COVID-19 Vaccine FAQs for Healthcare Professionals
Below are answers to commonly asked clinical questions that apply to all authorized COVID-19 vaccines.
For clinical questions on the following specific COVID-19 vaccines, see:
All staff supporting COVID-19 vaccination efforts should receive ongoing training as new COVID-19 vaccines become available and recommendations evolve. Review and complete training and core competencies by professional qualification. Additionally, for healthcare professionals new to vaccination, the COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionalspdf icon provide a comprehensive list of suggested training and reference materials.
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 given 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 in 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 recipient has a reminder for the second appointment.
No. 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.
Yes. Testing for TB infection with one of the immune-based methods, either the TST or an IGRA, can be done before or during the same encounter as COVID-19 vaccination. It is recommended that the TST be placed or blood drawn for the IGRA before administration of the COVID-19 vaccination. If it is not possible to test with TST or IGRA at the same time as COVID-19 vaccination, these tests should be delayed ≥4 weeks after the completion of COVID-19 vaccination with either the 2-dose mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) or single dose viral vector COVID-19 vaccine (Janssen). However, the decision whether a TST or IGRA that is being done for medical diagnosis of latent TB infection (for example, during a contact investigation after exposure to contagious TB disease) should be delayed for 4 weeks after completion of COVID-19 vaccination is at the discretion of the responsible medical provider and local tuberculosis program overseeing the contact investigation.
The reliability of a positive TST or IGRA result after COVID-19 vaccination is expected to be the same as without the vaccination. COVID-19 vaccination is not expected to cause false positive results from a TB test that is done at the same encounter as or after COVID-19 vaccination. It should be noted that the reliability of a negative TST or IGRA result after COVID-19 vaccination has not been studied. If these tests cannot be done at the time of COVID-19 vaccine administration or delayed until ≥4 weeks after administration, a false negative TST or IGRA cannot be excluded, and consideration should be given to repeating negative TST or IGRA tests at least 4 weeks after the completion of COVID-19 vaccination. For more information, please refer to the CDC’s Division of Tuberculosis Elimination “Dear Colleague” Letter.
Patients who have active TB disease or an illness that is being evaluated as active TB disease can receive a COVID-19 vaccine (note: the presence of a moderate or severe acute illness is a precaution to administration of all vaccines).
People who have received a COVID-19 vaccine can have axillary lymphadenopathy, which may cause a false reading on a mammogram. If it is not possible to schedule the mammogram before COVID-19 vaccination, some experts recommend waiting 4 to 6 weeks after COVID-19 vaccination to schedule the mammogram.
A patient is considered fully vaccinated ≥2 weeks after a 2-dose mRNA COVID-19 vaccine series or ≥2 weeks after a single dose of Janssen COVID-19 Vaccine. The need for and timing of COVID-19 booster doses have not been established. No additional doses are recommended at this time.
Antibody tests for COVID-19 look for the presence of antibodies made in response to a previous infection or vaccination. They are an indicator of the body’s efforts to fight off the SARS-CoV-2 virus. None of the currently authorized SARS-CoV-2 antibody testsexternal icon have been validated to evaluate specific immunity or protection from SARS-CoV-2 infection.
Antibody testing is NOT currently recommended to assess
- Immunity to COVID-19 following COVID-19 vaccination
- The need for vaccination in an unvaccinated person
There are several issues to consider when interpreting an antibody test for SARS-CoV-2 infection:
- Scientists have not yet established a serologic correlate of protection, which is the measurable threshold above which a person is protected against SARS-CoV-2 infection. This makes it difficult to interpret how laboratory results might translate to clinical protection.
- Antibody testing does not evaluate the cellular immune response, which may also play a role in vaccine-mediated protection.
- Vaccines trigger antibodies to specific viral protein targets. Currently authorized COVID-19 vaccines induce antibodies to the spike protein but not to the nucleocapsid protein, which is likely detected only after a natural infection with SARS-CoV-2. Therefore, COVID-19-vaccinated people who have not had previous natural infection will receive a negative antibody test result if the antibody test is designed to detect nucleocapsid protein.
- Antibody tests have different levels of sensitivity (i.e., the true positive rate, or ability to identify people with antibodies to SARS-CoV-2) and specificity (i.e., the true negative rate, or ability to identify those without antibodies to SARS-CoV-2).
