Pfizer-BioNTech COVID-19 Vaccine Questions

Below are answers to commonly asked clinical questions about Pfizer-BioNTech COVID-19 Vaccine. Get answers to other frequently asked questions:

General COVID-19 Vaccine FAQs
Janssen COVID-19 Vaccine (Johnson & Johnson) FAQs
Moderna COVID-19 Vaccine FAQs
Vaccine Supply and Distribution

The minimum order size for Pfizer-BioNTech COVID-19 Vaccine is 450 doses (3 trays of 25 vials each) per order.

Vaccination Schedule and Use

Pfizer-BioNTech COVID-19 Vaccine is authorized and recommended for people 12 years of age and older.

All people for whom vaccination is indicated should receive 2 doses 21 days apart. Do not schedule vaccine recipients to receive the second dose earlier than the recommended interval.

You should schedule the second dose of Pfizer-BioNTech COVID-19 Vaccine 21 days after the first dose (the recommended interval). Do not use the 4-day grace period to schedule appointments. Appointments for a second dose should be scheduled to meet the recommended interval.

Second doses of Pfizer-BioNTech COVID-19 Vaccine administered up to 4 days before the recommended date (4-day grace period) are considered valid. This means that when reviewing records, a second dose of Pfizer-BioNTech COVID-19 Vaccine administered 17 or more days after the first dose is considered valid.

If a dose is inadvertently administered before the 4-day grace period, it does not need to be repeated. This means that when reviewing records, a second dose of Pfizer-BioNTech COVID-19 Vaccine administered 16 or fewer days after the first dose does not need to be repeated. This is considered a vaccine administration error. Determine how the error occurred and implement strategies to prevent it from happening again. Additionally, you are required to report COVID-19 vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERSexternal icon).

No, the grace period cannot be used to schedule second doses. Administer doses as close to the 21-day interval as possible, but not earlier than recommended. The grace period should be used only for retrospectively reviewing records. If it is discovered a dose has been inadvertently administered within a grace period of ≤4 days from the recommended date for the second dose (i.e., 17–20 days after dose 1), the dose is considered valid.

You should administer the second dose as close as possible to the recommended interval of 21 days after dose 1. However, if it is not possible to follow the recommended interval, you may schedule the second dose of the Pfizer-BioNTech COVID-19 Vaccine for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on effectiveness of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered after these intervals, there is no need to restart the series.

We do not recommend that providers hold back stock for a second dose after administering a patient’s first dose. You should inform the patient that they need to return for the second dose.

COVID-19 vaccines are not interchangeable. The safety and effectiveness of a mixed-product series have not been evaluated. Every effort should be made to determine which vaccine product was administered as the first dose to ensure completion of the vaccine series with the same product. In exceptional situations:

  • When the vaccine product administered for the first dose cannot be determined or is no longer available, you may administer any available mRNA COVID-19 vaccine, with a minimum of 28 days between doses. If two different mRNA COVID-19 vaccine products are administered, no additional doses of either product are recommended at this time.
  • If a patient received the first dose of an mRNA COVID-19 vaccine but is unable to complete the series with either the same or a different mRNA COVID-19 vaccine (e.g., due to contraindication), you may consider administering a single dose of Janssen COVID-19 Vaccine, with a minimum of 28 days between doses. See contraindications and precautions for more information on use of Janssen COVID-19 Vaccine and additional precautions for people with a contraindication to mRNA COVID-19 vaccines.

Implement the following strategies to help ensure patients receive the second dose with the appropriate product and interval between doses:

  • Provide a COVID-19 vaccination record card to every vaccine recipient. Ask recipients to bring their card to their appointment for the second dose. Encourage them to make a backup copy (e.g., by taking a picture of the card with their phone).
  • Encourage vaccine recipients to enroll in v-safe, a free smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins as well as second-dose reminders.
  • Encourage vaccine recipients to enroll in VaxTextSM, a free text-message-based platform, to receive reminders to get their second dose of COVID-19 vaccine.
  • Record each recipient’s vaccination in the immunization information system (IIS).
  • Record vaccine administration information in the patient’s medical record.
  • Make an appointment for the second dose before the vaccine recipient leaves to increase the likelihood that patients will return to the same vaccination provider site for the second dose. Make sure that the vaccine recipient has a reminder for the second appointment.

No. When the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose up to 6 weeks following the first dose to administer the same product rather than administer a mixed series using a different product.

Learn more about interchangeability of COVID-19 vaccine products.

