Johnson & Johnson Submits Data To FDA To Support Booster Of Single-Shot COVID-19 Vaccine

(RTTNews) - Johnson & Johnson (JNJ) announced Tuesday it has submitted data to the U.S. Food and Drug Administration to support use of a booster shot of its COVID-19 vaccine in individuals 18 years of age and older.

The submission includes data showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S.

The recent results from the Phase 3 ENSEMBLE 2 study found a booster of the Johnson & Johnson COVID-19 vaccine, given 56 days after the primary dose, provided 94 percent protection against symptomatic COVID-19 in the U.S. and 100 percent protection against severe/critical COVID-19, at least 14 days post-booster vaccination.

The submission also included Phase 1/2a data showing substantial increase in immune response when booster was given six months after the single shot. Antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.

The vaccine, when given as a booster or primary dose, was generally well-tolerated.

Mathai Mammen, Global Head, Janssen Research & Development, Johnson & Johnson, said, "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."

Last month, the company released data reinforcing the strong and long-lasting protection of its COVID-19 vaccine.

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

The Johnson & Johnson single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received an EUA in the United States on February 27, 2021 and Conditional Marketing Authorization by the European Commission on March 11.