Covid-19, Healthcare

Johnson & Johnson To Seek FDA Authorization for Booster Shot This Week, Report Says

Johnson & Johnson To Seek FDA Authorization for Booster Shot This Week, Report Says

Johnson & Johnson plans to seek emergency authorization this week for a booster dose of its COVID-19 vaccine from the US Food and Drug Administration, according to a report Monday from The New York Times.

Last month, 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. Johnson & Johnson said it had given additional data to the FDA, which gave emergency use authorization for one dose of the company’s vaccine in February.

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 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.

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