US FDA Begins Investigation into AstraZeneca Clinical Trial Side Effects

Clinical Trials on Hold Until Side Effect Investigation Ends
Vaccine Release Unlikely Before US Presidential Election

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) announced that it has launched an investigation into AstraZeneca's novel coronavirus disease (COVID-19) vaccine, following reports of side effects during clinical trials in the United Kingdom. The FDA stated that it will not approve the resumption of clinical trials until a thorough investigation confirms that there are no serious safety issues, leading to predictions that vaccine rollout before the U.S. presidential election is practically unlikely.

According to CNBC and major foreign media on the 15th (local time), Steve Hahn, FDA Commissioner, said in an Instagram Live interview with U.S. Senator Tim Scott that AstraZeneca's vaccine clinical trials in the U.S. remain halted. He stated, "We will conduct extensive work related to AstraZeneca to determine if there are any serious safety issues." He added, "We have not yet secured all the facts and do not know the exact cause of the side effects," emphasizing the need for a careful review. The FDA indicated that it will not resume vaccine trials until safety inspections are complete, suggesting that the AstraZeneca vaccine's release will be delayed beyond initial expectations.

AstraZeneca, developing the vaccine in collaboration with Oxford University in the UK, announced on the 8th that it would halt global clinical trials after an unexplained illness was detected in one participant during ongoing trials in the UK. Subsequently, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine as safe, allowing clinical trials in the UK to resume. Health authorities in Brazil and the Republic of South Africa also approved the resumption, and clinical trials are currently underway in those countries.

The FDA has not disclosed how long the safety investigation will continue, so it is expected that the resumption of clinical trials in the U.S. will be difficult until the investigation results are announced. Accordingly, there are growing predictions that the Trump administration's plan to distribute the vaccine before the November 3 U.S. presidential election has become virtually impossible.