-- U.S. government to purchase at not-for-profit price 200 million doses in 
      2021 and 300 million in the first half of 2022 
 
   -- Doses to be donated to approximately 100 low- and lower middle-income 
      countries including those in the African Union via the COVAX Facility 
 
   -- Effort is part of the companies' recent pledge of two billion doses to 
      ensure global equitable access to the vaccine 
 
 
   NEW YORK and MAINZ, GERMANY, June 10, 2021 -- 
https://www.globenewswire.com/Tracker?data=nyHeD3NLQFE4C62is_XYU3_4noauqTy6yKDaQUna6zjTz7SovuevhUvYz2nREPphG8VZ98XK6r-XmYbPT599ag== 
Pfizer Inc. (NYSE: PFE) and 
https://www.globenewswire.com/Tracker?data=lAqhclgsqXvUvAbc6YdFzKMUB8i1x21LaCr0O3tace4KWVaw72OWysmn1BmajolfOjh4rxTYbWWkYJLrMkMIZQ== 
BioNTech SE (Nasdaq: BNTX) today announced plans to provide the U.S. 
government at a not-for-profit price 500 million doses of the companies' 
COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in the 
first half of 2022, to further support the multilateral efforts to 
address the surge of infection in many parts of the world and to help 
end the pandemic. The government will, in turn, donate the 
Pfizer-BioNTech vaccine doses to low- and lower middle-income countries 
and organizations that support them. 
 
   As part of the plan, the United States will allocate the vaccine doses 
to 92 low- and lower middle-income countries and economies as defined by 
https://www.globenewswire.com/Tracker?data=Fkm9gW8iqqllSzHJ6LHX0TwLPi3D5x0jwgjiQRzTtLwF9ZhjZMhdZgfs0hPkpqiDHEcO9ZFrV8PvXTxCN0Tf28Ji45FAA3bzwW9oiOFICRTWUYl74FMs3MT017R1Qe0uZUMThlyZZbso5ipBy5BqxOfTTXhIOPxmUk9DSInImUuT0Gd27Mo5ockKW_lpfYwUCq2ek0-sNa1WslwTYxRZyJty8vxVf0etrbS5H31XOSdKxYV-CxkjmrkimGL_1w3F 
Gavi's COVAX Advance Market Commitment (AMC) and the 55 member states of 
the African Union. The U.S. government and the companies will work with 
COVAX to ensure these vaccines are delivered to the specified countries 
around the world in a way that is most efficient and equitable. 
 
   These doses are part of Pfizer and BioNTech's previously announced 
pledge to provide two billion doses of the COVID-19 vaccine to low- and 
middle-income countries over the next 18 months. 
 
   "Our partnership with the U.S. government will help bring hundreds of 
millions of doses of our vaccine to the poorest countries around the 
world as quickly as possible. COVID-19 has impacted everyone, everywhere, 
and to win the battle against this pandemic, we must ensure expedited 
access to vaccines for all. I want to thank President Biden for his 
leadership in protecting the least advantaged of our global neighbors," 
said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Fair 
and equitable distribution has been our North Star since Day One and we 
are proud to do our part to help vaccinate the world, a massive but an 
achievable undertaking." 
 
   "As a vaccine developer, we felt the duty to develop a well-tolerated 
and highly effective vaccine and make it available to as many people 
worldwide as possible. Today's agreement underlines that the joint 
efforts of the private and the public sector are providing solutions to 
help end this pandemic," said Ugur Sahin, M.D., CEO and Co-Founder of 
BioNTech. "We are also committed to realizing sustainable solutions by 
supporting the establishment of manufacturing networks on various 
continents. Our first step has been the establishment of our Regional 
Headquarters for southeast Asia in Singapore which will also include 
mRNA manufacturing capacities for regional and global supply. It is our 
goal to leverage our proprietary mRNA technology to help improve the 
health of people around the world." 
 
   Deliveries of the 200 million doses will begin in August 2021 and 
continue through the remainder of the year. The 300 million doses for 
2022 will be delivered between January and end of June 2022. The U.S. 
government also has the option for additional doses in 2022. The plan is 
to produce the doses being purchased by the U.S. government in Pfizer's 
U.S. facilities. Those U.S.-based sites involved in the production of 
the COVID-19 vaccine include Kalamazoo, MI, Andover, MA, Chesterfield, 
MO, Groton, CT, and McPherson, KS. 
 
