LAL BAHADUR SHASTRI INSTITUE OF

MANAGEMENT

Assignment

EISCM

COVID-19 Vaccine Distribution across UK & US

Submitted to: Kumar Biswas Submitted by – Esha Aprajit

504/2019

PGDM-LSCM

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INTRODUCTION

The Medicines & Healthcare Products Regulatory Agency (MHRA) of the United Kingdom
has granted a temporary authorization for emergency use for their COVID-19 mRNA
vaccine, against coronavirus.

This includes the first Emergency Use Authorization following a global Phase 3 trial of a
vaccine. Pfizer and BioNTech are looking through further regulatory decisions across the
globe in the coming weeks and have decided to deliver vaccine doses following potential
regulatory authorizations or approvals from various nations.

The distribution of the vaccine in the United Kingdom will be prioritized according to the
populations identified in guidance from the Joint Committee on Vaccination and
Immunisation (JCVI).

Pfizer and BioNTech confirmed the deal with the U.S. Department of Health and Human
Services and the Department of Defense in the month of July to meet the U.S. government’s
OWS program to begin delivering 300 million doses of a vaccine for COVID-19 in the year
2021.

Pfizer is one of the most reliable vaccine manufacturer in the world. They cater to around 165
countries and manufactures more than 200 million doses of vaccines annually. US marshals
will be accompanying the tightly secured shipments from factory to final destination after
regulators authorised the vaccine from Pfizer and partner BioNTech for use.
The Centers for Disease Control and Prevention director Robert Redfield has accepted the
recommendation of the agency’s Advisory Committee on Immunization Practices that the
Pfizer vaccine should be given to people aged 16 and older

MANUFACTURING AND DELIVERY CAPABILITIES IN THE UNITED

KINGDOM

 The United Kingdom has secured 40 million doses of BNT162b2 in supply deals
through 2021.

 United kingdom has a smaller population as compared to the United States which has
a dense population and healthcare infrastructure, distribution of the vaccine via cold
chain should comparatively be easier and might go smoothly.

 In case if problems arise in the above mentioned conditions, it would act bad and not
go well for vaccine distribution in countries with longer distances to vaccine
distribution centres, not even mentioning countries with less developed infrastructure

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 and sparse and less well-equipped healthcare centres which comprises a large number.

 The United Kingdom’s Joint Committee on Vaccination and Immunisation (JCVI) has
prioritised all the older residents in care homes and care home workers as the first
recipients of a Covid-19 vaccine, this is going to be followed by elderly people aged
above 80 years and older and health and social care workers, and post that
subsequently lower age groups will be vaccinated.
 When it comes to the US, the Advisory Committee on Immunization Practices (ACIP)
that advises the Centers for Disease Control and Prevention (CDC) on immunisation
recommendations recommended to prioritse healthcare workers and patients in long-
term care facilities for the first doses of an approved Covid-19 vaccine.

 In an additional poll conducted by GlobalData in July 2021, 46% of survey response

said that people in high-risk groups, such as the elderly and patients with
comorbidities, should receive first access to a Covid-19 vaccine, followed by 21% for
people in areas with high infection rates, while 33% of respondents thought that
everyone should have the same access.

 Both the companies are leveraging leading vaccine manufacturing and distribution
capabilities to quickly measure, manufacture and distribute huge quantities of the
vaccine at the desired quality, this is done via help from the mRNA manufacturing
expertise of BioNTech gained over almost a decade.

 Pfizer has a 171-year track record of researching, developing, producing and

delivering new medicines and vaccines to patients all across the globe.

 Both the companies are confident in their ability to safely deliver the vaccine to the
people in the United Kingdom.

 Based on current projections, Pfizer’s and BioNTech’s combined manufacturing

network has the potential to supply globally up to 50 million vaccine doses in 2020
and up to 1.3 billion doses by the end of 2021.

 Through their current mRNA production sites in Mainz and Idar-Oberstein,

Germany, BioNTech has produced mRNA for commercial supply after having
already produced the vaccine dosages for the clinical trials.

 BioNTech will also increase its manufacturing capacity in the year 2021, once a
third site in Germany will start manufacturing to provide further capacities for a
global supply of the potential vaccine.

