Manufacturing and Distributing the COVID-19 Vaccine

Pfizer consistently and diligently monitors the supply of our medicines. We operate one of the most sophisticated supply chain systems in the industry, with over 40 Pfizer-owned sites and over 200 suppliers globally, which provides capacity and redundancy as needed. Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. We have implemented an unprecedented and comprehensive preparedness plan to control our site operations and will continue to provide timely updates if there is any new information to be shared.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com.

A Cold Chain Overview

with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group

A Look at Cold Storage & Distribution

with Mike McDermott, President, Pfizer Global Supply

How will the Pfizer-BioNTech COVID-19 vaccine be distributed?

Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. 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.

What is the path of a vaccine from Pfizer’s facilities to where it’s distributed to patients?

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.

Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. These distribution centers will have a dedicated area designated to store product that is not going direct from our Kalamazoo or Puurs sites to POU.

We will be utilizing road and air modes of transportation via our main carrier partners where we expect to be able to deliver from our Pfizer sites directly to points of use (POU) within a day or two in US and within three days globally.

Is Pfizer working with Operation Warp Speed?

Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat.

A few areas where we have been collaborating include:

  • a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use,
  • synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and
  • a second dose inventory management system.

The combination of OWS logistics expertise coupled with Pfizer’s deep manufacturing and distribution expertise provides a solid foundation for success.

How will Pfizer maintain vaccine integrity during distribution?

Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. Today, Pfizer manufactures more than 200 million doses of Pfizer vaccines annually and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year. We have experience working with customers in all markets to ensure success.

We have years of proven experience in supply chain and cold chain management, and we are accelerating the development of innovative technologies to further advance our capabilities as a supply chain leader.

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 also developed packaging and storage innovations to be fit for purpose to meet the needs of our global network.

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.

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.

What is a “cold chain”?

“Cold chain” is how the temperature of perishable products are managed in order to maintain quality and safety from end to end in the distribution process. Cold chain is used for consumer products like ice cream and other frozen foods, as well as medicines and vaccines.

How is Pfizer utilizing a cold chain process to distribute its vaccine?

We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days unopened. 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.

How can you prevent a cold chain failure?

We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. fully loaded.

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.

How will hospitals and pharmacies keep vaccines cold?

Once a POU receives a thermal shipper with our vaccine, they have three options for storage:

  • Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months.
  • The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage.
  • Refrigeration units that are commonly available in hospitals. The vaccine can be stored for five days at refrigerated 2-8°C conditions.

The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. Once opened, and if being used as temporary storage by a vaccination center, then it can be used for a total of 15 days with re-icing every five days.

After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8°C storage conditions for an additional five days, for a total of 20 days. Once thawed and stored under 2-8°C conditions, the vials cannot be re-frozen or stored under frozen conditions.

The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure.

 

For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”.