Pfizer, BioNTech to Supply Japan With 120 Million Doses of COVID-19 Vaccine

Pfizer and BioNTech have signed an agreement with Japan’s Ministry of Health to supply the country with 120 million doses of their COVID-19 vaccine.

The companies did not disclose the financial terms of the agreement but said they are based on the timing of delivery and the volume of doses. Deliveries are planned to begin in the first half of 2021.

The experimental vaccine, BNT162b2, advanced to an international global phase 2/3 trial last week. The study will involve up to 30,000 participants at approximately 120 sites globally (DID, July 28).

The companies said they are on track to seek regulatory review of the vaccine candidate as soon as October in the U.S. if the global clinical trials go well. Once they receive regulatory authorization or approval in the U.S., it would open the door to approvals elsewhere. The companies said they plan to supply up to 100 million doses globally by the end of the year and approximately 1.3 billion doses by the end of 2021.

Two additional vaccine candidates being developed by Pfizer and BioNTech were granted Fast Track designation by the FDA in mid-July, based on preliminary data from ongoing phase 1/2 studies in the U.S. and Germany (DID, July 14). — James Miessler