VRBPAC declined to vote on booster doses given at least 6 months from the initial dose, stating that it would be unlikely any adverse events (AEs) would arise at 6 months, but not at 2 months, and that the 6-month data presented by the sponsor was only from 17 people. FDA conducted an independent assessment of the immunogenicity of this 6-month booster data, from the COV1001 study, which involved healthy adults ages 18-55.
Johnson & Johnson submitted a post-hoc analysis, which showed that geometric mean titer ratios were “above the FDA-recommended non-inferiority criteria (lower bound of 95% CI >0.67).” FDA staff, however, noted the small number of participants and said the low sensitivity of the assay might be a confounder.
VRBPAC members took issue with the lack of independent verification by the FDA, but Doran Fink, MD, PhD, said the agency “recognized there was intense public interest and a sense of urgency in providing options for a second dose.”
Fink said that an advisory committee meeting was scheduled and the sponsor was asked to provide data. However, instead of providing immunogenicity data for a few hundred people, as Pfizer and Moderna had done, Johnson & Johnson submitted four trials consisting of thousands of people.
For more on this, click on the button below:
