US FDA Strengthens Emergency Approval Criteria for Vaccines... 'Pre-Election Release' Becomes Impossible

At Least 2 Months of Clinical Follow-up Required After Phase 3
White House Delays but Ultimately Approves After Review

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) has announced strengthened emergency use authorization criteria for the novel coronavirus disease (COVID-19) vaccines compared to previous standards. As a result, pharmaceutical companies developing vaccines must track the condition of clinical trial participants for at least two months after completing the clinical process to receive approval, making the "pre-election release" advocated by President Donald Trump impossible. It is reported that the White House initially opposed the FDA's new criteria but eventually approved them.

According to foreign media including The New York Times (NYT), on the 6th (local time), the FDA announced new criteria for the strengthened emergency use authorization of COVID-19 vaccines. According to these criteria, pharmaceutical companies must report on the condition of clinical trial participants for at least two months after the completion of Phase 3 clinical trials. With the addition of this two-month participant follow-up as a new requirement, the anticipated vaccine release in the U.S., expected as early as the end of this month or early next month, has become impossible. The vaccine releases from AstraZeneca, Moderna, and Pfizer, which are currently conducting Phase 3 trials, are also expected to be delayed by more than two months.

Among them, Pfizer's vaccine, which is expected to yield the fastest results, had its Phase 3 trial participants receive the final dose only at the end of last month. Accordingly, President Trump's earlier claim of a "vaccine release before the election" has become impossible. The release of a vaccine within this year has also become uncertain, and it is now anticipated that the first vaccine release will be possible in the first half of next year at the earliest.

According to The Wall Street Journal (WSJ), the White House had previously raised doubts and opposed the FDA's strengthened approval criteria. The FDA submitted the new criteria to the White House on the 21st of last month, but Mark Meadows, White House Chief of Staff, and other aides to President Trump opposed the approval of the criteria, and thus the White House had not approved it until now, WSJ reported. On the same day, FDA Director Stephen Hahn stated in a press release, "We hope that through the new criteria, our 'science-based decision-making process' that guarantees the quality, efficacy, and safety of vaccines will be understood," which was interpreted as subtly hinting at pressure from the White House.

The White House has completely denied these allegations. A spokesperson for the White House Office of Management and Budget told WSJ, "We have never opposed the FDA's criteria, nor have we delayed them."

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