SEC Suggests Removal of ‘Clinical Trial Mode’ Label For Covaxin, Know What It Means For Beneficiaries

Bharat Biotech International Covaxin: The current suggestion of the committee is based on its latest interim data from late-stage clinical trials of Covaxin, submitted to the regulator, in which it has shown 80.6 per cent efficacy.

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In a boost to Bharat Biotech International’s ambition in developing the Covid-19 vaccine, a subject expert committee (SEC) of the drug regulator has suggested doing away with the label saying ‘clinical trial mode’ from the emergency use licence granted to its covid-19 jab Covaxin.

How will it aid the company?

The government has approved two vaccines, and Covaxin is one of them.  However, the approval for Covaxin remained under scrutiny because it was granted approval despite the company’s inability to submit data from phase-3 trials. The label of ‘clinical trial mode’ being removed only increase the chances of its acceptability.

In its latest interim data from late-stage clinical trials, submitted to the regulator, the vaccine has shown 80.6 per cent efficacy. The company also stated that it was able to bring down symptomatic cases of Covid-19 by nearly 81 per cent in those taking the vaccination compared to those who did not receive the jab.

The current suggestion of the committee is based on Covaxin’s phase three trial data. In fact, the vaccine which didn’t acceptance among many health workers due to lack of final trial data, had shown efficacy better than the company’s previous guidance of around 60 per cent.

What does it mean to you?

According to the report in Mint, a subject expert committee has recommended to the top drug regulatory body, DCGI, which will decide on the matter.

If the recommendation of the panel is accepted then those willing to take the jab will no longer need to give informed consent. It means that the indigenously developed vaccine will get more acceptability and also put to rest the lingering concerns around the vaccine. This will give a push to the company struggling to find acceptance among beneficiaries in states such as Chhattisgarh, Kerala, and Punjab.

In fact, the interim efficacy data released on March 3 has already helped increase acceptance. For instance, Chhattisgarh health minister T.S. Singh Deo has mentioned allowing its use if the regulator grants full authorization.