Johnson & Johnson released data showing that a booster dose of its COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
In anticipation of the potential need for boosters, the company conducted two Phase 1/2a studies in people previously vaccinated with its single-shot vaccine, developed by subsidiary Janssen Pharmaceuticals. New interim data from these studies show significant increases in binding antibody responses in participants between the ages of 18 and 55, and in those 65 years and older, who received a lower booster dose, the company said.
In July, the company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization.
The study summaries were submitted to medRxiv on August 24.
Johnson & Johnson said it is working with the U.S. Food and Drug Administration (FDA), U.S. Centers for Disease Control and Prevention (CDC), European Medicines Agency (EMA) and other health authorities about approving the booster dose of the Johnson & Johnson COVID-19 vaccine.
The Phase 1/2a clinical trials (VAC31518COV1001 and VAC31518COV2001) have been funded, in part, with funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).
