AstraZeneca's late-stage U.S. study of COVID-19 vaccine still on hold - Azar

In an interview on CNBC today, HHS Secretary Alex Azar stated that the pivotal Phase 3 study in the U.S. evaluating the safety and immunogenicity of AstraZeneca's (AZN +1.7%) COVID-19 vaccine candidate AZD1222 remains on hold while federal investigators seek “answers to important questions” regarding its safety.

The study was paused on September 6 after a subject in the U.K. experienced a serious adverse reaction after inoculation.

The feds are taking time to thoroughly investigate the event amidst concerns among Americans that fast-tracked vaccines may not be subject to the requisite rigor to ensure their safety and efficacy.

“The president’s made it clear, I’ve made it clear, the FDA commissioner has made it clear, and the CEOs of the relevant companies have made it clear — this is going to be by the book based on science, data and the law,” Azar told CNBC.

https://seekingalpha.com/news/3616580-astrazenecas-late-stage-u-s-study-of-covidminus-19-vaccine-still-on-hold-azar