Indian Drug Regulator DCGI Approves Covid-19 Vaccines of AstraZeneca And Bharat Biotech

The Drugs Controller General of India (DCGI) today (Jan 3) approved the Covid-19 vaccines developed by Bharat Biotech and AstraZeneca-Oxford University for emergency use in restricted conditions.

"The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd." a statement released by Drugs Controller General of India (DCGI) said.

The Subject Expert Committee comprised of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

AstraZeneca-Oxford University vaccine

The AstraZeneca-Oxford University vaccine, a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein, is produced and marketed by the Pune-based Serum Institute of India.

Serum Institute of India 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%.

Serum Institute was also 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." Drugs Controller General of India (DCGI) said in its statement.

Bharat Biotech

According to DCGI, this vaccine developed on Vero cell platform has well established track record of safety and efficacy in the country & globally.

DCGI said that the vaccine 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.

Bharat Biotech conducted Phase I and Phase II clinical trials 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 of Bharat Biotech 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.

Cadila Healthcare

DGCA also permitted Cadila Healthcare Ltd to commence Phase-III clinical involving 26000 Indian participants for a novel corona Virus-2019-nCov-Vaccine that it has developed 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.

The vaccines would be used to inoculate 1 crore health care workers working in public and private health care facilities and subsequently 2 crore frontline workers, which include Armed Forces, Police and Sanitation workers. Other priority groups estimated to be 30 crore population has been identified by the National Expert Group to be vaccinated by July this year are those who are above 50 years of age and those with co-morbidities.