New Brunswick-based Johnson & Johnson (J&J) has temporarily paused further dosing in all of the company’s COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following company guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as J&J’s internal clinical and safety physicians.
The company reports that adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies.
“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have pre-specified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” the company states in a press release.
J&J is respecting the affected participant’s privacy as it learns more about the person’s illness. It is gathering all important data before it shares additional information.
According to the company, SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.
J&J’s vaccine has been undergoing tests in as many as 60,000 volunteers from Peru to South Africa.
Last week, the company announced that the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses.
J&J isn’t the only company that has halted a COVID-19 vaccine clinical trial. Last month, British drugmaker AstraZeneca Plc temporarily stopped tests of its own vaccine candidate after a participant fell ill. That study has resumed in a number of countries, but not in the US.
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