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    BNTX   US09075V1026

BIONTECH SE

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Press Release : Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses within Africa

07/21/2021 | 07:15am EDT

NEW YORK and MAINZ, GERMANY, July 21, 2021 -- https://www.globenewswire.com/Tracker?data=Y5ujU8fMzf78h8wWiTE6L4OQaBrOKa6or5_BkCn-osp__8Vp2Bs5udmzU_jMUkPGByqqumE7MKVMpcO5bY4ENQ== Pfizer Inc. (NYSE: PFE) and https://www.globenewswire.com/Tracker?data=U1L6ahoXqVVOsIlAW5Wam4XGn-9q_4lsgxVI57tmNrk9xqMuycvBD9z3h7dCeXsPOm5deQJSu5JzQW4JARiENQ== BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as "Biovac", a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

Biovac will perform manufacturing and distribution activities within Pfizer's and BioNTech's global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities. To facilitate Biovac's involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately.

Pfizer and BioNTech expect that Biovac's Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.

"From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 vaccine to everyone, everywhere," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines."

"We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent."

"We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 vaccine within Africa. This is testament of the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine," said Dr. Morena Makhoana, CEO of Biovac, "This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic. We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent."

Pfizer and BioNTech select contract manufacturers using a rigorous selection process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program. Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill, finish and distribution of the Prevenar 13 vaccine.

To date, Pfizer and BioNTech have shipped more than 1 billion COVID-19 vaccine doses to more than 100 countries or territories in every region of the world. The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 -- 1 billion each year. This includes an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, that the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40 million doses.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech's 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 https://www.globenewswire.com/Tracker?data=NsUlWKv3AxJMJxFySO3OqtZDR3YUcMjF9B57Us6UwUf96h4uqt7dchLOqjqMQKyD913BwHsCYX_71_Im73O8Eb8UXR2oRnYfrqdxcQQHUzY= 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 (eg, anaphylaxis) to any 
      component of the Pfizer-BioNTech COVID-19 vaccine 
 
   -- Appropriate medical treatment used to manage immediate allergic reactions 
      must be immediately avai lable 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) 
 
 
   -- Reports of adverse events following use of the Pfizer-BioNTech COVID-19 
      Vaccine under EUA suggest increased risks of myocarditis and pericarditis, 
      particularly following the second dose. The decision to administer the 
      Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of 
      myocarditis or pericarditis should take into account the individual's 
      clinical circumstances 
 
   -- 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%), 
      headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), 
      fever (14.2%), injection site swelling (10.5%), injection site redness 
      (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) 
 
   -- In a clinical study, adverse reactions in adolescents 12 through 15 years 
      of age included pain at the injection site (90.5%), fatigue (77.5%), 
      headache (75.5%), chills (49.2%), muscle pain (42.2%), fever 3 (24.3%), 
      joint pain (20.2%), injection site swelling (9.2%), injection site 
      redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) 
 
   -- Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the 
      following have been reported outside of clinical trials: 
 
   -- severe allergic reactions, including anaphylaxis, and other 
      hypersensitivity reactions, diarrhea, vomiting, and pain in extremity 
      (arm) 
 
   -- myocarditis and pericarditis 
 
   -- Additional adverse reactions, some of which may be serious, may become 
      apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine 
 
   -- Available data on Pfizer-BioNTech COVID-19 Vaccine administered to 
      pregnant women are insufficient to inform vaccine-associated risks in 
      pregnancy 
 
   -- Data are not available to assess the effects of Pfizer-BioNTech COVID-19 
      Vaccine on the breastfed infant or on milk production/excretion 
 
   -- There are no data available on the interchangeability of the 
      Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete 
      the vaccination series. Individuals who have received one dose of 
      Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of 
      Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series 
 
   -- Vaccination providers must report Adverse Events in accordance with the 
      Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For 

(MORE TO FOLLOW) Dow Jones Newswires

July 21, 2021 07:15 ET (11:15 GMT)

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Financials
Sales 2021 16 863 M 19 855 M 19 855 M
Net income 2021 8 881 M 10 456 M 10 456 M
Net cash 2021 9 100 M 10 715 M 10 715 M
P/E ratio 2021 8,93x
Yield 2021 -
Capitalization 76 502 M 90 003 M 90 078 M
EV / Sales 2021 4,00x
EV / Sales 2022 3,25x
Nbr of Employees 2 500
Free-Float 87,3%
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Number of Analysts 12
Last Close Price 316,75 €
Average target price 279,31 €
Spread / Average Target -11,8%
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Managers and Directors
Ugur Sahin Chief Executive Officer
Jens Holstein Chief Financial Officer
Helmut Jeggle Chairman-Supervisory Board
Özlem Türeci Chief Medical Officer
Sierk Pötting Chief Operating Officer
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