Johnson & Johnson seeks FDA emergency authorization for COVID-19 booster shot
The company saw a "substantial increase" in immune response when a booster of its vaccine was given six months after the first shot.
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Johnson & Johnson on Tuesday said it's seeking emergency authorization for a booster dose of its COVID-19 vaccine from the US Food and Drug Administration.
"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," said Dr. Mathai Mammen, global head of research and development at Johnson & Johnson, in a release. "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."
The move, which was reported Monday by The New York Times, comes after the company last month released additional data about its COVID-19 vaccine in adults 18 and older. Johnson & Johnson said that a booster dose of its vaccine, given two months after the first shot, was 94% protective against symptomatic COVID-19 in the US and 100% effective against severe COVID-19, which puts it in the same league as its mRNA cousins, Pfizer and Moderna.
When a booster was given six months after the first shot, "antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster," Johnson & Johnson said on Tuesday.
The COVID-19 vaccines are highly effective in preventing hospitalization and death, though recent studies show that the effectiveness of vaccines may start to decline after six to eight months and a vaccine booster would pump up immune protection against the virus and variants. Over the summer, as the delta variant took hold in the US, the number of cases, hospitalizations and deaths from COVID-19 surged. Those who are unvaccinated have accounted for nearly all the hospitalizations and deaths -- over 97% as of July.
At the end of September, the FDA and the Centers for Disease Control and Prevention endorsed booster shots of the Pfizer-BioNTech vaccine for older Americans, people living in long-term care facilities, adults with underlying medical conditions and front-line workers at an increased risk of COVID-19 exposure.
While the US already is offering a booster shot of the Pfizer-BioNTech vaccine to some people, just over 2% of people living in low-income countries have received at least one vaccine dose.
The FDA on Friday already scheduled an advisory committee meeting for Oct. 15 to discuss a booster dose of the Johnson & Johnson vaccine in adults.
"Once vaccinated, we want to ensure that individuals continue to be protected against the adverse effects of COVID-19," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a release.
Johnson & Johnson on Tuesday said it also plans to submit data to other global regulators, including the World Health Organization and the National Immunization Technical Advisory Groups, to inform vaccine strategies.