Pfizer and BioNTech have the ball rolling on their mRNA-based COVID-19 vaccine candidates with late-stage human testing set to begin later this month. And as they barrel toward a potential regulatory review, the partners are starting to cut deals with national buyers.
Pfizer and BioNTech inked a deal with the U.K. government to supply 30 million doses of an mRNA-based COVID-19 vaccine hopeful over the next two years, the partners said in a joint release Monday.
The U.K. pact is part of Pfizer and BioNTech's goal to churn out 100 million doses of a winning vaccine within the year and eventually produce 1.3 million doses by the end of 2021, the drugmakers said.
The partners plan to enter phase 2/3 human trials for multiple vaccine candidates later this month and hope to submit for regulatory review by October. The supply deal with the U.K. would be contingent on an eventual approval or emergency authorization, Pfizer said.
The drugmakers are studying four vaccine candidates as part of the BNT162 program, Pfizer said. Last week, the FDA fast-tracked its review of two of those hopefuls—BNT162b1 and BNT162b2—both of which are currently being studied in phase 1/2 trials.
Monday, Pfizer released new data from the BNT162b1 studies showing a dose-dependent response of neutralizing antibodies for SARS-Cov-2 and elevated T-cells in 60 patients.
The partners have entered "advanced discussions with multiple other government bodies and hope to announce additional supply agreements soon," BioNTech CEO and co-found Ugur Sahin, M.D., said in the release.
As Pfizer looks to piece together supply for its vaccine hopefuls, other major players in the COVID-19 shot race are looking to accomplish the same thing.
Last week, Reuters reported that a range of drugmakers and biotechs, including Johnson & Johnson, Sanofi, Moderna, Pfizer and CureVac, were looking to snare national supply deals for their own candidates.
J&J was reportedly in talks with the Japanese government and the Bill & Melinda Gates Foundation to supply doses of its COVID-19 vaccine hopeful as the drugmaker prepared to start human testing this week. In an interview with Reuters, CFO Joe Wolk said Japan and the Gates Foundation—which would distribute the vaccines to developing nations—are looking to lock in "a certain minimum level" of supply if J&J's vaccine receives international approval.
No deal has yet been finalized, Wolk said, but potential agreements would resemble the $1.2 billion development deal British drugmaker AstraZeneca signed with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) in May to secure capacity for U.S. supply.
Meanwhile, the European Union is also working to cobble together its own supply deals with most of the major vaccine players, including J&J, Sanofi, Moderna, BioNTech and Curevac, two EU sources told Reuters.
British drugmaker AstraZeneca has set the tone for the supply deal spree with a suite of pacts fleshing out its stated goal of producing 2 billion doses of the University of Oxford's adenovirus-based vaccine, AZD1222, each year.
In May, AstraZeneca inked pacts with the U.S. and UK pledging 400 million doses of its vaccine by the end of 2020. The drugmaker followed those deals up with a supply pact in June to give 400 million doses of the shot to the EU at no profit, AstraZeneca said.
According to Reuters, the EU is interested in renegotiating that deal—which was signed with just four countries—to ensure that supply is spread evenly to all 27 member states.