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Bharat Biotech International Ltd will in a week produce data that will prove its Covaxin shot is effective against the new virulent UK coronavirus strain, chairman and managing director Krishna Ella claimed on Monday.

“It’s only a hypothesis right now... Just give me one week’s time to come out with the data. I am confident it will work," Ella said in response to a question about the vaccine’s effectiveness on the mutant strain.

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His comment came after criticism of the drug regulator for approving Covaxin for emergency use in spite of incomplete data on its effectiveness against the coronavirus.

Protection against the more contagious mutant strain of the virus from the UK was the major reason for the company getting an authorization from Drugs Controller General of India V.G. Somani on Sunday, even though the company did not have data showing effectiveness against the original SARS-COV2 strain.

Lack of efficacy data from its ongoing phase 3 trial was a major criticism against the company, with leading scientists such as Gagandeep Kang, a board member of the Coalition for Epidemic Preparedness Innovations (CEPI), expressing concern. “For Covaxin, we have safety and immunogenicity data for more Indians than Covishield but no efficacy data at all. If we do not know efficacy against any currently circulating viruses, how can we be confident about efficacy against the variant strain?" Kang said in an interview on Sunday.

The company has set a target of enrolling 26,000 participants for its phase 3 trial and has recruited more than 23,000 participants so far. Ella said efficacy data from phase 3 trial may be out after March.

On Monday, Ella defended his vaccine using three arguments. The first was a “hypothesis" that the vaccine was an inactivated one, meaning it had an entire killed virus, which provided immunity against multiple proteins of the virus and not just the spike protein, which was the only target for many other vaccines, including AstraZeneca’s. This hypothesis meant that even if there were a mutation in the spike protein, as in the case of the UK strain, the vaccine would still work against the mutant variant.

Ella’s second argument was that the inactivated vaccine was a traditional technology with a proven safety record and that Bharat Biotech had submitted safety data for over 20,000 participants—more than any other Indian company’s covid-19 vaccine. Finally, he said, the company had received an authorization based on Clinical Trial Rules 2019, which allow a drug to receive accelerated approval based on phase 1 and 2 data in case of an emergency.

The provision states, “If remarkable efficacy is observed with a defined dose in the phase II clinical trial of an investigational new drug for the unmet medical needs of serious and life-threatening diseases, it may be considered for grant of marketing approval by the Central Licencing Authority based on phase II clinical trial data".

He also claimed precedence from the 2009 H1N1 pandemic, when vaccines against the disease were given emergency licence without an efficacy trial. Bharat Biotech has sent around 5 million Covaxin doses for quality checks at the Central Drugs Laboratory in Kasauli, Ella said, adding that he hopes to be able to roll out the doses soon. The firm has already stockpiled 10 million doses so far and will be ready with another 10 million by February. “We will be ready with 150 million doses by August," he said.

The company is preparing a protocol to expand testing of Covaxin to children between two and 15 years, and submit it to the regulator soon, he said.

However, no procurement deal has been finalized yet. The firm has also not made public the price it intends to charge the government for the two-dose vaccine.

“Right now the government is talking to us," Ella said. “The cost is (based on) the volume. In the beginning, the cost may be a little higher in the vaccine field, but as the scale-up of production increases, when market competition builds up, the price is automatically controlled by the market."

“We are trying to understand a lot of things...just give us time, we’ll figure out all those things," he added.

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