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The Coronavirus Disease-19 (COVID-19) is the new form of an acute infectious respiratory disease and has quickly around the globe with considerable mortality in high-risk groups, especially in the absence of approved therapies or vaccines. With this unprecedented endeavour is taking place exploring for rapid development of novel therapeutics and vaccines.
During normal circumstances, the drug development process takes years. The development takes place sequentially from preclinical testing of lead molecules (molecule showing the desirable biological activity) and through in-vitro (within the glass- test tubes, Petri dishes, etc) and in-vivo (within the living) animal studies before entering clinical trials in humans. The clinical development proceeds from early phase 1 trial in 20-50 healthy volunteers, which the main objective would be Safety and tolerability of the drug followed by Phase 2 trials in 100-200 Subjects, first in patients (who have the disease that the drug is expected to treat).
The primary objective phase 2 would be Efficacy in patients. Before embarking on large scale confirmatory Phase 3 trials involve 500 to 1000 patients (for therapeutics value of the efficacy, safety, and optimal dosage of the new drug). Phase IV - Post Marketing Surveillance (PMS) which is done after a drug has been marketed.
July 7, the World Health Organisation listed 160 vaccines in development at various stages of research and development. This makes it the biggest vaccine development effort in the history of mankind while a pandemic is still on, said the Indian virologist Shahid Jameel. Of these, 139 are currently in “preclinical evaluation" stages.
In India, at present, there are three vaccine candidates undergoing human trials. Pune-based Serum Institute of India (SII) conducting phase 2 and 3 of clinical trials for the Oxford-AstraZeneca candidate is head of the other two vaccine candidates 1. Bharat Biotech and 2. Zydus Candila.
Bharat Biotech has got approval from the Indian regulatory agency for phase 1 and phase 2 trial of the vaccine in June 2020. According to the local media reporters, Bharat has successfully completed phase 1 trial. The principal investigator of trials Dr. Savita Verma at Post-Graduate Institute (PGI) of Medical Sciences said that no adverse events were reported in subjects and vaccine is safe. Trial investigators are said to be collecting blood samples to analyze the vaccine’s immunogenicity. Meanwhile, participants are receiving the second dose. The Phase I study involves 375 volunteers at 12 sites across the country, All India Institute of Medical Sciences (AIIMS) was also ready for giving a second dose to the healthy volunteers. AIIMS principal investigator Sanjay Rai stated that so far, we have not seen anything unusual event in patients. It is safe.” News reports added that the trial sites are preparing for the Phase II trials, which are set to commence in the first week of next month.