What HCPs Should Know About Administering the Pfizer-BioNTech COVID-19 Vaccine
Key takeaways:
The FDA issued the first emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for patients age 16 and older.
Pfizer-BioNTech’s COVID-19 vaccine is a 2-dose series (0.3 mL each) intramuscular shot given 21 days apart.
This vaccine must be stored in ultra-low temperatures prior to use and diluted with 1.8 mL of 0.9% sodium chloride prior to administration.
While it didn’t receive an approval, the Food and Drug Administration’s (FDA) emergency use authorization this month for the Pfizer-BioNTech COVID-19 vaccine nonetheless shows promise in ongoing efforts to combat the disease caused by SARS-CoV-2. The vaccine is now being distributed and administered across the country.
The Pfizer-BioNtech vaccine uses messenger ribonucleic acid (mRNA) to create a protein that resembles the same proteins as the coronavirus. The vaccine’s overall efficacy is 95% and there were 44,000 participants in the clinical trials.
Here’s what healthcare providers need to know about the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine.
Who can I administer the vaccine to?
The Pfizer-BioNTech COVID-19 vaccine is indicated for anyone age 16 or older. To note, any immunocompromised patients may experience a decreased immune response to the vaccine, but they are still eligible.
The CDC clinical considerations state that patients with the following conditions may be vaccinated:
Family history of anaphylaxis
History of allergy to oral medications
History of food, pet, insect, environmental, latex, venom, or other allergies not related to vaccines or injectables
These patients should be observed for 30 minutes if they have a history of anaphylaxis and for 15 minutes if they have allergic reactions (not severe).
This vaccine has not been studied in either pregnancy or lactation. The CDC’s interim clinical recommendation for pregnant people is that they may choose to get vaccinated if they want to, because the CDC sees limited risks, the vaccine is not live, and studies show that the vaccine degrades rather quickly.
In summary, immunocompromised, lactating, and pregnant people may choose to get vaccinated, although there is limited to no data available in the studies.
How is this vaccine dosed?
The final volume once prepared and diluted is 0.3 mL. The vaccine will be administered intramuscularly in 2 doses. The second dose is to be administered 3 weeks after the first one. Anyone who receives the Pfizer-BioNTech COVID-19 vaccine should receive the same volume in the second dose.
Each vial should deliver 5 doses, but pharmacists have discovered that some vials may deliver extra doses, which could increase the United States’ supply of the vaccine by 40 percent. The FDA has said that “it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial.”
The FDA and Pfizer are working on approving the use of extra doses, so it’s important to follow the official authorization as things progress and continue to change.
What are the ingredients in the Pfizer-BioNTech COVID-19 vaccine?
The vaccine is broken down into three components.
Genetic component
Contains mRNA that has specific genetic code for the novel virus, specifically a spike protein called receptor-binding domain.
Lipid bubbles
ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate)
ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
1,2-distearoyl-sn-glycero-3-phosphocholine
Cholesterol
Saline solution
Phosphate buffer solution (PBS)
Sucrose (sugar)
Water
The lipid bubbles act like a coating to protect the genetic material on its way to the patient’s body, while the saline solution is used for pH maintenance. There’s a lot of vaccine hesitancy among patients with the vaccine rolling out “early.” It would be great to highlight that these ingredients are not toxic or dangerous and that the vaccine is safe and cannot cause COVID-19.
How is the vaccine stored?
Storage of this vaccine is critical. The vaccines will arrive in cartons of multiple doses in thermal containers with dry ice. Below are the FDA’s guidelines on storing and thawing the vaccine.
Prior to use
The vials must be removed from the thermal container and stored in a freezer at temperatures between -112°F and -76°F (-80°C to -60°C). The vials must also remain at this temperature until they’re ready to use. Avoid exposure to room light, sunlight, and ultraviolet light. Thawed vials should not be refrozen.
