AZ, US Approval Application Delayed... Data Organization Difficulties

On the 25th, one day before the COVID-19 vaccination, medical staff at Songpa-gu Public Health Center in Seoul are inspecting the AstraZeneca vaccine. Photo by Mun Ho-nam munonam@

[Asia Economy Reporter Cho Hyun-ui] The U.S. Food and Drug Administration (FDA) has delayed the emergency use authorization application for the AstraZeneca (AZ) COVID-19 vaccine, which has been associated with rare blood clot controversies. This is because AZ is facing difficulties in organizing the data required for U.S. approval.

The Wall Street Journal (WSJ) reported on the 29th (local time), citing sources, that "Last month, AZ said it would apply for emergency use authorization from the FDA by mid-May, but recently told U.S. authorities that it needs until mid-May."

It is reported that AZ is taking a long time to organize and edit data related to the vaccine’s real-world administration in the UK over four months, including preventive effects, virus transmission, and safety.

The U.S. has secured enough vaccines from Pfizer, Moderna, and Johnson & Johnson, so the AZ vaccine is not absolutely necessary. However, AZ, whose vaccine use was suspended in some countries due to concerns about blood clot side effects, is determined to obtain U.S. approval. A source said, "AZ expects FDA approval to increase confidence in its vaccine."

Countries around the world, including Europe, recommend the use of the AZ vaccine, judging that the risk of rare blood clots is smaller than the risk of COVID-19 infection, but they have restricted the age groups for its use. However, AZ stated that no such blood clot cases occurred in clinical trials conducted in the U.S.

In U.S. clinical trials, the preventive efficacy of the AZ vaccine was recorded at 76%. This is much higher than the FDA standard (over 50%) but lower than Pfizer and Moderna, which are in the 90% range.

This content was produced with the assistance of AI translation services.