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Novavax and J&J's COVID-19 vaccines seek regulator's nod for launch in India

For the national COVID vaccination programme, J&J’s single dose vaccine is slated as a crucial component as it may be logistically easy to administer and offers quick coverage to a vast population

Published: 06th August 2021 06:30 PM  |   Last Updated: 06th August 2021 06:30 PM   |  A+A-

Novavax

For representational purposes

Express News Service

NEW DELHI: India’s pool of COVID-19 vaccines is set to receive a shot in the arm with two more vaccines reaching the doors of the country’s apex drug regulator for approval and looking to receive the permissions within days.

The vaccines which have applied to the Central Drugs Standard Control Organisation for the restricted use authorisation include Novavax, being manufactured locally by the Serum Institute of India under the brand name of Covovax, and Johnson and Johnson’s single dose COVID vaccine

Sources in the CDSCO said that the companies had moved the applications on Thursday and a meeting of the COVID-19 expert panel has been called to scrutinise their data before taking a final decision.  

SII, in June, had already started the production of Covovax for stockpiling, which has shown an efficacy of over 90% in the phase 3 clinical trials in the US and is looking to launch the vaccine in India by September.

ALSO READ: Booster dose not part of India’s vaccine plan yet

In India, this recombinant nanoparticle protein-based vaccine—whose 20 crore doses have been projected to be available by the year end—is also undergoing a bridging trial.

In June, Novavax had said that the vaccine has an efficacy of 90.4% in preventing infection and 100% efficacy against moderate to severe disease while announcing results from its late-stage trials.

The company had also said in a statement that the vaccine was tested in nearly 30,000 volunteers between January-April in the US and Mexico and significantly, also included nearly 44% non-white participants.

The two doses of the vaccine are administered 21 days apart and its efficacy results have since been compared to the coronavirus vaccines by Pfizer and Moderna, as the phase 3 trials of this vaccine conducted later meant that it was pitted against the more dreaded delta variant of the COVID virus.

For the national COVID-19 vaccination programme, J&J’s single dose vaccine has also been slated as a crucial component in the coming days as it may be logistically easy to administer and offers quick coverage to a vast population.

A bid by the Association of Healthcare Providers of India to procure the J&J vaccines in private hospitals had, however, failed last month due to regulatory hurdles.

Nearly seven months since the launch of the nationwide COVID-19 vaccination programme, only about 8% of the adult population in India has been fully vaccinated and the government also missed the timeline of supplying 51 crore doses of vaccines by July.

The inoculation programme against COVID-19 in the country so far has largely been driven by Covishield, being produced by SII which had supplied nearly 45 crore doses till August 5 while Covaxin, being produced by Bharat Biotech, has remained a minor player at less than 7 crore doses.



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