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Bharat Biotech International Ltd will be coming out with the first set of interim efficacy data for Covaxin from its ongoing phase 3 trials in two weeks, chairman and managing director Krishna Ella said.

“We moved so fast, but unfortunately we missed the efficacy timepoint. Had we done the (phase) 2/3 combined, we would have captured efficacy faster. But anyhow, we should be coming out with efficacy in two weeks with the efficacy point data," Ella said at the BioAsia Summit on Monday.

The efficacy data would be the first such data for an indigenously developed covid-19 vaccine in India.

Bharat Biotech had got an emergency licensure from the Drugs Controller General of India V.G. Somani for its wholly-inactivated SARS-COV2 vaccine despite not having efficacy data.

The rationale given by the regulator for the controversial move was that the vaccine, comprising of entire killed virus particles, would be more effective in dealing with new strains, like those found in South Africa, that have mutations in the genetic sequence of the spike protein. Most vaccines, like Serum Institute of India’s Covishield, target only the spike protein and have been shown to have efficacy as low as 10% against the South Africa strain.

Ella said that his company can modify his vaccine within 15 days of getting the South Africa strain from Indian Council of Medical Research.

“We are not going to change our manufacturing process. Everything is exactly the same... Just switch in the (South Africa) strain," Ella said.

The Hyderabad-based vaccine maker will be commissioning its third facility by the end of this week and after that, will be able to produce at least 40 million doses of the vaccine every month, he said, adding that increased production for the vaccine will potentially help reduce shortage globally.

Ella said that the company wants to distribute its vaccine through the Covax—a facility aimed at equitable access to covid-19 vaccines globally, and is jointly led by the World Health Organization, Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance.

“The moment we come out with phase 3 efficacy data, if everything is alright, then I think we will really want to be part of Covax," he said.

Biological E managing director Mahima Dattle, who was also speaking at the summit, said that the company has also completed its phase 1 and 2 trial for its vaccine, co-developed with US-based Baylor College of Medicine, and would be able to publish the data in a “couple of weeks time".

The company is targeting production of 1 billion doses of vaccine annually. It is also contract manufacturing Johnson and Johnson’s single-shot vaccine, but Dattla declined to comment on it.

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