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SAGE, WHO Support Johnson & Johnson COVID-19 Vaccine Booster
In a Phase 3 trial, J&J’s COVID-19 vaccine booster provided 100 percent protection at least 14 days post-final vaccination and 75 percent protection against symptomatic COVID-19 globally.
The Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) recently supported using Johnson & Johnson’s COVID-19 vaccine booster shot in adults.
SAGE recommended that the Johnson & Johnson COVID-19 vaccine be used for homologous boosting, using the vaccine for both primary vaccination and the booster shot.
On the other hand, the WHO recommended the booster shot six months after the primary vaccination and favored a flexible approach to heterologous boosting, using the vaccine as a booster for eligible individuals aged 18 years and older.
“Today’s recommendation from the Strategic Advisory Group of Experts on Immunization for the World Health Organization is further affirmation that the Johnson & Johnson COVID-19 vaccine can help reduce the burden of the pandemic,” Mathai Mammen, MD, PhD, global head, Janssen research & development at Johnson & Johnson, said in the announcement.
“Our COVID-19 vaccine continues to play a critical role in the world’s fight to end this pandemic, and we welcome this recommendation as we work with the global community to protect as many people as possible from COVID-19,” Mammen continued.
SAGE based its recommendation on efficacy, safety, and immunogenicity data from Johnson & Johnson’s clinical trials and the South African Health Products Regulatory Authority-sponsored Sisonke Phase 3b study in South Africa.
In the Phase 3 ENSEMBLE trial, a booster shot of Johnson & Johnson’s COVID-19 vaccine at two months provided 100 percent protection at least 14 days post-final vaccination and 75 percent protection against symptomatic COVID-19 globally.
Additionally, antibody levels increased nine-fold one week after the booster and 12-fold higher four weeks later.
These data were consistent with a large real-world evidence study that showed stable vaccine effectiveness against COVID-19-related infections and hospitalizations, with no evidence of reduced effectiveness over the study duration of six months.
And in the South African Phase 3b study, the booster provided increased protection against symptomatic infection and severe disease and was generally well-tolerated after primary vaccination.
Johnson & Johnson is committed to making up to 900 million doses of its COVID-19 vaccine available to the African Union and COVAX, combined, through 2022.
