Covaxin boost: SEC says drop clinical trial mode label

The development follows the Hyderabad-based vaccine maker’s announcement on March 3, based on interim data from late-stage clinical trials, that Covaxin had an efficacy of 80.6 percent — it was able to bring down symptomatic cases of Covid-19 by nearly 81 percent in those vaccinated as opposed to those who did not receive a vaccine.

The SEC, reviewing Bharat Biotech’s request, decided to recommend that the regulator grant it an approval “like Covishield”, a source close to the development told The Indian Express.

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“They (Bharat Biotech) were asked to show efficacy data,” said another source on condition of anonymity. “They have shown the data,” the person added.

The next step in the process is for the Drugs Controller General of India (DCGI), Dr V G Somani, to review the SEC’s recommendation and decide whether the Central Drugs Standard Control Organisation (CDSCO) will grant Covaxin this approval.

Authorisations granted to the Covid-19 vaccines in India so far do not allow for commercial sale — both Covaxin and Covishield have only been approved for use in India’s immunisation programme at this time.

While both vaccines had earlier been granted a restricted use authorisation “in an emergency situation”, the approval to Covaxin was granted “as an abundant precaution”, but on the condition that it be administered in “clinical trial mode”. This was because, while SII had submitted interim data on the efficacy of Covishield from global trials of the AstraZeneca-University of Oxford vaccine, Bharat Biotech had not completed recruitment of participants for phase 3 trials of Covaxin.

At the time of its approval on January 3, Bharat Biotech had not been able to submit any information regarding the efficacy of Covaxin. This lack of information had stirred controversy, with some health experts questioning the regulator’s decision to give Bharat Biotech this approval without scrutinising enough data on its ability to bring down Covid-19 cases.

The “clinical trial mode” label meant that the Hyderabad vaccine maker had to seek informed consent prior to administering Covaxin to the healthcare and frontline workers, senior citizens and those with co-morbidities eligible for the government’s ongoing vaccination drive. It also meant the company had to submit updates on the safety, immunogenicity and efficacy of the vaccine from its phase 1, 2 and 3 clinical trials more regularly than SII, which has had to submit such data every 15 days so far.

As per this approval, the vaccine would be administered to everyone and they would be monitored closely as if they were in a clinical trial. In a regular clinical trial, some of the participants are given a placebo instead of the vaccine.

As per Bharat Biotech’s informed consent form and factsheet, the company had stated that it would pay compensation for serious adverse events that are “proven to be causally related to the vaccine.” SII’s fact sheet does not mention compensation in case of adverse events.

“There will be no need to take informed consent now,” said a third source also requesting anonymity.

“This will dispel the cloud of uncertainty that loomed over Covaxin’s efficacy and reassure people that the vaccine will confer immunity with a high level of safety. Uptake of this vaccine has already started rising after March 1 and this augmented level of regulatory clearance will give it greater momentum,” said Dr K Srinath Reddy, President, Public Health Foundation of India (PHFI).

As per government statistics, around 17.21 lakh people have been administered Covaxin since the immunisation programme started on January 16.