Pharma giant Johnson and Johnson pauses COVID-19 vaccine trial

Johnson & Johnson has temporarily paused its COVID-19 vaccine trial due to an unexplained illness in a study participant.

The US Food and Drug Administration made public its guidance for issuing emergency approval for a COVID-19 vaccine on October 6. Picture: AFP

Johnson & Johnson has temporarily paused its COVID-19 vaccine trial due to an unexplained illness in a study participant.

The phase-three trials have been suspended as the participant’s illness is reviewed by the independent Data Safety Monitoring Board and Johnson & Johnson’s own clinical and safety physicians.

The pause means the enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.

“At Johnson & Johnson, there is no greater priority than the safety and well-being of the people we serve every day around the world,” the company said in a statement.

“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.”

The development comes after AstraZeneca temporarily stopped tests of its vaccine after a trial participant fell ill.

That study has since resumed in a number of countries but remains halted in the US, where the Food & Drug Administration typically sets a higher standard for such trials than many other countries.

Johnson & Johnson said that adverse events are expected in any large clinical study, and said that as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.

The J&J Phase 3 trial had started recruiting participants in late September, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world, the company and the US National Institutes for Health (NIH), which is providing funding, said.

The other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

With the move, J&J became the tenth maker globally to conduct a Phase 3 trial against Covid-19, and the fourth in the US.

The US has given J&J about $1.45 billion in funding under Operation Warp Speed. The vaccine is based on a single dose of a cold-causing adenovirus, modified so that it can no longer replicate, combined with a part of the new coronavirus called the spike protein that it uses to invade human cells.

J&J used the same technology in its Ebola vaccine which received marketing approval from the European Commission in July.

Pre-clinical testing on rhesus macaque monkeys that were published in the journal Nature showed it provided complete or near-complete protection against virus infection in the lungs and nose.

With AFP