Pfizer-BioNTech COVID-19 Vaccine (Gray Cap) Age 12 and Over
DO NOT DILUTE THIS FORMULATION.
Discard vial when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials to obtain a dose.
Do NOT Dilute this formulation before administration.
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.
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.
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., 2nd 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., 3rd 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.
Before administering vaccine, screen recipients for contraindications and precautions, even if the recipient is scheduled to receive the second dose. The recipient’s health condition or recommendations regarding contraindications and precautions for vaccination may change from one visit to the next.
To assess recipients correctly and consistently, vaccination providers should use a standardized, comprehensive screening tool.
- 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.
- 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.
- Unpunctured vials may be stored in the refrigerator for up to 10 weeks
- Unpunctured vials may be stored between 8⁰C and 25⁰C (46⁰F and 77⁰F) for a total of 12 hours prior to first puncture.
- Room temperature: Up to 25⁰C (77⁰F)
- Unpunctured vials may be held at room temperature for up to 12 hours (including thaw time).
- Amount of time needed to thaw vaccine varies based on temperature and number of vials.
- Do NOT refreeze thawed vaccine.
- Use CDC’s beyond-use date labels for this vaccine to track storage time at refrigerated and frozen temperatures.
- Follow aseptic technique. Perform hand hygiene before vaccine preparation, between patients, when changing gloves (if worn), and any time hands become soiled.*
- 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 that does NOT require diluent has a gray cap and gray boarder on the label. Allow vaccine to come to room temperature. Vials can be held at room temperature for up to 12 hours before first puncture of the vial stopper
- Check the:
- Expiration date on the
- Any beyond use dates or times
- NEVER use expired vaccine. NEVER use vaccine after the beyond-use dates or times.
- 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 with no visible particles. Do not use if liquid is discolored or if particles are observed after inverting.
*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.
- Assess recipient status:
- Screen for contraindications and precautions.
- Review vaccination history.
- Review medical considerations.
- Choose the correct equipment, including the correct needle size. Use a new sterile needle and syringe for each injection.
- Clean the stopper on the multidose vial of vaccine with a new, sterile alcohol prep pad. Withdraw 0.3 mL of vaccine into the syringe.
- Remove any significant air bubbles with the needle still in the vial to avoid loss of vaccine. Ensure the prepared syringe is not cold to the touch.
- Not the date and time the vaccine was first punctured on the vial. Keep punctured vials of vaccine between 2⁰C and 25⁰C (36⁰F and 77⁰F) for up to 12 hours. Discard any unused vaccine after 12 hours. Do not return to ultra-cold freezer storage.
- 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 gray cap and gray border on the label. Do NOT administer vaccine with an orange cap or has an orange boarded label on the vial.
- Ensure staff has the correct PPE before administering vaccines and implement policies for the use of face coverings for vaccine recipients (if tolerated).
- Administer the vaccine immediately by intramuscular (IM) injection in the deltoid muscle.
- Observe recipients after vaccination for an immediate adverse reaction:
- 30 minutes: Persons with a history of
- 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 to 30 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., 2nd dose) for those who ARE NOT moderately or severely immunocompromised
- 3 months after the last dose of a COVID-19 mRNA primary series (i.e., 3rd 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.
COVID-19 vaccination providers must document vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction (i.e., immunization information system) as soon as practicable and no later than 72 hours after administration.
Store vaccine in an ultra-cold freezer or refrigerator.
DO NOT STORE VACCINE IN FREEZER.
See guidance below for each storage unit.
- Vaccine will arrive at a temperature between -90°C and -60°C (-130°F to -76°F) in a thermal shipping container with dry ice. The vial for people 12 years of age and older that does not require diluent has a gray cap and gray border on the label.
- An ancillary supply kit will arrive separately from the vaccine.
- Follow the manufacturer’s guidance for unpacking the vaccineexternal icon.
- Remove the temperature monitoring device from the shipping container and return using the included prelabeled foldable return box.
- Dispose of the single-use thermal shipping container. Do NOT use the thermal shipping container for storage.*
*Thermal shipping containers delivered to Alaska, Hawaii, and the US-affiliated Pacific Islands may be used as temporary storage. Refer to the manufacturer for more detailed guidance on using the thermal shipping container for storage: https://www.cvdvaccine-us.com/product-storage-and-dry-iceexternal icon
Do NOT store the 12 years of age and older formulation (gray cap) in the thermal shipping container.
Before mixing, the vaccine may be stored in an ultra-cold freezer between -90⁰C and -60⁰C (-130⁰F and -76⁰F).
Store vaccine vials upright in the tray or box.
- Protect from light.
- Vaccine may be stored until the expiration date. Vaccine expires 9 months after the manufacture date.
- The manufacture date is printed on the vial (gray cap)
- Count out 9 months, using the month printed on the vial as month 1.
- The vaccine expires on the last day of the 9th month
- Expired vaccine should NEVER be administered. To prevent this, use CDC’s COVID-19 Vaccine Expiration Date Tracking Tool
- As the expiration date approaches, contact the manufacturer to determine if it has been extended. Do not discard vaccine without ensuring the expiration date has passed.
Do NOT store the 12 years of age and older formulation (gray cap) in the freezer.
Before first puncture of the vial stopper, the vaccine may be stored in the refrigerator between 2⁰C and 8⁰C (36⁰F and 46⁰F) for up to 10 weeks. After ten weeks, contact the manufacturer for guidance. If directed to discard any remaining vials, follow manufacturer’s and jurisdiction’s guidance on proper disposal.
Use beyond use date labels to track how long the vaccine has been in the refrigerator.
Store vaccine in the tray or box and protect from light.
Do NOT refreeze thawed vaccine.
Ultra-cold freezer or 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.
- 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 TemperatureIf 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.
The 12 years of age and older formulation (gray cap) does NOT require 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.
- Storage and Handling Summary (Gray Cap)pdf icon
- Pfizer (Gray Cap) BUD Guidance and Labelspdf icon
- Storage and Handling Labels (Gray Cap)pdf icon
- Vaccine Expiration Date Tracking Toolpdf icon
- Refrigerator Storage Temperature Log (Celsius)pdf icon
- Refrigerator Storage Temperature Log (Fahrenheit)pdf icon
- Ultra-Cold Vaccine Storage Temperature Log (Fahrenheit)pdf icon
- Ultra-Cold Vaccine Storage Temperature Log (Celsius)pdf icon
- Vaccine Storage Troubleshooting Record for Temperature Excursionspdf iconexternal icon
- Dry Ice Safetypdf icon
Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. Complete and submit reports to VAERS onlineexternal icon.
For further assistance with reporting to VAERS, call 1-800-822-7967.
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