As the director of a large hospital in the Indian state that has seen the country’s most coronavirus cases, Dr. S.P. Kalantri had been waiting for the day a vaccine would be approved and bring protection not only to his community but also himself.

But now he has his doubts about getting the shots after India took a regulatory shortcut to approve a vaccine by Indian drugmaker Bharat Biotech before late clinical trials showed it was effective in preventing illness from coronavirus infections.

“I’d rather wait and watch,” said Kalantri, who runs a hospital in Maharashtra state’s Wardha district.

He’s not alone. Several groups and unions representing scientists and doctors have also expressed their concerns over scant evidence of the effectiveness of the vaccine.

Many scientists have said that approving a vaccine without evidence from late trials is risky and a lack of transparency in the approval process could increase vaccine hesitancy in the world’s second-most populated country, where more than 10.4 million coronavirus cases have been reported among the nearly 1.4 billion people.

The homegrown vaccine was one of two that India authorized for emergency use on Jan. 3. The approval for the other — a version of the AstraZeneca vaccine made by world’s largest vaccine maker Serum Institute of India — was given on the basis of partial results from studies in Britain and Brazil that suggested it was about 70% effective at preventing illness from coronavirus infection.

Initially, a member of India’s COVID-19 task force said that the Bharat Biotech vaccine would be a “backup.” But on Jan. 5, health officials said it would be given to people after getting their consent and ensuring more frequent follow-ups, suggesting both vaccines will be deployed. It remains unclear as to which states will receive which vaccine and on what basis.

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Prime Minister Narendra Modi has touted the vaccines as evidence of India’s growing self-reliance due to its protectionist policies.

On Jan. 16 India will start the massive undertaking of inoculating an estimated 30 million doctors, nurses and other front line workers, before attention turns to around 270 million people who are either aged over 50 or have co-morbidities.

China and Russia have also administered vaccines while late clinical trials were still underway. But India, which is the world’s largest manufacturer of vaccines, has drawn criticism for using two different standards — needing efficacy data for one and not the other — for greenlighting the use of the two vaccines as well as a lack of transparency in the process.

The panel of experts that eventually gave the nod to the vaccines met three times. In the first two meetings, on Dec. 30 and Jan. 1, they were dissatisfied with Bharat Biotech’s application and asked for more data on its ability to prevent illness from COVID-19, minutes from the meeting show. The AstraZeneca vaccine, meanwhile, was greenlit on Jan. 1.

But on Jan. 2, the experts permitted the restricted use of the Bharat Biotech vaccine as an “abundant precaution” after the company claimed that the …read more

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