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news.The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended grant of Emergency Use Authorization (EUA) for Johnson & Johnson’s (J&J) Covid-19 vaccine booster shot.
J&J Covid-19 vaccine booster shot will be administered at least two months after their first dose. Credit: Steven Cornfield on Unsplash.
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The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended grant of Emergency Use Authorization (EUA) for Johnson & Johnson’s (J&J) Covid-19 vaccine booster shot.
The booster dose will be administered for adults aged 18 and above at least two months after their first dose.
The recommendation was based on the data obtained from two clinical studies including the global Phase III ENSEMBLE 2 study as well as a large and robust real-world evidence study.
J&J Executive Committee vice chairman and chief scientific officer Paul Stoffels said: “The 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.”
The Phase III trial evaluated the booster dose administered two months following the first single shot.
It showed 94% protection against symptomatic Covid-19 in the US and 100% protection against severe/critical Covid-19.
The data from both the trials showed that the booster shot provided strong and long-lasting protection against Covid-19.
In addition, the company also submitted the data from a Phase I/II a study, which evaluated the effectiveness of the J&J Covid-19 booster vaccine that was given six months after the single shot.
The FDA is expected to announce its decision regarding the EUA amendment for the company’s booster dose in the coming days.
J&J Janssen Research & 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.
“The 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.”
