Covaxin end-phase trials begin in Bhubaneswar – updates

The search for a suitable vaccine for Covid-19 has almost reached the final stage, said Dr. E Venkata Rao, principal investigator of the Covaxin human trial and professor in the department of Community Medicine at the Institute of Medical Sciences and the SUM Hospital. .

Here are important updates on Covaxin, developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR):

-Last Friday, the Comptroller General of Drugs of India (DCGI) allowed Bharat Biotech to conduct phase 3 clinical trials of Covaxin under certain conditions.

-IMS and SUM Hospital in Bhubaneswar is among the 21 medical institutes selected across the country by the ICMR where the third phase of the trial would take place.

-After the completion of the first and second phase of the trial with a demonstrable safety and immunogenicity profile, the large-scale efficacy trial involving thousands of volunteers is now planned, said Dr. Rao.

-As in the previous phases, half of the volunteers would receive placebo and the remaining half would receive COVAXIN in this phase. Even healthcare workers would be recruited for the trial. The volunteers would be followed for a considerable period of time to observe the efficacy of the vaccine in preventing the development of Corona disease, he said.

-Rao also said there was a great response and enthusiasm from the people who volunteered for the trial. He said that people over the age of 18 will be brought to human judgment.

-The phase 3 clinical trial will cover around 28,500 subjects, aged 18 and over, and will be conducted at 21 sites in ten states, including Delhi, Mumbai, Patna, and Lucknow.

-The vaccine manufacturer had requested permission from DCGI on October 2 to conduct a multicenter, placebo-controlled, double-blind, randomized phase 3 trial of its COVID-19 vaccine.

-The application of the phase 3 clinical trial proposed a dose of 0.5 ml on days 0 and 28, sources told the PTI news agency.

-In July, the Comptroller General of Drugs of India (DCGI) had granted 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 grant the vaccine an emergency use authorization before then, based on data from earlier phases of the trials. clinicians, said CEO Sai Prasad.

-Meanwhile, Bharat Biotech is in talks with more than 10 countries that have shown interest in a possible COVID-19 vaccine it is developing with a government agency, a company executive recently told Reuters.

With contributions from the agency