Vaccines are being rolled out, but will refrigeration cause recalls?

December 14, 2020

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The world’s population has been waiting for the introduction of a COVID-19 vaccine since early 2020 – and after phenomenal progress, some are now in the initial phases of rollout.

One key issue to note is that pharmaceuticals have a relatively delicate shelf life, with many vaccines being highly dependent on ambient refrigeration.

There are major infrastructure processes underway right now to ensure countries across Europe have the required facilities to store the vaccine at very low temperatures.

Temperature recordings will become paramount as the companies behind the product have invented a distribution container that preserves the vaccine at -70 degrees Celsius for 10 days if unopened. Once thawed, this vaccine can be stored in a normal refrigerator at 2-8 degrees Celsius for up to five days.

Public Health England has very clear instructions on what to do if the integrity of vaccine storage and management processes is compromised. Its direction is to retain rather than dispose of any vaccines or storage equipment but label the vaccines as ‘do not use’ and quarantine the fridge until a thorough risk assessment has been carried out.

If potentially compromised vaccines have already been given to patients, Public Health England says that “failure to adhere to vaccine storage guidelines does not mean vaccines have been impaired to such an extent as to require recall/revaccination of patients, but a thorough risk assessment needs to be conducted to ascertain what action, if any, is necessary.”

The fact that the companies behind the COVID-19 vaccine have invented their own storage solution speaks volumes of the importance of keeping this drug at the appropriate temperature. However, the scale of the vaccination process is so vast that there will be pressure to share storage responsibilities, meaning that the companies behind the vaccines can relinquish full responsibility of storage and distribution.

When this occurs, it is possible that some small-scale recalls will occur. However, these recalls will only happen post risk assessment, which will take a great deal of time. As we move into spring, and the scale of the operation picks up pace, we should begin to see evidence on the data tables related to the vaccine.

Tags: Brand protection, coronavirus, COVID-19, Europe, Product recall, recall, UK, United Kingdom, Vaccine