Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate.
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in a study involving 12-to-15 year-olds. FDA has already authorized its vaccine for patients 16 or older.
Moderna (NSDQ:MRNA) announced plans to launch a Phase 2/3 study known as TeenCove that will test its COVID-19 vaccine in adolescents aged 12 to 18.
Johnson & Johnson’s recent announcement shared its plans to extend its randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to adolescents.
The study had previously intended to evaluate the reactogenicity and immunogenicity of its Ad26.COV2.S vaccine after administering it in a variety of dosing regimens. The trial had previously been constrained to healthy adults between the ages of 18 and 55.
The J&J study will also analyze the impact of one, two- and three-month intervals when administering the vaccine in two doses.
FDA has granted emergency use authorization to the Ad26.COV2.S vaccine for a single dose.
J&J intends to ultimately make its vaccine available to pregnant women and children as well, according to Dr. Mathai Mammen, global head, Janssen Research & Development at Johnson & Johnson.
First, however, the company intends to follow an incremental approach to lowering the age of clinical trial participants. It will begin testing adolescents aged 16 to 17 years.
The company will enroll participants in Spain, the U.K., U.S., the Netherlands, Canada, Brazil and Argentina.
Filed Under: clinical trials, Drug Discovery, Infectious Disease