Johnson & Johnson announced it has submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.
According to a statement, J&J said the submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination.
Also part of the submission is Phase 1/2a data showing that when a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster, the drugmaker said. The vaccine, when given as a booster or primary dose, was generally well-tolerated, it added.
“Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
J&J is the last to apply for booster authorization among the makers of the three COVID-19 vaccines used in the US. Yet, it is the booster that many health officials are most eager to see. The vaccine, which uses a viral vector strategy rather than an mRNA-based design, is the only available COVID-19 vaccine given as just one shot. Its efficacy has lagged behind the other vaccines throughout the pandemic.
Still, Moderna and Pfizer-BioNTech, both mRNA-based vaccines, have already submitted booster applications to US regulators. On September 22, the Food and Drug Administration granted authorization for a booster dose of the Pfizer-BioNTech vaccine for certain groups of people. The decision was tense, with experts torn over whether a booster for the highly effective vaccine was widely needed.
Days later, Director Rochelle Walensky of the Centers for Disease Control and Prevention overruled her agency’s expert advisors by widening the availability of the booster. A Pfizer-BioNTech booster is currently available in the US to people 65 years and older, people living in long-term care settings, people with underlying medical conditions, and people with high risk of exposure.
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