NEW DELHI – India’s ambitious but restless campaign to vaccinate its vast population against Covid-19 – and in the process of burning its own reputation as a manufacturer and innovator – has just received a big boost.
An Indian pharmaceutical company said late Wednesday that initial results from clinical trials involving nearly 26,000 subjects showed that the home-grown Indian vaccine was both safe and effective. The company, Bharat Biotech, said its Covaxin vaccine had an initial effectiveness rate of 81%.
The results of the interim analysis have yet to be reviewed, the company said. It was not clear how effective Covaxin would be in the final analysis.
Officials in Brazil, where the government has bought doses of Covaxin, recently questioned whether the vaccine actually works.
The results this week may allay some of those concerns, said Dr. Anant Bhan, a health researcher at Melaka Manipal Medical College in South India. Still, he said, questions would remain over Covaxin until the study was completed.
“These data will now have to be examined by the regulatory body in India and could then influence regulatory decisions regarding the vaccine,” Dr Bhan said.
If the results are maintained, they could also benefit Narendra Modi, India’s prime minister, and his Hindu nationalist political party. Mr Modi emphasized that India was self-sufficient and an effective vaccine developed by India could help this campaign.
India’s approval for emergency use of Covaxin 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 drive started in less than two weeks, most people were not allowed to choose which stroke to have.
To support the vaccine, Mr Modi publicly took a sample of Covaxin on Monday. Images of other federal ministers and heads of regional governments receiving the Indian-made vaccine have been posted on social media.
But Gargeya Telakapalli, a public health expert, said the urgent approval of Covaxin raised suspicions among front-line workers and raised questions about the regulatory process in India. This added uncertainty to the vaccination process as a whole.
“I know many health professionals who were not very confident about taking Covaxin and preferred Covishield,” said Mr Telakapalli, who works in India with the Public Health Movement, a global network of local health activists. “The speed of approval has not helped Covaxin, although no one says there is a problem with the vaccine.”
Partly because of the risk of getting a vaccine that has not been shown to be safe, many people in India refuse to be stabbed, contributing to the slow spread of the campaign. Efforts to vaccinate the country’s vast population have already been logistically challenging, involving transporting doses to remote locations while controlling the environment around them.
The government aims 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. Authorities have expanded the eligibility of key workers to include people over 60 and over 45 with significant health risks.
Last week, the advisory board of the Central Drug Control Organization, the pharmaceutical regulator in India, rejected Bharat Biotech’s request for a study of Covaxin in children aged 5 to 18, saying the company must first submit a report on the effectiveness of the vaccine. you are.
Uncertainty could hamper Bharat Biotech’s ambitions to sell Covaxin to countries such as Brazil. Last week, prosecutors there demanded an immediate halt to Covaxin’s purchases after the government signed a contract to buy 20 million doses.
The company is irresistible. Bharat Biotech, which developed Covaxin with the National Institute of Virology and the Indian Board of Medical Research, has already provided 5.5 million photos of its vaccine to the Indian government’s vaccination campaign.
On Wednesday, the company said 25,800 volunteers across the country were involved in the final phase of the Covaxin study.
Officials from the Indian Medical Research Council said in a statement that the eight-month effort to produce a locally produced vaccine was a testament to the country’s emergence as a global superpower of vaccines.
“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 in helping us win the war against Covid-19,” said Dr. Samiran Panda, an employee of the council.