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FDA Analysis of J&J COVID Vaccine Recall: Shots


Janet Gerber, a health department worker in Louisville, Ky., Processes boxes with vials of the Johnson & Johnson COVID vaccine in March.

Jon Cherry / Getty Images


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Jon Cherry / Getty Images

FDA Analysis of J&J COVID Vaccine Recall: Shots

Janet Gerber, a health department worker in Louisville, Ky., Processes boxes with vials of the Johnson & Johnson COVID vaccine in March.

Jon Cherry / Getty Images

A Food and Drug Administration analysis of Johnson & Johnson’s clearance request for its COVID vaccine recall begins deliberations at a public meeting of agency advisers on Friday. The document was released on Wednesday.

Questions that will be posed to the committee will include whether the data supports the safety and effectiveness of a booster dose of the company’s COVID vaccine after at least two months have passed since the initial vaccination with the single-injection vaccine and if the data shows that there is also a stronger response six months apart.

J&J requested authorization of a booster for people 18 years and older six months after the initial vaccination, with an option of vaccination after two months depending on local conditions and the needs of specific groups of people.

The company says its data shows that sustained protection against severe COVID, hospitalizations and deaths remains strong for at least six months.

In the event of a booster, the company cites studies that found that a booster dose resulted in 94% efficacy against moderate to severe COVID in the United States, compared to 70% for a single dose.

The FDA’s analysis consists primarily of a summary of data previously published by J&J. The agency said J&J data had not been submitted in time for independent validation, as usual.

The FDA is raising some questions about the strength of the data on several points that will likely be discussed on Friday. They include the adequacy of safety information, details of the immune response generated by the booster, and how well the booster helps protect against COVID, including the effect of the timing of the booster.

One thing to note, the agency claims that the J&J vaccine (also known as the Janssen COVID-19 vaccine) has not performed as well as the vaccines from Moderna and Pfizer-BioNTech, which use technology from the MRNA:

Overall, the data indicates that the Janssen COVID-19 vaccine still offers protection against severe COVID-19 disease and death in the United States, although the highest efficacy estimates (including for the disease More severe COVID-19) through clinical trials and real-world efficacy Studies evaluating the Janssen COVID-19 vaccine are consistently lower than the highest efficacy estimates for COVID-19 mRNA vaccines.

This statement is in line with a report released by the Centers for Disease Control and Prevention in September which found that the vaccine’s efficacy against hospitalization was highest for Moderna and lowest for J&J.