   To date, Pfizer and BioNTech have shipped 700 million doses to more than 
100 countries or territories around the world. The companies have direct 
supply agreements in place with 122 countries and discussions are 
ongoing with many more on the supply of the companies' COVID-19 vaccine. 
Based on current projections, Pfizer and BioNTech expect to manufacture 
up to 3 billion doses of the COVID-19 vaccine in 2021. The production 
capacity has consistently grown due to continued enhancements to the 
vaccine's supply chain, which include expanding existing facilities, 
adding more suppliers, and bringing on additional Pfizer/BioNTech sites 
and contract manufacturers around the world to produce the vaccine. 
 
   Pfizer and BioNTech have an existing agreement in place to supply 
vaccine doses to the COVAX Facility, a mechanism established by Gavi, 
the Vaccine Alliance, the Coalition for Epidemic Preparedness 
Innovations (CEPI) and World Health Organization (WHO) that aims to 
provide governments with early access to a large portfolio of COVID-19 
candidate vaccines using a range of technology platforms, produced by 
multiple manufacturers across the world. Pfizer-BioNTech doses allocated 
through COVAX have reached people in every region of the world, 
including Rwanda, South Korea, Colombia, Peru, Cabo Verde, Tunisia, 
Angola, West Bank and the Gaza Strip, Moldova, El Salvador, Mongolia, 
the Maldives, Bosnia and Herzegovina, Georgia, the Ukraine, Bolivia, 
Kosovo, Bhutan, Bangladesh, Laos, Pakistan and the Philippines. 
Deliveries to 47 countries and territories around the world are planned 
through June 2021 as part of the COVAX second round allocation of 
Pfizer-BioNTech COVID-19 vaccine doses. 
 
   Through both Pfizer and The Pfizer Foundation*, a number of other 
innovative assistance efforts have been supported, including: 
 
 
   -- Working with International Rescue Committee and the Jordanian Ministry of 
      Health to provide essential primary health services and vaccinations to 
      refugees in Jordan; 
 
   -- Collaborating with the UPS Foundation, which is donating freezers to 
      countries that need assistance with building out their ultra-cold chain 
      capacity; and 
 
   -- Partnering with Zipline through funding and technical expertise, to 
      design and test a delivery solution that can safely and effectively 
      distribute all COVID-19 vaccines in difficult to reach areas of the 
      countries where it operates. 
 
 
   The U.S. government, the companies and COVAX will finalize the plan and 
further operational details in the coming weeks. 
 
   The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech 
proprietary mRNA technology, was developed by both BioNTech and Pfizer. 
BioNTech is the Marketing Authorization Holder in the European Union, 
and the holder of emergency use authorizations or equivalent in the 
United States (jointly with Pfizer), Canada and other countries in 
advance of a planned application for full marketing authorizations in 
these countries. 
 
   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) caused by severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 
12 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 Emergency Use 
Authorization (EUA) Fact Sheet for Healthcare Providers Administering 
Vaccine (Vaccination Providers) and Full EUA Prescribing Information 
available at www.cvdvaccine-us.com. 
 
   AUTHORIZED USE IN THE U.S.: 
 
   The Pfizer-BioNTech COVID19 vaccine is authorized for use under an 
Emergency Use Authorization (EUA) for active immunization to prevent 
coronavirus disease 2019 (COVID-19) caused by severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and 
older. 
 
   IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION 
PRESCRIBING INFORMATION: 
 
 
   -- Do not administer Pfizer--BioNTech COVID-19 vaccine to individuals with 
      known history of a severe allergic reaction (e.g., anaphylaxis) to any 
      component of the Pfizer--BioNTech COVID-19 vaccine 
 
   -- Appropriate medical treatment used to manage immediate allergic reactions 
      must be immediately available in the event an acute anaphylactic reaction 
      occurs following administration of Pfizer--BioNTech COVID-19 vaccine 
 
   -- Monitor Pfizer-BioNTech COVID-19 vaccine recipients for the occurrence of 
      immediate adverse reactions according to the Centers for Disease Control 
      and Prevention guidelines ( 
      https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html 
      https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html) 
 
 
   -- Syncope (fainting) may occur in association with administration of 
      injectable vaccines, in particular in adolescents. Procedures should be 
      in place to avoid injury from fainting 
 
   -- Immunocompromised persons, including individuals receiving 
      immunosuppressant therapy, may have a diminished immune response to the 
      Pfizer--BioNTech COVID-19 vaccine 
 
   -- The Pfizer--BioNTech COVID-19 vaccine may not protect all vaccine 
      recipients 
 
   -- In clinical studies, adverse reactions in participants 16 years of age 
      and older included pain at the injection site (84.1%), fatigue (62.9%),

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June 10, 2021 02:00 ET (06:00 GMT)