Indian vaccine sparks safety fears for lack of data, efficacy report

India, the world’s second most populous country and one of the countries hit hardest by the coronavirus, has approved its first domestic COVID- 19 vaccine for emergency use only one month after the candidate was delivered into Phase III clinical trials, triggering concerns over safety and efficacy.

With the approval of the Indian domestic vaccine and sentiment against China fueled by some Indian politicians, the possibility for India to purchase quality Chinese vaccines may decrease, which could be a loss for India struggling to get its epidemic under control, observers said.

The vaccine, Covaxin, is an inactivated candidate developed by Bharat Biotech International Limited. Its Phase III clinical trials started on November 16, according to Indian media.

India reported about 10.3 million infections as of Monday, following the US with 20.7 million infections.

The serious epidemic may have allowed enough infections for interim analysis, experts said.

Using the same technology, theoretically, India’s inactivated vaccine should be no different from China’s, Tao Lina, a Shanghai- based vaccine expert, told the Global Times on Monday.

As to safety and efficacy, Tao said that there would not be any problem as long as trials could prove that India’s vaccine can induce equal- level antibodies, especially the neutralizing antibody, as China’s inactivated vaccine dose.

China announced it would grant conditional market approval for its first homemade COVID- 19 vaccine, which showed 79.34 percent efficacy and a 99.52 percent antibody positive conversion rate.

However, Tian Guangqiang, assistant research fellow at the National Institute of International Strategy at the Chinese Academy of Social Sciences, hesitated to express confidence in India’s vaccine, noting that as a major manufacturer of generic drugs in the world, India’s independent medical research and development capacity is not that competent.

Even though the vaccine proves good efficacy, India would meet practical difficulties when rolling out the mass vaccination due to underdeveloped medical facilities, especially in remote areas and slums, Tian noted.

“It will be very difficult to count the population and conduct vaccination in the slums due to high mobility,” Tian said.

India had announced a rollout of mass vaccination within a week, with 300 million people to be vaccinated by July 2021 for free, media said.