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NEW DELHI – India’s ambitious but troubled campaign to vaccinate its vast population against Covid-19 and, in the process, to polish its own reputation as a manufacturer and innovator, just got a big boost.
An Indian pharmaceutical company said late Wednesday that initial results from clinical trials involving nearly 26,000 subjects showed that a homegrown Indian vaccine was safe and effective. The company, Bharat Biotech, said its Covaxin vaccine had an initial efficacy rate of 81 percent.
The results of the interim analysis have not yet been peer-reviewed, the company said. It was unclear how effective Covaxin would turn out to be in a final analysis.
Still, the results were greeted with relief in India. The covaxin had been approved by government officials in January and administered to millions of people before it was publicly shown to be safe or effective. Many people in India, including frontline healthcare workers, had feared that Covaxin could be ineffective or worse, slowing down New Delhi’s campaign to vaccinate 1.3 billion people.
Officials in Brazil, where the government had bought doses of Covaxin, had recently questioned whether this vaccine really worked.
This week’s results could alleviate some of those concerns, said Dr. Anant Bhan, a health researcher at Melaka Manipal Medical College in South India. Still, he said, questions will remain about Covaxin until the investigation is complete.
“This data will now need to be scrutinized by the regulator in India and could later have an impact on regulatory decisions regarding the vaccine,” said Dr. Bhan.
If the results hold up, they could also benefit Narendra Modi, the prime minister of India, and his Hindu nationalist political party. Mr Modi has emphasized making India self-sufficient, and an effective vaccine developed in India could help that campaign.
India’s approval of Covaxin for emergency use was announced in early January on the same day as the approval of the Oxford-AstraZeneca vaccine, which is known in India as Covishield. When the vaccination campaign began less than two weeks later, most people were not allowed to choose which vaccine to receive.
To support the vaccine, Modi publicly took the Covaxin coup on Monday. Images of other federal ministers and heads of regional governments taking the Indian-made vaccine were posted on social media.
But Gargeya Telakapalli, a public health expert, said Covaxin’s emergency approval raised suspicions among frontline workers and raised questions about India’s regulatory process. That added uncertainty to the vaccination process in general.
“I know a lot of healthcare workers who weren’t really sure about taking Covaxin and they preferred Covishield,” said Telakapalli, who works in India with the People’s Health Movement, a global network of grassroots health activists. “The rush for approval has not helped Covaxin, although no one says there is a problem with the vaccine.”
Partly due to the risk of receiving a vaccine that had not been shown to be safe, many people in India have refused to receive needle sticks, contributing to the slow launch of the campaign. The effort to vaccinate the country’s huge population was already a logistical challenge, as it involved transporting doses to remote locations while controlling the environment around them.
The government aimed to vaccinate some 300 million people by August. As of Wednesday, it had inoculated about 16 million. At that rate, covering the population could take years. Authorities have expanded the eligibility of essential workers to include people over the age of 60 and people over the age of 45 with significant health risks.
Last week, an advisory board to the Central Drug Control Organization, India’s pharmaceutical regulator, rejected Bharat Biotech’s request for a trial of Covaxin in children between the ages of 5 and 18, saying the company should file first. a report on the effectiveness of your vaccine.
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The uncertainty could hamper Bharat Biotech’s ambitions to sell Covaxin to countries like Brazil. Last week, prosecutors sought immediate suspension of Covaxin purchases after the government signed a contract to buy 20 million doses.
The company has not been intimidated. Bharat Biotech, which developed Covaxin with the National Institute of Virology and the Indian Council for Medical Research, has already supplied 5.5 million injections of its vaccine for the Indian government’s vaccination campaign.
On Wednesday, the company said the final stage of the Covaxin trial had involved 25,800 volunteers across the country.
Officials with the Indian Council for Medical Research said in a statement that the eight-month effort to produce a locally manufactured vaccine was a testament to the country’s emergence as a global vaccine superpower.
“The development and deployment of Covaxin ensures that India has a powerful weapon in its arsenal in an ever-evolving pandemic situation and will go a long way toward helping us win the war against Covid-19,” said Dr. Samiran Panda, Official of the City Council.
