The U.S. government will pay $1.95 billion to Pfizer Inc. and Biontech SE for the first 100 million doses of their jointly developed mRNA-based COVID-19 vaccine once Pfizer manufactures it and receives the FDA’s approval or emergency use authorization. The two companies agreed, as part of Operation Warp Speed, to begin delivering 300 million doses of a COVID-19 vaccine in 2021.
Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, AGTC, Jazz, MC2, Redhill.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Channel Medsystems, Lifesignals, OralDNA Labs, Paige.
A safe, effective COVID-19 vaccine may be available by the end of the year or early next year, as will the supplies needed to deliver and administer hundreds of millions of doses. That’s the message five biopharma executives delivered to a House subcommittee July 21 as they updated U.S. lawmakers on the progress their companies are making on the vaccine front.
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