Johnson & Johnson (J&J) announced that the US Food and Drug Administration (FDA)’s advisory committee has recommended granting emergency use authorisation (EUA) for a booster dose of its Covid-19 vaccine for adults.
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the booster dose, two months after the initial single-shot vaccination.
US-based drugmaker’s subsidiary Janssen is currently developing the Covid-19 vaccine and is authorised in the US and Europe for use in people aged 18 years and above.
VRBPAC’s unanimous 19-0 voting was based on results from two clinical trials, including the Phase 3 ENSEMBLE 2 study, and Phase 1/2a study.
The company also submitted data from a large US real-world evidence study that support the increased potential of a booster when administered at six months.
Johnson & Johnson, Janssen research and development global head Mathai Mammen said: “Johnson & Johnson is steadfast in its commitment to protect as many people globally as possible against the continued spread of Covid-19.
“Today’s recommendation by the VRBPAC is another step toward ensuring that those who have received the single-shot Johnson & Johnson vaccine – or will receive it in the future – are provided the opportunity to increase their protection against Covid-19.
“We look forward to sharing these data with regulatory bodies and advisory groups around the world to address the continued threat of Covid-19.”
The Phase 3 ENSEMBLE 2 study evaluated the booster dose of the J&J Covid-19 vaccine, administered two months after the initial single-shot.
In the study, booster dose showed 94% protection against symptomatic Covid-19 in the US and 100% protection against severe Covid-19, at least 14 days post-booster vaccination.
The booster or primary dose of the vaccine was generally well-tolerated, with no new safety signals in the ENSEMBLE 2 trial, compared with single-dose studies.
The Phase 1/2a study assessed a booster shot given six months after the initial dose, where antibody levels increased nine-fold in one week, and up to 12-fold high in four weeks after the booster.
In the real-world data, the booster dose stable vaccine effectiveness of 76% for Covid-19-related infections and 81% for Covid-19-related hospitalisations.
Johnson & Johnson executive committee vice chairman and chief scientific officer Paul Stoffels said: “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.”
