India's Central Drugs Standard Control Organisation (CDSCO) has given the restricted emergency use approval for Covid-19 vaccines of Serum Institute of India and Bharat Biotech.
The approval has been given following the recommendation of its Subject Expert Committee (SEC).
Additionally, recommendation has been made for the approval of the Phase III clinical trial of Cadila Healthcare’s vaccine.
Serum Institute of India developed a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with AstraZeneca/Oxford University’s technology transfer.
The safety, immunogenicity and efficacy data generated on 23,745 participants aged more than 18 years from overseas clinical studies has been submitted by the firm.
Serum also secured permission to conduct Phase-II/III clinical trial of the vaccine on 1600 participants within the country.
In collaboration with ICMR and NIV (Pune), Bharat Biotech developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) on Vero cell platform.
The company has conducted phase I and phase II clinical trials for the vaccine in approximately 800 subjects.
In addition, it has undertaken Phase III efficacy trial in 25,800 volunteers across the county and the vaccine has been found to be safe till date, as per the data available.
In a statement, the Central Ministry of Health and Family Welfare stated: “The Subject Expert Committee (SEC) has 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.”
Moreover, Cadila Healthcare has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology.
The Phase-I/II clinical trial is ongoing in more than 1000 participants, and the interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally.
Cadila Healthcare has now secured permission to undertake Phase-III clinical trial in 26000 participants in India.
The vaccines of Serum and Bharat Biotech have to be administered in two doses while all the three vaccines have to be stored at 2-8° C.