For assistance with patient counseling and education related to COVID-19 testing and vaccination, please see:
- Test for Past Infection [CDC]
- Using Antibody Tests for COVID-19: Information for Patients and Consumers [CDC]
- Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers [FDA]external icon
For more detailed information, please see:
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.
People with a history of an episode of immune-mediated syndrome characterized by thrombosis and thrombocytopenia (e.g., heparin-induced thrombocytopenia) should be offered Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine if it has been 90 days or less since their illness resolved. After 90 days, patients may be vaccinated with any FDA-authorized COVID-19 vaccine.
More information is available at: Clinical Care Considerations for COVID-19 Vaccination
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. COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. Pregnant or lactating people can receive any of the currently authorized COVID-19 vaccines; the Advisory Committee on Immunization Practices (ACIP) does not state a product preference.
However, if a woman younger than 50 years chooses to receive the J&J/Janssen COVID-19 vaccine, you should talk to her about:
- The very low but increased risk of thrombosis with thrombocytopenia syndrome (TTS) after receipt of this vaccine
- The availability of other FDA-authorized COVID-19 vaccines (i.e., mRNA vaccines) for which the risk of TTS has not been observed
Increasing data on the safety and effectiveness of COVID-19 vaccination indicate that the benefits of vaccination outweigh any known or potential risks of COVID-19 vaccine during pregnancy. When making a decision about vaccination, you and your pregnant patient should consider the following:
- Known and potential benefits of vaccination
- Vaccine effectiveness
- Vaccine side effects
- Limited but growing evidence about the safety of COVID-19 vaccination during pregnancy
- 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
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.
No. There is no evidence that any of the COVID-19 vaccines impact menstrual cycles or future fertility. Those who are trying to become pregnant do not need to avoid pregnancy after COVID-19 vaccination. There is no recommendation for routine pregnancy testing before receipt of a COVID-19 vaccine. For more information, please visit Myths and Facts about COVID-19 Vaccines.
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.
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 of reinfection is low in the months after initial infection, people with a precaution to vaccination and recent COVID-19 may choose to delay vaccination.
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 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. 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.
For the Pfizer-BioNTech COVID-19 vaccine, there are additional considerations for using a TMD with the thermal shipping container. Refer to the Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summarypdf icon and Pfizer-BioNTech COVID-19 Vaccine web page for more information.
If the vaccine experienced problems during shipment (for example, damage or temperature excursion), contact:
- Directly distributed vaccine (Pfizer): Contact Pfizer at 800-666-7248 (option 8) or CVGovernment@Pfizer.com.
- Centrally distributed vaccine (for example, Moderna): Contact McKesson Specialty Customer Service at (833) 343-2703, Monday–Friday, 8 AM–8 PM Eastern Time.
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.
- Document the event and action taken for record-keeping requirements.
Intramuscular injection is the recommended route for all COVID-19 vaccines.
The recommended site to administer an intramuscular injection to adolescents and adults is the deltoid muscle. When coadministering vaccines, more than one vaccine may be injected into the deltoid muscle. Separate injection sites by 1 inch. If administering COVID-19 vaccine with vaccines that tend to be locally reactogenic (e.g., tetanus-toxoid–containing vaccines, vaccines with adjuvants), administer vaccine in separate limbs, if feasible. You may use the vastus lateralis muscle of the anterolateral thigh as an alternate site. Refer to the following job aids for identifying administration sites:
- Vaccine Administration: Intramuscular (IM) Injection Adults 19 years of age and olderpdf icon
- Vaccine Administration: Intramuscular (IM) Injection Children 7 through 18 years of agepdf icon
- HCP Vaccine Administration Resource Library (includes demonstration videos for intramuscular injections)
- ACIP Vaccine Administration Guidelines for Immunization
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 here: Identification, Disposal, and Reporting of COVID-19 Vaccine Wastagepdf icon.
The deltoid muscle of the arm is the preferred site for intramuscular injectionpdf icon. If the deltoid muscle cannot be used or accessed, the vastus lateralis muscle of the anterolateral thigh can be used.
No. The Z-track injection technique is more commonly used for irritating medication (e.g., iron preparation). It is not recommended for vaccine administration. CDC recommends expelling the air when drawing vaccine from a vial into a regular syringe because the amount of air drawn into the syringe may be larger than the amount in a manufacturer-filled syringe. Expelling the air is part of general medication guidelines for drawing medication into a syringe. To avoid loss of vaccine, leave the needle in the vial while expelling air.
