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10/15/2021

FDA panel recommends J&J COVID-19 booster shot

The FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend a booster for all recipients of the J&J Janssen COVID-19 vaccine, aged 18 years old and older, at least two months after their first dose.
Sandra Levy
Senior Editor
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Vaccine advisers to the Food and Drug Administration voted unanimously Friday to recommend a booster dose of Johnson & Johnson's vaccine at least two months after people get the first dose, according to a CNN report.

[Read more: FDA panel recommends emergency use clearance for Moderna's COVID-19 booster shot]

The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-0 to recommend the extra dose for all recipients of the J&J Janssen vaccine, aged 18 years old and older. They asked to simplify the original question being posed by the FDA, which had asked the committee to say whether the data showed that waiting six months or longer after getting the first shot would provide an even stronger immune response.

[Read more: Retailers begin offering Pfizer COVID-19 booster shots] 

The FDA will now consider the committee's advice. Then the Centers for Disease Control and Prevention's vaccine advisers will be asked to consider it.

"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, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.

"Johnson & Johnson is steadfast in its commitment to protect as many people globally as possible against the continued spread of COVID-19," said Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson. "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 Company's EUA amendment submission included results from the Phase 3 ENSEMBLE 2 study, which found a booster dose at two months provided 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the United States (CI, 58%-100%) and 100% protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination. Also submitted were findings from a Phase 1/2a study evaluating a booster dose given six months after the first shot, which show antibody levels increased nine-fold one week after the booster, and continued to climb to 12-fold higher four weeks after the booster.

The vaccine, when given as a booster or primary dose, was generally well-tolerated, with no new safety signals observed in the two-dose ENSEMBLE 2 trial compared with single-dose studies.

The submission also included data from a large and robust U.S. real-world evidence study, conducted from March to July 31, 2021, and recently extended to August 31, 2021. These real-world data demonstrated the single-dose Johnson & Johnson COVID-19 vaccine showed stable vaccine effectiveness of 76% (CI, 75%-77%) for COVID-19-related infections and 81% (CI, 79%-84%) for COVID-19-related hospitalizations, with no evidence of reduced effectiveness over the study duration of six months – including when the Delta variant became dominant in the U.S. (sequencing data were not available for analysis).

The company anticipates a decision from the FDA on the EUA amendment for a booster dose of the Johnson & Johnson COVID-19 vaccine in the coming days, and plans to submit relevant data to other regulators, the World Health Organization and National Immunization Technical Advisory Groups worldwide to inform decision-making on local vaccine administration strategies, as needed.

The CDC Advisory Committee on Immunization Practices will discuss the use of boosters and provide a potential recommendation on October 21.

The company noted that in the United States, there is sufficient supply to support boosting to those who have received the more than 15.1 million doses of the Johnson & Johnson COVID-19 vaccine that have been administered as primary vaccinations.

 

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