A long-awaited study has indicated that the Covid-19 vaccine, Covaxin, developed by an Indian biotech company and the country’s medical research agency, was 77.8% effective at preventing Covid-19 symptoms.
In usage, the investigators found that an antibody response was induced two weeks after the second dose of Covaxin was given, even though it used traditional, inactivated-virus technology.
Also, a randomized trial involving 24,419 adults did not result in severe adverse events or deaths due to vaccines.
The Lancet published the results of the study conducted in India between November 2020 and May 2021.
Based on laboratory confirmations of 130 infections, the temporary analysis aligns with the company’s earlier efficacy and safety disclosures.
India may be able to end the controversy sparked by the shot’s early approval in January.
Bharat Biotech and the Indian Council of Medical Research funded the research, both provided researchers for the project.
The immunization shot had not yet passed its final stage of trials when India approved it, causing a lot of hesitancy during the country’s early immunization drive.
In India, Covaxin has been distributed more than 120 million times since then.
The Covid vaccine, Covaxin, has been authorized for emergency use has been added to the World Health Organization’s list of vaccines.
However, the backing did not come as quickly as expected.
Following its months-long evaluation, WHO’s independent technical body repeatedly demanded further information from the company, delaying its inclusion on the prequalified list of vaccines, thereby creating frustration among Indian Prime Minister Narendra Modi’s government, which cited the vaccine as a nationalist cause.
Krishna Ella, chairman of Bharat Biotech, has previously chided critics of Covaxin and said at a conference this week that WHO approval was delayed because of criticism, which damaged the shot’s reputation.
The publication which is one of the world’s top medical journals “showcases the immense strength of ‘Atmanirbhar Bharat,’” the Indian academic community and industry are “fighting against the odds,” said ICMR head Balram Bhargava, while speaking about government initiatives to boost self-reliance.
Safety on a Long-term Basis
Long-term safety data will be collected from monitored participants for a year.
There also will be the need for more information regarding its effectiveness over time, as well as its effectiveness in preventing severe diseases, hospitalizations, and deaths.
One hundred and sixty-six people who were given placebos and twenty-four who were given vaccines contracted the virus.
Among those taking the placebo, fifteen developed a severe Covid infection, in comparison to one who received the vaccine, according to the researchers.
According to the researchers, the shot is 65% effective against more infectious delta varieties, although further tests are required to confirm the findings, the researchers said.
Covaxin, produced in India, is marketed heavily in the country, which holds the world’s largest vaccine manufacturing industry.
Despite this, the Covaxin shot represents only a little more than 1 out of 10 doses administered in this nation of 1.4 billion people. Covishield, a vaccine made and sold by AstraZeneca Plc, accounts for the majority of sales.
The Indian drug regulator is also evaluating Covaxin for use in children ages 2-18, although there is no plan to inoculate children against this virus yet.
After halting vaccine exports in April due to the second wave of infections, India resumed exports last month.
Covid’s global sharing body Covax, which satisfies the supply needs of many poor, developing nations, hasn’t yet resumed any vaccine batches from India. The government of Narendra Modi has not announced when it plans to do this.
“Some shipments have already taken place while others are in the pipeline including through the Covax facility,” the ministry’s spokesman, Arindam Bagchi, told reporters in Delhi on Thursday, without disclosing details.