Amid daily reporting of a huge number of novel coronavirus cases, India has taken a step forward in race against time to develop a vaccine. The Drugs Controller General of India (DCGI) has given approvals to the Serum Institute of India (SII) to conduct Phase 2 and 3 human clinical trials of the Oxford University developed COVID-19 vaccine candidate in the country.
SII, one of the largest manufacturers of vaccines in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine COVISHIELD once it is ready for larger use.
Currently, phase 2, 3 clinical trials of the Oxford-sponsor vaccine are ongoing in the United Kingdom, while phase 3 clinical trials are on in Brazil and phase 1, 2 clinical trials are going on in South Africa. The vaccine candidate has shown promising results during its phase 1 trials in the UK in which two Indians were also administered the vaccine.
SII had last month sought permission from DCGI to conduct these trials in India. The approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI on Sunday after an evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19.
SII will conduct an “observer-blind, randomised controlled study” to determine the safety and immunogenicity of COVISHIELD on healthy Indian adults, said sources. Accordingly, 1600 persons at 17 sites will participate in the trials. As per the study design, each subject will be administered two doses at a gap of 4 weeks -- first dose on Day 1 and second on Day 29.
Officials said the safety and immunogenicity will be assessed at predefined intervals. SII will have to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organization (CDSCO).
The clinical trial sites which have been proposed for the study be distributed across India and include AIIMS-Delhi, B.J. Medical College-Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS)-Patna, Post Graduate Institute of Medical Education and Research-Chandigarh, AIIMS-Jodhpur, Nehru Hospital- Gorakhpur, Andhra Medical College- Visakhapatnam and JSS Academy of Higher Education and Research-Mysore.
COVID-19 cases are on a steep rise as the country's COVID-19 tally increased to 18,55,745 with 52,050 people testing positive for coronavirus infection in a day, while the recoveries crossed the 12-lakh mark on Tuesday, according to the Union Health Ministry data.
The death toll due to COVID-19 climbed to 38,938 with 803 fresh fatalities being reported in 24-hours, the data updated at 8 am showed. A total of 12,30,509 people have recovered, while there are 5,86,298 active cases of coronavirus infection in the country presently.
India is now reporting the highest number of daily cases in the world followed by Mexico as daily high reporting in the United States of America and Brazil came under check. According to ICMR chief Dr Balram Bhargava it is difficult to predict whether or not India will see a second wave of COVID-19 infections and there will be smaller peaks at different times due to the varied geography of the country.
According to the union health ministry, India continues to improve the Case Fatality Rate (CFR) which is now 2.10 per cent and recovery rate is 66.31%. Country’s Test Per Million (TPM) has increased to 14640 and 24 states and UTs have reported higher testing per million than the national average.
Meanwhile, the union health ministry on Monday issued protocols to be followed at fitness centres like gymnasiums and yoga institutes. As per guidelines, only asymptomatic persons with Aarogya Setu app should be allowed and they must maintain social distancing and wear of visor while exercising. Such centres in containment zones will not be allowed to open and spas, sauna, steam bath and swimming pools too will remain closed across the country.