Two Coronavirus Vaccine in India gets Green Signal for Emergency Use
By: Ashwathy Nair
- Both the vaccine contenders in India received approval for restricted use.
- There is a third vaccine too that has been approved for Phase 3 clinical trials.
- The ongoing clinical trial by the company will continue within the country.
In India, two of the leading coronavirus vaccine contenders have been given a green signal for restricted usage. COVID vaccine of Oxford-AstraZeneca named Covishield, which is manufactured by Serum Institute of India along with coronavirus vaccine of Bharat Biotech, which is named as Covaxin has been approved emergency use authorization. VG Somani, the Drug Controller of India stated that the approval is given by the CDSCO (Central Drugs Standard Control Organisation), followed by the (Subject Expert Committee) SEC’s recommendation that suggested an emergency use for both the vaccines.
DCGI reported that “CDSCO has agreed to adopt the recommendations of the Expert Committee after a satisfactory evaluation of the vaccines and, accordingly, M/s Serum and M/s Bharat Biotech vaccines are allowed for restricted use in emergencies.”
It is stated that the vaccine by Oxford has been found to be efficient for 70.42 per cent. The DCGI stated that “M/s Serum and M/s Bharat Biotech vaccines, have to be administered in two doses. He also stated that “All three vaccines (the third vaccine referred to here is the candidate of Cadila Healthcare, successfully approved for Phase 3 clinical trials) are to be stored at 2-8 degrees Celsius temperatures.”
The Central Drugs Standard Control Organisation met on 1st and 2nd January and had made recommendations for restricted usage approval of the vaccines. The SEC that consists of experts available from various fields such as pulmonology, pharmacology, immunology, internal medicine, microbiology and more.
The DCGI has confirmed that a Recombinant Chimpanzee Adenovirus vector vaccine is the vaccine candidate proposed by the Serum Institute. The firm provided data on safety, immunogenicity and efficacy developed from overseas clinical trials on 23,745 participants aged 18 years or older. The overall efficacy of the vaccine was found to be 70.42 per cent. In addition, permission was granted to M/s Serum to perform Phase II/III clinical trials on 1600 participants within the region. The interim safety and immunogenicity data produced from this trial were also submitted by the company and the data were found to be consistent with the data from overseas clinical studies.
It stated that after thorough deliberations, it has been recommended for the grant of permission aimed at restricted usage of vaccines in emergencies, by the Subject Expert Committee, subject to certain regulatory conditions. The clinical trial that the firm is continuing within the country will proceed.
The vaccine, Bharat Biotech is a Whole Virion Inactivated coronavirus vaccine that is developed in collaboration with ICMR and NIV (Pune). All kinds of safety and immunogenicity data have been generated by the firm in various animal species such as mice, rabbits, rats, Syrian hamster, along with that it has also conducted challenge studies on hamsters and non-human primates (Rhesus macaques). The firm has shared all the data with CDSCO.
According to the data available till date, the vaccine has been found to be safe.