Zipline successfully completes world’s first long-range drone delivery of vaccines requiring ultra-cold-chain.

SAN FRANCISCO, NEW YORK and MAINZ, GERMANY, November 11, 2021 – Zipline, the global leader in instant logistics, Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that Zipline has successfully completed the first long-range drone delivery of both authorized mRNA COVID-19 vaccines requiring ultra-cold-chain in Ghana. The collaboration of the companies, which worked together earlier this year to develop and test an end-to-end vaccine delivery solution, will allow for the distribution of approximately 50,000 doses of the Pfizer-BioNTech COVID-19 Vaccine in Ghana, pioneering a new model for vaccine distribution.

In addition to financial support for the pilot program, Pfizer and BioNTech provided technical assistance and know-how specific to the management and storage of the Pfizer-BioNTech COVID-19 Vaccine at -90°C to -60°C. This partnership has paved the way for drone deliveries of all mRNA vaccines.

The companies share a goal to help ensure the safe and equitable distribution of COVID-19 vaccines. Pfizer and BioNTech have committed two billion doses of their COVID-19 vaccine to low- and middle-income countries through 2022 and are actively working on collaborating with both public and private organizations to accelerate the vaccine rollout worldwide. To date, the Pfizer-BioNTech COVID-19 Vaccine has reached 155 countries and territories in every region of the world, including through its agreement with COVAX.

To-date, more than 220,000 COVID-19 vaccine doses from multiple manufacturers have been successfully distributed across Ghana by Zipline, the first company to do so through an autonomous aircraft at national scale. Zipline plans to distribute millions more as supply becomes available. Through this partnership, Pfizer, BioNTech and Zipline have brought together their expertise and capabilities to help advance more equitable vaccine distribution.

“Delivery to people in remote and hard-to-reach places is a primary challenge for global vaccination,” said Keller Rinaudo, Co-founder and CEO, Zipline. “In partnership with Pfizer and BioNTech, we have created a solution to address this potential pain point head on. Together, we are working to help transform vaccine distribution into a more effective, equitable process.”

Making COVID-19 vaccines accessible to an entire country’s population presents logistical challenges for many governments and healthcare organizations, particularly in low- and middle-income countries. Zipline is helping to address these challenges by implementing an end-to-end distribution model that safely delivers any COVID-19 vaccine to all corners of a country through its autonomous aircraft.

“Pfizer has a history of investing with partners to improve access to medicines and vaccines in the most remote areas of the world,” said Caroline Roan, Chief Sustainability Officer, Senior Vice President, Global Health and Social Impact, Pfizer Inc. “We are proud of this collaboration with Zipline to implement breakthrough solutions that help advance equitable access to COVID-19 vaccines, particularly for hard to reach and underserved populations.”

“The global distribution of COVID-19 vaccines requires a coordinated effort. We are working together with local partners and governments to establish a robust local end-to-end manufacturing and distribution network,” said Sierk Poetting, Ph.D., Chief Operating Officer, BioNTech. “This collaboration between Pfizer, BioNTech and Zipline showcases our collective commitment to pioneering new solutions that can help address COVID-19 vaccine access challenges.”

Zipline, Pfizer and BioNTech tested and validated the end-to-end model for delivery of mRNA vaccines with ultra-cold-chain requirements, and Zipline will now utilize it to distribute Pfizer-BioNTech COVID-19 Vaccines, as well as COVID-19 vaccines from all manufacturers, to regions across Ghana. The companies have detailed the learnings in an executive summary and a separate white paper.

U.S. Indication & Authorized Use

HOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.

Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals:
65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
A single booster dose of the vaccine may be administered to certain individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding eligibility for, and timing of, the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under EUA to provide:
a 2-dose primary series to individuals 12 through 15 years
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series
EUA Statement

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are 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 Sheets at www.cvdvaccine-us.com.

IMPORTANT SAFETY INFORMATION

Individuals should not get the vaccine if they:

had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:

have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
Have ever fainted in association with an injection
The vaccine may not protect everyone.

Side effects reported with the vaccine include:

There is a remote chance that the vaccine could cause a severe allergic reaction
A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Additional side effects that have been reported with the vaccine include:
severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1?800? 822?7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

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Fact Sheets and Prescribing Information for individuals 12 years of age and older

Full Prescribing Information (16 years of age and older)
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)

Fact Sheets for individuals 5 through 11 years of age

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)

About Zipline
Zipline is the global instant logistics leader. Our purpose is to inspire possibility, transform systems and serve all people equally. We design, manufacture and operate the world’s largest automated on-demand commercial delivery service, which to date has made more than 200,000 commercial deliveries. Zipline is the trusted partner for governments, global brands and leading health care systems. For more information about Zipline, visit flyzipline.com.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice
The information contained in this release is as of November 11, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Pfizer
Global Media Relations
PfizerMediaRelations@Pfizer.com