Last Updated on January 6, 2024 by The Health Master
The Drug Control General of India (DCGI) is soon going to remove the ‘trial mode’ tag for Bharat Biotech’s Covaxin C-19 vaccine and is expected to pave way for granting permission for the vaccine’s regular usage for the general public, revealed the company sources.
With Bharat Biotech recently revealed the interim results of its third phase clinical trials, which claimed 81 per cent efficacy for its C-19 vaccine Covaxin, the company has filed an application with the drug authorities, requesting the regulator, to remove the tag of emergency authorization ‘trial mode’ approval for the vaccine and give full approval for administering the vaccine to all sections of people in all conditions.
According to sources from the company, as the third phase clinical trial results have already been submitted to the drug regulator and also an application by the firm has been filed requesting to remove the tag of ‘trial mode’ for its Covaxin, it will help the firm to go on full scale marketing and also ease the consumers from the hassles of complex procedure of signing the papers before administering the vaccine.
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“As you all know Covaxin has been given emergency usage approval by the DCGI for administering the vaccine only in emergency, however, after the third phase clinical trial results have already revealed 81 per cent efficacy with no major side effects, we have filed an application to the DCGI to remove the ‘trial mode’ tag. We are expecting the DCGI will soon remove the tag and give full authorization approval for the vaccine,” revealed the source.
In addition to Bharat Biotech’s Covaxin, it is also aware that the DCGI had also issued emergency usage approval for the AstraZeneca’s Covishield vaccine manufactured by Serum Institute of India (SII).
Very soon Sputnik V vaccine, developed by RDIF in Russia, which is undergoing trials in India by Dr. Reddy’s Labs, is also expected to get emergency usage approval by the DCGI, however, it is learnt that the subject experts are doing a detailed study of the clinical trial report by the firm and soon all Russia vaccine to be administered in India.
Apart from the above, it is also learnt that firms from America such as Pfizer, Modrena and Jonson and Jonson have also approached DCGI for granting approval for manufacturing and marketing their vaccines in India revealed the industry sources.
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