Moderna’s COVID-19 Second Booster Authorization Largely Thanks To Pfizer/BioNTech Data
Safety and effectiveness of an mRNA-1273 second booster dose was inferred in large part by extrapolation from reported evidence following use of the Pfizer/BioNTech COVID-19 vaccine in individuals 60 years and older in Israel, FDA review memos show.
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US FDA was trying to focus people on a one-booster-per year, updated fall COVID vaccine campaign to address what they perceive as the public’s inoculation exhaustion, but as BA.5 seems to be sending the US into another surge the White House is pushing a summer booster campaign.
FDA’s chief information officer talks to the Pink Sheet about why the agency relied on COVID data from foreign countries, and describes pilot projects to target inspections and manage warehouse data.
Application could be first major test of FDA’s comfort in authorizing a product with vaccine efficacy estimated to be at or below 50%. ‘Final components’ of the request to be submitted in the coming week. In interview, Moderna CMO Burton says results are ‘really strong.’