WHO says safety 'primary focus' after Johnson & Johnson halts COVID-19 vaccine trials

After Johnson & Johnson suspended its vaccine trials, the World Health Organisation (WHO) expressed pleasure over vaccine developers acting by the rules. A WHO spokesperson told Russia’s state-run news agency, Sputnik, that the UN agency believes safety in research is crucial. Johnson & Johnson has temporarily paused the Phase 3 clinical trial of its COVID-19 vaccine candidate after one of the participants fell sick.

"Safety is the primary focus for vaccine clinical trials. When a potentially unexplained illness occurs in a trial participant, which may or may not be related to the vaccine being evaluated, it is rigorous, routine practice to investigate," the spokesperson said.

The American multinational corporation issued a statement on its official website, saying there is “no greater priority than safety” of the people and that it is committed to providing transparent updates of its clinical development process. It added that the study participant showcased an “unexplained illness” which is currently being reviewed and evaluated. 

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The J&J Phase 3 trial had started enrolling participants in late September and set a goal of recruiting up to 60,000 volunteers across more than 200 sites in the US,  Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa. The US-based pharmaceutical company said that the studies are halted to enable “a careful review of all of the medical information before deciding whether to restart the study.”

Pledge signed by biopharma companies

This is not the first time that a biopharma company has paused the clinical trials of its vaccine candidate. In September, AstraZeneca also briefly paused the human trials due to an unexplained illness in a study participant. The decision to put the trial on hold came after leading biopharma companies signed a pledge to continue to make the safety and well-being of vaccinated individuals the top priority in the development of the first COVID-19 vaccines.

"We are pleased to see vaccine developers ensuring the scientific integrity of the trials and abiding by the standard guidelines and rules for the development of vaccines," the spokesperson added.

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(With ANI inputs)