1. Introduction
COVID vaccines are fast approaching review by the The United States Food and Drug Administration (FDA) for consideration of Emergency Use Authorization (EUA) or Expanded Access (EA) status. Each vaccine has different packaging and requirements for storage, preparation, and administration. These practical aspects are important to prepare healthcare providers who will be receiving and administering these vaccines and in order to preserve the optimal immunogenicity and efficacy of each administered vaccine. Several of these vaccines require ultra-cold or have cold-storage requirements that are different than what vaccine administrators are prepared for. The information provided is specific to each manufacturer, recognizing COVID vaccine development is an evolving process with frequently occurring modifications.
2. Pfizer
2.1. Packaging
The Pfizer mRNA vaccine will be packed as a 2 mL, glass preservative-free vial. Each tray is equivalent to the size of a “personal pan pizza box” and holds 195 vials. Each vial contains 5 doses. Five trays will be included in each shipper provided by Pfizer; each shipper will contain dry ice and weigh 75 lb. The shipper dimensions are 15.7” L × 15.7” W × 22” H and include 4,875 doses.
Beyond inspecting the vials once for quality measures (i.e., no broken vials), each shipper can be stored for up to 10 days if stored between 15 and 25 °C without opening the container. Dry ice should be replenished if the shipper is stored in a warmer climate and/or is opened more frequently than once for inspection of vials. GPS-enabled temperature-monitoring devices will be included in the shipper to ensure end-to-end distribution occurs within the required temperature range.
2.2. Storage
Pfizer’s mRNA vaccine necessitates the strictest storage needs. It is required to be stored in a −70 °C ultra-cold freezer. Once the shipper arrives from Pfizer, the vaccine must be transported into the ultra-cold freezer within five minutes. The GPS-enabled logger should be disabled by pressing the “stop” button on the device upon receiving the shipper. The shipper should be sent back to Pfizer within a 10–20 days.
2.3. Preparation
Two methods are available to thaw the vaccine: 1) it can be thawed at room temperature for 30 min (no longer than two hours); or 2) it can be moved to a refrigerator. Time to thaw in the refrigerator is approximately three hours for an entire tray. The vaccine can be stored in the refrigerator (2-8 °C) for up to five days (120 h).
When drawing up the vaccine into a syringe, it is important to equalize pressure into the vial to minimize lost doses. After reconstitution, using 1.8 mL normal saline, the vial should be gently inverted 10 times, not shaken. The optimal normal saline diluent vial is 2 mL. Other diluents such as bacteriostatic saline should not be used. Post-dilution, the vaccine is stable for up to six hours at room temperature, after which time it should be discarded.
2.4. Administration
Prior to administering the vaccine, the vial should be drawn up into five dosing syringes; each dose is 0.3 mL given intramuscularly. The second dose of the Pfizer vaccine is given 21 days after the first dose and is also a 0.3 mL dose. Pfizer has included a QR barcode, lot number, and expiration date on each vial label for documentation purposes. The QR code will link to the EUA website.
3. Moderna
3.1. Packaging
Moderna’s mRNA vaccine will be shipped and delivered at a temperature of −20 °C. The vaccine’s standard pack includes 10 vials, with each vial containing 10 doses. There are 100 doses per carton and the dimensions of the carton are 5.5″ L × 2.2″ W × 2.5″ H.
3.2. Storage
The vaccine must be transported to the refrigerator immediately upon receiving it. It can be stored for up to 30 days in the refrigerator (2–8 °C).
3.3. Preparation
Moderna’s vaccine does not require any reconstitution or special preparation. The vial should be kept in the refrigerator until ready for use. The vaccine is stable for up to 12 h at room temperature post-thaw, after which it should be discarded.
3.4. Administration
Each vial contains 10 doses; each dose is 0.5 mL and is administered intramuscularly. Vaccine must be used within six hours after the vial is first punctured. The second dose of the Moderna vaccine is given 28 days after the first dose and is also a 0.5 mL dose.
The vial will have a QR code printed on the label. When the QR code is scanned with a smart device (i.e., phone or tablet), it will link the device to the EUA-specific website for the Moderna vaccine. The website will contain product information and provide access to the fact sheets. In addition, since the expiration date will not be printed on the vial, there will be a function to search for the date on the website by entering the product lot number.
