COVID-19 Vaccine | Johnson & Johnson to conduct bridging trails in India, awaiting DGCI nod: Report
This comes even as NEGVAC Chairman VK Paul on May 13 said that drugmakers such as J&J are “welcome to apply for import license” and approval will be given “in two days”.
May 14, 2021 / 09:05 AM IST
Johnson & Johnson: The magazine has listed the company as "Delivering a one-dose vaccine". (Image: Reuters)
Johnson & Johnson is awaiting approval from the Drugs Controller General of India (DCGI) for bridging trials of its one-dose COVID-19 vaccine.
In a statement to the Economic Times, J&J said that it has submitted an application to the DCGI requesting approval to “conduct a bridging clinical study of our single-dose Janssen COVID-19 vaccine candidate in India to comply with local regulations,” J&J said in an emailed statement to ET.
The report noted that it is unclear why J&J is pushing through with a bridging trail when India has said that it will allow easy access and regulatory clearances to US Food and Drugs Administration (FDA) or European Union (EU) approved vaccines
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National Expert Group on Vaccine Administration Committee (NEGVAC) Chairman VK Paul on May 13 said that drugmakers such as J&J are “welcome to apply for import license” and approval will be given “in two days”.
Besides its one-jab offering, the US pharma giant has also partnered with Hyderabad-based Biological E to manufacture its vaccine for global supply, but apart from the announcement in August 2020, no indication of timeline has emerged, the report added.
Sources told the paper that Biological E “may have prioritised its own vaccine candidate over J&J’s, besides the US maker’s advance commitments to other countries also having “pushed India to the back of the queue”.Follow our full COVID-19 coverage here