Johnson & Johnson’s coronavirus vaccine booster shot appears to offer benefits, the Food and Drug Administration said in an analysis released Wednesday, but it questioned the sensitivity of a test the company used in its trials, and the regulator said it did not have time to verify much of the data that J&J submitted.
Data submitted by J&J showed that a second dose of the vaccine given two months after the first boosted efficacy in preventing disease to 75%, although it dropped in people ages 60 and above to about 66%, according to a briefing document released ahead of a meeting of an FDA advisory panel Friday that will consider whether to recommend use of a J&J booster shot.
However, J&J’s data sets were not submitted in time for the FDA to independently verify the company’s analysis ahead of the meeting, the document says.
The authors raised concerns that a test J&J used to measure immune responses in trial participants who received a booster after six months may not have been sensitive enough and could have inflated a detected increase in immune response, as well as noting that there were only 17 study subjects in that trial.
The Johnson & Johnson coronavirus vaccine is a single-dose vaccine made using traditional carrier virus methods rather than the mRNA technology used in the Moderna and Pfizer vaccines, which both require a double dose. Johnson & Johnson submitted booster shot information to the FDA for authorization on October 5. The FDA is also reviewing evidence submitted by Moderna to authorize a booster dose. Last month, the agency authorized Pfizer booster doses for seniors and other high-risk patients. Studies indicate vaccinated Americans are widely optimistic about coronavirus vaccine booster shots. A Morning Consult poll released Wednesday found that 80% of vaccinated respondents either planned to get a booster shot or already had.
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