You may consider referring the patient to another provider or the state or local immunization program. You or your patient may use Vaccines.gov to find a location that stocks other vaccine products.

No. For both adults and adolescents, you may administer COVID-19 vaccine and other vaccines without regard to timing. This includes simultaneous administration of COVID-19 vaccine and other vaccines (including live, attenuated vaccines such as the measles-mumps-rubella [MMR] vaccine) on the same day, as well as coadministration at any time interval. It is unknown whether reactogenicity of COVID-19 vaccine is increased with coadministration, including with other vaccines known to be more reactogenic, such as adjuvanted vaccines or live vaccines.

When deciding whether to coadminister another vaccine(s) with COVID-19 vaccine, consider:

  • Whether the patient is behind or at risk of becoming behind on recommended vaccines
  • The patient’s risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures)
  • The reactogenicity profile of the vaccines

Learn more about coadministration with other vaccines.

Vaccine Indications

Yes, you may administer any currently authorized COVID-19 vaccine to people with underlying medical conditions; the Advisory Committee on Immunization Practices (ACIP) does not state a product preference. This includes people with:

  • Immunocompromising conditions or people who take immunosuppressive medication or therapies
  • Autoimmune conditions
  • A history of Guillain-Barré syndrome
  • A history of Bell’s palsy
  • A history of dermal filler use

Learn more about vaccinating patients with underlying medical conditions.

Immunocompromised patients can receive any currently authorized COVID-19 vaccine; however, you should consider counseling them and timing immunosuppressive therapies.

Counsel immunocompromised patients about the:

  • Unknown vaccine safety profile and effectiveness in immunocompromised populations
  • Potential for reduced immune responses
  • Need to continue to follow current guidance to protect themselves against COVID-19

Data are currently insufficient to inform optimal timing of COVID-19 vaccination and receipt of immunosuppressive therapies. However, based on general best practices for vaccination of immunocompromised people, ideally COVID-19 vaccination should be completed at least 2 weeks before initiation of immunosuppressive therapies. When it is not possible to administer a complete COVID-19 vaccine series (i.e., 2 doses of an mRNA vaccine or a single dose of Janssen COVID-19 Vaccine) in advance, you may still vaccinate patients receiving immunosuppressive therapy. Decisions to delay immunosuppressive therapy to complete COVID-19 vaccination should consider the patient’s risks related to their underlying condition.

At this time, revaccination is not recommended after patients regain immune competence. Recommendations on revaccination or additional doses of COVID-19 vaccines may be updated when more information is available.

Learn more about vaccinating patients with underlying medical conditions.

Yes. Pregnant or lactating people are eligible for and can receive any of the currently authorized COVID-19 vaccines; the ACIP does not state a product preference.

When making a decision about vaccination, you and your pregnant patient should consider the:

  • Level of COVID-19 community transmission
  • Patient’s personal risk of contracting COVID-19
  • Risks of COVID-19 to the patient and potential risks to the fetus
  • Known and potential benefits of vaccination
  • Vaccine effectiveness
  • Vaccine side effects
  • Limited but growing evidence about the safety of COVID-19 vaccination during pregnancy

Encourage pregnant people who choose to be vaccinated to enroll in v-safe, a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after COVID-19 vaccination. A v-safe pregnancy registry has been established to follow outcomes among pregnant people who are vaccinated.

Learn more about vaccination of pregnant or lactating people.

Recommendations for vaccination depend on when a person has or had SARS-CoV-2 infection and when they received treatment.

People with a history of infection: Offer vaccination regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection, including to people with prolonged post-COVID-19 symptoms.

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity.

People with a history of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A): These people may choose to be vaccinated, but should consider delaying vaccination until they have recovered from their illness and for 90 days after the date of diagnosis. Considerations for vaccination may include:

  • Clinical recovery from MIS-C or MIS-A, including return to normal cardiac function
  • Personal risk of severe acute COVID-19 (e.g., age, underlying conditions)
  • Level of COVID-19 community transmission and personal risk of reinfection
  • Lack of safety data of COVID-19 vaccines following these illnesses
  • Timing of any immunomodulatory therapies

People with a current infection: Defer vaccination of people with known current SARS-CoV-2 infection until the person has recovered from acute illness (if the person has symptoms) and until criteria have been met for them to discontinue isolation. This recommendation applies to any vaccine, including the first and second doses of COVID-19 vaccine.

