27 August 2021 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) have signed a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture Comirnaty (COVID-19 Vaccine, mRNA) for distribution within Latin America, the companies said.

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 US, and manufacturing of finished doses will commence in 2022.

At full operational capacity, the annual production is expected to exceed 100 m finished doses annually. All doses will exclusively be distributed within Latin America.

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 bn 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 bn doses to low and middle income countries in 2021 and 2022 1bn each year.

This includes direct supply agreements with individual country governments; an agreement to supply 500m doses to the US 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 countries; and a direct supply agreement with COVAX for 40 m 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.