Coronavirus Update: Moderna’s Omicron Vaccine Study Successful, But Data Draw Skepticism
AstraZeneca also published efficacy data for Evusheld in patients with mild-to-moderate COVID-19, while Pfizer is investing $120m in expanding its Paxlovid manufacturing footprint in Michigan.
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FDA advisors will vote 28 June on whether an Omicron component should be included in new COVID-19 booster vaccines. Following WHO recommendations, the FDA may no longer also be looking to update the primary vaccine series at this time.
The bivalent vaccine is likely to get regulatory support, along with government contracts, but competitors, notably Moderna, will also step into the ring.
The company announced updated results from a standard-risk study, which it will include in its overall new drug application, but whether Paxlovid will see approval or uptake in that group is another question.