People who previously received passive antibody therapy as part of COVID-19 treatment: Defer vaccination for at least 90 days after receipt of passive antibody therapy (monoclonal antibodies or convalescent plasma). This recommendation applies to people who receive passive antibody therapy before receiving any COVID-19 vaccine dose and to those who receive passive antibody therapy after the first dose of an mRNA COVID-19 vaccine but before the second dose, in which case the second dose should be deferred for at least 90 days following receipt of the antibody therapy.

Learn more about COVID-19 vaccination and SARS-CoV-2 infection.

Administer the second dose of Pfizer-BioNTech COVID-19 vaccine 21 days after the first dose. The second dose may be administered up to 6 weeks (42 days) after the first dose, even though it may not be at least 90 days since the passive antibody therapy.

No, your patient may be vaccinated. Although people who have received passive antibody therapy as treatment for COVID-19 should wait at least 90 days before vaccination, there is no minimum interval between antibody therapies not specific to COVID-19 treatment and COVID-19 vaccination.

As with other vaccines, a moderate or severe illness is a precaution to receiving any currently authorized COVID-19 vaccine. It is not considered a contraindication. Generally, vaccination should be delayed until the acute illness has improved. However, if you and your patient feel the potential benefits of vaccination outweigh the potential risks, they may receive COVID-19 vaccine.

The following considerations can be used to help the provider conduct a risk assessment for COVID-19 vaccination:

  • Risk of exposure to SARS-CoV-2 (e.g., living in a congregate setting, such as a long-term care facility; occupation)
  • Risk of severe disease or death due to COVID-19 (e.g., because of age or underlying medical conditions)
  • Whether the patient has previously been infected with SARS-CoV-2 and, if so, how long ago
    • Note: Vaccination is recommended for people with a history of COVID-19; however, because the risk for reinfection is low in the months after initial infection, people with a precaution to vaccination and recent COVID-19 may choose to delay vaccination.

Pfizer-BioNTech COVID-19 Vaccine and Risk of Myocarditis/Pericarditis

Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. In both cases, the body’s immune system causes inflammation in response to an infection or some other trigger. Symptoms can include chest pain, shortness of breath, or palpitations.

The severity of cases of myocarditis and pericarditis can vary. For the cases reported after mRNA COVID-19 vaccination, most who presented to medical care have responded well to medications and rest.

The ACIP COVID-19 Vaccines Work Group reviewed:

  • Clinical trial and post-authorization safety data for myocarditis/pericarditis after receipt of mRNA COVID-19 vaccines
  • A risk-benefit assessment of myocarditis/pericarditis after receipt of mRNA COVID-19 vaccines

On June 23, 2021, after reviewing available evidence, ACIP determined that the benefits of using mRNA COVID-19 vaccines under the FDA’s Emergency Use Authorization (EUA) clearly outweigh the risks of myocarditis in all populations, including adolescents and young adults.

For more information see: Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021

Yes. People who have a history of myocarditis or pericarditis unrelated to mRNA COVID-19 vaccination may receive any FDA-authorized COVID-19 vaccine after the episode of myocarditis or pericarditis has completely resolved. This includes resolution of symptoms attributed to myocarditis or pericarditis, as well as no evidence of ongoing heart inflammation or sequelae as determined by the person’s clinical team, which may include a cardiologist, and special testing to assess cardiac recovery.

A person is considered fully vaccinated against COVID-19 2 or more weeks after receipt of the second dose in a 2-dose series (Pfizer-BioNTech and Moderna) or 2 or more weeks after receipt of the single dose of the Janssen vaccine. A person who only receives one dose of a 2-dose mRNA COVID-19 vaccine series is not considered fully vaccinated.

It is unclear if people who developed myocarditis or pericarditis after a first dose of an mRNA COVID-19 vaccine may be at increased risk of further adverse cardiac effects following a second dose of the vaccine. Until additional safety data are available, experts recommend that people who develop myocarditis or pericarditis after a first dose of an mRNA COVID-19 vaccine defer receiving the second dose. People with a history of myocarditis or pericarditis who choose to receive the second dose of an mRNA COVID-19 vaccine should wait at least until their initial episode of myocarditis or pericarditis has completely resolved. Decisions about proceeding with the second dose of an mRNA vaccine should include a conversation between the patient, their parent, guardian, or caregiver (when relevant), and their clinical team.

Although myocarditis or pericarditis after mRNA COVID-19 vaccination can occur in both men and women, more cases have been reported in men in younger age groups. Consider myocarditis and pericarditis in adolescents or young adults with acute chest pain, shortness of breath, or palpitations. Ask about prior COVID-19 vaccination if you identify these symptoms, as well as relevant other medical, travel, and social history. For more information, please refer to Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination.

