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 the company’s test used in its trials and the regulator said its Don’t have time to verify pass. Most of the data submitted by J&J
Data presented by J&J showed that the second dose of the vaccine given two months after the first increased efficacy in preventing disease by 75%, although it is more common for people 60 years of age and older. People have fallen to about 66%, according to a briefing document released earlier. FDA advisory panel meeting on Friday to consider whether to recommend the use of the J&J booster shot.
However, J&J’s data sets were not submitted on time For the FDA to independently verify the company’s analysis prior to the meeting, the document says.
The authors raised concerns that a test used to measure the immune response in J&J trial participants may have received a booster after six months. very sensitive And could have amplified a known increase in immune response, as well as noting that there were only 17 study subjects in that trial.
FDA staff reported that some cases were involved in trials submitted by Johnson & Johnson infectious delta version, which is now the major strain in transmission in the US
The Johnson & Johnson coronavirus vaccine is a single-dose vaccine made using traditional carrier virus methods instead of the mRNA technology used in 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 the evidence presented by Moderna to authorize booster doses. Last month, the agency authorized a Pfizer booster dose for seniors and other high-risk patients. Studies indicate that vaccinated Americans are widely optimistic about coronavirus vaccine booster shots. A Morning Consult poll released on Wednesday found that 80% of vaccination respondents had either planned to or had already had a booster shot.
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