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Full licence for Covaxin may take time

A healthcare worker holds a vial of Covaxin. File   | Photo Credit: Thulasi Kakkat

Bharat Biotech, the manufacturer of Covaxin, may not be given full licensure for its COVID vaccine just yet, said a senior health official, saying the vaccine will continue to be used under emergency authorisation.

While the company refused to comment on the latest development, Union Health Ministry officials said the authorities have sought more data from follow up studies.

The company earlier this week had submitted data from phase-3 trials to the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). The yet-to-be published data submitted showed that Covaxin had demonstrated 77.8% efficacy in its phase-3 trial, which was conducted on 25,800 subjects.

“The proposal seeking full licensure for Covaxin, was looked into and we have sought more details. Till then Covaxin will continue to be available to public under the earlier emergency authorisation,” said an official.

Allocation transparent

Meanwhile the Health Ministry on Thursday denied allegations of non-transparent allocation of COVID-19 vaccines to States. The Central Government continues to allocate COVID-19 vaccines to States and Union Territories in a transparent manner, it said, adding that distribution of vaccines is based on population of a State, caseload or disease burden and State’s utilisation efficiency.

The Ministry noted that allocation is negatively affected by the vaccine wastage.

“India’s National COVID Vaccination Program is built on scientific and epidemiological evidence, WHO guidelines and global best practices. Anchored in systematic end-to-end planning, it is implemented through effective and efficient participation of States and Union Territories and the people at large,” said the Ministry.

It noted that information about the vaccine supply by Central Government, consumption by the States and Union Territories, balance and unutilised vaccine doses available with them, along with vaccine-supply in the pipeline, is regularly shared.


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Printable version | Aug 4, 2021 2:02:14 AM | https://www.thehindu.com/news/national/full-licensure-for-covaxin-will-take-time-says-health-ministry/article34949046.ece

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