BioCentury
ARTICLE | Regulation

AZ COVID-19 vaccine back on track in U.S. as Moderna, Pfizer look ahead to EUA submission

October 24, 2020 1:44 AM UTC

FDA’s decision Friday to allow AstraZeneca to restart evaluation of AZD1222 provides the first indicator of how long clinical holds for COVID-19 countermeasure trials may last in the U.S., assuming the candidate is eventually deemed safe enough for trials to continue.

The announcement came a day after Moderna Inc. (NASDAQ:MRNA) became the first COVID-19 vaccine developer to announce it had completed enrollment in a pivotal trial for its candidate, mRNA-1273. The biotech, which is developing the vaccine with NIAID, expects to have enough safety data to seek an EUA, assuming the vaccine has also met efficacy criteria in the Phase III COVE study, on Nov. 25...

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