FDA panel supports J&J COVID booster: Shots
Frederic J. Brown / AFP via Getty Images
A panel of experts unanimously decided to recommend that the Food and Drug Administration approve a booster dose of the Johnson & Johnson COVID vaccine.
In a 19-0 vote, the panel recommended that the booster dose should be given at least two months after the first vaccination with a shot of the J&J vaccine.
During the meeting, J&J presented data showing that the protection of the single shot remained largely stable over time, but that a second dose brought protection to a higher level.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said J & J’s morning presentations did not provide any other relevant information about why a booster might be valuable after the initial immunization. “There is data to suggest that the vaccine’s effectiveness is actually less robust than the company’s presentation here,” he said.
Marks then called Dr. Amanda Cohn, a panelist who is also the chief medical officer of the National Center for Immunizations and Respiratory Diseases at the Centers for Disease Control and Prevention. She quoted a study published by the CDC in September That showed that the J&J vaccine had about 68% effectiveness in keeping people out of hospital for COVID-19, compared to more than 90% for Moderna’s vaccine and about 77% for Pfizer-BioNTech after about four months .
Cohn said the protection of the J&J vaccine is significantly less than that of the Moderna and Pfizer mRNA vaccines – even when the declining protection is taken into account.
“I think honestly this was always a two-dose vaccine,” said Dr. Paul Offit, Director of the Vaccine Education Center at Children’s Hospital of Philadelphia, during the pre-voting panel discussion.
The FDA is not required to follow the advisory panel’s recommendations, but it usually does.
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