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J&J (JNJ) Coronavirus Vaccine Candidate Study Fully Enrolled
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Johnson & Johnson (JNJ - Free Report) announced that the large-scale, multi-country phase III study, ENSEMBLE, of its experimental COVID-19 single-dose vaccine candidate (JNJ-78436735) is now fully enrolled with approximately 45,000 participants.
The study was originally supposed to enroll 60,000 patients. However, given the widespread prevalence of COVID-19 among the general population in the countries, where the study is being conducted, the company believes this number of participants will be adequate to generate the data needed to determine the efficacy and safety of the vaccine.
The study is a randomized, double-blind, placebo-controlled clinical study designed to evaluate the safety and efficacy of a single dose of a vaccine versus placebo in adults (18 years old and older), including those who are more than age 60.
We remind investors that J&J resumed recruitment in the ENSEMBLE study in late October in the United States, after a temporary pause. Dosing was paused in the study due to an unexplained illness observed in a participant, which was thereafter reviewed and evaluated by the independent Data Safety Monitoring Board (“DSMB”). The DSMB later recommended resuming trial recruitment as no clear cause of the illness was determined and there was no evidence that the vaccine candidate caused the event. Interim data from the study is currently anticipated to be available by the end of
January 2021. J&J plans to submit an Emergency Use Authorization application to the FDA in February if data from the vaccine is safe and effective.
The study 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”).
A separate phase III study of the investigational vaccine candidate to explore a two-dose regimen (ENSEMBLE 2) is ongoing.
J&J’s shares have risen 4.1% in the year so far compared with the industry’s 3% growth.
As the pandemic registers a spike again, the pharma/biotech companies are racing against time to come up with effective vaccines on an urgent basis.
Last week, the FDA granted emergency use authorization (EUA) to Pfizer’s (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based coronavirus vaccine candidate, BNT162b2.
Earlier, Moderna (MRNA - Free Report) confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the company’s COVID-19 vaccine candidate, mRNA-1273.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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J&J (JNJ) Coronavirus Vaccine Candidate Study Fully Enrolled
Johnson & Johnson (JNJ - Free Report) announced that the large-scale, multi-country phase III study, ENSEMBLE, of its experimental COVID-19 single-dose vaccine candidate (JNJ-78436735) is now fully enrolled with approximately 45,000 participants.
The study was originally supposed to enroll 60,000 patients. However, given the widespread prevalence of COVID-19 among the general population in the countries, where the study is being conducted, the company believes this number of participants will be adequate to generate the data needed to determine the efficacy and safety of the vaccine.
The study is a randomized, double-blind, placebo-controlled clinical study designed to evaluate the safety and efficacy of a single dose of a vaccine versus placebo in adults (18 years old and older), including those who are more than age 60.
We remind investors that J&J resumed recruitment in the ENSEMBLE study in late October in the United States, after a temporary pause. Dosing was paused in the study due to an unexplained illness observed in a participant, which was thereafter reviewed and evaluated by the independent Data Safety Monitoring Board (“DSMB”). The DSMB later recommended resuming trial recruitment as no clear cause of the illness was determined and there was no evidence that the vaccine candidate caused the event.
Interim data from the study is currently anticipated to be available by the end of
January 2021. J&J plans to submit an Emergency Use Authorization application to the FDA in February if data from the vaccine is safe and effective.
The study 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”).
A separate phase III study of the investigational vaccine candidate to explore a two-dose regimen (ENSEMBLE 2) is ongoing.
J&J’s shares have risen 4.1% in the year so far compared with the industry’s 3% growth.
Last week, the FDA granted emergency use authorization (EUA) to Pfizer’s (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based coronavirus vaccine candidate, BNT162b2.
Earlier, Moderna (MRNA - Free Report) confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the company’s COVID-19 vaccine candidate, mRNA-1273.
J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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