The committee’s two-day meeting resulted in recommended approvals for both J&J’s and Moderna’s COVID-19 booster.
The FDA’s Vaccines and Related Biological Products Advisory Committee recommended authorizing a second dose of Johnson & Johnson vaccine for as early as two months after the initial dose. The committee voted unanimously 19-0 in favor of the emergency use authorization.
“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,” Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer, Johnson & Johnson, said in a statement.
In materials released ahead of the meeting, the company indicated that the administration of a booster dose would strengthen immune responses and ensure optimal and durable protection against symptomatic COVID-19 as well as increase protection against severe/critical COVID-19 across populations and SARS-CoV-2 variants.
J&J had submitted data to support its application for an emergency use authorization early in October 2021. The submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the J&J COVID-19 vaccine given 56 days after the primary dose provided 94% protection against moderate-to-severe/critical COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination.
Also part of the submission is phase 1/2a data showing that when a booster of the vaccine was given six months after the single shot, 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.
In September, the company released data that confirmed the long-lasting protection of its COVID-19 vaccine. There was no evidence of reduced effectiveness over the study duration conducted from March to July 31, 2021. Comparable vaccine effectiveness was demonstrated when the study was extended to August 31, 2021, including when the Delta variant became dominant in the United States.