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  1. SpotSee
20 April 2021

SpotSee Launches WarmMark Indicator with Additional Time and Temperature Thresholds to Match Covid-19 Vaccines

SpotSee®, a global leader in supply chain temperature indicators used to monitor test specimens in the SARS and H1N1 virus outbreaks, has introduced new temperature thresholds for its WarmMark indicators to address temperature requirements associated with the vaccine for the coronavirus disease 2019 (Covid-19).

“In the rush to get vaccines developed and distributed to vaccination sites, there hasn’t been much attention paid to the last ten feet after the vaccines have thawed at the administration site, where the opportunity for vaccine efficacy erosion due to temperature exposure is greatest,” said Tony Fonk, CEO of SpotSee.

“Our indicators help administrators in hospitals, nursing homes, retail pharmacies and other vaccination sites know if a vaccine has exceeded its temperature threshold over time. Our products are well-known for similar use in annual flu vaccinations, and we have customised our indicator time and temperature requirements to match the Covid-19 vaccine efficacy thresholds.”

According to the Centres for Disease Control and Prevention’s (CDC) guiding principles, during a pandemic, the efficient, expeditious and equitable distribution and administration of approved vaccines is critical. It also states that vaccine safety standards will not be compromised in efforts to accelerate Covid-19 vaccine development or distribution.

The Covid-19 vaccine, regardless of manufacturer, must maintain a specific temperature threshold or else the vaccine is rendered ineffective. Each temperature threshold is different but can range from -70°C to 8°C depending on if the vaccine is being distributed, stored or thawed for use. All Covid-19 vaccine candidates have some limited time period where they can be stored in a refrigerated environment (2°C to 8°C) before being administered to patients.

SpotSee’s WarmMark indicator is used at various times throughout the supply chain of vaccines. Some major vaccine manufacturers apply the indicator at the point of production to vaccine vial boxes or place the indicator inside. In other cases, large pharmaceutical distributors add the indicators as they break down bulk shipments into smaller, insulated shippers.

One of the largest applications of the WarmMark indicators is at vaccine administration sites, after a shipment of vaccines has been received. The vaccines are exposed to different temperatures as refrigerators are opened and closed and vaccines travel back and forth in the ‘last 10 feet’ before injection. This is where most temperature-related efficacy and safety issues can occur. Using the time and temperature feature, administrators will know if doses have experienced unacceptable deviations from the predetermined temperature thresholds.

The WarmMark temperature indicator is available in different temperature sensitivities ranging from -18°C/0°F to 37°C/99°F, with specific requirements for acceptable out-of-refrigeration periods. The new variants include both 8°C and 25°C versions with shorter run-out times. The new time and temperature ranges are as follows:

  • 8°C / 6 hours
  • 8°C / 14 days
  • 25°C / 6 hours
  • 2°C / 48 hours

The indicator can be applied to Covid-19 vaccine packaging before it is shipped or stored to maintain the vaccine’s efficacy throughout the supply chain. This low-cost solution provides a clear, easy-to-read indication so healthcare workers can be completely confident when vaccinating patients.

SpotSee’s temperature indicators are used throughout the world to ensure accurate results for shipping and administration of various vaccines, biologics and specimens.

Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines and other temperature‐sensitive products are commercialised for a global clientele.
Delivering Covid-19 vaccines to 7.8 billion people is a daunting challenge that will stretch supply chains past their limits.
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