BARDA-Supported Johnson & Johnson Unit Janssen COVID-19 Vaccine Candidate Gets Closer: Requiring Only 1 Dose & Potential EUA Request May Occur by Feb

BARDA-Supported Johnson & Johnson Unit Janssen COVID-19 Vaccine Candidate Gets Closer: Requiring Only 1 Dose & Potential EUA Request May Occur by Feb TrialsiteN

TrialSite predicted months ago that the vaccine, sponsored by the world’s largest pharmaceutical company by revenue–Johnson & Johnson, could become the most prominent of COVID-19 vaccine options available due to a number of factors, such as the need for only one dose plus, potential cost, associated distribution logistics, etc. Known as Ad26.COV2-S (JNJ-78436735), the experimental viral vector vaccine uses as a weakened live pathogen (adenovirus) for the actual delivery of the recombinant vaccine for COVID-19. This vaccine class actually exploits a snippet of genetic material from SARS-CoV-2, which triggers an individual’s immune response. Once in the body, the genetic material cannot replicate. This type of vaccine, again known as a recombinant vaccine, is generally common and safe. This class of vaccine can present challenges as well, such as this can include a need for booster shots. That’s because the adenovirus is common, hence making the vaccine less potent. The company released interim Phase 1/2a data published in the New England Journal of Medicine, showing that the single-dose investigational COVID-19 vaccine product offers an immune response that lasts for 71 days across a group of study participants aged 18-55. Although the study is primarily meant to investigate safety data, the results nonetheless point in the right direction. Thanks to support from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR), at the U.S. Department of Health and Human Services, the sponsors have committed over $1 billion to fund the clinical development of this vaccine. With Pharma industry heavyweight Dr. Paul Stoffels at the helm, backed by a small army of smart people at J&J, U.S. government research support and a dedicated cadre of trial site organizations and, of course, research participants, a successful outcome could positively disrupt the COVID-19 vaccine market, serving to accelerate the battle against SARS-CoV-2 and help American society, along with others transcend the ongoing pandemic crisis.

Vaccine Background

Known originally as Ad26.COV2-S, the Janssen vaccine was originally developed in collaboration with Beth Israel Deaconess Medical Center as research groups worked together investigating a number of vaccine targets. They leveraged the Janssen AdVac® technology platform, leading ultimately to the existing target recombinant candidate for COVID-19. More specifically, the teams benefited from the Janssen Advac as well as PER.6® platform, which was employed by Janssen for the development of the company’s Ad26.ZEBOV, a vaccine for Ebola reports Precision Vaccinations.

TrialSite suggests if the company can actually generate compelling, positive results on par with Moderna and Pfizer from its Phase 3 trials by February, then it moves into a strong position to potentially overcome both of the previously mentioned companies sometime in 2021. 

On the other hand, if the company is delayed in delivering positive data, and/or if the data isn’t close to that of Moderna or Pfizer, it could take far longer to get to market.

Recent Study Data

As reported in a recent J&J company press release, the data from this interim analysis revealed the vaccine candidate induced an immune response and was generally well tolerated across all study participants. According to the data after a single vaccination, neutralizing antibodies against COVID-19 showed up in over 90% of the study participants by Day 29 and 100% of the participants aged 18-55 by Day 57. The neutralizing antibodies remained stable through Day 71, representing the latest timepoint available in this ongoing study. Data for the elderly (65 and up) will be available late in January.

The Phase 1/2 study has been supported by government funds, including the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).

Forthcoming Data Could Lead to EUA Submission

As the company is sponsoring major Phase 3 clinical trials (ENSEMBLE and ENSEMBLE 2), interim topline data should be available in late January 2021, but this is subject to change. Importantly, if this data reveals overall safety and efficacy, Janssen will move to submit an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA), followed by regulatory agencies in other nations.

Phase 1/2 a Study Design

As reported in the company’s press release, the company designed a Phase 1/2, a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the safety, reactogenicity and immunogenicity of the experimental vaccine candidate at two dose levels, including (5×1010 or 1×1011 viral particles), administered intramuscularly as single-dose or two-dose schedules, eight weeks apart, in healthy adults aged 18 to 55 (405) and over 65 (405). This study proceeds ongoing in both Belgium (headquarters of Janssen) and America.

Overall, the safety data looks promising. Out of the total subjects, five serious adverse events (SAE) were reported including one participant who developed a fever and then went to the hospital, but recovered in 12 hours. The remaining four were confirmed to not be associated with the study, according to the company’s press release.

The Candidate Could Emerge as the Leading COVID-19 Vaccine

The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates. Janssen’s AdVac® technology has been used to vaccinate more than 200,000 people to date.

Janssen is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy. The Company is studying a single-dose of its vaccine candidate in the Phase 3 ENSEMBLE trial, which completed enrollment on December 17, 2020, and a two-dose regimen in the Phase 3 ENSEMBLE 2 study, which is ongoing.

Johnson & Johnson continues to develop and test its COVID-19 vaccine candidate in accordance with ethical standards and sound scientific principles. The Company is committed to transparency and sharing information related to its ongoing clinical studies – including the ENSEMBLE study protocol.

ENSEMBLE was initiated in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under Other Transaction Agreement HHSO100201700018C, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS.

Heavy Hitters

Johnson & Johnson is the largest pharma company worldwide as measured by revenues. Back in May, TrialSite discussed the company and its lead executive on top of the vaccine effort, Dr. Paul Stoffels—the company’s chief scientific officer and prominent figure in the industry. Although back in May, targets for completion in 2020 were raised mostly on the inside, it would take a little more time. Stoffels and company have mobilized elite teams within the company, and should they be successful, a competitive new entrant in the COVID-19 vaccine space will undoubtedly capture market Share. The need for only one jab is a big deal. A summary of The ENSEMBLE and ENSEMBLE 2 data will hopefully be out soon.

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