 Critical to distribution in the U.K. will be Pfizer’s manufacturing site in Puurs,

Belgium which is one of Pfizer’s largest injectable sites. The Puurs site is being used
currently for the European supply but will also serve as back up supply to
Kalamazoo, Michigan, for the U.S. market.

 To maintain the desired product quality, both the companies have developed specially
designed, temperature-controlled shippers for the BNT162b2 vaccine candidate,
which can maintain the desired storage conditions (-70°C ±10°C) for extended

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 periods of time without any additional machinery other than dry ice.

 The delivery partner can maintain temperature for 10 days unopened which allows for
transportation to all the markets globally.

 After the container is opened. The vaccination center may use the specially same
shippers as a temporary storage units to maintain the recommended storage conditions
that is - (-70°C ±10°C) up to 30 days with re-icing every 5 days in accordance with
the handling instructions.

 All the shippers will contain a GPS-enabled thermal sensor to track the location and
temperature of each vaccine shipment 24 hours a day, seven days a week. Once
thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C)
conditions.

 Pfizer and BioNTech have throughout successfully supplied and distributed their
various sets of trial vaccines to more than 150 clinical trial sites across the U.S as well
as Europe, Latin America and South Africa. They have reached approximately 44,000
participants altogether.

AGREEMENTS WITH THE GOVERNMENT IN THE UNITED STATE

 During the first stage, Pfizer will be providing doses according to countries and their
preferred channel and designated vaccination locations.

 Vaccination will start on the basis of priority and they have anticipated that points of
vaccination may vary but will include hospitals, outpatient clinics, community
vaccination locations and pharmacies.

 They have developed multiple logistical plans and gathered various tools to support
effective vaccine transportation, storage and continuous temperature monitoring.

 Their distribution is based on the Just-in-time system, which will ship the frozen vials
direct to the point of vaccination.

 Federal officials have stated that the first shipments of Pfizer’s vaccine will be
staggered and will be arriving in 145 distribution centers all across the United States
of America with an additional 425 sites getting shipments coming on the second day
and the remaining 66 on the third.

DISTRIBUTION CHANNEL IN THE UNITED STATES

 According to the statement made by Pfizer, In the United States, their distribution
approach will be to mainly ship directly from Kalamazoo, Michigan site to the point
of use (POU).They will also be using their existing distribution center in Pleasant
Prairie, Wisconsin.

 They will also be utilizing road and air modes of transportation in the United States.

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 They have developed packaging and storage innovations to be fit for purpose for the
range of locations where they believe vaccinations will take place.

 They have designed new temperature-controlled thermal shipping containers, utilizing

dry ice to maintain the required storage temperature conditions of -70°C±10°C for up
to 10 days unopened.

 The main intent is to utilize their strategic transportation partners to ship by air to
major hubs within a country/region and by ground transport to other locations.

 They have kept 3 options for storage once a POU receives a thermal shipper with the
vaccine.

- Very low-temperature freezers, which are available for sale and can extend
shelf life for up to six months.

- The Pfizer’s own thermal shippers, in which doses will arrive, that can be
used as temporary storage units by refilling with dry ice every five days for up
to 30 days of storing. Their dry–ice cooled packages can hold as many as 4,875
doses in a single batch.

- Refrigeration units that are commonly available in hospitals can also be used.
The vaccine can be stored for five days at refrigerated 2-8°C conditions.

 After being stored for up to 30 days in the Pfizer thermal shipper, vaccination centers
can transfer the vaccines to 2-8°C storage conditions for an additional five days, for a
total of up to 35 days.

 After being stored at 2-8°C conditions, the vials cannot be re-frozen or stored under
frozen conditions.

 Even after all these steps enough vaccine doses to vaccinate the entire population will
most likely only be available in the summer of 2021 in most countries.

 United states Postal Service and FedEx package delivery drivers will deliver many of
the “suitcases” into the hands of healthcare providers across the United States.

 Courier companies all across the United States are giving the vaccine top priority,
reserving space on planes and trucks at a time when pandemic and holiday-related e-
commerce are creating more demand for deliveries than carriers can handle.
 Both the companies have expertise handling fragile medical products and are leaving
very little to no room for error.