WHO, "Approving COVID Vaccine Too Quickly May Overlook Side Effects"

Russia-China Phase 3 Clinical Trial Pre-Approval Followed by US Moves, Warning Intended
"Emergency Approval Must Be Accompanied by Subsequent Safety Measures"

[Image source=AP Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The World Health Organization (WHO) has warned that caution is needed regarding the rapid approval of COVID-19 vaccines by various countries, as the United States is showing signs of approving vaccines that have not completed clinical trials, following Russia and China. It is pointed out that if approval is granted too quickly, it becomes difficult to properly identify risks such as side effects.

According to foreign media including CNBC on the 31st (local time), Soumya Swaminathan, WHO Chief Scientist, said at a press conference held that day, "Countries have the authority to approve drugs that have not completed clinical trials, but this is not something to be taken lightly," and warned, "Vaccine development and approval must be approached with caution."

Mike Ryan, head of the WHO Emergency Response Team, also said, "When Ebola broke out in Africa, WHO used vaccines that had not undergone Phase 3 clinical trials for emergency use and achieved success, but vaccines that have not completed full clinical trials require intensive follow-up and safety measures," adding, "If vaccination is rushed for millions of people, some side effects may be missed."

In the vaccine development process, it is customary to undergo three phases of clinical trials to prove the efficacy and safety of the vaccine. Typically, Phase 3 clinical trials are conducted on a large number of participants to check efficacy and safety, including side effects. However, as the damage from COVID-19 snowballs, cases of countries granting fast-track approval before completing Phase 3 trials are increasing.

Recently, the U.S. Food and Drug Administration (FDA) announced that it is ready to approve COVID-19 vaccines before the completion of Phase 3 clinical trials, sparking controversy. It is reported that fast-track approval may be applied to the vaccine jointly developed by AstraZeneca and Oxford University. Earlier, Russia also approved its domestically developed vaccine immediately after completing only Phase 2 clinical trials, raising concerns about efficacy and safety.

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