Canada Begins Reviewing AstraZeneca's Coronavirus Vaccine, U.S. Study Still Not Restarted
Add Canada to the list of countries reviewing AstraZeneca's (NYSE: AZN) coronavirus vaccine, AZD1222, before the phase 3 clinical trial is complete. The European Medicines Agency is also conducting a rolling review of the vaccine.
The rolling submissions likely include information from the chemistry, manufacturing, and controls section of the marketing applications. In addition to efficacy results, regulators look at the manufacturing of a drug to make sure there aren't variations between manufacturing runs. The section also contains stability tests, which determine what temperature the drug is stored at and its shelf life. AstraZeneca can also submit preclinical animal safety data before the phase 3 data is ready to be submitted.
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Source Fool.com