Needle gauge and length recommendations vary for adolescents based on age, and for adults based on age, gender, and weight. Use CDC’s Vaccine Administration: Needle Gauge and Lengthpdf icon job aid to help you determine the appropriate gauge and length. A discussion of vaccine administration best practices can be found in the “Vaccine Administration” chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book).
COVID-19 vaccines are administered by intramuscular injection. For all intramuscular injections, the needle should be long enough to reach the muscle mass and prevent vaccine from seeping into subcutaneous tissue. Ensuring the vaccine is given in the muscle is important to optimize immunogenicity and minimize adverse reactions at the injection site. If vaccine is given subcutaneously with the incorrect needle length, patients may experience more pain, irritation, and redness at the injection site.
Needle gauge and length recommendations vary for adolescents based on age, and for adults based on age, gender, and weight. CDC’s needle gauge and length chartpdf icon, included in the ancillary kits, outlines ACIP’s recommendations for needle length. Other vaccine administration and injection resources can be found in CDC’s Vaccine Administration Resource Library.
No. You should not aspirate before giving any vaccine, including COVID-19 vaccines. Aspiration can increase pain because of the combined effects of a longer needle-dwelling time in the tissues and shearing action (wiggling) of the needle. A discussion of vaccine administration best practices can be found in the “Vaccine Administration” chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book).
No. These devices or a needle should not be left inserted into a medication vial septum for multiple uses. This provides a direct route for microorganisms to enter the vial and contaminate the fluid in these devices. Additional injection safety information can be found here: Information for Providers | Injection Safety | CDC.
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:
- Inform the recipient of the vaccine administration error.
- Consult with the state immunization program or immunization information system (IIS) to determine how the dose should be entered into the IIS, both as an administered dose and to account for inventory.
- Report the error to the Vaccine Adverse Event Reporting System (VAERS) unless otherwise indicated in the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Providers are required to report all COVID-19 vaccine administration errors—even those not associated with an adverse event—to VAERSexternal icon.
- Determine how the error occurred and implement strategies to prevent it from happening again. A discussion on strategies to prevent errors can be found in the “Vaccine Administration” chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Additional resources can be found on CDC’s vaccine administration web page, including a job aid for preventing 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. If advised to dispose of the vaccine, properly dispose of the vaccine as biohazard waste. Never return unused or expired vaccines with the shipping containers back to the manufacturer. Additionally, promptly report any expired or unused vaccine. This helps CDC accurately monitor the amount of vaccine in the field. Keep in mind that there are no negative consequences for reporting waste, and it will not negatively impact future allocations. CDC recognizes that unused expired vaccine is a normal part of any vaccination program, especially one of this scope and size.
Vaccination providers enrolled in the COVID-19 Vaccination Program are required to:
- Document vaccine administration in their medical record systems within 24 hours of administration.
- Report administration data to the relevant system (i.e., IIS) for the jurisdiction as soon as practicable and no later than 72 hours after administration. See data reporting requirements.
- Report inventory daily using Vaccines.gov. In some jurisdictions, providers may report vaccine inventory to the jurisdiction’s IIS for the jurisdiction to upload into Vaccines.gov. If you have questions about the process for your jurisdiction, please contact your jurisdiction’s immunization program.
- Report the following to VAERSexternal icon:
- Vaccine administration errors
- Serious adverse events
- Multisystem inflammatory syndrome
- Cases of COVID-19 that result in hospitalization or death after the recipient has received COVID-19 vaccine
There are additional requirements for COVID-19 vaccination providers besides documentation (e.g., providing the Emergency Use Authorization (EUA) Fact Sheet for Recipients and Caregivers to vaccine recipients). Please refer to your COVID-19 vaccination provider agreement for all provider requirements.
Some people may have received a COVID-19 vaccine outside of the United States. Consider the following for these patients:
- People who received an FDA-authorized COVID-19 vaccine and have received all the recommended doses do not need any additional doses. People who received the first dose of an FDA-authorized COVID-19 vaccine that requires two doses do not need to restart the vaccine series in the United States but should receive the second dose as close to the recommended time as possible.
- People who have received all recommended doses of a COVID-19 vaccine listed for emergency use by the World Health Organization (WHO) do not need any additional doses with an FDA-authorized COVID-19 vaccine. See Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States for a list of WHO vaccines listed for emergency use.
