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Single-dose Johnson and Johnson vaccine gets Indian drug regulator nod

J&J has tied up with Hyderabad-based Biological E for the global supply chain network, hoping to supply its Covid-19 vaccine Janssen through extensive collaborations and partnerships.

Published: 08th August 2021 08:45 AM  |   Last Updated: 08th August 2021 08:51 AM   |  A+A-

A beneficiary takes a selfie while receiving Covid-19 vaccine in Kolkata.

A beneficiary takes a selfie while receiving Covid-19 vaccine in Kolkata. (Photo | PTI)

NEW DELHI:  India’s apex drug regulator on Saturday, August 7, 2021, approved the single dose Covid-19 vaccine by Janssen, a subsidiary of the US pharma giant Johnson and Johnson, making it the fifth vaccine against coronavirus to receive emergency use authorisation for the national vaccination drive.

“India expands its vaccine basket! J&J’s single-dose Covid-19 vaccine is given approval for emergency use in India. Now India has 5 EUA vaccines,” tweeted union health minister Mansukh Mandwiya.
The company had applied for the EUA, along with the Serum Institute of India which sought the same approval for its version of Novavax Covid vaccine, on Thursday.

As per the US Center for Disease Control and Prevention, J&J’s vaccine was shown to be 66.3% effective in efficacy trials at preventing laboratory-confirmed Covid-19 infection and people had the most protection two weeks after getting vaccinated.

A company statement issued in July said the vaccine is nearly 85% effective against severe or critical disease and demonstrates protection against hospitalization and death. “The advantage of this viral vector-based vaccine is that it is a single shot vaccine and can be stored in regular refrigerators for up to three months,” a senior government official said, adding that given its cost of about Rs 2,000 per dose, it may be mainly available in private hospitals in the coming days.

The firm had also said the vaccine elicited neutralising antibody activity against the delta variant at an even higher level than what was recently observed for the beta variant in South Africa where high efficacy against this strain had been demonstrated.

J&J has tied up with Hyderabad-based Biological E for the global supply chain network, hoping to supply its Covid-19 vaccine Janssen through extensive collaborations and partnerships with governments, health authorities and organisations such as Gavi and the Covax facility.

The vaccine had received emergency use authorization in the US in February followed by conditional marketing authorisation in March. Authorities in private hospitals said the vaccine may be particularly apt for India given that it is a single dose vaccine and can be stored easily.

“These two features make it useful for a large chunk of population in tier II and III cities and remote parts in the country,” Girdhar J Gyani, director general of the Association of Healthcare Providers of India had earlier said.



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