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FREMONT, CA: Concerns over vaccine storage and distribution from Pfizer and BioNTech remain a hurdle even as the companies prepare to fulfill  commitments of dose delivery by the end of 2020. With data set to be released and an emergency use authorization to be granted by the end of the year 2020, how to ensure the integrity of the vaccines once they reach their destination and who will receive the first doses remain largely unknown. 

More than 300 freezers are currently at a plant in Kalamazoo, with plans to create an equally sized “freezer farm” in Wisconsin. The Michigan plant can hold 100 million doses, and the company executives believe that it is sufficient to hold the necessary doses for shipment. The vaccines will be moved from the freezers to innovative shipping boxes with continuous GPS monitoring approved by the Federal Aviation Administration to ensure the temperature remains controlled to their point of use. 

Rather than relying on the Federal government’s distribution process, the company is directly delivering vaccines to the health systems and other priority recipients using shipping companies FedEx and UPS. The shipping containers use dry ice, which can be replaced, to maintain the ultra-cold temperature of -70 degrees celsius for up to 15 days.

The company takes pride in being one among various vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID-19 vaccine.

Pfizer’s COVID-19 vaccine development and manufacturing costs are entirely self-funded. The company has invested close to $2 billion at its own risk, and is prepared to continue to bear costs.

Pfizer uses GPS devices to monitor vaccine shipments. It is setting up a supply chain control tower to ensure real-time monitoring, as well as the ability to intervene if any shift in temperature is detected to avoid spoiling the vaccines. Once the shipments arrive at their destination, it is up to the end-user to maintain the vaccine's integrity. While few recipients are likely to have cold storage, it is noted that the 15-day window for the shipping boxes and the vaccine's ability to maintain its integrity for 5 days in a refrigerator is sufficient to avoid ultra-cold temperatures.

The company has also started to work on a form of vaccine that doesn’t require the ultra cold chain. Pfizer and BioNtech are actively exploring a lyophilized (powered) presentation of BNT162b2, which might be more stable at refrigerator temperatures than the current frozen  liquid formulation. They  look forward to bring this formulation to the market to meet patients’ needs potentially by 2022.

While the first phase of deliveries will target healthcare workers and the most vulnerable populations, the federal government has recently expanded the number of locations where Americans could get the vaccine by partnering with pharmacies across the country.

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