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J&J Pauses Late-stage COVID-19 Vaccine Trial On Unexplained Illness

johnsonjohnson oct13 lt

Johnson & Johnson (JNJ) has paused the phase III study of its COVID-19 vaccine candidate, JNJ-78436735, due to an unexplained illness in a study participant, Stat News reported, citing a document sent to outside researchers running the 60,000-patient clinical trial.

"We must respect this participant's privacy. We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information," the company reportedly said in a statement.

Johnson & Johnson emphasized that adverse events such as illnesses and accidents are an expected part of a clinical study. The vaccine study is currently under a study pause, and not under a clinical hold, which is a formal regulatory action that can last much longer.

Last month, AstraZeneca Plc (AZN) had paused the phase III study of its COVID-19 vaccine candidate, AZD1222, following an adverse reaction in a trial participant. The study has resumed in a number of countries but remains halted in the U.S.

In late September, Johnson & Johnson commenced its large-scale, pivotal, multi-country phase III trial for its COVID-19 vaccine candidate, JNJ-78436735, dubbed ENSEMBLE.

The ENSEMBLE will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

The Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) collaborated with the company in initiating the ENSEMBLE study.

Johnson & Johnson had agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland on a separate phase III clinical trial in multiple countries to explore a two-dose regimen of JNJ-78436735.

The company has said it expected to deliver the JNJ-78436735 vaccine for emergency use authorization in early 2021.

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