JOIN USBharat Biotech’s vaccine cleared for phase-3 trial
Indian vaccine manufacturer Bharat Biotech has received regulatory approval to carry out a phase-3 clinical trial of its Covid-19 vaccine, which came out in flying colours in phase-I/II of the trial.
The phase-3 trial is likely to be conducted on more than one thousand individuals to find if the vaccine offers any lasting protection.
Named Covaxin, the vaccine is made from an ineffective strain of the Covid-19 virus isolated at the National Institute of Virology, Pune.
The Drugs Controller General of India had approved the phase-3 trial on October 20 based on the results of the phase-I/II trial and animal studies.
The regulator asked the company to be extra careful in picking up the right candidates as the recipient of the vaccine.
Numerous such vaccines, including the shots for seasonal influenza, Polio, Pertussis, Rabies and Japanese Encephalitis, use the same technology.
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 the immune system as a dead virus to mount an antibody response towards the virus.
New treatment option
Meanwhile, Pune-based Serum Institute of India has joined hands with the International AIDS vaccine Initiative and pharmaceutical giant Merck to produce a type of monoclonal antibodies against Covid-19 for the world.
An effective and safe method of treatment, monoclonal antibodies offer an alternate therapeutic regimen for Covid-19 as several of them are various stages of research and development.
SII and Merck would develop SARS-CoV-2 neutralising monoclonal antibodies co-invented by IAVI and Scripps Research as an innovative intervention to address the pandemic.
Neutralising antibodies are widely considered to be promising candidates for Covid-19 treatment and prevention.
Encouraging results for Covid-19 antibody treatment have emerged from preclinical research and initial clinical trials.