Final Stage Trails India’s First COVID-19 Vaccine Covaxin Begins From Bhubaneswar

Highlights:

• Final Stage Trial of India’s first COVID-19 vaccines started
• The vaccines named Covaxin was developed by Bharat Biotech in collaboration with the ICMR
• The vaccine will be tested at 21 medical institutes across 10 states in the country

As the whole world is in a race to develop a potential and working vaccine for the novel Coronavirus, India’s very own first indigenously developed CIVID-19 vaccine named Covaxin will commence its Phase III of clinical trials at a private hospital in Bhubaneswar soon, said an official.

On Sunday, the Principal Investigator in the Covaxin human trial and Professor in the Department of Community Medicine at the Institute of Medical Sciences and SUM Hospital, Dr E Venkata Rao, said, the search for a vaccine for the novel Coronavirus has almost come to the final stage.

The major updates on Covaix, Indian COVID-19 vaccine which is being developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) are as follows:

• Just last Friday, the Drugs Controller General of India (DCGI) had permitted Bharat Biotech to conduct the final stage aka phase 3 clinical trials for Covaxin, however DGCI said the company will have to follow certain conditions.

• IMS in Bhubaneswar along with SUM Hospital is among the 21 medical institutes which have been selected across India by the ICMR where the third phase clinical trial will be conducted for Covaxin.

• Dr Rao said that after the completion of the first and second phase of the clinical trial with demonstrable safety profile and immunogenicity,

• Dr Rao added that a large-scale efficacy trial which will include thousands of volunteers across the country has been planned now.

• Similar to the previous phases, half of the volunteers would receive placebo in the clinical trial while the remaining half would be administered COVAXIN in the final phase.

• Additional health care workers would be recruited for the trial.

• The volunteers of the trial 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.

• Dr 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 three of the clinical trial will cover around 28,500 subjects, who will be of age 18 years and above.

• The trial will be conducted at 21 sites across 10 states in India including Delhi, Mumbai, Patna and Lucknow.

• Bharat Biotech had applied to the DCGI on the 2^nd of October 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, as per reports.

• Back in July this year, the DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.

• According to a report, Bharat Biotech plans to launch its COVID-19 vaccine – Covaxin – by June next year (June 2021), 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 of the firm Sai Prasad said.

In the meantime, Bharat Biotech is in discussions with over 10 countries that have shown an interest in a potential COVID-19 vaccine which the firm is developing with a government agency said a company executive.