India’s Covaxin Found 77.8% Effective in Lancet Covid Study
(Bloomberg) -- Covaxin, a vaccine developed by India’s medical research agency and Bharat Biotech International Ltd., was 77.8% effective at preventing symptomatic Covid-19 in an interim analysis of a long-awaited study.
Covaxin, which uses traditional, inactivated-virus technology, induced a robust antibody response two weeks after the second dose was given, the investigators concluded. No severe adverse events or vaccine-related deaths occurred during the randomized trial involving 24,419 adults. The research, conducted between November 2020 and May 2021 in India, was published in The Lancet.
The interim analysis based on 130 laboratory-confirmed infections is in line with the company’s earlier efficacy and safety announcements and may help end the controversy surrounding the shot’s early authorization in January in India. The study was funded by Bharat Biotech and the Indian Council of Medical Research, and researchers with both organizations participated in the work.
At the time of India’s approval, the shot hadn’t yet cleared its final-stage trials, prompting widespread hesitancy in the early weeks of the country’s immunization drive. Since then more than 120 million doses of Covaxin have been deployed across India. Last week the World Health Organization added the inoculation to its list of Covid vaccines authorized for emergency use.
The backing didn’t come quickly. In the course of its months-long analysis, the WHO independent technical body evaluating the vaccine repeatedly asked the company for further information, delaying its addition to the body’s pre-qualified list of shots and frustrating Prime Minister Narendra Modi’s government, which had championed the locally-developed shot as a nationalist cause.
Bharat Biotech’s Chairman Krishna Ella previously lashed out at those questioning Covaxin and this week told a conference that the WHO approval took as long as it did due to criticism of the vaccine, which hurt the shot’s image.
Publication in one of the world’s leading medical journals “showcases the immense strength of ‘Atmanirbhar Bharat,’” with Indian academics and industry “fighting against the odds,” said Balram Bhargava, the head of the ICMR, in a statement referring to the government’s self-reliance campaign.
The researchers will monitor participants for a year for long-term safety data. Additional information is also needed about its effectiveness over time, as well as protection against severe disease, hospitalization and death.
In the study, 106 people given placebo and 24 who got the vaccine contracted the virus. Fiften on placebo developed a severe Covid infection, compared with one given the vaccine, the researchers found. The shot appeared 65% effective against the more infectious delta variant, though more work is needed to confirm the findings, they said.
Home to the world’s largest vaccine manufacturing industry, India had heavily promoted Covaxin. However the shot accounts for just over one out of 10 doses administered in the country of 1.4 billion people, with AstraZeneca Plc’s vaccine -- made and known locally as Covishield -- making up the lion’s share.
Covaxin is also being evaluated by India’s drug regulator for use in those aged 2 to 18, though the country has yet to start inoculating children against Covid.
Meanwhile, India resumed vaccine exports last month after halting them in April when a second-wave of infections slammed the country. It is unclear when it will restart sending batches to the WHO-backed Covax global sharing body, which many poor nations are dependent on for supplies of Covid vaccines.
“Some shipments have already taken place while others are in the pipeline including through the Covax facility,” Arindam Bagchi, a foreign ministry spokesman, told reporters in Delhi on Thursday, without giving details.
©2021 Bloomberg L.P.