Johnson & Johnson halts coronavirus vaccine trials over ‘unexplained illness’
Share article:
Share article:

Johnson & Johnson halts coronavirus vaccine trials over ‘unexplained illness’

© Belga

Late-stage clinical trials for Johnson & Johnson’s (J&J) coronavirus vaccine have been halted after one person in the study developed an “unexplained illness.”

“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 press release.

The company did not provide further details regarding the illness developed by the participant nor on their condition, citing personal privacy concerns.

Related News:


“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 wrote.

The participant will be medically examined by the pharma firm’s physicians and their illness will be evaluated by the trial’s Data Safety Monitoring Board, an independent body surveying participants’ safety throughout the trials.

The pause will also mean that future recruiting of new study participants will be paused until the review of the illness in question is completed.

The company stressed that study pauses were a common and expected occurrence during not always publicly communicated on by firms, and stressed that they were not the same as a regulatory hold, which is a paused ordered by a national health authority.

For the start of Phase 3, the last stage in the development on a vaccine, J&J’s ENSEMBLE double-blind trials aimed to recruit 60,000 volunteers with and without comorbidities in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.

When an illness or adverse effect appears, the company told medical news outlet Statnews that it is not immediately clear whether the participant in question received a placebo or an actual dose of the candidate vaccine.

In early August, AstraZeneca also paused its Phase 3 trials —the last stage in the development of a vaccine— after one study participant in the UK developed a “serious side effect.” The trials have resumed since, except in the United States, according to Statnews.

Gabriela Galindo
The Brussels Times

Latest news

Thousands protest against the Covid health pass in France
Demonstrations against the health pass and other measures aimed at preventing the spread of the Coronavirus mobilised tens of thousands of protesters ...
Record-breaking 770-metre highline installed in Freÿr, Beglium
A 770-metre long highline was installed at an altitude of 70 metres at the Freÿr Rocks on Saturday, setting a new Belgian record, according to ...
Will Brussels bounce back?
The lockdowns have tested the city and forced it to confront key questions about its future. Derek Blyth looks back at an extraordinary moment in our ...
Huge cannabis farm discovered inside closed down Chinese restaurant near Charleroi
A cannabis plantation with several hundred mature plants was dismantled on Friday evening in a former Chinese restaurant on Chaussée de Bruxelles ...
Citizen founded wind turbine project launched in Liège region
A citizen founded wind turbine project was inaugurated in the Liège Region on Saturday by Walloon Energy Minister Philippe Henry (Ecolo) together ...
Five questions to philosopher Philippe Van Parijs on Leopold II and embarrassment in Brussels’ public space
The worldwide explosion of the Black Lives Matter movement in the aftermath of the death of George Floyd, combined with the 60th anniversary of the ...
Belgium to invest in sustainable heating in 2022
The federal government will set aside about one million euros in its 2022 budget for a social tariff for sustainable heating, Federal Energy Minister ...
Anti-vaxxers demonstrate against Covid Safe Ticket in Brussels
Hundreds of supporters of the anti-vaxx movement gathered on Saturday outside the headquarters of the Pfizer pharmaceutical company to protest ...
Belgium’s investment funds total 260 billion euros in assets
Belgium’s funds industry grew by 5.3% (13 billion euros) in the second quarter of this year, bringing investment funds available to the public to ...
Brussels to Luxembourg by train in two hours soon possible
The fastest train ride between Brussels and Luxembourg currently takes almost three hours, but that could be slashed to about two hours thanks to the ...
Daily Covid infections up by almost 30% in Belgium
Between 6 and 12 October, an average of 2,438 people were infected with the Covid-19 virus every day, according to figures from the Sciensano public ...
Over 80,000 companies in Belgium non-compliant with anti-money laundering meassures
Over 80,000 companies and non-profits in Belgium are still not compliant with the Ultimate Business Owner (UBO) register, which is required of them ...