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 – has just received a huge boost.
An Indian pharmaceutical company said on Wednesday that the initial results of clinical trials involving about 26,000 individuals showed that an Indian vaccine grown domestically was safe and effective. The company, Bharat Biotech, said that its Covaxin vaccine had an initial efficacy rate of 81 percent.
The results of the interim analysis have yet to be reviewed by peers, the company said. It was unclear how effective Covaxin would prove to be in a final analysis.
Still, the results were received with relief in India. Covaxin was approved by government officials in January and administered to millions of people before it was publicly proven to be safe or effective. Many people in India, including frontline health professionals, feared that Covaxin could be ineffective or worse, delaying the New Delhi campaign to inoculate 1.3 billion people.
Authorities in Brazil, where the government bought doses of Covaxin, recently questioned whether this vaccine really worked.
This week’s results may alleviate some of those concerns, said Dr. Anant Bhan, a health researcher at Melaka Manipal Medical College in southern India. Still, he said, the questions will remain at Covaxin until the survey is completed.
“This data will now need to be examined by the regulator in India and may have an impact on regulatory decisions regarding the vaccine,” said Dr. Bhan.
If the results continue, they could also benefit Narendra Modi, India’s prime minister, and his Hindu nationalist political party. Mr. Modi emphasized making India self-sufficient, and an effective vaccine developed by India could help with this campaign.
Indian approval of Covaxin for emergency use was announced in early January on the same day as the approval of the Oxford-AstraZeneca vaccine, known in India as Covishield. When the vaccination campaign started, less than two weeks later, most people were not allowed to choose which vaccine they would receive.
To support the vaccine, Mr. Modi publicly took the Covaxin vaccine on Monday. Images of other federal ministers and heads of regional governments taking the Indian vaccine have been published on social media.
But Gargeya Telakapalli, a public health expert, said that Covaxin’s emergency approval raised suspicions among frontline workers and raised questions about India’s regulatory process. This added uncertainty to the vaccination process in general.
“I know many health professionals who were not too confident to accept Covaxin and preferred Covishield,” said Telakapalli, who works in India with the People’s Health Movement, a global network of grassroots health activists. “The race for approval has not helped Covaxin, although no one says there is a problem with the vaccine.”
Partly because of the risk of obtaining a vaccine that has not been proven safe, many people in India have refused the injection, contributing to the slow launch of the campaign. The effort to vaccinate the country’s huge population was already a logistical challenge, involving transporting doses to remote places while controlling the environment around them.
The government intended to vaccinate about 300 million people by August. As of Wednesday, he had inoculated about 16 million. At this rate, covering the population can take years. The authorities expanded the eligibility of essential workers to include people over 60 and those over 45 with significant health risks.
Last week, an advisory board of the Central Drugs Standard Control Organization, India’s pharmaceutical regulator, rejected Bharat Biotech’s request for a trial of Covaxin in children aged 5 to 18, saying the company should first report on the effectiveness of your vaccine.
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The uncertainty could undermine Bharat Biotech’s ambitions to sell Covaxin to countries like Brazil. Last week, prosecutors there called for an immediate suspension of Covaxin purchases after the government signed a contract to buy 20 million doses.
The company was not intimidated. Bharat Biotech, which developed Covaxin with the National Institute of Virology and the Indian Medical Research Council, has already supplied 5.5 million injections of its vaccine for the Indian government’s vaccination campaign.
On Wednesday, the company said the final phase of the Covaxin study involved 25,800 volunteers across the country.
Officials at the Indian Medical Research Council said in a statement that the eight-month effort to produce a vaccine made locally was 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 a constantly evolving pandemic situation and will do a lot to help us win the war against Covid-19,” said Dr. Samiran Panda , employee of the Council.