DGCI approves vaccines of SII, Bharat Biotech for restricted use in emergency situation

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(Online Desk)

Drug Controller General of India (DGCI) V G Somani on Sunday announced that the recommendations of a government-appointed panel to grant restricted emergency use authorization to Covid-19 vaccines by Serum Institute of India and Bharat Biotech in the country are being accepted.

The Pune-based SII is manufacturing and clinical trial partner for the coronavirus vaccine by Oxford University-AstraZeneca under the brand name ‘Covishield’ while the Hyderabad-based Bharat Biotech, in collaboration with the ICMR has developed the country’s first indigenous vaccine- ‘Covaxin’.

After adequate examination, the Central Drugs Standard controller CDSCO has decided to accept the recommendations of the expert committee and accordingly vaccines of SII and Bharat Biotech for restricted use in emergency situations, said Somani in a press briefing.

Prime Minister Narendra Modi took to twitter to call the development a ‘decisive turning point to strengthen a spirited fight’, against coronavirus.

In a briefing to the press, in which no questions were taken, Somani meanwhile said that the subject expert committee of the CDSCO consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine,  among others.

In the case of Covishield, Somani said SII submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies.

“The overall vaccine efficacy was found to be 70.42 %..The firm also submitted the interim safety and immunogenicity data generated from local trial and the data was found comparable with the data from the overseas clinical studies,” Somani said that despite the approval of the vaccine, the clinical trial ongoing within the country will continue.

In case of Covaxin, the DCGI said that the firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.

All these data has been shared by the firm with CDSCO, he said adding that phase 1 and 2 clinical trials were conducted in nearly 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response.

“The Phase 3 efficacy trial was initiated in India in 25,800 volunteers and till date about 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date,” said Somani.

Reading from a statement, the official also said that for the vaccine, an expert committee has recommended for grant of permission for restricted use in emergency situations in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.

He, however, did not share specific details of what it meant to roll-out the vaccine in “clinical trial mode”.

As per the details shared, the clinical trial ongoing within the country by the firm will continue.

Somani also said that both Covishield and Covaxin have to be administered in two doses and all the three vaccines—third being one by Zydus Cadila which has been issued permission to begin phase 3 trial- have to be stored at 2-8-degree Celsius.

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