US FDA Grants Formal Approval for Remdesivir Just Two Months After Application... Controversy Over Hastiness (Comprehensive)

Gilead Approval Application in Just Over Two Months... US First Official COVID-19 Treatment
FDA Credibility Questioned After WHO Declares "Ineffective" a Week Ago
FDA "Vaccine Approval Will Be Live-Streamed via Video Conference"

[Image source=EPA Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) has officially approved remdesivir, an antiviral drug developed by Gilead Sciences, as a treatment for COVID-19. This decision by the FDA comes despite the World Health Organization (WHO) and the international medical community having already given negative evaluations regarding remdesivir's effectiveness in treating COVID-19. Concerns have arisen not only about the controversy over its efficacy but also interpretations that the FDA may have succumbed to pressure from U.S. President Donald Trump to approve the drug before the election, raising doubts about the credibility of U.S. health authorities.

According to foreign media including CNBC on the 22nd (local time), the FDA has granted full approval for remdesivir to be used for all hospitalized COVID-19 patients. Remdesivir had previously received emergency use authorization in May for severe cases. It is now the first COVID-19 treatment to receive full approval from U.S. health authorities.

However, the approval of remdesivir as a treatment has instead fueled controversy. Both its efficacy and the speed of approval unfolded contrary to expectations. The full approval came just over two months after Gilead Sciences submitted its application to the FDA in August. Considering that it usually takes years for a treatment to receive full FDA approval, this recognition came at a lightning-fast pace. Daniel O’Day, CEO of Gilead Sciences, emphasized the unusually rapid approval in a statement released that day, saying, "It is unbelievable that in less than a year, remdesivir has been approved for use in all patients in the U.S. who need it."

Questions about its effectiveness have also surfaced. This is because the U.S. health authorities overturned the WHO’s announcement made just a week earlier that remdesivir was ineffective. On the 15th, WHO announced the results of a trial involving 11,266 COVID-19 patients testing remdesivir and other drugs that had received emergency approval in various countries. The results showed that these drugs did not reduce mortality in severe patients and had no effect on mild cases. Gilead Sciences protested against the WHO’s announcement. In a statement released immediately after WHO’s announcement, Gilead Sciences criticized, "The WHO Solidarity Trial is inconsistent and is a randomized, uncontrolled experiment."

Seemingly aware of the controversy surrounding the full approval, the FDA announced it would make the approval process for vaccines transparent. The FDA declared that it would livestream the vaccine advisory committee meeting held that day via YouTube. According to CNN, the vaccine advisory committee meeting consists of 15 expert advisors who discuss the approval and distribution plans for COVID-19 vaccines. This is the first time the FDA has made such a meeting publicly available in real time.

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