J&J, erring on caution, tests new 2-dose regimen for COVID-19 vaccine

Johnson & Johnson is confident that it has a one-dose knockout vaccine that can protect against COVID-19, but it’s now starting a late-stage two-dose test just in case.

The Big Pharma’s vaccine, Ad26.COV2.S (now also known as JNJ-78436735), is currently in a major 60,000-subject phase 3 known as ENSEMBLE assessing whether it can stop COVID-19 infections with a single shot.

Early data have already shown it can produce an immune response at one dose, but now it wants to test out a two-dose schedule.

This will be done under the phase 3 ENSEMBLE 2 program, made up of 30,000 patients and running parallel to its ongoing ENSEMBLE phase 3.

If it’s already running a one-shot-and-done program, which puts it at an advantage over rivals Pfizer/BioNTech and Moderna, which need two, why spend the time and money doing a multidose test?

“While a potentially safe and effective single-dose preventive COVID-19 vaccine would have significant benefits, particularly in a pandemic setting, Janssen’s COVID-19 vaccine program has been designed to be extremely thorough and driven by science. As such, we are investigating multiple doses and dosing regimens to evaluate their long-term efficacy,” the U.S. Pharma said in a statement.

The test is being kick-started today and breaks down as a randomized, double-blind, placebo-controlled trial set up to see it evaluate safety and efficacy in a two-dose vaccine regimen versus placebo. Recruitment should be done by March 2021, and the trial will last for a year.

The test is focused on adults with and without comorbidities associated with an increased risk for severe COVID-19. The second dose will come 57 days later, much longer than the current two-dose regiments of its rivals, which are typically giving two within a 28-day period.

This also comes as J&J said that the Biomedical Advanced Research and Development Authority, which has already kicked in $1.4 billion for Janssen’s COVID-19 work, is adding an extra $454 million, with J&J throwing in $604 million, for the ENSEMBLE phase 3.

RELATED: Why did J&J hit pause on its COVID-19 vaccine trial? Stay tuned, execs say

Like AstraZeneca/University of Oxford, J&J is a part of Operation Warp Speed, the U.S. government's effort to deliver 100 million doses of a viable COVID-19 vaccine by January 2021. And that's not all they have in common—both are developing adenovirus-based vaccines, unlike Warp Speed peers Pfizer/BioNTech and Moderna, which are working on mRNA-based jabs.

Both have also been hit by safety worries after several patients fell ill across their trials, leading to trial halts, though these have now been both resolved.

Pfizer and BioNTech recently announced, via a press release, that their mRNA vaccine could produce a 90%-plus efficacy, although we will have to wait and see the breakdown of the data to fully assess this claim. Moderna released its data today, topping Pfizer's efficacy with a 94.5% hit rate and apparently also able to stop severe disease.