=BioNTech (BNTX) and Pfizer (PFE) to deliver 600 mln doses of SARS-CoV-2 vaccine candidate

BioNTech (BNTX) and Pfizer (PFE) reach agreement with the US government for up to 600 mln doses of SARS-CoV-2 vaccine candidate

Pfizer and BioNTech today announced the execution of an agreement with the US Department of Health and Human Services and the Department of Defense to meet the U.S. government's Operation Warp Speed program goal to begin delivering 300 mln doses of a vaccine for COVID-19 in 2021. Under the agreement, the US government will receive 100 mln doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the FDA.

• The US government will pay the companies $1.95 bln upon the receipt of the first 100 mln doses, following FDA authorization or approval. The US government also can acquire up to an additional 500 mln doses.

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

The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 mln doses by the end of 2020 and potentially more than 1.3 bln doses by the end of 2021.