A panel of experts recommended on Wednesday the removal of the “clinical trial mode” label attached to the emergency authorization of Bharat Biotech’s Covid-19 Covaxin vaccine, The Indian Express has learned.
The recommendation of the Subject Matter Expert Committee (SEC), if accepted by the head of India’s main drug regulatory body, would mean that the vaccine can be administered under less stringent conditions and could lead to increased absorption of the vaccine.
The development follows the Hyderabad-based vaccine maker’s announcement on March 3, based on interim data from late-stage clinical trials, that Covaxin was 80.6 percent effective. was able to reduce symptomatic cases of Covid-19 by almost 81 percent in those vaccinated versus those who did not receive the vaccine.
The SEC, reviewing Bharat Biotech’s application, decided to recommend that the regulator grant it an approval “like Covishield,” a source close to the development said. The Indian Express.
“They (Bharat Biotech) were asked to show efficacy data,” said another source on condition of anonymity. “They have shown the data,” added the person.
The next step in the process is for the Comptroller General of Medicines of India (DCGI), Dr. VG Somani, to review the SEC recommendation and decide whether the Central Medicines Standard Control Organization (CDSCO) will grant Covaxin this approval. .
The authorizations granted to Covid-19 vaccines in India so far do not allow commercial sale; both Covaxin and Covishield have only been approved for use in the Indian immunization program at this time.
Although both vaccines had previously received a restricted use authorization “in an emergency situation”, the approval of Covaxin was granted “as a general precaution”, but on the condition that it be administered in “clinical trial mode”. This was because, while IBS had submitted interim data on the efficacy of Covishield from the global trials of the AstraZeneca-University of Oxford vaccine, Bharat Biotech had not completed the recruitment of participants for the phase 3 trials of Covaxin.
At the time of its approval on January 3, Bharat Biotech had not been able to present any information on the efficacy of Covaxin. This lack of information had sparked controversy, with some health experts questioning the regulator’s decision to grant Bharat Biotech this approval without analyzing enough data on its ability to eliminate Covid-19 cases.
The “clinical trial mode” label meant that the Hyderabad vaccine manufacturer had to seek informed consent before administering Covaxin to healthcare and frontline workers, the elderly, and people with comorbidities eligible for the campaign. government vaccination program. It also meant that 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 IBS, which has had to submit such data every 15 days so far.
Under this approval, the vaccine would be given to everyone and they would be closely monitored as if they were in a clinical trial. In a regular clinical trial, some of the participants receive a placebo instead of the vaccine.
According to the informed consent form and the Bharat Biotech fact sheet, the company had stated that it would pay compensation for serious adverse events that “have been shown to be causally related to the vaccine.” The IBS fact sheet does not mention compensation for adverse events.
“There will be no need to take informed consent now,” said a third source who also requested anonymity.
“This will dispel the cloud of uncertainty about the efficacy of Covaxin and reassure people that the vaccine will confer immunity with a high level of safety. Acceptance of this vaccine has already started to increase after March 1 and this increased level of regulatory clearance will give it a further boost, ”said Dr. K Srinath Reddy, President of the Public Health Foundation of India (PHFI). .
According to government statistics, around 17.21 lakh people have received Covaxin since the immunization program began on January 16.
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