Johnson & Johnson to launch single-dose COVID-19 vaccine in India
Johnson & Johnson (J&J) said it was engaged in discussions with the Indian government to launch its single-dose COVID-19 vaccine and the reports about the company withdrawing its proposal for speedy vaccine approval in India is untrue.
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Johnson & Johnson (J&J) said it was engaged in discussions with the Indian government to launch its single-dose COVID-19 vaccine and the reports about the company withdrawing its proposal for speedy vaccine approval in India is untrue.
"We look forward to ongoing discussions with the Government of India and will continue to explore how to accelerate availability of the Johnson & Johnson COVID-19 vaccine in India," J&J statement added.
In order to speed up access to COVID-19 vaccines, DCGI earlier said that COVID-19 vaccines approved for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which were listed in WHO Emergency Use Listing (EUL) and which were well established vaccines from the standpoint that millions of individuals had already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli was exempted.
J&J's vaccine was approved by USFDA, EMA and UK MHRA for emergency use, and was listed by WHO. The US drug maker has also tied-up with Hyderabad-based vaccine maker Biological E to manufacture the vaccine.