Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.

SK Bioscience has received the world’s first approval of its in-house developed recombinant protein COVID-19 vaccine SKYCovione (GBP510), in its home market of South Korea, two years after it began development. Strong support from the domestic government and international cooperation helped pave the way.

The company’s lipid nanoparticle technology can deliver mRNA, gene editing and other cargoes to multiple cell and organ types. ReCode aims to expand its pipeline beyond lung diseases.

CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.