Covaxin’s phase three trial data likely to be published in a week, says Centre
NITI Aayog member (health) VK Paul said Indian regulators have sufficient data on the vaccine’s efficacy and the trials.
Data from phase three trials of Bharat Biotech’s Covid-19 vaccine, Covaxin, would be published in the next seven to eight days, NITI Aayog member (health) VK Paul said on Friday.
Paul made the announcement while responding to a question about the United States Food and Drug Administration refusing to grant emergency use authorisation to Covaxin. He was speaking at the Union health ministry’s briefing on India’s Covid-19 situation.
The NITI Aayog member said that the US regulatory body’s decision would not affect India’s inoculation programme. “We are satisfied, our regulator has approved Covaxin,” Paul said.
The official added that every country has its own regulatory system.
“Some things may be common, some are different,” Paul said. “They [the US] have their own parameters and we respect them.”
Paul said Indian regulators have sufficient data on Covaxin’s efficacy and phase three trials. “The data has been screened by them and I have been told that the data will be published in the next seven to eight days,” he said. “The findings will be published in a peer-reviewed journal.”
Bharat Biotech had on Wednesday said that the data will be made public only in July. “Once data from final analysis of phase 3 studies are available, Bharat Biotech will apply for full licensure for Covaxin,” the company had said.
In April, an interim analysis of Covaxin’s phase three data had shown that it was 78% effective against Covid-19. This was slightly lower than the 81% efficacy reported by the company in March.
Bharat Biotech had been facing criticism for not sharing its phase three trial data nearly six months after its vaccine was granted emergency-use authorisation in India. In January, the company had said it would submit efficacy results by March.
78% decline in daily new cases since May 7
Union Health Ministry Joint Secretary Lav Agarwal said that there had been a nearly 78% decline in daily new Covid-19 cases since India reported a peak in infections on May 7. India had recorded 4.14 lakh cases that day.
Agarwal added that the weekly Covid-19 positivity rate in the country had also reduced by 74%. “An overall decline in cases ia being noticed in the country,” he added.
The official emphasised on the need to keep following Covid-appropriate behaviour in order to break the chain of transmission. “Cases are falling but we need to take appropriate precautions,” he added.
The government also announced that the Indian Council of Medical Research will do national sero-surveys, PTI reported.
Serological surveys reveal how many people may have been infected with the novel coronavirus in an area but they do not show how many people are immune to the virus. It still isn’t clear how long antibodies last in infected persons and how many antibodies are needed to protect a person from reinfection.
India on Friday reported 91,702 new coronavirus cases, taking its total number of cases since the outbreak of the pandemic in January 2020 to 2,92,74,823. For the fourth consecutive day, the country recorded less than 1 lakh cases. Deaths rose by 3,403 to 3,63,079.