Such pauses are an expected part of any clinical study, especially large studies which includes thousands of people, said the company which is conducting highest profile efforts to contain the global pandemic. It said the company guidelines have allowed them to pause the study and it is different from a regulatory hold. Citing the participants’ privacy, the company has refused to disclose any more details about the illness.

As per reports of Stat News, a document was sent to outside researchers which stated a “pausing rule” had been met.

In an early-to-mid stage clinical trial, J&J’s experimental Covid-19 vaccine produced strong immune response.Following which, last month it had started enrolling upto 60,000 volunteers for Phase 3 clinical trials.

Due to pause, the online enrollment system had been closed and the independent patients safety committee would be convened, reported Stat News.

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Meanwhile,the late stage trials of a Covid-19 vaccine developed by AstraZeneca and Oxford University in the US remains on hold pending a regulatory review. In September, the company had paused the clinical trials due to similar challenges as faced by Johnson & Johnson. The trial was stopped when a UK study participant developed severe neurological symptoms and a rare inflammation of the spinal cord.

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

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“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project,” the letter says. ICMR sources confirm authenticity of the letter but say it was meant for internal communication.

The indigenous vaccine being developed in India is one of the top-priority projects which is being monitored at the top-most level of the government, the statement further read. PM Modi had recently held a high-level meeting to take stock on the indigenous vaccine efforts.

Meanwhile, the Drug Controller General of India has approved pharmaceutical firm Zydus Cadila to start Phase I and Phase II human clinical trials of its COVID-19 vaccine. This is the second vaccine after Hyderabad-based Bharat Biotech’s COVAXIN to get the approval. The approval process was fast-tracked following recommendation by the subject expert committee on COVID-19, considering the emergency and unmet medical need during the pandemic. The assent for human trials was given after the company submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to safety and immunogenicity, sources said. The company is likely to start enrolment of subjects soon. “The phase I and II trials will take around three months to be completed,” the source said.

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