CDC Panel Okays Use Of Omicron Bivalent COVID-19 Vaccines Despite Lack Of Clinical Data
One member says the vote was premature, but others conclude extrapolation of clinical data from another vaccine was sufficient given similar experience with flu vaccines and the potential to save thousands of lives.
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New COVID Treatments Face FDA, Commercial Barriers Despite Ongoing Need
Sponsors want more endpoint clarity as current state of government pandemic response, along with scientific and regulatory hurdles, is constraining efforts to refill a shrinking COVID medicine cabinet and could create vulnerabilities for future pandemics.
Novavax Hopes COVID-19/Flu Vaccine Combo Can Help It Keep Up With mRNA Leaders
Novavax recently slashed its revenues forecasts, but is hoping a two-in-one COVID-19 and flu combination could help it carve out space in the post-pandemic market.
COVID-19 Vaccine Manufacturers Urged To Make Labeling Changes To Avoid Administration Errors
CDC advisory panel members voice concerns about mix-ups in the administration of COVID-19 vaccines. Pfizer’s bivalent and monovalent vaccines have the same gray cap while Moderna has different colored caps for its two versions.