Based on data from VAERS, confirmed cases have typically occurred within several days after COVID-19 vaccination.

Adverse events that occur after receipt of any COVID-19 vaccine should be reported to VAERS. Information on how to submit a report to VAERS is available at https://vaers.hhs.govexternal icon or 1-800-822-7967.  Healthcare providers are required to report:

  • Vaccine administration errors
  • Serious adverse events
  • Cases of multisystem inflammatory syndrome
  • Cases of COVID-19 that result in hospitalization or death following COVID-19 vaccination under an EUA

Contraindications and Precautions

Contraindications to vaccination with Pfizer-BioNTech COVID-19 Vaccine include:

  • 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 after a previous dose or known (diagnosed) allergy to a component of the vaccine (see Appendix C for a list of vaccine components)

Do not vaccinate people with a contraindication. Consider referral to an allergist-immunologist or administering a different COVID-19 vaccine. You may consider Janssen COVID-19 Vaccine for people with a contraindication to mRNA COVID-19 vaccines (including a contraindication due to a known polyethylene glycol [PEG] allergy). People with a contraindication to mRNA COVID-19 vaccines have a precaution to Janssen COVID-19 Vaccine. In these cases, 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 COVIDvax Project. Vaccination of these people should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions. People who have received one mRNA COVID-19 vaccine dose but for whom the second dose is contraindicated should wait at least 28 days after the mRNA vaccine dose to receive Janssen COVID-19 Vaccine.

Learn more about COVID-19 vaccine contraindications and precautions.

Precautions to Pfizer-BioNTech COVID-19 Vaccine include:

  • History of an immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies)
  • Contraindication to Janssen COVID-19 Vaccine
  • Moderate or severe acute illness

The following considerations can be used to help the provider conduct a risk assessment for vaccination of patients with a precaution to vaccination:

  • Risk of exposure to SARS-CoV-2
  • Risk of severe disease or death due to COVID-19
  • Unknown risk of anaphylaxis (including fatal anaphylaxis) following COVID-19 vaccination in a person with a history of an immediate allergic reaction to other vaccines or injectable therapies
  • Ability of the patient to be vaccinated in a setting where appropriate medical care is immediately available for anaphylaxis. For people with a contraindication to another type of COVID-19 vaccine (i.e., Janssen viral vector vaccine), vaccination with another type (i.e., mRNA vaccines) should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

Learn more about COVID-19 vaccine contraindications and precautions.

PEG can be found in:

  • Osmotic laxatives and oral bowel preparations for colonoscopy procedures
  • Many medications as an inactive ingredient or excipient (e.g., certain injectable contraceptives, steroids)
  • Some therapeutic medications (e.g., some chemotherapeutics)

Additionally, cross-reactive hypersensitivity can occur between PEG and polysorbates.

Screen patients for contraindications and precautions prior to vaccination. If a patient identifies a history of allergic reaction to a medication with which you are unfamiliar, you may consider using the following resources to determine if a specific medication contains PEG, a PEG derivative, or polysorbates:

Yes. A side effect is not a contraindication to a second dose of mRNA COVID-19 vaccine. Common side effects after vaccination may include:

  • Injection site pain, redness, or swelling
  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Fever
  • Nausea

For most people, side effects last no longer than 1–2 days. Encourage patients to enroll in v-safe to tell CDC about any side effects after getting a COVID-19 vaccine and to receive reminders for a second dose.

People with an immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine should not receive additional doses of either of the mRNA COVID-19 vaccines. An immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within 4 hours following administration. Attempt to determine whether reactions reported following vaccination are consistent with immediate allergic reactions versus other types of reactions commonly observed following vaccination, such as a vasovagal reaction or post-vaccination side effects (which are not contraindications to receiving the second vaccine dose).

People with a contraindication to mRNA COVID-19 vaccines may be able to receive Janssen COVID-19 Vaccine at least 28 days after the mRNA vaccine, but it is considered a precaution. In these cases, 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 COVIDvax Project. Vaccination of these people should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

See more information on:

Vaccine Storage and Handling

There are four options for storing Pfizer-BioNTech COVID-19 Vaccine. It may be stored in:

  1. Ultra-cold freezer between -80°C and -60°C (-112°F and -76°F) up to the expiration date. Keep vaccine vials upright and in their tray and protect from light.
  2. Thermal shipping container using the Controlant temperature monitoring device (TMD). Maintain the appropriate temperature by adding dry ice to the shipping container according to the manufacturer’s guidance. Keep vaccine vials upright and in their tray and protect from light.
  3. Freezer between -25°C and -15°C (-13°F and 5°F) for up to 2 weeks. Keep vaccine vials upright and in their tray and protect from light.
  4. Refrigerator between 2°C and 8°C (36°F and 46°F) for up to 31 days.

