NEW YORK, USA and MAINZ, GERMANY, August 26, 2021 -- https://www.globenewswire.com/Tracker?data=co0aop_UkWAnVfXh-l-K9Fc0prZchFT6S-3cozgL34lHwW6gLk3YNVgRdl0Nzv7cPyNM8ZW_umkVBdmjEMDJtg== Pfizer Inc. (NYSE: PFE) and https://www.globenewswire.com/Tracker?data=GrWxClhSgVZ1KhSc6n4QQYm9QFHW0-Mn3K1i9mRyWv7E2ioeURoa8AVGM-pzr6jXIxYkd99YB0lLbHRgL0pPcQ== BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY(R) (COVID-19 vaccine, mRNA) (BNT162b2) for distribution within Latin America.

Eurofarma will perform manufacturing activities within Pfizer's and BioNTech's global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. To facilitate Eurofarma's involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately. Per the agreement, Eurofarma will obtain drug product from facilities in the U.S., and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. All doses will exclusively be distributed within Latin America.

"Everyone -- regardless of financial condition, race, religion or geography -- deserves access to lifesaving COVID-19 vaccines," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Our new collaboration with Eurofarma expands our global supply chain network to another region -- helping us continue to provide fair and equitable access to our COVID-19 vaccine. We will continue to explore and pursue opportunities such as this to help ensure that vaccines are available to all who are in need."

"We have been continuously increasing the manufacturing capacity of our own facilities and included dozens of manufacturing partners into our global network. Together with Pfizer, we have delivered more than 1.3 billion doses and we plan to deliver 3 billion doses in total by the end of the year. Today's partnership is an important step to broaden the access to vaccines in Latin America and beyond by expanding our global manufacturing network," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We will continue to enable people worldwide to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses."

"At such a difficult time as this one, being able to share this news fills us with pride and hope. Eurofarma is about to turn 50 years old and signing this collaboration in the production of the COVID-19 vaccine represents another milestone in our trajectory. We are making available our best resources in terms of industrial capacity, technology and quality to this project, so that we can meet the contract with excellence and contribute to supplying the Latin American market," said Maurízio Billi, President, Eurofarma.

Pfizer and BioNTech select contract manufacturers using a rigorous 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.

To date, Pfizer and BioNTech have shipped more than 1.3 billion COVID-19 vaccine doses to more than 120 countries and 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 and 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 direct supply agreements with individual country governments; an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, which the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries; and a direct supply agreement with COVAX for 40 million doses in 2021.

COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

COMIRNATY(R) (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 Emergency Use Authorization (EUA) to be 
      administered for emergency use to: 
 
          -- prevent COVID-19 in individuals 12 through 15 years, and 
 
          -- provide a third dose to individuals 12 years of age and older who 
             have been determined to have certain kinds of immunocompromise

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


   -- prevent COVID-19 in individuals 12 years of age and older, and 
 
   -- provide a third dose to individuals 12 years of age and older who have 
      been determined to have certain kinds of immunocompromise

The FDA-approved COMIRNATY(R) (COVID-19 vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY(R) (COVID-19 vaccine, mRNA) or the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement

This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and 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.

Important Safety Information

Individuals should not get the Pfizer-BioNTech COVID-19 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 
 
   -- 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); diarrhea; vomiting; arm pain 
 
   -- These may not be all the possible side effects of the vaccine. Serious 
      and unexpected side effects may occur. The vaccine is 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

There is no information on the use of the vaccine with other vaccines.

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August 26, 2021 06:46 ET (10:46 GMT)