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US drugmaker Johnson & Johnson has stopped all trials of its experimental Covid-19 vaccine after one of the participants developed an “adverse reaction.”
It was not immediately clear what caused the reaction in the participant, or if it was related to the vaccine, J&J said in a statement, without revealing further details.
Last month, the company became the first leading pharmacist to test a single-dose Covid-19 vaccine, as it launched a Phase 3 trial that will include up to 60,000 participants on three continents.
J & J’s vaccine is one of several in development, as governments and the pharmaceutical industry compete to find one for a pandemic that has killed more than 1 million people. Like its British competitor AstraZeneca, J&J has said it will not seek to profit from its vaccine during the pandemic.
In a statement released late Tuesday, J&J said of the decision to pause the trials that “it is important to have all the facts before sharing additional information,” adding that it is not always immediately apparent whether a participant received the vaccine or a placebo. .
The participant’s adverse reaction is being reviewed by an independent data safety monitoring board and the company’s own doctors, the New Jersey-based drugmaker said. He added that serious adverse events are not uncommon in clinical trials, and their frequency is expected to increase as the size of the trials expands.
The company is currently studying its vaccine candidate in one- and two-dose regimens. It is not clear which trial the participant was enrolled in.
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The company said a pause in a study differs from when a regulator, such as the US Food and Drug Administration, steps in and requires the test to be stopped for a generally longer period. J&J said it generally does not communicate study breaks to the public, although it does inform all researchers.
The vaccine that J&J is developing uses an adenovirus vector, like the one AstraZeneca is working on with the University of Oxford. Last month, trials of the AstraZeneca vaccine were stopped after at least one participant developed unexplained neurological symptoms. They have since resumed, with the exception of the United States.
J&J reports its quarterly results later on Tuesday. New York-listed stocks were mostly flat in after-hours trading.
