Bharat Biotech's Covaxin Has To Wait Longer For Full Licence

The Covaxin Covid-19 vaccine created by Hyderabad-based Bharat Biotech is likely to be administered under emergency authorization and it may soon get full license approval, according to a senior health official.

The data from Covaxin's Phase 3 trial, which included 25,800 volunteers, was submitted to the Central Drugs Standard Control Organisation's subject expert committee (SEC) earlier this week (CDSCO). The trials yielded a 77.8% effectiveness rate.

"We have looked into the proposal for a complete license for Covaxin and have requested more information. Then, Covaxin will be available to the public for emergency authorization," said an official.

The Health Ministry denied complaints of a lack of transparency in the distribution of Covid-19 vaccinations to states, saying that vaccine distribution is based on the state's population, caseload or disease burden, and utilization efficiency.

"India's National Covid Vaccination Program is based on scientific and epidemiological facts, WHO recommendations, and best practices from around the world. It is implemented through effective and efficient participation of States and Union Territories, as well as the general public," the Ministry stated on Thursday, adding that vaccination supply is unaffected by the state's actions.

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