FDA Advisory Committee Recommends Authorization of Johnson & Johnson COVID-19 Booster Dose

An FDA advisory committee has voted unanimously to recommend emergency use authorization for a booster dose of the COVID-19 vaccine from Johnson & Johnson, according to reporting by NPR.¹

The panel recommended that the booster dose be administered at least 2 months after initial immunization with the single-shot vaccine. The recommendation is for individuals ages 18 years of age and older.¹

“Our single-shot vaccine generates strong immune responses and long-lasting immune memory,” said Mathai Mammen, MD, PhD, global head of Janssen research and development at Johnson & Johnson, in a press release. “And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases.”²

The committee’s recommendation is based on data from Johnson & Johnson demonstrating that the protection from the single primary dose remains largely stable over time, although a second dose increased protection. Some experts, however, expressed doubt about the vaccine’s efficacy, especially compared to the high rates of efficacy for Moderna and Pfizer’s vaccines.¹

“There are data suggesting the effectiveness of the vaccine is actually less robust than the company’s presentation here,” said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, according to NPR.¹

Data from Johnson & Johnson released in September found stable vaccine efficacy of 79% for COVID-19-related infections and 81% efficacy for COVID-19-related hospitalizations, according to a press release. Furthermore, researchers found no evidence of reduced efficacy over the study duration between March and late July 2021.²

In addition, the investigators found that a booster shot administered 56 days after the initial shot provided 94% protection against COVID-19. According to the press release, the booster dose also provided 100% protection against severe or critical COVID-19, 75% protection against symptomatic COVID-19 globally, and 94% protection against symptomatic COVID-19 in the United States.²

When the booster dose was administered 2 months after the first shot, the investigators found that antibody levels rose between 4 and 6 times higher than observed after the single shot. When a booster was administered 6 months after the initial vaccine, antibody levels increased 9-fold 1 week after administration and continued to increase to 12-fold higher 4 weeks after administration. All antibody level increases were found regardless of age.²

“It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19,” said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer of Johnson & Johnson, in the press release. “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. 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.”²

REFERENCES

1. Hensley S. An FDA panel of experts backs J&J COVID vaccine booster. NPR; October 15, 2021. Accessed October 15, 2021. https://www.npr.org/sections/health-shots/2021/10/15/1046374353/an-fda-panel-of-experts-backs-j-j-covid-vaccine-booster

2. Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the US. News release. Johnson & Johnson; September 21, 2021. Accessed October 15, 2021. https://www.jnj.com/johnson-johnson-announces-real-world-evidence-and-phase-3-data-confirming-strong-and-long-lasting-protection-of-single-shot-covid-19-vaccine-in-the-u-s