Pfizer-BioNTech COVID-19 Vaccine (Purple Cap) Age 12 and Over

Updates on 02/25/22

• Pfizer materials have been updated to include the updated Interim Clinical Considerations for the Use of COVID-19 Vaccines Currently Authorized in the United States posted on February 22, 2022. This includes new materials for the Pfizer-BioNTech COVID-19 vaccine formulation for 12 years of age and older (gray cap).

Updates on 02/25/22 and 03/04/22

The following have been updated to reference the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States: February 22, 2022

• Pfizer-BioNTech COVID-19 Vaccine Preparation and Administration Summary for Persons 12 years of age and older (purple cap)
• Pfizer-BioNTech COVID-19 Vaccine Standing Orders for Persons 12 years of age and older (purple cap)

Materials for Pfizer-BioNTech COVID-19 Vaccine 12 years of age and older (gray cap) formulation have been added:

• Standing orders
• Preparation and administration summary

Updates on 12/21/2021

Materials for Pfizer-BioNTech COVID-19 Vaccine 12 years of age and older (gray cap) formulation have been added:

• Beyond-use date labels
• Storage and handling labels
• Storage and handling summary

Vaccine MUST be mixed with diluent before administration Prepare the vaccine using a NEW vial of diluent EVERYTIME. Discard the diluent vial and remaining diluent after mixing the vaccine.
Multidose vial: Up to 6 doses per vial
Dosage: 0.3 mL

12 years of age and older

mRNA COVID-19 vaccines are preferred over Janssen COVID-19 Vaccine for primary series and booster doses.

Primary Series:
2-dose series separated by  at least 3-8 weeks*
A series started with Pfizer-BioNTech COVID-19 Vaccine  should be completed with this product

*An 8-week interval may be optimal for some people ages 12 years and older, especially for males ages 12 to 39 years. A shorter interval (3 weeks for Pfizer-BioNTech; 4 weeks for Moderna) between the first and second doses remains the recommended interval for:

• People who are moderately or severely immunocompromised;
• Adults 65 years of age and older; and
• Other who need rapid protection due to increased concern about community transmission or risk of severe disease

Additional Primary Dose:
Moderately and severely immunocompromised people:  Administer an additional primary dose at least 4 weeks after the initial 2-dose primary series.

Booster Dose:
Persons 12 years of age and older should receive a booster dose.

• Persons who ARE NOT moderately or severely immunocompromised: Administer a booster dose at least 5 calendar months after the last dose of COVID-19 mRNA vaccine primary series (i.e., 2^nd dose)
• Persons who ARE moderately or severely immunocompromised: Administer a booster dose at least 3 months (12 weeks) after the additional primary dose of COVID-19 mRNA vaccine series (i.e., 3^rd  dose).
• Administer age-appropriate vaccine.
  • Heterologous – mix and match – booster doses are allowed for persons 18 years of age and older. Note: mRNA vaccines are preferred.
• Some people may be able to receive a second booster dose. Learn more about considerations for COVID-19 vaccine booster doses.
• For detailed information see Interim COVID-19 Immunization Schedule for Ages 5+pdf icon

Intramuscular (IM) injection in the deltoid muscle

Contraindications

• History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine
• Known diagnosed allergy to a component of the vaccine
• History of thrombosis with thrombocytopenia syndrome (TTS) following receipt of a previous Janssen COVID-19 Vaccine (or other COVID-19 vaccines not currently authorized in the United States that are based on adenovirus vectors)
  • Additionally, people with a history of an episode of immune-mediated syndrome characterized by thrombosis and thrombocytopenia, such as spontaneous or classic HIT, should not receive Janssen COVID-19 Vaccine. These people should receive an mRNA COVID-19 vaccine

