Today, a company spokesperson answered several questions about when and how they plane to ship millions of doses across the U.S.
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Are the vaccine doses already manufactured and ready to ship if the FDA grants emergency use authorization (EUA)?
"Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. We're manufacturing the vaccine candidate now and have hundreds of thousands of doses at the 'formulation, fill and finish' manufacturing sites in Puurs, Belgium and Kalamazoo, Michigan."
How many doses of the vaccine will be available and when?
"Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021."
How will Pfizer ship and distribute the vaccine?
"Pfizer is working extremely closely with the U.S. government including state officials on the vaccine distribution and we are very grateful for their partnership.
Pfizer is a proven, reliable multi-national vaccine producer, supplying vaccines to over 165 countries. Today, Pfizer manufactures more than 200 million vaccine doses, and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year.
Our track record gives us confidence in our ability to quickly scale and manufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the US and Europe. We have experience working with differing customers with different infrastructures in all markets to ensure success.
During the initial pandemic stage, our contracts are with the governments and we'll be providing doses according to their preferred channel and designated vaccination locations. We seek to work with governments to support distribution to their defined priority groups, and we anticipate that points of vaccination will vary, but may include: hospitals; outpatient clinics; community vaccination locations and pharmacies.
We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination.
In the U.S. our distribution approach will be to largely ship from our Kalamazoo site direct to the point of use (POU) due to the temperature requirements. However, we will also be using our existing distribution center for the COVID-19 distribution in Pleasant Prairie, WI.
These distribution centers will have a dedicated area designated to store product that is not going direct from our Kalamazoo site to POU.
We will be utilizing road and air modes of transportation in the U.S. where we expect to be able to get product to any point of use within a day or two.
We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Our distribution is built on a flexible just-in-time system which will ship the frozen vials direct to the point of vaccination.
We have also developed packaging and storage innovations to be fit for purpose for the range of locations where we believe vaccinations will take place. We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended storage condition -70C10C up to 10 days. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations.
We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen.
Once a POU receives a thermal shipper with our vaccine, they have three options for storage:
o Ultralow temperature freezers, which are commercially available now and can extend shelf life for up to 6 months
o The vaccine can be stored for five days at refrigerated 2-8C conditions. Refrigeration units a very commonly available in hospitals.
o Utilize the Pfizer thermal shippers (that doses will arrive in) which can be used as temporary storage units by refilling with dry ice for up to 15 days of storage"
Where is Pfizer making the vaccine?
"Pfizer has manufacturing sites across the U.S. Initially for the COVID-19 U.S. commercial vaccine program, we are leveraging three of them:
Saint Louis, MO (Raw material manufacturing)
Andover, MA (Drug Substance)
Kalamazoo site (Formulation, fill and finish)
Pfizer's Puurs, Belgium, site is being used for European supply.
BioNTech Drug Substance Supply will also be part of the network for commercial supply.
And we anticipate more sites will be selected."
Are there efforts to change the -70 degree Celsius storage temperature requirement of the vaccine?
"We hope to have a new lyophilized formulated vaccine in 2022 which will be stored at 2-8C."
Will the vaccines be guarded?
"We track these trends very carefully and have processes in place to identify threats to the legitimate supply chain."
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