With interim results out of the way, Pfizer and BioNTech are looking to speed their COVID-19 vaccine ahead to a regulatory approval in the coming weeks and into high-risk patients' arms. And, thanks to a new supply deal with the EU, the road is clear for a rollout on the continent.
Pfizer and partner BioNTech snared a distribution deal with the EU for up to 300 million doses of their mRNA-based COVID-19 shot candidate, BNT162b2, with initial deliveries slated by the end of the year, the companies said Tuesday.
While the financial terms of the deal were not disclosed, a similar pact signed between the partners and the U.S. back in July could illuminate Pfizer and BioNTech's expected revenue. The U.S. secured 100 million doses for a cool $1.95 billion—or $19.50 per dose—which would put the EU supply deal's value at $5.85 billion.
However, an EU official told Reuters that the per-dose price tag for the bloc's deal would be lower than in the U.S., given Europe's funding for the shot's development. Where the price will fall is still unknown, but the official said it would be closer to $20 than $10.
Finalized terms for the long-awaited pact in Europe come just days after Pfizer and BioNTech announced results showing their shot's strong efficacy in early, limited data from their phase 3 trial—the first drugmaker to do so in the race for a COVID-19 vaccine.
The mRNA vaccine comes in a two-dose regimen, meaning up to 150 million EU residents could potentially be vaccinated under the deal. The EU bagged an initial 200 million doses with an option to get an additional 100 million at a later date.
All European doses will be produced at BioNTech's German facilities as well as a Pfizer site in Belgium, the companies said. The EU bloc will be in charge of distribution to its member states.
With the EU locked up in the short term, Pfizer and BioNTech aren't done icing new supply deals for BNT162b2, which the companies hope to submit for the FDA's emergency use authorization later this month, pending expanded efficacy data and two months of safety follow-up.
The partners have also sent an "expression of interest" to supply the COVAX facility, a vaccine clearinghouse for emerging markets established by the World Health Organization; Gavi, the Vaccine Alliance; and the Coalition for Epidemic Preparedness Innovations.
With supply deals inked or in the works through most of the world's most populous regions, Pfizer will soon be tasked with putting its global rollout plans to the test. That will include hurdling cold-storage requirements for its vaccine that could impede distribution efforts in developing nations.
While most protein subunit vaccines, like rival COVID-19 shots in development at Sanofi and Novavax, can be held at refrigerated temps for months, Pfizer's vaccine must be kept at a frigid -94 degrees Fahrenheit (-70 degrees Celsius), and will last for only 24 hours at refrigerated temps between 35.6 F and 46.4 F (2 C and 8 C).
Meanwhile, in the U.S., Pfizer is striking out alone on distribution rather than relying on the government's distribution partner, McKesson.
Pfizer's $1.95 billion deal with the U.S. covers 100 million doses to be shipped to vaccination sites by the end of 2021, Pfizer said. The company hopes to distribute around 40 million doses in the U.S. before the end of this year and will be ready to launch immediately after receiving the FDA's emergency nod, CEO Albert Bourla, Ph.D., said in an October earnings call with analysts.