Refer to the Pfizer-BioNTech COVID-19 Vaccine product information or Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summarypdf icon for more detailed information on storage.

Because of the ultra-cold storage requirements, the manufacturer recommends that you not open the vial tray and inspect individual vials. Rather, keep the trays closed and inspect only the outside of the package and trays. You may inspect vials when you are ready to thaw and use the vaccine.

If you have concerns about the condition of the package, contact the manufacturer.

See Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summarypdf icon for more storage and handling information.

No. Once an individual vial is removed from a vial tray at room temperature, it should not be returned to frozen storage; it should be thawed for use.

See Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summarypdf icon for more storage and handling information.

Determine the number of vials/doses needed before opening the thermal shipping container. Open the thermal shipping container no more than twice per day for no more than 3 minutes each time. Use vaccine vials stored in the refrigerator before removing additional vials from frozen storage.

See Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summarypdf icon for more storage and handling information.

If you are using the thermal shipping container for temporary storage, you will need to replenish dry ice pellets within 24 hours of delivery and every 5 days thereafter. Unless you opt out when placing the vaccine order, a kit to support one replenishment of dry ice in the thermal shipping container will be provided within 24 hours of vaccine receipt. It will contain:

  • Dry ice (~35 pounds)
  • Gloves for working with dry ice (1 pair)
  • Face shield (1)
  • Ice scoop (1)
  • OSHA dry ice safety card (1)

Additional dry ice shipments will NOT be provided. Arrange for dry ice to maintain the temperature of the container after the first re-ice.

For more information, see:

Yes, there are three time periods to track based on storage.

  • Before mixing, vaccine may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 31 days. After 31 days, contact the manufacturer for guidance before discarding any vials.
  • Before mixing, vaccine may be stored in the freezer between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks.
  • Once mixed, vaccine must be discarded within 6 hours.

Resources:

Yes. After the 2-week time frame, you have two options:

  • You may transfer vaccine to refrigerated storage between 2°C and 8°C (36°F and 46°F) for up to 31 days. After 31 days, contact the manufacturer for guidance.
  • You may return vaccine one time to ultra-cold temperature storage (-80°C to -60°C [-112°F to -76°F]).

See Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summarypdf icon for more storage and handling information.

If using an ultra-cold freezer, freezer, or refrigerator to store vaccine:

CDC requires vaccination providers participating in the COVID-19 Vaccination Program to use a specific type of TMD called a “digital data logger” (DDL) to monitor vaccine temperatures. A DDL provides the most accurate storage unit temperature information, including details on how long a unit has been operating outside the recommended temperature range (referred to as a “temperature excursion”). DDLs using a buffered temperature probe provide the most accurate way to measure actual vaccine temperatures. Always use DDLs with a current and valid Certificate of Calibration Testing. Note that not all DDLs can measure ultra-cold temperatures.

If using the thermal shipping container to store vaccine:

Use the Controlant TMD included with the shipping container.

For more storage and handling information, see:

Not all DDLs are designed to register or measure ultra-cold temperatures. Check with the DDL manufacturer to verify your DDL can measure ultra-cold temperatures. Additionally, many DDL manufacturers use pure propylene glycol (freezing point -59°C) or a glycol mixture with a warmer freezing point. For accurate ultra-cold temperature monitoring, it is essential to use an air-probe or a probe designed specifically for ultra-cold temperatures with the DDL.

No. Each multidose vial contains 6 doses. After dilution, vials must be stored between 2°C and 25°C and used within 6 hours of dilution. Discard any remaining vaccine after 6 hours according to your state immunization program’s directions for proper disposal.

If the vaccine experienced problems during shipment (for example, damage or temperature excursion), contact:

  • Pfizer at 800-666-7248 (option 8) or CVGovernment@Pfizer.com.

If the vaccine experienced problems after it was received and placed into storage, contact the vaccine manufacturer for guidance on improper storage and handling.

For temperature excursions (out-of-range temperatures), take immediate action:

  • Label the vaccine “Do Not Use” and store at the recommended temperature range until you receive manufacturer guidance.
  • Document the date and length of time of the excursion, storage unit temperature, room temperature, and inventory affected.
  • Record any other relevant information.
  • Contact the manufacturer for guidance on whether to use affected vaccines and whether patients need to be recalled for revaccination.
  • If advised to dispose of the vaccine, properly dispose of the vaccine as biohazard waste. Never return vaccines with thermal shipping containers back to the manufacturer.
  • Document the event and action taken for record-keeping requirements.

