J&J Seeks FDA Authorization for COVID-19 Booster Shot
Johnson & Johnson (J&J) submitted its application yesterday to the FDA for emergency authorization of a booster dose of its COVID-19 vaccine in adults 18 years and older.
The Emergency Use Authorization (EUA) application was supported by previously reported phase 3 trial data showing a booster dose of the J&J vaccine given nearly two months after a single shot conferred 94 percent protection against moderate-to-severe COVID-19 and 100 percent protection against severe COVID-19, at least two weeks post-booster shot.
The company’s submission also includes phase 1/2a data demonstrating that a booster dose given six months after an initial dose led to antibody levels increasing nine-fold after one week, before reaching a 12-fold increase four weeks after getting the booster dose (DID, Sept. 22).
J&J plans to submit the data to other global regulators and the World Health Organization.
Next week, the FDA’s vaccines advisory committee will convene to consider recommending booster doses of J&J’s and Moderna’s COVID-19 vaccines and decide whether to endorse a mix-and-match approach using different jabs (DID, Oct. 4).
The agency previously authorized Pfizer/BioNTech COVID-19 boosters for people 65 years and older, those at high-risk of progressing to severe disease and those at high risk of frequent exposure to SARS-CoV-2 because of their workplace (DID, Sept. 23). ― Jason Scott