Moderna Looks To Catch Up In COVID-19 For Kids, While Still Branching Out In Other Areas
Biotech Teases Non-COVID Respiratory Programs
The company hopes to expand Spikevax’s reach beyond the current approved population while also looking to take the lead in mRNA vaccines in other diseases.
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FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’
Under FDA guidance, the companies submitted clinical data for BA.1-targeting bivalent vaccines together with BA.4/BA.5 preclinical data. Novavax got a nod for its COVID-19 vaccine in adolescents, but its own Omicron development efforts remain behind the two mRNA heavyweights.
Xevudy, which was part of the deal, has already seen restrictions on its use due to diminished efficacy against Omicron. Plus, Ocugen is back in the game as the FDA has released the clinical hold on its Phase II/III vaccine trial, while Pfizer/BioNTech release new booster shot data for Comirnaty in children aged 6 months-5 years.