BENGALURU: Multinational pharma conglomerate Johnson & Johnson has applied to India’s drug regulator seeking permission to conduct a phase-3 clinical trial of its single-dose COVID-19 vaccine, which was paused in the United States last week on reports of rare blood clots.
They said the company has sought an early meeting of the subject expert committee on COVID-19 of the CDSCO to take a decision on its application.
This comes close to the heels of the central government last week deciding to fast-track emergency approvals for all foreign-produced coronavirus vaccinations that have been given a similar approval by the WHO or regulators in the US, Europe, Britain or Japan.
The company said on Tuesday it had submitted an application to India's drug regulator - the Drugs Controller General of India - requesting approval for the "bridging" safety and immunogenicity study for its vaccine. The global rollout of the single-dose vaccine, which is seen as a vital weapon in the fight against the COVID-19 pandemic, received a jolt when U.S. federal health agencies last Tuesday recommended pausing its use.
As per sources who told a leading media daily, Johnson & Johnson had applied on April 12 in the Global Clinical Trial Division through the Sugam online portal, instead of applying to the biological division which deals with vaccines and other biologicals.
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