In an encouraging development, India is all set to get its second indigenous vaccine after Biological E has successfully completed phase-II trials and has received the nod to go ahead with the phase-III trials.
Biological E Ltd has announced that the company has successfully completed phase I and II clinical trial of its Covid-19 protein subunit vaccine candidate in India. Reportedly, the Hyderabad based vaccine maker studied the safety and immunogenicity of the candidate in about 360 participants in the age group of 18 to 65 years in the first and second phase of the trial which was started in November 2020.
The vaccine maker also stated that the subject expert committee of the Indian regulator has granted approval to start the Phase III clinical trial.
For the uninitiated, Bharat Biotech’s Covaxin is India’s first indigenous vaccine. The firm developed it in collaboration with the Indian Council of Medical Research (ICMR). Covaxin completed its Phase-II trials earlier this year and its efficacy was approved even by the medical journal – the Lancet. Now the vaccine is being widely used in India’s vaccination drive and even for exports under the ‘Vaccine Maitri’ initiative along with SII’s Covishield.
In a statement, Biological E managing director Mahima Datla said, “We are delighted with the success of the Phase I/II clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials.”
The vaccination schedule of this vaccine will involve two doses administered through an intramuscular injection 28 days apart.
It is pertinent to note that the subject expert committee’s recommendation for approval for the trial is the penultimate step with the clearance of the Drugs Controller General of India, the final step. Usually, the DGCI accepts the committee’s recommendations.
In the phase III trial of the Biological-E vaccine, 1,268 healthy participants between the age of 18 and 80 years will be selected from 15 sites across India where the company will study and evaluate the immunogenicity and safety of its vaccine. In a marked change, the vaccine maker will not evaluate the efficacy and instead will focus on immunogenicity, according to the company.
More than two months after starting the word’s biggest vaccination drive, the Indian government last week finally opened the vaccination process for all individuals over the age of 18 who will be eligible for the shot, come May 1. The biggest change introduced in the process is that states can now buy coronavirus vaccines directly from manufacturers – who can release up to 50 per cent of their supply for this purpose at a “pre-declared price”.