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FDA Analysis of the J&J COVID Vaccine Booster: Shots

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Janet Gerber, a health department worker in Louisville, Kentucky, processes boxes of vials of the Johnson & Johnson COVID vaccine in March.

Jon Cherry / Getty Images

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Jon Cherry / Getty Images

Janet Gerber, a health department worker in Louisville, Kentucky, processes boxes of vials of the Johnson & Johnson COVID vaccine in March.

Jon Cherry / Getty Images

An analysis by the Food and Drug Administration of Johnson & Johnson for approval of its COVID vaccine booster boosts deliberations at a public meeting of the agency’s advisors on Friday. the Document was released on Wednesday.

The questions that will be put before the committee Includes whether the data support the safety and effectiveness of a booster dose of the company’s COVID vaccine after at least two months have passed since initial vaccination with the single-dose vaccine, and whether the data shows a stronger response at a monthly interval.

J&J has applied for approval of a booster vaccination for people aged 18 and over six months after the initial vaccination, with the option to vaccinate after two months depending on local conditions and the needs of certain groups of people.

the The company says its data shows continued protection against severe COVID, Hospitalization and death remain severe for at least six months.

In the case of a booster, the company cites studies that found that a booster dose in the US resulted in 94% effectiveness against moderate to severe COVID, compared to 70% for a single dose.

The FDA analysis consists mainly of a summary of the data previously published by J&J. According to the agency, the J&J data was not submitted in time for independent validation to be carried out, as is the custom.

The FDA is raising some questions about the strength of the data on several issues that are likely to be discussed on Friday. This includes the adequacy of safety information, details of the immune response generated by the booster, and how much the booster does in protecting against COVID, including the effects of booster timing.

Notably, the J&J vaccine (also known as the Janssen COVID-19 vaccine) didn’t do quite as well as the vaccines from Moderna and Pfizer-BioNTech, which use mRNA technology:

Overall, the data suggest that the Janssen COVID-19 vaccine still offers protection from severe COVID-19 disease and death in the United States, although the highest estimates of effectiveness (including for more severe COVID-19 diseases) are in clinical Studies and Real World Studies evaluating the Janssen COVID-19 vaccine are consistently below the highest effectiveness estimates for the mRNA COVID-19 vaccines.

This statement is in line with a report published by the Centers for Disease Control and Prevention in September that the effectiveness of the vaccine against hospitalization was highest at Moderna and lowest at J&J.

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