Johnson & Johnson to submit EUA for booster shot approval

Johnson & Johnson said Oct. 4 that it will submit paperwork this week to federal regulators seeking to authorize a booster shot of its COVID-19 vaccine.

The New Brunswick-based pharmaceutical company is the last of the three federally-authorized vaccine providers to seek authorization.

The U.S. Food and Drug Administration (FDA) last week scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to grant emergency use authorization for a booster shot of J&J’s vaccine after the company presented findings that its single-shot vaccine demonstrated strong and long-lasting protection and durable immune responses in clinical studies. The health care conglomerate last month issued a release stating that an additional second shot of its vaccine, given about two months after the first, increased its effectiveness to 94%, compared with 70% protection with the single dose.

More than 15 million Americans have received J&J’s vaccine, which is administered as a single dose, according to the latest data from the Centers for Disease Control and Prevention.

“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%. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Dr. Mathai Mammen, 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.”

Johnson & Johnson plans to submit the data to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies, as needed.