Johnson & Johnson requests FDA emergency use authorization for COVID-19 booster vaccine

Ending speculation, Johnson & Johnson (J&J) this week officially submitted data to the United States Food and Drug Administration (FDA) to request emergency use authorization (EUA) for a booster version of its COVID-19 vaccine among patients at least 18 years old.

Recent data showed that the J&J vaccine booster increased protection against symptomatic, moderate to severe COVID-19 cases to 94 percent. In the Phase 3 ENSEMBLE 2 study, vaccines given 56 days after the primary dose also provide full protection against critical COVID-19 cases for at least 14 days after vaccination. The most substantial increase in immune responses could be seen when the booster was given six months after the initial treatment course, at which point antibody levels increased from nine-fold after a single week to 12-fold four weeks out.

Data on primary vaccination has shown that in real-world studies the J&J vaccine provided a stable efficacy of 79 percent on its own against COVID-19 related infections and 81 percent against affiliated hospitalizations. No decreased efficacy has been observed over a period of at least six months.

In all cases, the vaccine has been well-tolerated.

“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 of J&J’s Janssen Research & Development, said. “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.”

Following the FDA submission, J&J also signaled intentions to submit data to other regulators worldwide, as well as the World Health Organization and National Technical Advisory Groups. In the U.S., the primary, single dose version of the J&J vaccine has operated under an EUA since Feb. 27, 2021.