Precautions

• History of an immediate allergic reaction^† to any non-COVID-19 vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies [excluding subcutaneous immunotherapy for allergies, i.e., “allergy shots”])
  • This includes non-COVID-19 vaccines or injectable therapies with multiple components, and the component(s) that elicited the reaction is unknown.
• History of an immediate (within 4 hours after vaccination) non-severe, allergic reaction after a dose of one type of COVID-19 vaccine (i.e., mRNA or Janssen) have a precaution to the same type of COIVD-19 vaccine
• Contraindication to one type of COVID-19 vaccines (mRNA) is a precaution to other types of COVID-19 vaccines (Janssen)^±
• Moderate to severe acute illness with or without fever
• For mRNA COVID-19 vaccines, history of myocarditis or pericarditis after a dose of mRNA COVID-19 vaccine
• For Janssen COVID-19 Vaccine, a history of GBS
  • People who develop GBS within 6 weeks after receipt of Janssen COVID-19 Vaccine should not receive another dose of Janssen COVID-19 Vaccine. These people should receive an mRNA COVID-19 vaccine.

†An immediate allergic reaction is defined as any hypersensitivity-related signs or symptoms, such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within 4 hours following exposure to a vaccine or medication.

^± Consider consultation with an allergist-immunologist to help determine if the patient can safely receive vaccination. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVID vax Project. Vaccination of these individuals should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

• Vaccine may be thawed in the refrigerator or at room temperature.
• Refrigerator: Between 2°C and 8°C (36°F and 46°F)
  • Unpunctured vials can be stored in the refrigerator for up to 1 month (31 days).
• Room temperature: Up to 25⁰C (77⁰F)
  • Unpunctured vials may be held at room temperature for up to 2 hours (including thaw time).
• Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours or returned to the refrigerator.
• Do NOT refreeze thawed vaccine.
• Use CDC’s beyond-use date labels for this vaccine to track storage time at refrigerated and frozen temperatures.

1. Follow aseptic technique. Perform hand hygiene before vaccine preparation, between patients, when changing gloves (if worn), and any time hands become soiled.*
2. Remove vaccine from the freezer or refrigerator. Check the vial label to ensure it is the correct formulation based on the age of the recipient. The vial for persons 12 years of age and older has a purple cap and purple boarder on the label. Allow vaccine to come to room temperature. Vials can be held at room temperature for up to 2 hours before mixing. After 2 hours, return unmixed vials to the refrigerator.
3. Before mixing check the:
   • Expiration date on the vaccine and diluent
   • Any beyond use dates or times
   • NEVER use expired vaccine or diluent
   • NEVER use vaccine after the beyond-use dates or times
4. With the vaccine at room temperature, gently invert the 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 particles. Do not use if liquid is discolored.
5. Using a new, sterile alcohol prep pad for each vial, wipe off the stoppers of the diluent and vaccine vials.
6. Using a 21-gauge (or narrower) needle, withdraw 1.8 mL of 0.9% sodium chloride (normal saline, preservative-free) into a mixing syringe. After use, discard diluent vial and any remaining diluent.
   • Do NOT use or save the remaining diluent to mix additional vaccine or for other uses.
   • Do NOT use bacteriostatic normal saline or other diluents to mix the vaccine.
7. Inject 1.8 mL 0.9% sodium chloride (normal saline, preservative-free) diluent into the vaccine vial.
8. Using the mixing syringe, remove 1.8 mL of air from the vaccine vial to equalize the pressure in the vaccine vial.
9. Gently invert the vial containing vaccine and diluent 10 times. The vaccine will be off-white in color. Do not use if discolored or contains particulate matter. Do NOT If the vial is shaken, contact the manufacturer.
10. Note the date and time the vaccine was mixed on the vial.
11. Keep mixed vaccine between 2⁰C and 25⁰C (36⁰F and 77⁰F) and administer within 6 hours. Discard any unused vaccine after 6 hours. Do not return to freezer storage.
    • Minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light.
12. Choose the correct vaccine formulation based on the age of the recipient and equipment, including the correct needle size.
    • The vial for persons 12 years of age and older that must be diluted has a purple cap and may have a purple border on the label. Do NOT administer vaccine with an orange cap or orange bordered label on the vial.
    • Use a new, sterile needle and syringe for each injection.
    • Low dead-volume syringes/needles can be used to extract 6 doses from a vial. If all low dead-volume syringes are not available use a combination of low dead-volume syringes and non-low dead-volume syringes.
13. Cleanse the stopper on the vial of mixed vaccine with a new, sterile alcohol prep pad. Withdraw 0.3 mL of mixed vaccine into the syringe. Ensure the prepared syringe is not cold to the touch.
    • Regardless of the type of syringe used, ensure the amount of vaccine in the syringe is 0.3mL.
    • If the amount of vaccine remaining in the vial cannot provide a full 0.3mL dose discard the vial and contents.
    • Do NOT combine vaccine from multiple vials to obtain a dose.
14. Remove any significant air bubbles with the needle still in the vial to avoid loss of vaccine. Use the same needle† to withdraw and administer the vaccine, unless contaminated or damaged. Check the vial label, again, to ensure it is the correct formulation based on the age of the recipient.

