The Indian Council of Medical Research (ICMR) on Thursday said that it has partnered with Bharat Biotech International Limited (BBIL) to fast-track clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID
Vaccine). In an official statement, ICMR Director General Balram Bhargava stated that ICMR aims to launch the indigenous COVID-19 vaccine by August 15. Bharat Biotech recently got a nod for clinical trial of its vaccine – Covaxin.
Aiming to make Covaxin available for public use by August 15, ICMR chief Dr Balram Bhargava in a letter told the medical institutions chosen for the vaccine’s trials to ensure all phases of testing were completed by then.
The Indian Council of Medical Research (ICMR) has tied up with Bharat Biotech India (BBIL) to “fast-track” trials of the Hyderabad firm’s Covid-19 vaccine, Covaxin. While ICMR chief Dr Balram Bhargava on July 2 wrote to all the trial
sites stating that all of the clinical trials had to be completed by August 15 in time for a “public launch” of the vaccine, bioethics experts are sceptical. They have raised questions over how a vaccine candidate that is yet to
even start human trials can crunch all three phases of testing for safety and effectiveness of the vaccine into a timeframe of a month.
Even vaccine candidates like those of AstraZeneca and the University of Oxford, at the most advanced stages of trials globally, do not expect to launch their product before the end of the year.
What is Covaxin?
Covaxin is BBIL’s vaccine candidate to immunise people against Covid-19. The vaccine candidate was developed in collaboration with ICMR’s National Institute of Virology (NIV). NIV isolated a strain of the novel coronavirus from an asymptomatic Covid-19 patient and transferred it to BBIL early in May. The firm then used it to work on
developing an “inactivated” vaccine — a vaccine that uses the dead virus — at its high-containment facility in Hyderabad
“Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus,” said the company, adding that inactivated vaccines usually have a proven safety record.
When does ICMR want Covaxin launched?
Aiming to make it available for public use by August 15, ICMR chief Dr Balram Bhargava in a letter told the medical institutions chosen for the vaccine’s trials to ensure all phases of testing were completed by then.
“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the
cooperation of all clinical trial sites involved in this project,” stated Bhargaa in the letter dated July 2.
“This is the first indigenous vaccine being developed by lndia and is one of the top priority projects which is
being monitored at the topmost level of the Government,” he stated. Any non-compliance would be viewed “seriously”, he added.
What stage of testing is Covaxin at right now?
The Drug Controller General of India, who heads apex drug regulatory body Central Drugs Standard Control Organisation (CDSCO), has given BBIL approvals for phase I and II clinical trials so far.
The company on July 1 registered its vaccine candidate for these two trials. The details of the trials on the Clinical Trial Registry of India shows it plans to test a total of 1,125 people in these trials and plans the first enrollment of subjects for this trial on July 13.
According to the registry, BBIL has estimated the trials to take one year and three months. Of this, phase I trials alone will take at least a month. The firm is expected to submit an interim report from the first phase of the trials to CDSCO after the first 28 days of this trial.
“The ultimate goal is the selection of a safe, well-tolerated, and immunogenic intramuscular vaccine, which will be further evaluated in the phase 2 study,” stated the registry.
The country’s apex medical body has selected 12 institutes, including one from Odisha, for the clinical trial of the country’s first indigenous COVID-19 vaccine, an official said on Thursday. In view of the public health emergency
due to COVID-19 pandemic and urgency to launch the vaccine, the selected institutes are strictly advised to fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrolment is initiated during the first week of July.
— Krishna ® (@Krishnaatheist) July 3, 2020