Pfizer-BioNTech COVID-19 Vaccine

Contraindications

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of an mRNA COVID-19 vaccine (Moderna or Pfizer-BioNTech)
• Immediate allergic reaction^† of any severity to a previous dose or known (diagnosed) allergy to a component of the vaccine

Note: Persons who have a contraindication to an mRNA COVID-19 vaccine (Moderna or Pfizer-BioNTech) may be able to receive the Janssen COVID-19 vaccine (see footnote).^±

Precautions

• History of an immediate allergic reaction^† to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies)
  • This includes people with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is a vaccine component, but for whom it is unknown which component elicited the immediate allergic reaction.
• People with a contraindication to Janssen COVID-19 vaccine have a precaution to both mRNA vaccines (see footnote). ^±
• Moderate to severe acute illness

†For the purpose of this guidance, 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.

• People with a contraindication to mRNA COVID-19 vaccines (including due to a known 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 receive Janssen COVID-19 vaccine.
• People with a contraindication to Janssen COVID-19 vaccine (including due to a known polysorbate allergy) have a precaution to mRNA COVID-19 vaccination.

• 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 120 hours (five 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. 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 dates of the vaccine and diluent. NEVER use expired vaccine or diluent.
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 vaccine 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 shake. 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.
12. Choose the correct equipment, including the correct needle size.
    • 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.

*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:

1. • 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.
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:

1. • 30 minutes: Persons with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy, contraindication to Janssen COVID-19 Vaccine who received Pfizer- BioNTech COVID-19 Vaccine, history of 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 16 years and older should receive 2 doses at least 21 days apart.
  • Second doses should be administered as close to the recommended interval as possible.
    • If it is not feasible to adhere to the recommended interval, you may schedule the second dose up to 6 weeks (42 days) after the first dose; there is limited efficacy data beyond this window, but a dose after this time does not need to be repeated.
    • Doses inadvertently given less than 21 days apart do not need to 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.
• Administer the vaccine series alone. Separate mRNA COVID-19 vaccine 14 days before or after administration of any other vaccine.
  • If mRNA COVID-19 vaccines are inadvertently administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine.

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. Return the shipping container with Controlant TMD after 30 days, using the shipping label provided.

Replenish dry ice pellets (10 mm to 16 mm) within 24 hours of delivery and every 5 days thereafter. Follow the manufacturer’s guidance for adding dry ice.

• Dry ice will be sent for the first re-icing unless you opt out when placing vaccine order.
• Additional dry ice shipments will NOT be provided. Arrange for dry ice to maintain the temperature of the container after the first re-ice.

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.

Before mixing, the vaccine may be stored in an ultra-cold freezer between -80⁰C and -60⁰C (-112⁰F 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.

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

Vials stored in the freezer can be transferred to the refrigerator for an additional 120 hours (5 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 120 hours (5 days). After 120 hours (5 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.

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.