The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J subsidiary Janssen Pharmaceutical appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those from Pfizer/BioNTech and Moderna.
Additionally, a report from The New York Times said that, as of Jan. 14, results from the trial could be expected in as little as two weeks, although, if approved, immediate production of doses promised to the U.S. government may be hindered by “unanticipated manufacturing delays.”
J&J published interim phase 1/2a data from its vaccine trial in the New England Journal of Medicine last week, with the data demonstrating that the single-dose vaccine candidate provided an immune response that lasted for at least 71 days, which is the duration of time measured in the study for participants between ages 18 and 55.
The data showed that the vaccine candidate not only induced an immune response but was generally well-tolerated across the study participants. Neutralizing antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants (between 18-55) at day 57. Those antibodies remained stable through day 71, which was the last timepoint available in the ongoing study.
Further data for immune responses in trial participants over 65 years old is expected to come in “late January,” according to a news release, with long-term follow-up to year one planned as well.
Overall, the company expects topline Phase 3 data for its vaccine candidate in “late January,” too, with intentions to file for FDA emergency use authorization (EUA) shortly after evidence is presented demonstrating the safety and efficacy of the vaccine. Further regulatory applications would be made subsequently, J&J said.
While the company has yet to release such data as the final week in January nears, J&J is announcing its fourth-quarter financial results on Jan. 26. That announcement could potentially be accompanied by the Phase 3 data for the vaccine candidate.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease