Every day it seems like there is new and exciting information available that indicates we are closer to having access to new COVID-19 vaccines. The CDC released the COVID-19 Vaccination Playbook for Jurisdiction Operations; updates to this Playbook were already made in late October.
Because cold chain management is critical to safeguarding vaccines, and new COVID-19 vaccines are expected to have unique cold chain requirements, the CDC directs providers to the CDC Vaccine Storage and Handling Toolkit. The CDC has indicated that an addendum will be made available that is specific to new vaccines. A fully updated toolkit is not expected until 2022 according to the CDC.
The following information has recently been released about new COVID-19 vaccines:
- Pfizer and Moderna vaccines demonstrated around 95% efficacy. It is expected that Pfizer will submit their vaccine for Emergency Use Authorization (EUA) with the FDA within days. According to a Moderna Press Release on November 16, they expect to do the same “in the coming weeks”. EUA of one or both of these products is possible in December.
- Moderna’s mRNA vaccine candidate was originally described as requiring standard freezer temperatures (-25C to -15C) for long-term storage, and refrigerated storage (2C to 8C) for up to 7 days. However, earlier this week Moderna released additional information indicating that stability at refrigerated temperatures will likely be extended to 30 days to help simplify distribution and reduce handling risks. It is still expected that lab freezers will be required for long-term storage and shipping of the Moderna vaccine, but 30 day stability at refrigerated temperatures facilitates easier storage at points of administration at locations including hospitals, pharmacies, and clinics.
- Pfizer’s vaccine is expected to require ultra-low temperatures for long-term storage and refrigerated storage (2C-8C) for up to 5 days after the vaccine is thawed. This product will ship in thermal shippers that may be recharged with dry ice. According to the CDC Playbook providers will not be required to store the vaccine beyond the period of time the product can remain in the thermal shipper or a refrigerator during the first phase of immunizations. The Playbook also indicates orders for the Pfizer vaccine will only be available in large quantities and will only be for large provider sites, at least initially. The Playbook notes that stability testing is ongoing, storage and handling requirements may shift, and the guidance listed in the playbook is likely the strictest set of requirements possible. In addition, Pfizer’s Chief Science Officer, Mikael Dolsten, M.D, Ph.D, commented to Business Insider that Pfizer may have a next generation version of the vaccine that could simplify ultra-cold cold chain logistical challenges in 2021.
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We are excited as the first two COVID-19 vaccines approach EUA. Cold chain considerations continue to be crucial to ensure these vaccines remain efficacious and safe through administration. Additional COVID-19 vaccines in Phase 3 U.S. trials are expected to have primarily refrigerated cold chain requirements; we continue to learn more about these additional candidates each day! We have created a Vaccine Storage Readiness Guide as a resource – please download this guide using the following link.