NEW DELHI – India’s ambitious yet tumultuous campaign to vaccinate its large population against Covid-19 – and in the process win its own reputation as a manufacturer and innovator – has only received a major boost.
An Indian medicine company said late on Wednesday that the initial results of clinical trials involving nearly 26,000 subjects showed that a homemade Indian vaccine is safe and effective. The company, Bharat Biotech, said its Covaxin vaccine has an initial efficacy rate of 81 percent.
The results of the interim analysis have yet to be peer-reviewed, the company said. It was unclear how effective Covaxin would eventually prove to be.
Yet the results in India are relieved. Covaxin was approved by government officials in January and administered to millions of people before being publicly proven to be safe or effective. Many people in India, including frontline health workers, feared that Covaxin would be ineffective or worse, delaying New Delhi’s campaign to vaccinate 1.3 billion people.
Officials in Brazil, where the government bought doses of Covaxin, recently questioned whether this vaccine actually works.
The results this week may alleviate some of the problems, said dr. Anant Bhan, a health researcher at Melaka Manipal Medical College in southern India, said. Still, he said, questions about Covaxin will linger until the research is complete.
“This data will now have to be investigated by the regulator in India, and could then have an impact on the regulatory decisions regarding the vaccine,” said Dr. Bhan said.
If the results are true, it could also benefit Narendra Modi, India’s prime minister, and his Hindu nationalist political party. Mr. Modi has emphasized the need to make India independent, and an effective, Indian-developed vaccine could help the campaign.
India’s approval for 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 starts less than two weeks later, most people are not allowed to choose which sting they get.
In support of the vaccine, Mr. Modi took the Covaxin jab in public on Monday. Images of other federal ministers and heads of regional governments taking the Indian-made vaccine have been posted on social media.
But Gargeya Telakapalli, a public health expert, said the approval of Covaxin aroused emergencies among frontline workers and raised questions about India’s regulatory process. This added uncertainty to the vaccination process in general.
“I know many health workers who were not very confident in taking Covaxin and preferred Covishield,” he said. Telakapalli, which works in India with the People’s Health Movement, a global network of grassroots health activists, said. “The rush for approval has not helped Covaxin, although no one is saying there is a problem with the vaccine.”
Partly because of the risk of getting a vaccine that has not been proven safe, many people in India have refused to get stuck, which is contributing to the slow start of the campaign. The attempt to vaccinate the large population of the country was already logistically challenging, and involved transporting doses to distant places while controlling the environment around them.
The government plans to vaccinate about 300 million people by August. As of Wednesday, it has grafted about 16 million. At the same rate, the coverage of the population can last for years. The government has expanded the need for essential workers to include people over 60 and people 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 Covaxin trial on children between the ages of 5 and 18, saying the company must first submit a report on the efficacy of its vaccine.
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The uncertainty could hamper Bharat Biotech’s ambitions to sell Covaxin to countries such as Brazil. Last week, prosecutors there demanded the immediate suspension of Covaxin purchases after the government signed a contract to buy 20 million doses.
The company is dissatisfied. Bharat Biotech, which developed Covaxin with the National Institute of Virology and the Indian Council of Medical Research, has already delivered 5.5 million shots of its vaccine for the Indian government’s vaccination campaign.
The company said Wednesday the final phase of the Covaxin trial involved 25,800 volunteers across the country.
Officials of the Indian Medical Research Council said in a statement that the eight-month effort to produce a locally produced vaccine is proof of the rise of the country 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 that it will help us a lot to win the war against Covid-19,” said Dr. Samiran Panda, an official of the council.