On August 23, 2021, the Food and Drug Administration (FDA) granted full approval of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older.
Currently, Pfizer’s COVID-19 vaccine is the only vaccine with emergency use authorization for individuals 12 to 15 years of age.
Pfizer, Johnson & Johnson, and Moderna COVID-19 vaccine products are not interchangeable. The same COVID-19 product must be administered for both doses of the mRNA COVID-19 vaccine series. The Advisory Committee on Immunization Practices (ACIP) does not state a product preference. A person may receive any recommended COVID-19 vaccine series.
Pfizer’s COVID-19 vaccine is:
- A two-dose, mRNA COVID-19 vaccine.
- Stored either in an ultra-cold freezer, thermal shipping container, freezer, or refrigerator.
- Authorized for people 12 years of age and older for the prevention of COVID-19 infection.
- Administered intramuscularly.
Do not administer the vaccine to people with a known history of a severe allergic reaction (for example, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 vaccine. The list of ingredients is available in the clinical considerations.
DHS Guidance and Updates
Full approval of Comirnaty
On August 23, 2021, the Food and Drug Administration (FDA) granted full approval of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The decision to grant full approval is the result of rigorous review of thousands of pages of additional safety and efficacy data, as well as inspections of vaccine production sites, consistent with all other full approval processes. The vaccine also continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain individuals who are immunocompromised.
CDC COVID-19 vaccination program provider agreements
Providers are responsible for adhering to all requirements outlined in the agreement. Specifically, providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of CDC, the Advisory Committee on Immunization Practices, and the FDA. This applies to COVID-19 vaccines that have received full FDA approval and emergency use authorization. Accordingly, use of these products outside of those that have been approved and authorized by FDA (often referred to as “off-label use”) is not recommended. It would violate the provider agreement and could expose providers to the following risks:
- 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 an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
- CDC has defined the scope of the CDC COVID-19 Vaccination Program in terms of how the USG-provided vaccines may be used in the program. Providers giving off-label doses would be in violation of the CDC Program provider agreement potentially impacting their ability to remain a provider in the CDC program.
- Administration fees may not be reimbursable by payers.
Interchangeability of FDA-authorized and FDA-approved COVID-19 products
The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA and the FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under the EUA to administer the vaccination series for those seeking the approved vaccine. The vaccine information fact sheet for recipients provides additional information about both the approved and authorized vaccine. Providers should continue to use the vaccines on their shelves.
Vaccination of adolescents ages 12-17
On May 12, 2021, ACIP voted, and the Wisconsin Department of Health Services (DHS) accepted the recommendation, that adolescents ages 12-15 are eligible to receive the Pfizer COVID-19 vaccine. Vaccinators may begin administering the Pfizer vaccine to this age group. The Pfizer COVID-19 vaccine requires two doses, separated by 21 days, for full protection and is currently the only vaccine available for this age group.
In clinical trials, the Pfizer COVID-19 vaccine was 100% effective at preventing COVID-19 in children 12 to 15 years old. The side effects were similar to what has been seen in vaccinated older teens and young adults. The most common reactions were pain at the injection site, fatigue, and headache.
Vaccinators are required to give the EUA fact sheet for recipients and caregivers to every vaccine recipient and/or caregiver. The Morbidity and Mortality Weekly Report (MMWR) and COVID-19 vaccine clinical considerations outline the expanded recommendation.
The Centers for Disease Control and Prevention (CDC) published a webpage for children, teens, and their families considering COVID-19 vaccination. DHS encourages all vaccinators to actively reach out to parents and guardians of this age group. DHS published the fact sheet For Ages 12 and Older: What Parents and Guardians Should Know.
Parental consent for vaccination of individuals under the age of 18
According to the CDC, state laws establish vaccination requirements for school-aged children. In Wisconsin, the age of majority is 18 years of age, unless emancipated. Therefore, all unemancipated individuals under 18 years of age require parent or guardian consent to receive the COVID-19 vaccine.
In Wisconsin, vaccinators are able to accept written or verbal (such as via telephone) consent to administer the COVID-19 vaccine from the minor’s legal parent or guardian who cannot be present at the time of vaccination. Vaccinators are not required to accept written or verbal consent but are permitted to accept these forms of consent should they choose to do so. DHS does not have a sample written consent form for vaccinators to use. Vaccinators are encouraged to work with their own legal counsel regarding methods of consent for vaccinating minors in their clinic.
On February 25, 2021, the U.S. Food and Drug Administration (FDA) announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF).
On May 19th, the FDA authorized an amendment to the Pfizer-BioNTech COVID-19 vaccine emergency use authorization. The amendment allows for undiluted vials of Pfizer-BioNTech vaccine to be stored in the refrigerator (2°C to 8°C) for up to one month. This is a change from the previous 120 hours of allowable storage time at 2°C to 8°C. This applies to vaccine currently on-hand as well.
