Activists question panel’s change in stance on Covaxin in four days

Health activists and patient groups have raised concerns about the “abrupt” manner in which the health ministry’s expert panel appeared to have changed its position in recommending approval of

Bharat Biotech

’s Covaxin.


The minutes of meetings of the subject expert committee (SEC) show that a day after it noted that efficacy data for Covaxin was not available it gave the go-ahead for restricted use of the vaccine citing efficacy data from non-human trials.

The minutes of meetings held on December 30, January 1 and January 2 – the day the approval was granted – have been put out by the Drug Controller General of India (DGCI). In the January 1 meeting, the committee noted that Bharat Biotech had submitted safety and immunogenicity data, but said “efficacy is yet to be demonstrated”, the minutes show. The committee recommended that “the firm should try to expedite recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval”.

The committee said Covaxin had the “potential to target mutated coronavirus strains” and that the data generated so far demonstrated a strong immune response (both antibody as well as T cell).

The minutes of the January 2 meeting noted that the “firm has presented the safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective”. This in effect is data from study in primates or monkeys.

The committee then recommended grant of permission for restricted use in emergency situation in public interest in clinical trial mode, “to have more options for vaccinations, especially in case of infection by mutant strains”. It added that the company should continue with the ongoing Phase III clinical trial and submit data emerging from the trial as and when available.

Earlier, on December 30, the SEC had said, "After detailed deliberations, the committee recommended that the firm should update and present immunogenicity, safety and efficacy date for further consideration."

On the efficacy of Covaxin against the mutant strain of Covid-19, Dr Krishna Ella of Bharat Biotech in his press conference on Monday stated that it would take a couple of weeks to get data that might show how the vaccine fared against the new variant. ICMR announced the isolation and culturing of the mutant strain in India on January 2.

"There seems to be a surprising change in SEC’s opinion, as on the first day the panel asked for more efficacy data, while suddenly after two days, approval was given to the firm. What happened in the meeting needs to be clarified, so as to avoid guesswork. This raises even more questions and concern, and has the potential to cause damage to the domestic vaccine industry and scientists”, Dr Anant Bhan, former president of the International Association of Bioethics, told TOI.

“We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended, while apparently discounting the need for efficacy data as the condition of the approval”, said Malini Aisola, co-convenor of

All India Drug Action Network

, a civil society organisation working for patients’ rights.

At the time of going to press, there was no response from the

DCGI

’s office or from Bharat Biotech to a question on what changed between January 1 and 2 for the SEC to grant approval to Covaxin. This report will be updated if and when they respond.