Final-stage trials

NEW DELHI, Oct 26 : Amid the race to develop a 'potential' vaccine against novel coronavirus pandemic, India's first indigenously developed Covid-19 vaccine, Covaxin will commence its Phase III clinical trials at a private hospital in Bhubaneswar soon, an official said.
The search for a suitable vaccine for Covid-19 has almost come to the final stage, Dr E Venkata Rao, Principal Investigator in the Covaxin human trial and Professor in the Department of Community Medicine at the Institute of Medical Sciences and SUM Hospital said on Sunday.  
Here are major updates on Covaxin, developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR):
-On last Friday, the Drugs Controller General of India (DCGI) permitted Bharat Biotech to conduct phase 3 clinical trials of Covaxin with certain conditions.
-Bhubaneswar's IMS and SUM Hospital is among the 21 medical institutes selected across the country by ICMR where the third phase trial would be conducted.
-After completion of the first and second phase of the trial with demonstrable safety profile and immunogenicity, the large-scale efficacy trial involving thousands of volunteers has been planned now, Dr Rao said.
-Like the previous phases, half of the volunteers would receive placebo and the remaining half would be administered COVAXIN in this phase. Even health care workers would be recruited for the trial. The volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing the development of the Corona disease, he said.
-Rao also said there had been a huge response and enthusiasm among people who had offered themselves to be volunteers for the trial. He said persons above 18 years will be taken for the human trial.
-The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
-The vaccine maker had applied to the DCGI on October 2 seeking permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine.
-The phase 3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, sources told news agency PTI.
-In July, the Drug Controller General of India (DCGI) had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.
-According to a Mint report, Bharat Biotech plans to launch its covid-19 vaccine--Covaxin--by June next year, unless the government decides to give the vaccine an emergency use authorisation before that, based on data from earlier phases of clinical trials, executive director Sai Prasad.
-Meanwhile, Bharat Biotech is in discussions with more than 10 countries that have shown an interest in a potential COVID-19 vaccine it is developing with a government agency, a company executive told Reuters recently.
TheMint