DGCI approves Serum Institute, Bharat Biotech COVID-19 vaccines for restricted emergency use

New Delhi, January 3, 2021

Drugs Controller General of India (DGCI) V G Somani today announced the approval of two COVID-19 vaccines -- Covishield of Serum Institute of India (SII) and Covaxin of Bharat Biotech -- for restricted use in emergency situation in the country, paving the way for the immunisation of millions of Indians against the deadly virus in the coming months.

Somani told media persons that the Central Drugs Standard Control Organisation (CDSCO), which accepted the recommendations of its Subject Expert Committee (SEC) in this regard, had also granted permission to Zydus Cadila for the conduct of the Phase III clinical trials of its vaccine, ZyCoV-D.

"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trials," he said.

The SEC, which consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, and so on, had made its recommendations after a two-day meeting here on January 1 and 2.

Serum Institute of India (SII), Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.

The firm 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%.

Further, SII was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.

"After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue," Somani said.

Bharat Biotech, Hyderabad, has developed an indigenous Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with the Indian Council of Medical Research (ICMR) and NIV (Pune), from where they received the virus seed strains. "This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country and globally," he said.

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. Phase I and Phase II clinical trials were conducted in approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~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," he said.

Somani said the SEC had reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial being conducted within the country by the firm will continue, he said.

Cadila Healthcare Ltd. has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26,000 Indian participants, which has been recommended by the SEC.

SII and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C.

The announcement came a day after the Government conducted a nationwide dry run at 285 session sites to test the end-to-end planned operations and the mechanism set up to ensure smooth conduct of the vaccination campaign that is expected to begin soon.

The dry run of the vaccination drive spread across 125 districts covered all States and Union Territories (UTs) with adequate representation of urban and rural districts along with hard-to-reach areas.

Also yesterday, Union Health & Family Welfare Minister Harsh Vardhan said that, in the first phase, the vaccine would be provided free to three crore healthcare and frontline workers.

The Government is also finalising details of how to vaccinate the remaining 27 crore people in the priority categories, including senior citizens, before covering the rest of India's 1.3 billion population.

At 10,323,965 as of this morning, India accounts for the second highest number of confirmed COVID-19 cases in the world after the United States, which has recorded more than 20.427 million cases so far.

In terms of the number of deaths, India ranks third after the US (350,186) and Brazil (195,725).

NNN