India now reporting highest number of daily Covid cases
Amid daily reporting of a huge number of 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.
The 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 going on 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.
The 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 the DCGI after an evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.
The SII will conduct an “observer-blind, randomised controlled study” to determine the safety and immunogenicity of COVISHIELD on healthy Indian adults, said sources. Accordingly, 1,600 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 Organisation (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 ResearchM-ysore.
Covid-19 cases in India are on a steep rise as the country reported 57,972 fresh cases in the last 24 hours taking the country’s overall figures to 18,03,695, as per union health ministry. So far 38,135 deaths have been reported out of which 771 took place in the last 24 hours. However, according to COVID19India.org by Monday evening, India had about 18.31 lakh total cases and close to 38,500 deaths.
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 2.11 per cent and recovery rate is 65.77%. Country’s Test Per Million (TPM) has increased to 14,640 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. Swimming pools too will remain closed across the country.