Johnson & Johnson Asks US Regulators to Authorize COVID-19 Booster Shot

Vials of the Johnson & Johnson COVID-19 vaccine are seen at a pharmacy in Denver, Colo., in a file photograph. (David Zalubowski/AP Photo)

Johnson & Johnson on Tuesday asked the Food and Drug Administration (FDA) to authorize a second shot of its COVID-19 vaccine.

The New Jersey-based company officially asked for an expansion of the emergency use authorization that U.S. regulators granted in late February for the single-shot vaccine.

Johnson & Johnson says analysis of U.S. insurance claims show the vaccine proved effective in preventing infection and hospitalization but that clinical trial data revealed a second shot boosted that protection.

The vaccine was 81 percent effective in preventing infections, according to the claims analysis, while a second shot increased protection against moderate to severe disease to 94 percent, according to the trial data.

“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,” Dr. Mathai Mammen, global head for research and development at Johnson & Johnson’s subsidiary Janssen, said in a statement.

“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,” he added.

The Johnson & Johnson shot was hailed when it was first authorized because the only two other vaccines that are legally allowed to be administered in the United States require two doses. But a pause due to concerns of blood clotting and low blood platelet levels stymied the momentum.

Regulators later said the vaccine likely leads to an increased risk of thrombosis with thrombocytopenia but lifted the pause because they believe the benefits of the shot outweigh the risks. Still, only 15 million Johnson & Johnson vaccines have been administered through Sunday, compared to 229 million Pfizer doses and 152 million Moderna ones.

Regulators authorized and recommended a booster of Pfizer’s vaccine for millions of Americans last month after two lengthy advisory panel meetings. But government scientists said the booster shouldn’t be used unless people received Pfizer’s initial regimen.

A decision on Johnson & Johnson’s submission likely won’t come until later this month. The FDA’s vaccine advisory panel is set to meet on Oct. 14 and Oct. 15 to consider data on boosters for the vaccine as well as Moderna’s jab.

Panel members will also hear from the National Institute of Health’s National Institute of Allergy and Infectious Diseases regarding a proposal to let people mix and match boosters, or get a booster that’s different from their initial series.