AstraZeneca’s COVID-19 vaccine candidate will undergo increased scrutiny by regulators because of the promising but confusing interim analysis results from a late-stage trial that found a one-and-a- half-dose regimen — given by mistake — was significantly more effective than a full double dose.

The FDA yesterday issued a final guidance outlining the process for sponsors and researchers to submit plans for new drug development tools (DDT) to the agency for approval.

AstraZeneca’s (AZ) and the University of Oxford’s COVID-19 vaccine candidate — which has been shown to be 90 percent effective at a one-and-a-half-dose level — could be a godsend for low- and middle-income nations due to its relative ease of distribution, high manufacturing capacity and the not-for-profit price the drugmaker has vowed to offer developing countries “in perpetuity.”