Johnson & Johnson (NYSE: JNJ) (the Company) today announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine.
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.
In anticipation of the potential need for boosters, the Company conducted two Phase 1/2a studies in individuals previously vaccinated with its single-shot vaccine. New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson 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. Significant increases in binding antibody responses were observed in participants between ages 18 and 55, and in those 65 years and older who received a lower booster dose. The study summaries were submitted to medRxiv on August 24.
"We have established that a single shot of our COVID-19 vaccine generates strong and robust immune responses that are durable and persistent through eight months. With these new data, we also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson COVID-19 vaccine, boosting eight months or longer after the primary single-dose vaccination."
The Company is engaging 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 regarding boosting with the Johnson & Johnson COVID-19 vaccine. Johnson & Johnson continues to diligently generate and evaluate data from ongoing trials as well as emerging real-world evidence.
The Phase 1/2a clinical trials (VAC31518COV1001 and VAC31518COV2001) have been funded in part with federal 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), under other transaction authority ("OTA") agreement No. HHSO100201700018C.
For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.
Authorized Use The Janssen COVID-19 vaccine is authorized for use in the U.S. under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.