Moderna Prepping for Global Distribution as It Remains on Pace to File for Vaccine EUA in Next Couple Weeks

Moderna is still on track to file for Emergency Use Authorization (EUA) for its COVID-19 vaccine in the later part of November and is currently gearing up for worldwide distribution.

CEO Stéphane Bancel said Thursday that the company still expects to have the two-month safety follow-up data needed to file for an EUA for its candidate, mRNA-1273, in the second half of November. The company will request emergency authorization from the FDA after confirming the vaccine safety and efficacy data are positive. The pharma executive presented the same timeline last week, meaning the company remains on track to potentially receive an EUA before the end of the year (DID, Oct. 21).

An interim analysis of phase 3 trial data is expected next month, Bancel added, and the study is now fully enrolled with 30,000 participants, more than a third (37 percent) of whom are from “diverse communities.”

So far, Moderna has received $1.1 billion in cash payments from governments securing doses of the company’s promising vaccine and is on track to supply between 500 million and 1 billion vaccine doses next year. The drugmaker expects to have around 20 million doses ready to ship in the U.S. by the end of the year and is actively preparing to supply the vaccine around the globe.

Currently, Moderna’s smaller-scale agreements price the vaccine between $32 and $37 per dose, while the U.S. is paying $25 per dose for its first 100 million doses when factoring in a grant from HHS’ Biomedical Advanced Research and Development Authority and potential performance-based payments, the company said.

Also on Thursday, Moderna announced a three-way partnership with Takeda Pharmaceuticals and the Japanese government that nets Japan 50 million doses of the vaccine candidate.

Pfizer may also file for an EUA late in November for its vaccine candidate, BNT162, which it is developing jointly with BioNTech, Pfizer CEO Albert Bourla said earlier this month (DID, Oct. 19). That puts Pfizer neck and neck with Moderna in the race to become the first vaccine authorized for emergency use.

AstraZeneca (AZ) and Johnson & Johnson, which just recently resumed their late-stage U.S. trials after safety event investigations had halted them, also have strong contenders in the vaccine research race, but they may not be as close to the finish line. AZ said that it currently anticipates having phase 3 trial results “later this year,” while J&J did not give an estimated forecast for regulatory approval after it announced it was resuming its trial. — James Miessler