J&J to seek federal OK for booster

Johnson & Johnson reportedly plans to ask federal health regulators early this week to authorize a booster shot for its experimental COVID-19 vaccine, making it the third pharmaceutical company to call for extra shots.

The New Jersey-based drugmaker, whose vaccine currently is given as a single-dose inoculation, has submitted data to the Food and Drug Administration in support of the proposal, saying its booster can increase protection against symptomatic cases to more than 90%.

The company is preparing to file a formal request seeking emergency use authorization for additional injections, The New York Times reported Monday, citing officials familiar with the company’s plans.

J&J did not address the report in a statement to the Daily News, with a spokesman commenting only on the firm’s plans to submit available data to regulators around the world, an effort “to inform decision-making on local vaccine administration strategies, as needed.”

The FDA plans to discuss whether to authorize J&J’s booster shot at an Oct. 15 meeting, which was scheduled even before the company filed for authorization. The meeting will come a day after the FDA’s advisory committee looks into a booster authorization request by Moderna.

The federal government so far has only approved booster shots for the vaccine developed by Pfizer and BioNTech. The extra injections are being offered to people 65 and older, adults with underlying health problems and those whose jobs put them at higher risk of contracting the virus.

Data released by J&J last month suggest an additional shot given two months after the first one can boost the vaccine’s effectiveness against mild to severe cases to 94%, up from 74%. If a booster is given after six months following the single shot, antibody levels increase ninefold one week later and twelvefold four weeks later, according to the company.

“It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19,” said Dr. Paul Stoffels, the company’s chief scientific officer.

“A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection, is crucial to vaccinating the global population,” he said in a Sept. 21 statement. “At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”