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J&J's Coronavirus Vaccine Studies Paused Post Adverse Event
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Johnson & Johnson (JNJ - Free Report) has paused dosing in all clinical studies on its coronavirus vaccine candidate, JNJ-78436735, including the large pivotal phase III study, ENSEMBLE, which was initiated last month. The pause was the result of an unexplained illness observed in a study participant that is now being probed by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) and J&J’s own internal physicians.
J&J said that such adverse events are part of clinical studies, especially large ones. The studies have been halted to allow careful review of the event and the data available before the studies can resume. However, the company did not specify whether the unexpected serious adversity was related to the vaccine shot. It was not exactly clear whether the participant was given the vaccine shot or placebo.
So far this year, J&J’sshares have risen 4.1% against the industry’s 0.5% increase.
J&J launched ENSEMBLE to evaluate the safety and efficacy of a single dose of JNJ-78436735. While J&J is testing a single dose of its COVID-19 vaccine candidate, other companies whose vaccine candidates are in late-stage development, Pfizer (PFE - Free Report) /BioNTech, AstraZeneca (AZN - Free Report) /Oxford University and Moderna (MRNA - Free Report) are testing two shots of their respective candidates.
Last month, AstraZeneca/Oxford University had also temporarily paused all its global late-stage studies on AZD1222, their COVID-19 vaccine candidate, as a patient in U.K. suffered an unspecified illness. However, while studies have resumed in the UK, Brazil, South Africa, India and Japan, the study in the United States remains on hold and the company is in discussion with the FDA to provide the necessary information to re-start it.
J&J’s ENSEMBLE study is expected to enroll 60,000 adult participants and compares a single vaccine dose of JNJ-78436735 to placebo. It aims to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States across more than 200 sites. The ENSEMBLE study has been initiated in collaboration with BARDA and NIAID.
J&J had earlier announced plans to manufacture one billion doses of its vaccine every year and has been increasing its manufacturing capacity accordingly. J&J originally expected to file for emergency use authorization of its vaccine candidate in early 2021. However, it is quite unclear how the study pause will impact the vaccine’s development progress and regulatory plans.
The company is due to report its third-quarter earnings results on Tuesday, before market open. In the third quarter, J&J’s Pharma segment is expected to have performed above market while the Medical Devices segment might have been hurt by the COVID-19 impact in the third quarter.
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J&J's Coronavirus Vaccine Studies Paused Post Adverse Event
Johnson & Johnson (JNJ - Free Report) has paused dosing in all clinical studies on its coronavirus vaccine candidate, JNJ-78436735, including the large pivotal phase III study, ENSEMBLE, which was initiated last month. The pause was the result of an unexplained illness observed in a study participant that is now being probed by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) and J&J’s own internal physicians.
J&J said that such adverse events are part of clinical studies, especially large ones. The studies have been halted to allow careful review of the event and the data available before the studies can resume. However, the company did not specify whether the unexpected serious adversity was related to the vaccine shot. It was not exactly clear whether the participant was given the vaccine shot or placebo.
So far this year, J&J’sshares have risen 4.1% against the industry’s 0.5% increase.
J&J launched ENSEMBLE to evaluate the safety and efficacy of a single dose of JNJ-78436735. While J&J is testing a single dose of its COVID-19 vaccine candidate, other companies whose vaccine candidates are in late-stage development, Pfizer (PFE - Free Report) /BioNTech, AstraZeneca (AZN - Free Report) /Oxford University and Moderna (MRNA - Free Report) are testing two shots of their respective candidates.
Last month, AstraZeneca/Oxford University had also temporarily paused all its global late-stage studies on AZD1222, their COVID-19 vaccine candidate, as a patient in U.K. suffered an unspecified illness. However, while studies have resumed in the UK, Brazil, South Africa, India and Japan, the study in the United States remains on hold and the company is in discussion with the FDA to provide the necessary information to re-start it.
J&J’s ENSEMBLE study is expected to enroll 60,000 adult participants and compares a single vaccine dose of JNJ-78436735 to placebo. It aims to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States across more than 200 sites. The ENSEMBLE study has been initiated in collaboration with BARDA and NIAID.
J&J had earlier announced plans to manufacture one billion doses of its vaccine every year and has been increasing its manufacturing capacity accordingly. J&J originally expected to file for emergency use authorization of its vaccine candidate in early 2021. However, it is quite unclear how the study pause will impact the vaccine’s development progress and regulatory plans.
J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The company is due to report its third-quarter earnings results on Tuesday, before market open. In the third quarter, J&J’s Pharma segment is expected to have performed above market while the Medical Devices segment might have been hurt by the COVID-19 impact in the third quarter.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot stocks we're targeting >>