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Latest From BioNTech SE
Operational actions, organizational responses and clinical development model improvements led to a 26-month acceleration, on average, in a set of COVID-19 vaccine pivotal trials versus similarly sized pre-pandemic studies, with the database lock and analysis stage delivering dramatic gains, a study by IQVIA Institute indicates. Can these benefits be recapitulated across the portfolio in the post-pandemic era?
The company will shift development of INO-4800 to a booster strategy. It also announced it must conduct additional studies of the cervical dysplasia drug VGX-3100 after an FDA meeting.
Peter Marks says agency will proceed to meeting once Pfizer and/or Moderna complete their submissions and that the two may be considered at the same VRBPAC panel. FDA's effectiveness standard has not changed, CBER director says, but acknowledges that vaccines might be a little less effective than 50% in subpopulations.
The path for developing a variant-adapted COVID-19 vaccine remains uncertain, but the company expects to have more clarity following an FDA advisory committee meeting in June.
- Antisense, Oligonucleotides
- Large Molecule
- Other Names / Subsidiaries
- BioNTech US Inc.
- Biopharmaceutical New Technologies AG
- Neon Therapeutics, Inc.
- BioNTech AG