Bharat Biotech’ submitted application late on Monday evening for emmergencu use authorization. Covaxin producer, Bharat Biotech has applied to the Drug Controller General of India (DGCI) for approval of its emergency use in India on the basis of the interim data collected from early-to-middle stage human trials it has conducted in India. Covaxin in on its third phase trial in India that is being conducted on 25, 000 volunteers. The process will end latest by February informed a person close to the vaccine’s testing arrangement.
Bharat Biotech’ application that was submitted late on Monday evening mentioned that it is seeking permission to either import or manufacture a drug or for a no-objection certificate for a clinical trial, reported IE. The Hyderabad-based drug maker becomes the third company to seek emergency use authorization for its vaccine after Pfizer nad Pune-based Serum Institute of India.
Serum Institute’s application to DGCI submitted on Saturday cited efficacy data from its late-stage human trials of the AZD1222 vaccine candidate in the United Kingdom and safety data of Covishield-a variant of the AstraZeneca-Oxford University vaccine on its human trial on candidates ongoing in India.
According to the Indian Council of Medical Research (ICMR) officials, the vaccine candidates that are seeking nod must submit data from human trials conducted in India. But the authorisation while deciding upon their fate can consider both Indian and international data before drawing conclusions. Approval for emergency use will be given the extraordinary situation in the country, an expert said.
Bharat Biotech sources revealed that they have to seek regular marker authorization as the portal under which the submissions are made, SUGAM doesn’t come with Use Authorisation category. The subject expert committee hence has to grant approval as speedy access to the vaccine with certain restrictions in place. The same process applies for other vaccine candidates as well who will have to approach the Central Drugs Standard Control Organisation (CDSO)
The vaccine candidates are yet to release data on how effectively it will bring down the number of symptomatic Covid-19 cases on administration but it is likely that with SII’s having an efficacy a little over 60 per cent, India might get early access to the vaccine. Pfizer on the other hand is expected to provide 90 per cent reduction in the number of symptomatic Covid-19 cases, trial data suggest. Covishield, however, can show around 90 per cent efficiency when given in two doses, with first dose half the strength of the second dose, preliminary findings suggest. But, SII has only sought marketing approval of the regime where both shots are of equal strength yielding only 62 per cent efficacy.
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