Vaccine Administration

Yes. The vaccine is concentrated and must be mixed with 0.9% sodium chloride (normal saline, preservative-free), provided in the ancillary supply kit, before administering.

See Pfizer-BioNTech COVID-19 Vaccine Preparation and Administration Summarypdf icon and Preparation Infographicpdf icon for more information.

No. Pfizer-BioNTech COVID-19 Vaccine requires mixing ONLY with sterile 0.9% sodium chloride (normal saline, preservative-free). NEVER use bacteriostatic normal saline or any other diluent. Diluent will arrive separately from vaccine in an ancillary supply kit. No other diluent can be used. CDC has developed an infographicpdf icon that can be posted in medication preparation areas as a reference.

No. You must mix the vaccine using a NEW vial of diluent and a NEW vial of vaccine EVERY TIME. You may receive diluent in 0.2 mL or 1.0 mL volume. These are both single-use vials. Discard the diluent vial after mixing the vaccine.

Because 0.9% sodium chloride (normal saline) is preservative-free, it is important to enter the vial only once. Inserting the needle twice could provide a direct route for microorganisms to enter the vial and contaminate the fluid in these devices. By entering the vial only once you will prevent inadvertent contamination of the vial that could lead to infection transmission.

See Questions about Single-Dose/Single-Use Vials for more information.

After dilution, each multidose vial of Pfizer-BioNTech COVID-19 Vaccine contains six 0.3mL doses. The amount of excess vaccine left in the vial can vary based on provider technique and ancillary supplies. Always follow these practices when extracting the final dose:

  • Extract the proper dose. Each dose MUST contain 0.3 mL of vaccine, regardless of whether it is intended for an adult or adolescent recipient. There is no weight-based dosing for the Pfizer-BioNTech COVID-19 Vaccine.
  • Do NOT combine remaining vaccine from multiple vials to obtain a full dose.
  • If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and contents.

See Pfizer-BioNTech COVID-19 Vaccine Preparation infographicpdf icon to learn more about withdrawing 6 doses.

CDC recommends healthcare providers follow the dosing guidance from the manufacturer as outlined in the Emergency Use Authorization (EUA)external icon. CDC will update its guidance if the EUA and ancillary supply kits support obtaining additional doses per vial in the future.

Low dead-volume syringes and/or needles can help you withdraw 6 doses. Your ancillary supply kit contains approximately 80% low dead-volume syringes and/or needles and 20% non-low dead-volume syringes and/or needles in various sizes.

To maximize the number of vaccine doses, use a combination of low dead-volume syringes and/or needles for each vial as follows:

  • When supplies allow, use at least 3 low dead-volume syringes and 3 non-low dead-volume syringes per vial.
  • Avoid extracting an entire vial with all low dead-volume syringes. This will leave you with too few low dead-volume syringes as you near the end of your ancillary supplies, and you may not be able to withdraw 6 doses.
  • Do not prioritize using low dead-volume products over selecting the proper needle gauge and lengthpdf icon for vaccine recipients.

See Pfizer-BioNTech COVID-19 Vaccine Preparation infographicpdf icon to learn more about withdrawing 6 doses.

See USP’s FAQ for Maximizing COVID-19 Vaccine Dosespdf iconexternal icon to identify specific low dead-volume products from ancillary supply kits.

No. CDC recommends following these practices:

  • Never combine or “pool” partial doses from two or more vials to obtain one or more doses of vaccine.
  • Withdraw only the number of doses authorizedexternal icon for the specific vaccine.
  • Discard the vaccine vial and remaining vaccine if the amount of vaccine left in the vial is not a full dose.

Although no one wants to waste vaccine, it is crucial for infection control and patient safety to administer vaccine properly. Combining vaccine doses from multiple vials can result in cross-contamination, potentially causing bacterial infection in patients.

No. While it is important to try to use every dose of vaccine possible, that should not be at the expense of missing an opportunity to vaccinate every eligible person when they are ready to get vaccinated. Strategies to ensure providers do not miss an opportunity to vaccinate every eligible persons and limit wastage can be found online: Identification, Disposal, and Reporting of COVID-19 Vaccine Wastagepdf icon.

