NEW DELHI: A meeting called by India’s drug regulator on Wednesday to discuss the applications by Serum Institute of India and Bharat Biotech to approve their Covid-19 vaccines remained inconclusive and a next meeting to further analyse the submissions has been called two days later.
The development comes even as the Medicines and Healthcare products Regulatory Agency of the UK approved the vaccine by Oxford University-AstraZeneca in the country — becoming the first nation to authorise its use anywhere globally.
The Subject Expert Committee of the Drugs Controller General of India on Covid-19 meanwhile met following the MHRA’s authorisation granted to the vaccine, for which Serum Institute of India is manufacturing and trial partner locally, but was not satisfied with the applications of either of the companies.
“SII has been asked to submit more data from AstraZeneca trial globally while Bharat Biotech has been asked to submit at least the interim analysis of phase 3 trial,” said a source in the regulator following the meeting.
SII is conducting a bridging phase 3 clinical trial of the AstraZeneca vaccine Covishield on 1700 volunteers in India while Bharat Biotech, whose homegrown vaccine Covaxin has been developed in collaboration with the ICMR, is being tested on 26,000 people in the late-stage trial.
Covishield has been found to be about 70 % effective in preventing Covid-19 infection in multi-country phase 3 trials while a recent scientific paper published on Covaxin’s phase 1 and 2 trials said that it could lead to generation of antibodies lasting up to 6-12 months.
The US-based Pfizer which was the first company to apply for its Covid-19 vaccine in the country however sought for more time to submit data for its vaccine’s consideration, said the union ministry of health and family welfare,
“The additional data and information presented by SII and Bharat Biotech Pvt. Ltd. was perused and analysed by the SEC,” said the ministry. “The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday),” it added.
The meeting on Wednesday was the second time the SEC had met specifically to consider the vaccine applications.
Some experts meanwhile expressed disappointment at the delay by the committee in approving the vaccine.
“The vaccine by SII despite having run a shoddy trial still passes a minimum efficacy criterion by the World Health Organisation which has set the minimum criteria of 50 % efficacy for granting emergency use authorisation,” said Anupam Singh, an infectious disease expert.
He added: “In my view, a vaccine with 50% mean or median protection for high-risk people is better than nothing and while it’s good to be cautious, the regulator must consider a group focussed approval on a risk benefit basis.”