US FDA Expert: "Moderna Fails to Meet Booster Shot Requirements... Limited Expected Effect"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Suhwan] Experts affiliated with the U.S. Food and Drug Administration (FDA) stated that the Moderna vaccine does not fully meet the requirements for a booster shot (additional vaccination). As the FDA's decision on approving the Moderna booster shot approaches, the conclusion reached by internal experts is likely to influence the FDA's decision.

According to the Wall Street Journal (WSJ) on the 12th (local time), after reviewing data related to the Moderna vaccine, FDA experts reported that "the additional dose of the Moderna vaccine was found to be safe," but they were unable to decide that it was suitable for use as a booster shot.

The internal experts explained that the reason for this conclusion was that two doses alone provided sufficient immune response.

Through the data released that day, they confirmed that the additional Moderna vaccine dose increased immune effectiveness. However, experts expressed a cautious stance on approving the use of the booster shot, as it was reported that not enough new antibodies were formed to justify a full-scale booster shot administration.

This report came ahead of the FDA's decision on approving the Moderna vaccine booster shot.

Although the opinions of these experts are largely advisory, considering that the FDA typically follows their recommendations, it is highly likely that their views will influence the final approval decision for the booster shot.

Professor John Moore of Weill Cornell Medical College questioned, "There was an effect from the booster shot. But was it sufficient?"

Another issue is the lack of sufficient clinical data on the Moderna vaccine booster shot.

Previously, in the case of the Pfizer vaccine, large-scale booster shot administration in Israel provided ample clinical data.

Professor Eric Topol of the Scripps Research Translational Institute pointed out, "There seem to be many gaps in the various data related to the Moderna vaccine," highlighting the limited clinical data available for booster shot approval.

Meanwhile, on the same day, The New York Times (NYT) disclosed Moderna's booster shot application documents, reporting that Moderna requested the FDA to approve a half-dose of the regular vaccine as a booster shot for individuals who completed their vaccination at least six months prior.

They explained that clinical trial results showed that the third dose raised antibody levels, one of the indicators of immune system response, higher than before the second dose.

Moderna stated in its own analysis that its vaccine overall "still provides protective effects against severe COVID-19 disease and death in the United States."

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