In the hunt for a COVID-19 vaccine, no front-runner is moving as quickly as Pfizer and BioNTech's mRNA-based shot, which is scoping an October regulatory review. Despite some technical concerns about their proposed rollout plans, the partners are moving ahead with their largest supply deal yet.
Pfizer and BioNTech are working to close a supply deal with the EU for up to 300 million doses of their vaccine starting at the end of the year, the partners said in a Wednesday release.
A final EU deal—which could be nearing after the parties "concluded exploratory talks" this week—would be the single largest signed by Pfizer and BioNTech in their quest to distribute 100 million doses of their BNT162 shot by the close of 2020.
The agreement would provide an initial order of 200 million doses to the EU's 27 members states with the option for an additional 100 million doses at a later date, the companies said.
European supply of BNT162, a clinical program investigating four variations of an mRNA-based vaccine, would be produced at Pfizer's manufacturing site in Belgium and BioNTech's facilities in Germany, the partners said. The deal is contingent on the shot securing regulatory approval, and financial terms were not disclosed.
The FDA has fast-tracked development and review of two BNT162 candidates with one of those, BNT162b2, entering a phase 2/3 human trial that hopes to enroll 30,000 patients worldwide. Pfizer and BioNTech are aiming for a first wave of regulatory approvals as early as October, with a goal of churning out 1.3 billion doses by the end of 2021, they said.
In addition to the proposed EU deal, Pfizer and BioNTech are also aiming to secure a supply pact with Covavax, a joint initiative between the World Health Organization, the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance, to supply vaccines to emerging markets.
Among the COVID-19 vaccine front-runners, Pfizer and BioNTech are aiming for the speediest regulatory go-ahead for their candidate, but the logistical challenge of getting their shot into patients' hands could be a major issue.
Citing discussion from a Centers for Disease Control and Prevention advisory committee meeting, SVB Leerink analysts last month said experts expressed concern that the temperatures required to store mRNA vaccines, including Pfizer and BioNTech's, were "severely limiting" to distributors' ability to ship the shots and to clinics' ability to administer them to a wide swath of patients.
Analysts specifically cast doubt on Pfizer and BioNTech's rollout plans given the stringent cold-storage needs for their candidate, which must be kept at a frigid -94° Fahrenheit (-70° Celsius), and will last for only 24 hours at refrigerated temps between 35.6°F and 46.4°F (2°-8°C).
By contrast, most protein subunit vaccines—the type being developed for COVID-19 by Sanofi and Novavax, among others—can be held at refrigerated temps for months, analysts said.
Even still, Pfizer and BioNTech are moving ahead to lock in a number of supply deals for a global-scale rollout if their candidate passes regulatory muster.
In July, the partners signed what was then their largest distribution pact with the U.S. for $1.95 billion and at least 100 million doses of their shot. The drugmakers followed that up with Japanese supply deal worth 120 million doses, with the financial terms contingent on the timing of the future deliveries.
Pfizer was one of a group of drugmakers in the vaccine race that pledged this week not to rush inconclusive human data through an FDA emergency use process that has courted accusations of political influence in the lead-up to the Nov. 3 election.