Add Canada to the list of countries reviewing AstraZeneca's (AZN 5.38%) 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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A rolling submission will shave time off the review, although it's hard to know exactly how much time it will save. Normally, regulators take months to review drugs, but given the unmet need, regulatory agencies are likely to have all hands on deck. By reviewing everything but the phase 3 data, the regulators should be able to wrap up the review fairly quickly.
Regulators will likely want to spend substantial time looking at the safety section of the application after a serious illness in a participant in the phase III U.K. study of AZD1222 caused the worldwide studies to be paused. Clinical trials of the vaccine in the U.K., Brazil, South Africa, India, and Japan have resumed, but the Food and Drug Administration will continue to review the safety data before letting the U.S. study resume.