No, the dosage should NOT be adjusted regardless of the type of needles and syringes used. ALWAYS withdraw the amount of vaccine indicated by the manufacturer. After mixing with the diluent, withdraw 0.3 mL of vaccine into the syringe.

Contact the manufacturer. mRNA vaccine is very fragile and should not be shaken. Vials should only be gently inverted.

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. See ACIP’s General Best Practice Guidelines for Immunization, “Vaccine Administration,” for more information.

If Pfizer-BioNTech COVID-19 Vaccine is administered before the authorized age (i.e., age 12 years), do not administer the second dose until the person becomes eligible to receive vaccination (either by reaching the authorized age or if the authorization is extended to include additional age groups), even if this results in the second dose being administered after the recommended interval between doses.

This is considered a vaccine administration error. Determine how the error occurred and implement strategiespdf icon to prevent it from happening again. Report this error to VAERSexternal icon.

If any of the currently authorized COVID-19 vaccines are administered subcutaneously, do not repeat the dose. If the dose given in error is the first dose, administer the second dose at the recommended interval of 21 days. If this dose is the second dose, the series is complete, and no additional doses are needed.

Inform the recipient of the potential for local and systemic adverse events.

This is considered a vaccine administration error. Determine how the error occurred and implement strategiespdf icon to prevent it from happening again. Report this error to VAERSexternal icon.

Review resources on vaccine administration:

If a lower-than-authorized dose volume is administered for any of the currently authorized vaccines, adhere to the following interim recommendation:

  • If more than half of the dose was administered, do not repeat the dose. If the dose given in error is the first dose, administer the second dose at the recommended interval of 21 days. If this dose is the second dose, the series is complete, and no additional doses are needed.
  • If less than half of the dose was administered or the proportion of the dose cannot be estimated, administer the authorized dose immediately in the opposite arm. If the dose given in error is the first dose, administer the second dose at the recommended interval of 21 days from the date of receipt of the valid dose (not the date of receipt of the erroneous dose).

This is considered a vaccine administration error. Determine how the error occurred and implement strategiespdf icon to prevent it from happening again. Report this error to VAERSexternal icon.

Interim recommendations for COVID-19 vaccine administration errors differ from ACIP’s general best practice guidelines. Review vaccine administration errors and deviations for COVID-19 vaccines to learn about the interim recommendation for each type of error.

For all vaccine administration errors:

To reduce the risk of fake or counterfeit vaccines, dispose of vials and packaging as medical waste by placing vials in a sharps container and packaging in a red medical waste bag. If medical waste containers are in short supply, deface or safely crush packaging materials so they cannot be reintroduced or reproduced. After the products are sufficiently defaced or destroyed, dispose with regular waste.

The disposal process for unused COVID-19 vaccine and diluent may be different. For guidance, contact your jurisdiction’s immunization program.

Yes. CDC recommends the following observation periods after COVID-19 vaccination:

  • 30 minutes for people with:
    • History of an immediate allergic reaction of any severity to another vaccine or injectable therapy
    • Contraindication to Janssen COVID-19 Vaccine who receive Pfizer-BioNTech COVID-19 Vaccine
    • History of anaphylaxis due to any cause
  • 15 minutes for all other people

Vaccine Safety and Efficacy

Before vaccination, counsel patients about expected local and systemic side effects.

Common side effects include:

Local reactions:

  • Pain
  • Redness
  • Swelling

Systemic reactions:

  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Fever
  • Nausea

Clinical trial data demonstrated vaccine efficacy was 95.0% against symptomatic, laboratory-confirmed COVID-19 in people age 16 years and older without evidence of previous SARS-CoV-2 infection following receipt of 2 doses of Pfizer-BioNTech COVID-19 Vaccine. In adolescents age 12–15 years, efficacy was 100% in the clinical trial.

For both adults and adolescents, both doses are necessary for developing the most protection; effectiveness of a single dose has not been systematically evaluated.

Off-Site Clinics

CDC does not recommend predrawing vaccine. If vaccine must be predrawn:

  • Set up a separate administration station for each vaccine type to prevent medication errors.
  • Draw up vaccines only after arriving at the clinic site or mass vaccination event.
  • Each person administering vaccines should draw up no more than one multidose vial or 10 doses* at one time.
  • Monitor patient flow to avoid drawing up unnecessary doses.
  • Predraw reconstituted vaccine into a syringe only when ready for administration.
  • If predrawn vaccine is not used within 30 minutes of being reconstituted, follow manufacturer guidance for storage conditions and time limits.

