Updated: December 8, 2020 7:15:08 am
Hyderabad-based Bharat Biotech has included interim data from early and mid-stage human trials of its Covaxin vaccine candidate. (Archive)
In its application for emergency use approval, Hyderabad-based Bharat Biotech has included interim data from early to mid-stage human trials of its Covaxin vaccine candidate, sources said.
Bharat Biotech submitted its application to the drug regulator late Monday night, the sources said, making it the third company after the US pharmaceutical giant. Pfizer and based in Pune Serum Institute of India (SII) to request an emergency use authorization for your Covid-19 vaccine candidate.
“This (from Bharat Biotech) is an application (in the category of) issuance of a permit to import, manufacture a drug or for the granting of a NOC (certificate of no objection) clinical trial,” a person close to the development told The Indian Express. .
Separately, a different set of sources told The Indian Express that SII had completed the application process for its Covishield candidate, a variant of the Oxford University-AstraZeneca candidate that SII is manufacturing and testing under license in India, the Saturday. IBS presented efficacy data from late-stage human trials of the AZD1222 vaccine candidate in the UK, and safety data from ongoing trials of the candidate in India.
Senior officials from the Indian Council for Medical Research (ICMR), the country’s main biomedical research body, said a candidate destined for use in India must submit data from clinical trials conducted in India. However, the licensing expert committee, when considering data from India, may also draw conclusions based on data from international trials. Approval can be granted given the extraordinary emergency in the country, experts told The Indian Express.
The source close to the development of Bharat Biotech said that India does not have specific regulations or permits for emergency use authorization (USA) and therefore the portal under which these submissions are made, SUGAM, does not have a USA category. . This means that companies have to seek regular market authorization, and a committee of subject matter experts examining the application may decide to allow rapid access to the vaccine with certain restrictions.
This was also the case with requests made by Pfizer and SII when they approached the Central Drug Standards Control Organization (CDSCO), according to a senior government official.
“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorization for the first vaccine manufactured in India, COVISHIELD,” IBS CEO Adar Poonawalla posted on Twitter on Monday. “This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.”
While it is not clear how effectively Covaxin will reduce the number of symptomatic Covid-19 cases, given that its efficacy information has yet to be released, it is likely that the US application for IBS for Covishield could give India early access to a vaccine effectively. of a little more than 60 percent. By comparison, Pfizer’s vaccine can provide a more than 90 percent reduction in the number of symptomatic Covid-19 cases, trial data suggests.
Preliminary findings from AZD1222, on which Covishield is based, showed that the candidate provided about 90 percent efficacy when administered in a two-dose regimen in which the first dose was about half the concentration of the second. . A senior government official aware of the IBS application to the CDSCO said the firm has so far only sought marketing approval for the regimen where both injections of the vaccine were full doses, a regimen that had yielded only around the 62 percent effective.
Bharat Biotech, which is currently conducting phase 3 trials in more than 25,000 participants across the country, is expected to complete the process in February, according to a person familiar with the progress of vaccine trials.
© The Indian Express (P) Ltd
.
