Two pharmaceutical companies announced successful results from Phase III clinical trials of potential COVID-19 vaccines.
The interim results of Moderna’s trial suggests its vaccine prevents COVID-19 in 94.5 percent of cases. Two days later, on November 18, Pfizer/BioNTech presented complete trial results that indicate its vaccine is 95 percent effective.
For Pfizer/BioNTech and Moderna, however, the next challenge is how to quickly manufacture and distribute vast quantities of the COVID-19 vaccines. That is, assuming the US Food and Drug Administration (FDA) provides expedited authorization for the pharmaceutical companies to do so for the US market.
Pfizer/BioNTech forecasts producing up to 50 million doses for what remains of 2020, while Moderna is aiming for 20 million. In 2021, Pfizer/BioNTech wants to manufacture 1.3 billion doses, while Moderna expects to produce around half of that. Each dose is stored in a little glass vial, and one complete vaccination requires two doses administered three to four weeks apart.
The glass vials are transported on trays by the thousand, and the trays are stacked in fives for each box before its ready for shipment. Like all vaccines, the difficulty with the distribution of the glass vials is they must be kept at a steady, frozen temperature otherwise they rapidly deteriorate and become useless.
For Moderna, its vaccine must be kept at -20 degrees Celsius (-4 degrees Fahrenheit). It can be stored at this temperature for up to six months, but once the vaccine arrives at its final destination and thaws in a refrigerator at two to eight degrees Celsius (36 to 46 degrees Fahrenheit) it will spoil after 30 days.
Pfizer/BioNTech’s cold chain distribution challenge is even more daunting. Its glass vials containing doses of the COVID-19 vaccine must be kept in ‘deep freeze’ conditions of -70 degrees Celsius (-94 degrees Fahrenheit). They can then only be stored in a refrigerator for up to five days. The potential for spoilage along the cold chain distribution line is very high for a commodity that will likely be precious for years to come.
Thankfully, there are validated insulated vaccine shippers available which are proven to protect vaccine shipments against extreme ambient conditions.
What’s more, only around 25 to 30 countries have the deep freeze infrastructure Pfrizer/BioNTech’s vaccine requires. Even in those countries, supply can be limited. These limitations coupled with the urgency to administer the COVID-19 vaccine at scale means Pffizer/BioNTech’s vaccine is probably better suited for distribution to densely populated urban environments. On the other hand, Moderna could cater to rural or less well-serviced locations, at least until the supply of vaccines increases or other options arise.
Moderna will manufactures its vaccine from sites in New Hampshire, Pennsylvania and Indiana, while its distribution center is located in Irving, Texas at the heart of the Trump administration’s Operation Warp Speed initiative to develop and distribute a COVID-19 vaccine.
Pfizer/BioNTech will manufacture its vaccine at its site in Michigan, and since it’s not part of Operation Warp Speed it will rely on standard delivery companies like UPS and FedEx to get its vaccines where they need to be in the condition they need to be in. Pfizer/BioNTech carried out several delivery test runs at controlled temperatures from Michigan to New Mexico, Rhode Island, Tennessee and Texas without any major problems. Here’s hoping it will be able to do the same when the time comes to distribute millions of doses of the COVID-19 vaccine across America daily.