*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.

†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.

1. Assess recipient status:
   • Screen for contraindications and precautions.
   • Review vaccination history.
   • Review medical considerations.
2. Bring the dose of vaccine from the designated preparation area immediately to the patient treatment area for administration. The vial for persons 12 years of age and older has a purple cap and may have a purple border on the label. Do NOT administer vaccine with an orange cap or has an orange boarded label on the vial.
3. Ensure staff has the correct PPE before administering vaccines and implement policies for the use of face coverings for vaccine recipients (if tolerated).
4. Administer the vaccine immediately by intramuscular (IM) injection in the deltoid muscle.
5. Observe recipients after vaccination for an immediate adverse reaction:
   • 30 minutes: Persons with a history of

1. • • A contraindication to another type of COVID-19 vaccine product
     • Immediate (within 4 hours of exposure) non-severe allergic reaction to a non-COVID-10 vaccine or injectable therapies
     • Immediate allergic reaction of any severity to a non-COVID-19 vaccine or injectable therapies
     • Anaphylaxis due to any cause

• 15 minutes: All other persons

*Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.

• Persons age 12 years and older should receive 2 doses at least 3-8 weeks apart.
  • Second doses should be administered as close to the recommended interval as possible.
  • An 8-week interval may be optimal for some people ages 12 years and older, especially males ages 12-39 years.
    • Doses inadvertently given before the 4-day grace period (i.e., less than 17 days apart) should be repeated.
  • Both doses should be Pfizer-BioNTech COVID-19 Vaccine.
    • Every effort should be made to determine which vaccine product was received as the first dose.
    • In exceptional situations, if the vaccine product given as the first dose cannot be determined or is no longer available, any mRNA COVID-19 vaccine product may be administered at least 28 days after the first dose.
• Moderately to severely immunocompromised people: Administer an additional dose at least 4 weeks after the initial 2-dose primary series.
  • For more information, please see Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States
• Administer a booster dose:.
  • 5 months after the dose of a COVID-19 mRNA primary series (i.e., 2^nd dose) for those who ARE NOT moderately or severely immunocompromised
  • 3 months after the dose of a COVID-19 mRNA primary series (i.e., 3^rd dose) for those who ARE moderately or severely immunocompromised
  • The booster dose may be a different product than the primary series; however, mRNA COVID-19 vaccines are preferred
• COVID-19 vaccines and other vaccines may be coadministered with other vaccines, including simultaneous administration.

CDC recommends using the thermal shipping container for temporary storage only. The container requires significant support to store vaccine at proper temperatures, including trained staff, a regular supply of dry ice, and standard operating procedures for regular maintenance.

Use the Controlantexternal icon temperature monitoring device (TMD), included with the thermal shipping container, to monitor the temperature.

