NEW YORK & MAINZ, Germany– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY® (COVID-19 Vaccine, mRNA) 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.