*You may withdraw a total of 12 doses (2 multidose vials) of Pfizer-BioNTech COVID-19 Vaccine. This applies only to Pfizer-BioNTech COVID-19 Vaccine.

See CDC’s Vaccine Storage and Handling Toolkitpdf icon for more information.

CDC recommends transporting vaccine in vials. However, there may be instances when the only option is to transport predrawn vaccine in a syringe. U.S. Pharmacopeia includes guidance for transporting predrawn vaccine in syringes in the USP COVID-19 Vaccine Toolkit: Operational Considerations for Healthcare Practitionersexternal icon.

Off-Label Use

No. Off label use of the COMIRNATY/Pfizer-BioNTech COVID-19 Vaccine is not authorized at this time. The Administration is preparing systems and logistics to be able to offer COVID-19 booster shots to fully vaccinated adults this fall. The regulatory and clinical details of this booster plan are contingent on FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the mRNA vaccines (Pfizer and Moderna) and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing recommendations based on a thorough review of the evidence when those recommendations are adopted by the CDC Director.

An additional dose for individuals beyond those with certain conditions associated with immunocompromise would be an off-label use at this time. Administration of the product off label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims. Individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use also would be in violation of the CDC COVID-19 Vaccination Program provider agreement and therefore may not be reimbursable, and may impact the ability of a provider to remain in the CDC Program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.

No. At this time, clinical trials in this age group are still ongoing and no product has been authorized or approved for this age group yet. Children under age 12 likely will require a different dose of the vaccine than older individuals, and the safety and effectiveness of Pfizer-BioNTech’s product COMIRNATY (COVID 19 Vaccine, mRNA) in children under 12 remains yet to be determined. Pfizer has stated publicly that it plans to submit a request to amend the EUA to include children 5 through 11 years of age by the end of September, following the completion of their clinical trial.

Further, any off-label use of the COMIRNATY/Pfizer-BioNTech COVID-19 Vaccine, including administration of the vaccine in children under 12, is not authorized at this time.
Administration of the off-label product may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims. Individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 Vaccination Program provider agreement and therefore may not be reimbursable, and may impact the ability of a provider to remain in the CDC Program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.

No. Vaccine providers should continue to administer all COVID-19 vaccines in accordance with the current BLA/EUAs and the CDC COVID-19 Vaccination Program provider agreement. The FDA-approved Pfizer-BioNTech product COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Providers should continue to use the vaccine on their shelves that was provided under EUA.

Vaccination of Minors

The federal government does not have specific requirements for medical consent for vaccination. States/jurisdictions have medical consent laws that address the circumstances under which a medical provider must seek consent prior to a medical procedure and the processes for obtaining that consent. These laws vary across jurisdictions. Providers may also be subject to policy requirements for consent within their own organizations.

To access COVID-19 vaccine in the United States, a provider must enroll in the Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program and sign the applicable CDC Provider Agreement. The CDC COVID-19 Vaccination Program Provider Agreement requires the provider to comply with applicable patient assent and consent laws in their state/jurisdiction for administration of COVID-19 vaccines.

The Emergency Use Authorization (EUA) does not require the parent or legal guardian to be physically present. However, some state, tribal, and territorial laws may require a parent or legal guardian to accompany an eligible minor to receive vaccinations. Some jurisdictions’ laws may allow parent/guardian consent without a requirement to be present for the vaccination if the provider is given evidence of the consent prior to vaccination. Providers may also have to comply with policy requirements determined by their organizations.

No, in-person provision of the EUA Fact Sheet is not a federal requirement. Under the CDC COVID-19 Vaccination Program Provider Agreement, the vaccine provider may provide the EUA Fact Sheet to the parent or legal guardian prior to the visit on paper, or through an electronic link if the individual agrees to receive it electronically.

There is no such federal requirement. If a state, tribal, or territorial patient consent law requires a parent or legal guardian to complete the prescreening questions for the minor, the CDC COVID-19 Vaccination Program Provider Agreement requires the provider to comply with such a requirement. In addition, if a jurisdiction authorizes a minor to consent to receipt of COVID-19 vaccine, the minor can complete the prescreening questions themselves, but the provider must confirm that this complies with state, tribal, or territorial laws.

A parent or legal guardian may complete the prescreening questions online provided this is done prior to administration of COVID-19 vaccine to the minor. Providers must comply with any applicable state, tribal, or territorial laws.

No. Since applicable medical consent laws are a matter of state, tribal, or territorial law, providers are advised to consult with legal counsel to assure compliance with the scope of those consent laws.

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Page last reviewed: August 23, 2021