine between 2ยฐC andย 25ยฐC (36ยฐF to 77ยฐF) and administerย within 6 hours. Discard any unusedย vaccine after 6 hours.ย Do not return to freezer storage.

Administer the Vaccine

Assess recipient status

Screen for contraindications and precautions.

Review vaccination history.

Review medical considerations.ย 

Choose the correct equipment,ย including theย correct needle size.

Use a new, sterile needle and syringe for eachย injection. Use low dead-volume syringes/needlesย to extract 6 doses from a single vial. If sufficientย low-dead volume syringes are not available,ย withdraw vaccine using a combination of lowย dead-volume syringes and non-low dead-volumeย syringes per vial (e.g., 4 low dead-volume syringesย and 2 non-low dead-volume syringes).

Cleanse the stopper on the vial of mixed vaccineย a new, sterile alcohol prep pad. Withdrawย 0.3 mL of mixed vaccine into the syringe.

Regardless of the type of syringe used, ensureย the amount of vaccine in the syringe equalsย 0.3 mL.

If the amount of vaccine remaining in the vialย cannot provide a full 0.3 mL dose, discard theย vial and contents.ย 

Do NOT combine vaccine from multiple vialsย to obtain a dose.ย 

Remove any significant air bubbles with theย needle still in the vial to avoid loss of vaccine.ย Use the same needle to withdraw andย administer the vaccine. Ensure the preparedย syringe is not cold to the touch.ย 

Bring the dose of vaccine from the designatedย preparation area immediately to the patientย treatment area for administration.ย 

Ensure staff has the correct PPE beforeย administering vaccines and implement policiesย for the use of face coverings for vaccine recipientsย older than 2 years of age (if tolerated).ย 

Administer the vaccine immediatelyย by intramuscular (IM) injection in theย deltoid muscle.ย Observe recipients after vaccination for anย immediate adverse reaction:

30 minutes: Persons with a:

History of an immediate allergic reaction ofย any severity to a vaccine or injectable therapy

Contraindication to Janssen COVID-19ย Vaccine who receive Pfizer-BioNTech vaccine

History of anaphylaxis due to any cause

15 minutes: All other persons

Contraindications

Severe allergic reaction (e.g., anaphylaxis) after a previous doseย or to a component of an mRNA COVID-19 vaccine (Moderna orย Pfizer-BioNTech)

Immediate allergic reaction* of any severity to a previous doseย or known (see Table 1 for a list of ingredients in COVID-19ย vaccine products)

Note: Persons who have a contraindication to an mRNA COVID-19ย vaccine (Moderna or Pfizer-BioNTech) may be able to receive theย Janssen COVID-19 Vaccine (see footnote).โ€ 

Precautions

History of an immediate allergic reaction* to any other vaccineย or injectable therapy (i.e., intramuscular, intravenous, orย subcutaneous vaccines or therapies).ย This includes people with a reaction to a vaccine or injectableย therapy that contains multiple components, one of whichย is a vaccine component, but for whom it is unknown whichย component elicited the immediate allergic reaction.

People with a contraindication to Janssen COVID-19 Vaccineย have a precaution to both mRNA vaccines (see footnote).

Moderate to severe acute illness

Management of Anaphylaxis

Be prepared to manage medical emergencies.

Have a written protocol to manage medical emergenciesย following vaccination, as well as equipment and medications,ย including at least 3 doses of epinephrine, H1 antihistamine,ย blood pressure monitor, and timing device to assess pulse.

Healthcare personnel who are trained and qualified toย recognize the signs and symptoms of anaphylaxis as well asย administer intramuscular epinephrine should be available atย the vaccination location at all times.ย 

Document the Vaccination

COVID-19 vaccination providers must document vaccineย administration in their medical record systems within 24 hours ofย administration and use their best efforts to report administrationย data to the relevant system (i.e., immunization informationย system) for the jurisdiction as soon as practicable and no laterย than 72 hours after administration. Document each recipientโ€™s vaccine administration informationย in the:

Medical record:

Vaccine and the date it was administered

Manufacturer and lot number

Vaccination site and route

Name and title of the person administering the vaccine

Personal vaccination record card (shot card):

Date of vaccination, product name/manufacturer, lot number,ย and name/location of the administering clinic or healthcareย professional. Give to the vaccine recipient.

Immunization information system (IIS) or โ€œregistryโ€:ย 

Reportย the vaccination to the appropriate state/local IIS.

Reporting Adverse Events

Healthcare professionals are required to report to the Vaccineย Adverse Event Reporting System (VAERS):

Vaccine administration errors (whether associated with anย adverse event [AE] or not)

Serious AEs (irrespective of attribution to vaccination)

Multisystem inflammatory syndrome (MIS) in adults or children

Cases of COVID-19 that result in hospitalization or death

Any additional AEs and revised safety reporting requirementsย per the Food and Drug Administrationโ€™s conditions for use of anย authorized vaccine throughout the duration of the EUA.

ย Adverse events should be reported even if the cause is uncertain.ย Healthcare professionals are also encouraged to report anyย clinically significant AEs that occur after vaccine administration.

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