Appointed less than two weeks before the coronavirus outbreak, commissioner Stephen Hahn has found himself at a crossroads between FDA, Congress and the White House throughout the pandemic (AP Images)
Covid-19 roundup: Moderna starts lining up potential EU approval for vaccine; Hahn rejected White House push to rebrand EUA — Politico
Underscoring Moderna’s global ambitions for its Covid-19 vaccine, the company says that the EMA has confirmed its eligibility to file for marketing authorization using its centralized process. The move sets up a fast-track review process aimed at maneuvering through the regulatory group and onto the European market in speedy fashion — provided the data continue to line up.
Moderna is allied with Lonza on a manufacturing plan for Europe, looking to make 500 million to a billion doses a year, beginning in 2021.
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