- People who have not received all the recommended doses of a COVID-19 vaccine listed for emergency use by WHO may be offered a complete FDA-authorized COVID-19 vaccine series. Wait at least 28 days after the last dose of the non-FDA-authorized vaccine before administering an FDA-authorized COVID-19 vaccine.
People who received all or some of the recommended doses of a COVID-19 vaccine not listed for emergency use by WHO and not authorized by FDA may be offered a complete FDA-authorized COVID-19 vaccine series. Wait at least 28 days after the last dose of the non-authorized vaccine before administering an FDA-authorized COVID-19 vaccine.
No. VISs are only available for certain licensed vaccines. Under an EUA, there is not a VIS for an authorized vaccine. Instead, providers are legally required to provide the FDA-authorized EUA Fact Sheet for Recipients and Caregivers to vaccine recipients or their guardians. The Fact Sheet for Recipients and Caregivers includes:
- Basic information on COVID-19, symptoms, and what to discuss with a healthcare provider before vaccination
- Who should and should not receive the vaccine
- A statement that recipients have the choice to receive the vaccine
- Vaccine series information
- Potential and known risks and benefits of the vaccine, including common side effects
- Information on reporting side effects to VAERS
- An explanation of what an EUA is and why it is issued
- Any approved available alternatives for preventing COVID-19
- Additional resources
Although you are required to provide the vaccine-specific Fact Sheet for Recipients and Caregivers to vaccine recipients or their caregivers, you are not required to document that you did so. However, to help facilitate such documentation in electronic medical records/immunization information systems for vaccination providers who choose to do so, CDC is leveraging the existing vaccine information statement (VIS) Code Set infrastructure, barcoding, and URLs to provide the information needed for various systems. This is similar to the electronic system and workflow documentation of the VIS. The barcode at the bottom of the last page of the EUA Fact Sheet for Recipients and Caregivers may be scanned to capture in electronic medical records/immunization information systems that the fact sheet was provided to the vaccine recipient or caregiver.
COVID-19 vaccine providers are required by law to report vaccination to a state IIS. Providers or patients can contact the appropriate immunization information system (IIS) to obtain documentation. Contact the appropriate state or local IIS or immunization program for information on obtaining vaccination record information.
Please note CDC does not have vaccination record information for individuals.
Adverse events that occur in a recipient following COVID-19 vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS)external icon. Vaccination providers are required by the FDA 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
Reporting is encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Also, vaccine recipients can report adverse events that occur after vaccination. Information on how to submit a report to VAERS is available at https://vaers.hhs.govexternal icon or by calling 1-800-822-7967. For more information on VAERS, please refer to the VAERS FAQsexternal icon.
The VAERS reporting requirements for COVID-19 vaccines (under Emergency Use Authorization) are different from those for routine vaccines licensed in the United States. Healthcare providers are strongly encouraged to report vaccine administration errors involving any licensed vaccine. However, healthcare providers are required to report COVID-19 vaccine administration errors to VAERSexternal icon.
Before vaccination, counsel patients about expected local and systemic side effects.
Common side effects include:
- Muscle pain
If receiving Janssen COVID-19 Vaccine, women younger than 50 years old should be made aware of the rare but increased risk of blood clots with low platelets following vaccination and the availability of other COVID-19 vaccines where this risk has not been observed. Provide recipients or caregivers (as applicable) the EUA Fact Sheet for Recipients and Caregiversexternal icon.
Recent studies show that the mRNA vaccines (Pfizer-BioNTech, Moderna) help keep people from spreading the virus that causes COVID-19, and studies are underway to learn more about the benefits of Johnson & Johnson’s Janssen vaccine. Guidance for fully vaccinated people is available and will continue to be updated as more information becomes available.
The potential for asymptomatic transmission of the virus that causes COVID-19 underscores the importance of applying infection prevention practices to encounters with all patients while in a healthcare facility. These include physical distancing, respiratory and hand hygiene, surface decontamination, and source control. Vaccination providers should refer to the guidance developed to prevent the spread of COVID-19 in healthcare settings, including outpatient and ambulatory care settings.
General practices for the safe delivery of vaccination services is available in the Interim Guidance for Routine and Influenza Immunization Services During the COVID-19 Pandemic.
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.
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.
Please contact CDC-INFO for further questions on COVID-19 vaccines.