Undiluted vials maybe stored at the following temperature ranges:
- Between -80°C and -60°C until the expiration date
- Between -25°C and -15°C for up to two weeks
- Note: These temperatures are within the appropriate range for routinely recommended vaccines, but the temperature range for this vaccine is tighter. If storing the vaccine in a freezer with routinely recommended vaccines, carefully adjust the freezer temperature to the correct temperature range for this vaccine.
- Between 2°C and 8°C for up to one month (31 days)
Please note: The Pfizer thermal shipping containers cannot be used to store vials at -20°C. These shippers are to be used for dry ice storage only.
Do not refreeze thawed vaccine.
For additional information on Pfizer-BioNTech cold storage see the updated EUA Fact Sheet for Healthcare Providers Administering Vaccine. Pfizer also provides “on-demand” training, fact sheets, and other resources at https://www.cvdvaccine-us.com/resources.
Deactivation of on-site monitoring
Many sites that receive direct shipments of Pfizer COVID-19 vaccine are not properly deactivating monitoring. Monitoring should be deactivated once the shipping container is empty.
- If vaccine was transferred to a proper storage freezer, monitoring should be deactivated when this takes place.
- If vaccine is stored in the shipping container it arrived in, monitoring should be deactivated when the last doses of vaccine from that container are used.
The only way to deactivate monitoring is through the email you receive from Controlant. You must click the link within the email (unique to the particular device of your shipment) and click through the proper steps to deactivate monitoring. Page 9 of the Controlant Onsite Temperature Monitoring Playbook for Sites provides step-by-step instructions for performing this task.
The “Stop Shipment” button does not deactivate monitoring.
Take this opportunity to read through the instructions linked above. Please ensure that your site is appropriately deactivating the on-site monitoring as outlined above. This process is critical to properly monitoring vaccine. If you have questions, please reach out to your regional manager.
Updated doses per vial
As of February 22, 2021, Pfizer’s COVID-19 vaccine vials are considered six-dose vials. Vaccine received the week of February 22 and after reflect the six doses per vial in your WIR inventory.
The ancillary kits for the Pfizer vaccine have been updated to include supplies to increase the likelihood of being able to draw up the sixth dose. This change has already been implemented and no action is required of providers. See below for an update about syringes for the sixth dose.
If the sixth dose is not obtained after February 22, you will need to report this dose as “wasted” in WIR. See more information about vaccine wastage reporting on the COVID-19: General Guidance for Vaccinators page.
Syringes for sixth dose
As of February 22, DHS implemented the necessary changes to reflect that the Pfizer vials contain six doses. Per CDC’s emergency use authorization fact sheet, after dilution, one vial contains six doses of 0.3 mL. Vial labels and cartons may state that after dilution a vial contains five doses of 0.3 mL. The original guidance stated this was best accessed using a 3:3 ratio of low dead-volume (LDV) syringes to non-LDV syringes.
CDC has reassessed this guidance and the syringes currently available on the market. The new guidance showing a 5:1 ratio of low dead volume (LDV) syringes to non-LDV syringes is needed to ensure the availability of the sixth dose.
Moving forward, the Pfizer ancillary kits are supplied to support this new guidance. The syringes in the ancillary kit with the one-inch needle (attached or separate) are LDV syringes and the 1.5-inch needle/syringe combination (attached or separate) are not considered LDV syringes.
Given this information, providers should draw up doses from each vial using five one-inch needles/syringes and one 1.5-inch needle/syringe. Please keep in mind this guidance does not replace the need to use the correct needle size for intramuscular (IM) injection based on the individual.
Key webpages with clinical resources include:
Pfizer's COVID-19 vaccine website
The following resources are also available on the above webpages:
EUA Fact Sheets
- For vaccination providers
- For recipients and caregivers
- Translations of the fact sheets are available on Pfizer's website and FDA's website. Vaccine manufacturers are responsible for translating the EUA fact sheets, and may be outdated.
- Preparation infographic on how to withdraw six doses of vaccine from a Pfizer vaccine vial
- Pfizer COVID-19 vaccine standing orders
- Preparation and administration summary
- Pre-vaccination screening form in English and Spanish
- Mixing diluent and vaccine poster
Storage and Handling
- Storage and handling summary
- Storage and handling labels
- Delivery checklist
- Dry ice safety
- McKesson updated ancillary supply kit information: Contents and quantities for mega kits to support Pfizer vaccine
- Temperature monitoring:
|Topic or Problem||Contact|
|Medical information||Pfizer Medical Service
|General product inquiries||Pfizer Medical and Customer Service
|Pfizer vaccine shipment has a problem||Pfizer Customer Service
|Pfizer ancillary kit has a problem||
Contact McKesson MedSurg to report
|Temperature excursions within the clinic or site|| Phone: 800-666-7248
|A complex COVID-19 vaccine safety question about an individual patient residing in the U.S. not readily addressed by CDC guidance||
Health care personnel or health departments in the U.S. can request a consultation from