Bharat Biotech Defends Vaccine After Controversial India License

The head of India’sBharat Biotech International Ltd. defended the company’s locally-developed coronavirus vaccine that was granted emergency authorization by the country’s regulator even though final-stage human trials haven’t been completed.

Bharat Biotech was “confident” over the vaccine’s use, Chairman and Managing Director Krishna Ella said at a press briefing on Monday, while criticizing media reporting surrounding Covaxin, which should finish final-phase recruitment within “two or three” days, he said. No phase-3 efficacy data has been analyzed yet and a full read out should come between March and October, according to a 41-page slide show he presented.

Over the weekend, India’s drug regulator grantedrestricted approval to Covaxin, a move that was widely criticized by health experts as premature. The Drugs Controller General of India said the vaccine — which has been partly funded by the government — was given an emergency green light so the country, which has 10.3 million confirmed infections, had more options in case mutant strains emerge.

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The All India Drug Network, a health watchdog, said in a statement that it was “shocked to learn of the recommendation” without phase-3 efficacy data or proof that it worked against mutant strains. “Anybody would tell you that this is bad vaccine development science,” Malini Aisola, the body’s co-convenor, said by phone from New Delhi on Monday.

Bharat Biotech has already produced about 20 million doses, Ella said, which will be increased to about 150 million before July or August. The firm has previously said its vaccine — that uses a dead version of the virus — hasefficacy rates of at least 60%, though it has yet to release detailed data. Ella said Covaxin will feature in two peer reviews in international health journals on Jan. 10.

“We are under pressure,” he said. “We don’t want the government of India to take a risk on us.”

The regulator also gave a restricted license for local use to the vaccine developed byAstraZeneca Plc and theUniversity of Oxford, which is being produced by theSerum Institute of India Ltd., the world’s largest vaccine maker by volume.

Awaiting Deal

In aninterview on Sunday, Serum’s Chief Executive Officer Adar Poonawalla said the company had yet to sign a pricing or supply agreement with the Indian government, but is expecting one within days. He has offered the Astra vaccine at a price of 200 rupees ($2.74) for the first 100 million doses and 1,000 rupees for private use as that is authorized.

Bharat Biotech is currently talking to the Indian government on pricing and hasn’t signed any deal, Ella said. Between 200 million to 500 million doses of annual Covaxin capacity will come online this year from multiple facilities, according to the presentation.

The reaction over the weekend shows that vaccine development in India is “getting political,” Ella said, adding that no one in his family is a member of any party.

“Why are Indian scientists being bashed?” Ella said. “When the U.K. does something, ‘oh it’s great’ — I want Indian scientists to get recognition globally.”

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