A vial labelled “Covaxin”. Photo: bharatbiotech.com.
New Delhi: The national drug regulator’s expert committee recommended the approval of Bharat Biotech’s COVID-19 vaccine candidate a mere 24 hours after it noting that the firm’s data was not convincing enough for the panel to recommend restricted emergency use approval, minutes of the committee’s meetings held on January 1 and 2 show.
According to a report in the Indian Express, the Subject Expert Committee (SEC) on January 1, said that while Bharat Biotech’s Covaxin had the “potential” to target the mutated coronavirus strains, the data presented by the firm was not sufficient.
Bharat Biotech chairman and managing director Dr Krishna Ella had questioned why data from global trials of AZD1222, a variant of the vaccine produced by the Serum Institute of India, was not being subjected to similar scrutiny.
In an online address on Monday, Ella said the company had carried out “200 percent honest clinical trials”.
The minutes of the SEC’s meeting on January 1 noted that the data on Covaxin “demonstrates a strong immune response and in-vitro viral neutralisation”.
“The ongoing clinical trial is a large trial on 25,800 Indian subjects in which already 22,000 subjects have been enrolled including subjects with comorbid conditions as well which has demonstrated safety till date,” the minutes of the meeting said and added, “However, efficacy is yet to be demonstrated.”
After a “detailed deliberation”, the panel asked Bharat Biotech to “try to expedite the recruitment” of volunteers for its phase 3 human trials and recommended that the Hyderabad-based company carry out an “interim efficacy analysis for further consideration” of its vaccine candidate for emergency use approval.
However, the very next day on January 2, citing efficacy data from a challenge study on non-human primates, the committee recommended restricted use approval for Covaxin “in clinical trial mode” after Bharat Biotech requested consideration of its proposal “in the wake of incidence of new mutated coronavirus infection”.
The minutes of the meeting for January 2 noted that the firm had “presented the safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective”.
“As already noted by the committee, this vaccine is Inactivated Whole Virion, CoronaVirus Vaccine having potential to target mutated coronavirus strains,” the minutes noted and said that the firm had presented “updated data” and “justification”. However, the minutes did not make any note of the nature of this data and justification.
“In view of above, after detailed deliberation, the committee recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. Further, the firm shall continue the on-going Phase III clinical trial and submit data emerging from the trial as and when available,” the minutes said.
The following day, the candidate was approved for restricted emergency use by Drug Controller General of India (DCGI) Dr V.G. Somani.
Speaking to the Indian Express, Dr Ella said that Bharat Biotech had “not submitted any interim efficacy data at all”.
“What we have done is, we have produced (data on the) highest antibody response, long-term immunogenicity and how neutralisation protection is there,” the company’s chairman said. Efficacy data from the company’s ongoing late-stage trial should be available by March, Ella said.
“We have four facilities coming up and we are planning (to make) around 200 million doses in Hyderabad, 500 million doses in other cities,” Ella also said and added that the company had 20 million doses available so far, he added.
The approval for Covaxin was also hailed by Prime Minister Narendra Modi and his ministers as a success in India’s push to be self-reliance.
Health minister Harsh Vardhan also stressed on Sunday that the emergency use approval for Covaxin was “in clinical trial mode”, wherein all recipients of the vaccine would be tracked and monitored as if they are in trial.
“The [subject expert committee] argument is that Covaxin would work as some sort of insurance against the UK variant, but I am completely unaware of any data on Covaxin’s efficacy on any strain of SARS-CoV-2, let alone any special efficacy against the variant strain,” clinician and vaccine expert Gagandeep Kang told Deccan Herald. “It is quite a stretch to say it would work against the UK variant.”
Professor Kang also discussed various concerns she has regarding the manner in which Covaxin – and also Serum Insititute’s Covishield – were cleared for emergency use by the DCGI in an interview to Karan Thapar for The Wire. The video interview can be seen here.