FDA, Approval of COVID-19 Vaccine Without Completed Clinical Trials? Possibility of Approval Within This Week Raised

U.S. Food and Drug Administration (FDA) Headquarters
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[Asia Economy Reporter Lee Chun-hee] The U.S. Food and Drug Administration (FDA) is expected to soon approve the updated COVID-19 vaccines that have not yet completed clinical trials, according to the Wall Street Journal (WSJ) on the 28th (local time).

Currently, Pfizer and Moderna are developing updated vaccines targeting the Omicron subvariants BA.4 and BA.5, and have applied to the FDA for emergency use authorization. However, clinical trials involving humans for these vaccines have not yet been completed. Moderna has started clinical trials, but Pfizer has not yet begun them.

Nonetheless, there is a forecast that the FDA will approve the use of the vaccines without human clinical trial data. The FDA is reportedly planning to evaluate the safety of the vaccines using other data such as studies on mice and analyses of the original vaccines, since the safety of existing COVID-19 vaccines has already been demonstrated through their use. Robert Califf, FDA Commissioner, recently posted on his Twitter, "Research results on messenger RNA (mRNA) COVID-19 vaccines administered to millions show that these vaccines are safe."

However, approving vaccines without clinical trial data is not the first time this approach has been applied to COVID-19 vaccines. The FDA takes a similar approach every year for newly updated influenza vaccines developed to respond to mutations.

William Schaffner, a professor at Vanderbilt University Medical Center, said, "If we wait for clinical trial results, we would only receive them in the spring," adding, "It is merely an update of the vaccines we have used before."

Nevertheless, some vaccine experts still argue that we should wait until human clinical trial results are available.

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