• Review contact information.
  • If the contact for your order (inVTrckS) is not valid, you will NOT be notified in the event of a temperature excursion. Contact your jurisdiction’s immunization program for assistance.
  • If your contact is valid and you are not receiving e-mails or cannot load email hyperlinks, refer to Controlant for troubleshooting.
  • Identify up to 4 contacts to receive e-mails and text alerts on the temperature status of the container.
• Review DAILY e-mails on the status of the container.
• Click the link in daily emails to access and download all temperature data. Save the Excel file summarizing all temperature data for at least 3 years.
• Save the return shipping label provided in your shipping container at delivery. Use the shipping label to return the thermal shipping container with the Controlant TMD within 10 days.*

Limit temporary storage in the thermal shipping container to 10 days when possible.*

• Arrange for dry ice to maintain the appropriate temperature in the thermal shipping container. Replenish dry ice pellets (10 mm to 16 mm) within 24 hours of delivery and every 5 days thereafter. Follow manufacturer’s guidance for adding dry ice.
• Dry ice will NOT be provided to replenish the container.
• Transfer any vaccine remaining in the thermal shipping container after 10 days* to a:
  • Freezer for up to 2 weeks, then
  • Refrigerator for up to 1 month (31 days)

Removing vaccine vials/doses for use:

• Determine the number of vials needed before opening the thermal shipping container.
• Open the thermal shipping container no more than 2 times per day for up to 3 minutes each time. Use packaging tape to reseal the outer carton after each entry.

Store vaccine vials upright in the tray and protect from light.

*It is preferred to return the shipping container within 10 days; however, if maintained properly, the thermal shipping container can be used for up to 30 days.

Before mixing, the vaccine may be stored in an ultra-cold freezer between -90⁰C and -60⁰C (-130⁰F and -76⁰F).

Vaccine may be stored until the expiration date. The expiration date could be extended as more stability data become available. Store vaccine vials upright in the tray and protect from light.

Before mixing, vaccine may be stored in a freezer between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks. The total time vials are stored at these temperatures should be tracked and should not exceed 2 weeks. Use CDC’s beyond-use date labels to track how long the vaccine has been in the freezer.

• These temperatures are within the appropriate range for routinely recommended vaccines, BUT the temperature range for this vaccine is tighter.

Store vaccine vials upright in the tray and protect from light.

Vials stored in the freezer can be transferred to the refrigerator for up to 1 month  (31 days). Once thawed, they cannot be refrozen.

Vials stored in the freezer can be returned one time to ultra-cold temperature storage. Once returned, the 2-week time frame is suspended.

Before mixing, the vaccine may be stored in the refrigerator between 2⁰C and 8⁰C (36⁰F and 46⁰F) for up to 1 month (31 days). After one month (31 days), remove any remaining vials from the refrigerator and discard following manufacturer and jurisdiction guidance on proper disposal.

Use beyond-use date labels to track how long the vaccine has been in the refrigerator.

Thawed vaccine cannot be refrozen.

Ultra-cold freezer, freezer, refrigerator: Storage unit temperatures must be monitored regularly, checked, and recorded at the beginning of the workday to determine if any temperature excursions have occurred since the last temperature check. For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe that best reflects vaccine temperatures.

• Ultra-cold temperatures: Use a probe designed specifically to measure ultra-cold temperatures.
• Frozen and refrigerated storage: Use a probe buffered with glycol, glass beads, sand, or Teflon®.

Check and record the temperature daily using CDC’s temperature log. Use one of the options below:

• Option 1 (preferred): Minimum/Maximum (Min/Max) Temperatures Most DDLs display min/max temperatures. Check and record the min/max temperatures at the start of each workday.
• Option 2: Current Temperature If the DDL does not display min/max temperatures, check and record the current temperature at the start and end of the workday. Review the continuous DDL temperature data daily.

Thermal shipping container: Use the Controlant temperature monitoring device.

For CDC temperature logs, see Storage and Handling Resources below.

0.9% sodium chloride (normal saline, preservative-free) diluent is included in the ancillary supply kits. Follow the manufacturer’s guidance for storing the diluent.

Temperature excursions or inappropriate storage conditions for any vaccine require immediate action. Any temperature reading outside the recommended ranges is considered a temperature excursion. Responses to temperature excursion reports are dependent on information given by the provider to the manufacturer. Completing the Vaccine Troubleshooting Record can help provide needed information for manufacturers to determine the viability of the vaccine.