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NEW DELHI: Defending his covid-19 vaccine Covaxin from criticism by various experts, Bharat Biotech International Ltd chairman and managing director Krishna Ella on Monday said that the company would in a week come out with data proving that his vaccine can work against the new mutant strain of novel coronavirus.

“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 when asked about the studies the company was conducting on the mutant strains of novel coronavirus.

Protection against the more virulent mutated strain of the virus from UK was the major reason for the company getting an authorisation from the 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 from its ongoing phase 3 trial was a major criticism against the company, with renowned scientists like Gagandeep Kang, board member of the Coalition for Epidemic Preparedness Innovations (CEPI), pointing out that the company lacked of data on the efficacy of Covaxin.

“For Covaxin, we have safety and immunogenicity data for more Indians than for Covishield but no efficacy data at all. If we do not know efficacy against any currently circulating viruses, how can we be confident to efficacy against the variant strain?" Kang said on Sunday.

The company is currently conducting a phase 3 efficacy trial for Covaxin, and has set target of enrolling 26,000 participants. So far, it has enrolled over 23,000 participants.

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, included that of AstraZeneca. So even if there was a mutation in the spike protein, like in the case of the UK strain, the vaccine would still work against the mutant variant.

The second argument he gave was that the inactivated vaccine was a traditional technology with a proven safety record and said that Bharat Biotech also had submitted safety data for over 20,000 participants, which was more than any other Indian company’s covid-19 vaccine so far.

His final argument was that said that the company had received an authorisation based on Clinical Trial Rules 2019, which allow a drug product to receive accelerated approval based on phase 1 and 2 data in case of an emergency.

Ella was citing a provision in the rules that stated, “if remarkable efficacy is observed with a defined dose in the Phase II clinical trial of investigational new drug for the unmet medical needs of serious and life-threatening diseases in the country, it may be considered for grant of marketing approval by the Central Licencing Authority (DCGI) based on Phase II clinical trial data".

He also claimed precedence from the 2009 H1N1 pandemic, when vaccines against the disease were given emergency licensure even without an efficacy trial, not just in India but also abroad.

Bharat Biotech has sent around five 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 as soon as possible. The firm has already stockpiled around 10 million doses of the vaccine so far and will be ready with another 10 million by February. "We will be ready with 150 million doses by July-August," he added.

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

However, no procurement deal has been finalised as yet. The firm has also not made public the price that 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 size of the volume/scale. 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," he said, but did not indicate a price for the vaccine.

“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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