An expert body under India’s top drug regulator has asked Bharat Biotech to send data on the effectiveness of Covaxin to consider the company’s request to test the Covid-19 vaccine in children, it reported The Indian Express.
He has also commissioned Dr. Reddy’s lab, which requested emergency approval of the Russian-made Sputnik V, to submit final data on the safety and ability of the vaccine to elicit an immune response from clinical trials of India.
On January 3, Bharat Biotech’s Covaxin received a restricted use approval for use in people over 18 years of age. To date, the vaccine has been administered to health care workers and front-line workers “in clinical trial mode” as part of the government’s mass vaccination campaign against the virus.
The company had approached the Central Drug Control Organization (CDSCO) for approval to conduct end-stage clinical trials of Covaxin in children ages 5 to 18, according to a source close to the development .
The committee of thematic experts (SEC) that examined the application on Wednesday told the Hyderabad vaccine maker to submit data on the effectiveness of Covaxin (a marker of how well the vaccine prevents symptomatic cases of Covidin- 19) in adults.
“First they have to bring the provisional data of effectiveness in adults. It has not yet been presented, “the source told The Indian Express on condition of anonymity.” Without knowing about the effectiveness in adults, the committee considered that it was not yet advisable (administering the vaccine in children’s trials). “.
Earlier this week, the president and CEO of Bharat Biotech, Dra. Krishna Ella said the company was expecting provisional data on the effectiveness of Covaxin in two weeks.
The SEC also told Dr. Reddy to submit “complete safety and immunogenicity data” for Sputnik V “according to the approved protocol” in order to be considered for restricted approval for emergency use, the font. On February 19, the Hyderabad company announced that it had approached the General Controller of Drugs of India (DCGI), which runs CDSCO, to obtain emergency approval of the vaccine, which it has been testing. about 1,500 participants in mid- or late-stage trials. in India.
The company had submitted provisional data on the immunogenicity of the vaccine (its ability to elicit an immune response), as well as Russian data on its effectiveness in support of its application, according to the source.
Questions to Dr. Reddy and Bharat Biotech about when they could send the data requested by the SEC remained unanswered in the press on Wednesday.
To date, the DCGI has approved Covaxin and Covishield (the Indian version of the vaccine developed by Oxford University and AstraZeneca) for restricted use in Covid-19 vaccines.