Early Purchase of AstraZeneca Vaccine by Korea, US Approval Unlikely Within This Year

[Asia Economy Reporter Koo Chae-eun] An analysis has emerged that the COVID-19 vaccine developed by the British company AstraZeneca may not receive approval for use from the U.S. government within this year. The AstraZeneca vaccine is currently the only vaccine for which South Korea has signed a pre-purchase agreement.

On the 8th (local time), The New York Times (NYT) reported, citing sources, that AstraZeneca has lost the trust of the U.S. Food and Drug Administration (FDA), making it difficult to obtain FDA approval within the year.

According to the report, the FDA's concern lies in AstraZeneca's opaque communication methods. AstraZeneca halted clinical trials twice, in July and September. At those times, most senior FDA officials did not receive proper explanations from AstraZeneca. The same was true when the September trial was suspended. AstraZeneca did not report the trial suspension at the FDA meeting held on September 8.

The NYT stated, "FDA officials only learned about it hours after the meeting during a conference call with investors hosted by JP Morgan." In response, AstraZeneca rebutted, "We are sharing all data with the FDA and regulatory authorities worldwide in a timely manner."

Questions have also been raised about the vaccine's preventive efficacy. Previously, AstraZeneca announced that the Phase 3 clinical trial results showed an average preventive efficacy of 70%. Later, it was revealed that the low-dose administration method, which showed 90% efficacy, was due to a research team's error, and additional trials are currently underway.

Meanwhile, the AstraZeneca vaccine is the COVID-19 vaccine for which South Korea has completed a pre-purchase contract for 20 million doses, enough to vaccinate 10 million people. The government announced plans to secure vaccines for about 44 million people from four global pharmaceutical companies, including AstraZeneca, Janssen, Moderna, and Pfizer. Among these, the contract with AstraZeneca has already been finalized.

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