US FDA’s Comirnaty Review By The Numbers
Executive Summary
A timeline of the review and development of the first COVID-19 vaccine to win BLA approval.
You may also be interested in...
Novavax Readies COVID-19 Vaccine Request For EUA, But How Much Longer Will The Door Be Open?
Availability of emergency authorization route in US depends upon lack of 'adequate, approved and available alternatives,' but as more vaccines make their way through the BLA process sponsors may find the EUA door slowly closing.
Pfizer First: Oral Antiviral Paxlovid Wins EUA As Merck’s COVID Pill Languishes At US FDA
Authorized for mild-to-moderate COVID-19 in patients 12 and older at high risk for severe disease, Paxlovid (nirmatrelvir/ritonavir) jumped ahead of Merck & Co./Ridgeback’s molnupiravir in the EUA queue for oral antivirals, with the latter possibly hung up by efficacy and safety concerns.
Data Integrity: COVID-19 Impacted Studies Pose Unique Enforcement Risks
Move toward decentralized trials means sponsors may be working with naïve clinical investigators who lack experience, Greenleaf’s Cynthia Schnedar says; DoJ’s Gustav Eyler urges drug sponsors to look for oddities in clinical trial data and to voluntarily report potential misconduct.