Section 4: Johnson & Johnson One of Top 5 COVID-19 Vaccine Finalists
The Johnson & Johnson (J&J) Pharmaceutical Research and Development group has focused its COVID-19 vaccine efforts on a single-dose replication-defective human adenovirus 26 vector (Ad26.COV2.S).1,2,3 This vector deliver recombinant SARS-CoV-2 S protein genes to human cells. While no vaccines of this type are commercially available to prevent human disease, the one licensed vaccine is for the prevention of animal rabies. Development has moved into a Phase 2-2a trial supported by $456 million in grants, aiming to recruit up to 30,000 participants. This phase entails the evaluation of the effectiveness and safety of the vaccine, which follows studies on healthy individuals with various dose ranges in Phase 1. Phase 2a, specifically, aims to identify dosing requirements as well as optimal frequency of dosing. Should the study move to Phase 2b, they will directly assess its efficacy in preventing COVID-19.4 J&J, along with Janssen Vaccines & Prevention, published a preprint of clinical trial results assessing the efficacy of AD26.COV2.S in preventing moderate-to-severe COVID-19 in adults.5 A multicenter Phase 1/2a randomized, double-blinded, placebo-controlled study assessed safety, immunogenicity, and reactogenicity of Ad26.COV2.S at a dose level of 5 x 1010 or 1 x 1011 viral particles (vp) per vaccination, in either single dose or two doses 56 days apart in healthy individuals (18-55 years n = 402; >65 years n = 394). Fatigue, headache, myalgia, and pain at injection site were the most frequent adverse events. After a single dose, seroconversion rate in wtVNA (50% inhibitory concentration – IC50) at day 29 among adults 18-55 years reached 92% for both dose levels. Overall, this study found that a single 5 x 1010 vp dose of Ad26.COV2.S may be protective against COVID-19.
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