30 June 2022 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) have inked a new vaccine supply agreement with the US government to support the continued fight against COVID-19, the companies said.

Under the agreement, the US government will receive 105 m doses (30 µg, 10 µg and 3 µg).

This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the US Food and Drug Administration.

The doses are planned to be delivered as soon as late summer 2022 and continue into 4Q22.

The US government will pay the companies USD 3.2bn upon receipt of the first 105m doses.

Under this agreement, the US government also has the option to purchase up to 195m additional doses, bringing the total number of potential doses to 300 m.

On June 25, 2022, Pfizer and BioNTech reported pivotal data demonstrating the safety, tolerability and immunogenicity of two Omicron-adapted vaccine candidates.

These data have been shared with regulators, including the FDA, and a request for US Emergency Use Authorization is planned.

The companies have begun manufacturing the Omicron-adapted vaccine candidates at risk so that they can begin deliveries rapidly upon authorization or approval and subsequent recommendation by the US Centers for Disease Control and Prevention's, if received, and as directed by the US government.

Eligible US residents will continue to receive the vaccine for free, consistent with the US government's commitment for free access to COVID-19 vaccines.

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 United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.