"72% Effectiveness After One Dose... Increases to 94% with Booster Shot"
[Asia Economy Reporter Kim Suhwan] Internal experts at the U.S. Food and Drug Administration (FDA) have expressed positive opinions on approving the booster shot of Johnson & Johnson (J&J) subsidiary Janssen's COVID-19 vaccine, stating that the booster provides significant immune benefits.
On the 13th (local time), CNBC and The Wall Street Journal (WSJ) reported that FDA internal experts concluded that the booster shot of the Janssen vaccine has a substantial effect.
They released a report stating, "Based on the data available so far, it appears that receiving an additional dose within two months after the initial Janssen vaccine dose results in a significant immune response."
However, they added that further review is necessary for the final approval of the Janssen vaccine booster shot.
Although the opinions of FDA internal experts are advisory in nature, considering that the FDA typically follows their recommendations, these views are likely to influence the final decision on booster shot approval.
FDA researchers particularly noted that when the Janssen vaccine is administered as a single dose according to existing guidelines, it shows relatively lower immune efficacy compared to Pfizer and Moderna vaccines, and thus expressed a positive stance on booster shot administration.
Until now, the Janssen vaccine has been reported to provide sufficient immune protection with just one dose, unlike other vaccines.
However, FDA researchers reviewed the data and found that the immune efficacy after one dose of the Janssen vaccine was 72%, which is relatively lower than the over 90% efficacy shown by Pfizer and Moderna vaccines.
They analyzed that administering an additional dose within two months after the initial Janssen vaccine shot increased immune efficacy significantly to 94%, highlighting the necessity of the Janssen vaccine booster shot.
However, they noted that the sample size of clinical data for individuals aged 60 and older was limited, stating, "We have not reached a conclusion regarding booster shot administration for the elderly."
FDA experts also added, "Even with just one dose of the Janssen vaccine, there is considerable effectiveness in preventing severe COVID-19 infection and reducing mortality."
Previously, FDA experts had expressed a cautious stance on the booster shot for the Moderna vaccine.
The internal research report released on this day came ahead of the FDA's planned meeting on the 15th, where external experts will discuss whether to recommend approval of the Janssen vaccine booster shot. The FDA intends to make a final decision a few days after summarizing expert opinions from the meeting.
Norman Baylor, who worked as a vaccine expert at the FDA, told CNBC on this day, "The booster shot effect of the Janssen vaccine appears to be quite significant," adding, "From the beginning, the Janssen vaccine should have been administered as a two-dose regimen."
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