The carton will have the same QR code (referenced above) printed on it. In addition, the carton will have a 2D barcode printed, which is encoded with the GTIN (product ID), lot number, and an expiration date that is hard coded to 12/31/2069.
4. Johnson & Johnson
4.1. Packaging
Johnson & Johnson (J&J)’s adenovirus-vectored vaccine will be delivered at a temperature of −20 °C. It will be delivered as 10 vials per carton and 48 cartons per shipper case. The carton dimensions are 3.66″ L × 1.5″ W × 2.13″D. The shipper dimensions are 15.06″ L × 9.38″ W × 4.5″D. Each shipper will contain 2,400 doses; five doses per vial.
4.2. Storage
The J&J vaccine must be transported to the refrigerator upon arrival. It can be stored for up to three months in the refrigerator (2–8° C). Stability information at room temperature is still forthcoming.
4.3. Preparation
No reconstitution or special preparation is required. After the vial is initially punctured it can be stored in the refrigerator for up to 6 h, after which is should be discarded.
4.4. Administration
Each vial contains five doses; each dose is 0.5 mL and administered intramuscularly. At this time, J&J anticipates a one-dose IM injection; however, future study results may identify a need for a booster injection following the original injection. The J&J vial label will have a one-dimensional barcode with human-readable NDC.
5. AstraZeneca
5.1. Packaging
AstraZeneca (AZ)’s adenovirus-vectored vaccine will be shipped in pallets. Each pallet will include 85 cases (20,400 vials). There are 24 cartons per case (2400 doses) and 10 vials per carton (100 doses). Each vial contains 10 doses. Case dimensions are 11.6″ L × 9.3″ W × 7.4″ H.
5.2. Storage
AZ’s vaccine is required to be stored in the refrigerator upon arrival (2–8 °C). It should be light-protected and can be stored for up to six months in the refrigerator (2–8 °C). The vaccine must not be frozen and must be kept in the original packaging until use to prevent prolonged light exposure.
5.3. Preparation
No reconstitution or special preparation is required. After the vial is initially punctured, it can be stored in the refrigerator for up to six hours, after which the vaccine must be discarded.
5.4. Administration
As of the date of this publication, it is unclear whether the first dose will be a 0.25 mL or 0.5 mL IM injection and a 0.5 mL injection intramuscularly for the second dose. The second dose is anticipated to be administered 28 days following the first dose. For documentation purposes, AZ will provide a lot/batch number for each vial, and each carton will include a lot/batch number, date of manufacturer, GTIN code, serial number, 2D barcode and a QR code.
6. Conclusion
It is important for providers to be familiar with the practicalities of vaccine packaging, storage, preparation, and administration (Table 1 ). It is also anticipated that COVID vaccine storage requirements, dosing, and scheduling may evolve over time. Vaccine immunogenicity and efficacy is critically dependent upon the following: vaccines must be kept in the appropriate cold chain; the cold chain must be properly monitored; and vaccines must be used only within critical timepoints after removal from the cold chain or once a multidose vial is punctured. The authors plan to provide an update to this article as new information becomes available following the FDA approval of the COVID vaccines. Finally, all who administer vaccines should be familiar with proper needle length for IM administration based on weight and gender—as well as proper anatomic deltoid injection technique—to prevent increased local reactions, subdeltoid bursitis (too high in the deltoid muscle), or inadvertent nerve damage (too low in the deltoid muscle).
Table 1.
Cold Storage Requirements of mRNA and Adenovirus-vectored COVID-19 Vaccines.
| Manufacturer | Dose | Storage temperature | Refrigeration storage duration | Duration after reconstitution |
|---|---|---|---|---|
| Pfizer | 0.3 mL | −70 °C | 5 days | 6 hr room temp |
| Moderna | 0.5 mL | 2–8 °C | 30 days | 6 hr room temp |
| J & J | 0.5 mL | 2–8 °C | 3 months | 6 hr in refrigerator |
| AZ | 0.25/0.5 mL | 2–8 °C | 6 months | 6 hr in refrigerator |