One Goal, Four Paths: Comparing COVID-19 Vaccine Pivotal Trial Protocols
Phase III protocols for COVID-19 vaccine candidates from Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson are similar – but definitely not the same.
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Updated: a graphic tracker of key developments from the leading vaccine candidates.
In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.