Johnson & Johnson confirmed on Monday that it had paused its COVID-19 vaccine study because one of its participants was taken ill.
The trial is taking place in three continents, including in Sub-Saharan Africa.
Johnson & Johnson said the study was on hold because of “an unexplained illness in a study participant.”
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“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.
“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 prespecified 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.
“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.
“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,” the company said.
“Last month, one of the three major worldwide coronavirus vaccine trials was paused in Phase 3 after a participant had a suspected adverse reaction. The trials for that vaccine, being developed by Oxford University and manufactured by AstraZeneca, were resumed a few days later, after a monitoring committee determined that it was safe to resume the trial,” noted the Daily News.
Last month Johnson & Johnson announced it had started a 60,000 person clinical trial of its single-dose COVID-19 vaccine on three continents, including in Sub-Saharan Africa, and that it could learn key results from the trial by early next year. The vaccine is being developed by Janssen Pharmaceutical Companies.
The final-stage trial will include 60,000 adult volunteers, those with and without comorbidities associated with an increased risk for progression to severe COVID-19, and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
With more than 16,000 COVID-19 related deaths and over 660,000 cases, South Africa currently has the highest death toll and number of infections in Africa, according to the latest data released on Wednesday by the Africa CDC, and Johnson & Johnson intends to carry out trials in places with high incidence of COVID-19.
The New Brunswick, New Jersey-based company said in order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and clinical trial sites which have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated.
With the announcement, Johnson & Johnson has become the fourth experimental coronavirus shot to enter final-testing in the United States.
The company said it will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles.
“The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol,” J & J said in a statement.
“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson.
“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic. This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
According to Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, the company remains “fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world.”
“We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021.”