Updated: December 10, 2020 7:08:31 am
Pfizer, which received emergency clearance for the use of its Covid-19 vaccine in the UK, with the first doses delivered on Tuesday, had approached DCGI with a request that no clinical trials be needed in India.
The expert committee examining applications from three companies for the authorization of emergency use of their Covid-19 vaccines in India on Wednesday asked the Serum Institute of India (SII) and Bharat Biotech for additional safety and efficacy data in the later stages. of its ongoing clinical trials. The third applicant, US pharmaceutical giant Pfizer, sought more time to submit its data.
Sources told The Indian Express that the Committee of Experts on the Issue (SEC), which met for the first time on Wednesday, has sought detailed answers for the next meeting, the date of which has not yet been decided. The SEC will give its recommendations to the Comptroller General of Drugs of India (DCGI), on the basis of which it will make a final decision on vaccines, and the whole process will take a few weeks.
The SEC also authorized conditional permission for the Covid-19 vaccine candidate Phase 1 and 2 trials developed by Pune-based Gennova Biopharmaceuticals Ltd, in collaboration with HDT Biotech Corporation, USA. The Department of Biotechnology had previously said it had provided seed funding for the development of the mRNA-based candidate vaccine.
According to the minutes of the SEC meeting, the IBS was specifically asked to submit safety data on phase 2/3 clinical trials in India of its candidate vaccine called Covishield, developed by Oxford-AstraZeneca; immunogenicity data from clinical trial in the UK and India; as well as the result of the UK regulatory authority’s assessment of your request for emergency use authorization. The expert committee noted that IBS has only “submitted safety data up to November 14” and that their study’s principal investigator, Dr. Sushant Meshram, who is involved in the trials, did not attend the meeting.
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Bharat Biotech, which is currently conducting Phase 3 trials on its indigenous vaccine candidate Covaxin, has only submitted interim safety and immunogenicity data from its Phase 1 and Phase 2 trials in the country. After his presentation on Wednesday, the SEC told him to “submit the safety and efficacy data from the ongoing phase 3 clinical trial for further consideration.”
“Both Bharat Biotech and the Serum Institute said they will return with the data sought,” the sources said, adding that the three companies had been given separate spaces to appear before the panel and Pfizer had sought a later date to present data on the vaccine. has developed with the German firm BioNTech, which has not been tested in India. “Their experts in the United States were not available,” said a source.
Inquiries sent to SII and Pfizer went unanswered, while Bharat Biotech declined to comment on the meeting.
Bharat Biotech began its phase 3 trials only in mid-November and has presented interim data from early to mid-phase phase 1 clinical trials for Covaxin in 1,125 participants. It has also presented “to some extent” data from its ongoing phase 3 trials on 25,800 participants, but the SEC did not deem it appropriate, a source said. Phase 3 testing of Bharat Biotech is expected to continue until February 2021.
IBS has presented efficacy data from trials being conducted abroad (UK, Brazil and South Africa), as well as in India for its vaccine, and safety data from late-stage trials in India. A senior government official said the Pune-based company had only submitted interim safety data from its Phase 2, 3 trials on 1,600 participants and supplemented it with additional data from global trials.
Pfizer, which received emergency clearance for the use of its Covid-19 vaccine in the UK, with the first doses delivered on Tuesday, had approached DCGI with a request to waive the need for clinical trials in India. According to the 2019 New Drug and Clinical Trials Rules, a company can request such an exemption if the product is approved and marketed in certain countries.
While Phase 1 of human clinical trials provides details on the safety of a vaccine candidate, Phase 2 determines its immunogenicity or ability to trigger an immune response. Phase 3 reveals crucial information about the efficacy of a candidate vaccine.
The sources said the SEC would also do detailed scrutiny of biochemical, laboratory and animal data regarding vaccines, in addition to data from human clinical trials.
On Tuesday, Dr. Balram Bhargava, head of ICMR, said that in an extraordinary pandemic situation, the regulator analyzes the risk-benefit ratio to grant a temporary license. “The benefit has to be more than the risk,” Bhargava said.
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