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Johnson & Johnson's Covid-19 Vaccine Safe, Well-tolerated

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Johnson & Johnson announced that its Covid-19 vaccine candidate, JNJ-78436735, being developed by its unit Janssen Pharmaceutical Companies and currently undergoing in a Phase 3 trial, has been found to be safe and well tolerated.

The interim Phase 1/2a data was published on Wednesday in the New England Journal of Medicine. A preview of part of these interim data was posted on medRxiv in September 2020.

As per the data, the single-dose investigational COVID-19 vaccine candidate provided an immune response that lasted for at least 71 days. This is the duration of time measured in this study in participants aged 18-55 years.

The ongoing Phase 1/2a multi-center, randomized, double-blind, placebo-controlled trial aims to evaluate the safety, reactogenicity, and immunogenicity of Janssen's COVID-19 vaccine candidate at two dose levels, administered intramuscularly as single-dose or two-dose schedules, eight weeks apart, in healthy adults, aged 18 to 55 years. The study is ongoing at multiple clinical sites in Belgium and the United States.

According to the company, the COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants. After a single vaccination, neutralizing antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100 percent of participants aged 18-55 years at Day 57.

These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years.

The study also evaluated a two-dose regimen, in which the data showed that a second dose of the vaccine candidate, administered 56 days apart, was less reactogenic while it triggered more than a two-fold increase in antibodies against COVID-19.

Johnson & Johnson expects to announce topline Phase 3 data for its single-dose COVID-19 vaccine candidate in late January 2021.

If the single-dose vaccine is shown to be safe and effective, the company expects to submit an application for Emergency Use Authorization with the U.S. Food and Drug Administration shortly afterwards. Other regulatory applications around the world will be made subsequently.

Janssen is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy.

The single-dose regimen in the Phase 3 ENSEMBLE trial completed enrollment on December 17, 2020, while a two-dose regimen in the Phase 3 ENSEMBLE 2 study is ongoing.

Johnson & Johnson's phase III study of its COVID-19 vaccine candidate, JNJ-78436735, which was initiated in late September, was temporarily paused in early October due to an unexplained illness in a study participant. However, the trial resumed later after clearance from a regulatory board.

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