Thawed vials before dilution
If you’re looking for immediate use, you can thaw the vials at room temperature for 30 minutes before they can be diluted. It’s important to note that undiluted vials can only be stored at room temperature for up to 2 hours.
If you’re looking to prepare for clinics or appointments, you may thaw and store undiluted vials in the refrigerator at temperatures ranging from 35°F to 46°F for up to 5 days. For reference, a carton of 25 vials can take 2 to 3 hours to thaw in the fridge.
Vials after dilution
Once the vials have been diluted, they must be stored between 35°F and 77°F and used within 6 hours. If the vial hasn’t been used in that time period, it must be discarded.
What if I don’t have access to proper storage?
Most vaccines don’t require ultra-low temperature freezers, so if you don’t have the proper storage conditions, there is a temporary fix. You may use the thermal container that the vaccine arrives in as temporary storage while consistently using dry ice. This should be used only if there is no access to the recommended storage. It is not a replacement for the specified storage instructions.
How is the dose prepared?
The Pfizer-BioNTech multiple dose vial is diluted with 1.8 mL of 0.9% sodium chloride injection to formulate the COVID-19 vaccine. Sodium chloride does not come with the vaccine, so it’s imperative to have enough of it in stock to prepare the vaccine. No other diluent should be used.
Here are the preparation instructions:
Thaw vials before use, following either of the thawing methods mentioned above.
Invert vaccine vial 10 times while being careful not to shake it. Inspect the liquid to make sure it’s a white to off-white suspension.
Using aseptic technique, withdraw 1.8 mL of 0.9% sodium chloride solution and add to the thawed vaccine vial. Make sure to equalize the vial pressure before removing the needle.
Mix the vaccine by inverting the vial 10 times without shaking.
Inspect the vaccine in the vial to confirm off-white suspension without discoloration or particles.
If there is any suspension left in the vaccine vial, make sure to mark the time of dilution to avoid using after the 6 hours have passed.
Withdraw 0.3 mL of the vaccine suspension after dilution to administer immediately.
What side effects are expected?
Some adverse reactions may include:
Injection site pain
Headache
Fatigue
Muscle pain
Joint pain
Is there anything else I should know about?
Like most vaccines, the person administering the vaccine must do the following.
Inform the patient
Communicate to the patient receiving the Pfizer-BioNTech COVID-19 vaccine or to their caregiver the information on the COVID-19 Fact Sheet, stating:
This vaccine is not FDA-approved yet.
The patient or caregiver is not mandated to get or administer this vaccine.
The extent of the risks and benefits is unknown.
Any other alternative vaccines that may or may not be available.
Report adverse events
Report to the Vaccine Adverse Event Reporting System (VAERS) if there are:
Any serious adverse events
Errors in administration
Cases of Multisystem Inflammatory Syndrome
Cases of COVID-19 that cause death or result in hospitalization
Report vaccine information
Report vaccination information to their local jurisdiction’s immunization information system.
Dosage information
Use the chart below for a quick reference on dosage and storage information for the vaccine.
| Indication | 16 years and older |
| Dose | 0.3 mL (for each of the 2 doses) |
| Dose per vial | 5 doses* |
| Time between doses | 3 weeks |
| Route | Intramuscularly |
| Diluent | 1.8 mL of 0.9% of sodium chloride |
| Storage of frozen vials | -112°F to -76°F (-80°C to -60°C) |
| Storage of thawed vial under refrigeration | 35°F to 46°F (2°C to -8°C) up to 5 days |
| Storage of thawed vial at room temperature | Up to 77°F (25°C) for 30 minutes |
| Storage of vials after dilution | 35°F to 77°F within 6 hours from time of dilution |
| Shelf-life in refrigerator | 5 days |
*Some vials may deliver up to 6 or 7 doses instead of 5.
These considerations and facts to note are key to vaccination providers. More information for healthcare professionals on administering the COVID-19 vaccine is available from the FDA and the CDC.
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