FDA Recommends Authorization For J&J’s COVID-19 Vaccine Booster

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended emergency use authorization for a booster dose of Johnson & Johnson’s COVID-19 vaccine.

VRBPAC unanimously voted 19-0 to recommend the booster dose to adults aged 18 years and older at least two months following initial vaccination with a single-shot vaccine. 

The committee based its vote on findings from two clinical trials, including the Phase 3 ENSEMBLE 2 study and a large and robust real-world evidence study. 

At the end of August, The Phase 3 ENSEMBLE trial found that a booster dose of the vaccine generated a robust increase in spike-binding antibodies and elicited 94 percent protection against COVID-19.  

Additionally, a Phase 1/2a study evaluating a booster dose given six months after the first shot found that antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks later.

Finally, the submission included data from a real-world evidence study. The study showed that the single-dose COVID-19 vaccine was 76 percent effective against COVID-19-related infections and 81 percent effective against COVID-19-related hospitalizations.

“Today’s recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer of Johnson & Johnson, said in the announcement.  

Johnson & Johnson will submit relevant data to other regulators, including the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) globally to inform decision-making on local vaccination strategies.

FDA’s decision on the emergency use authorization is expected in the coming days.

Mathai Mammen, MD, PhD, global head of Janssen research and development, stated that the recommendation from VRBPAC is another step towards ensuring those who have received the Johnson & Johnson COVID-19 vaccine can increase their protection.