By Dr C Hemavathi
Mysuru, July 7:- The Central Drugs Standard Control Organisation is the competent authority to give clearance for new drugs after several testing operations. It has permitted Bharat Biotech India, Hyderabad, to conduct human clinical trials for ‘Covaxin.’ It is the first indigenously developed Covid-19 vaccine for approval. These trials are scheduled to start across India in July for the vaccine. Covaxin is a vaccine developed against the novel coronavirus (Covid-19) in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). It was recently developed from a local strain of the virus and proved to be safe in animal testing. The Drug Controller General of India has approved the company’s request for conduction of Phase I and II clinical trials of Covaxin.
It is observed that 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 and mounts an antibody response towards the virus as reported by the company. The inactivated vaccines usually have a better safety record. The clinical trials can reveal the utility of the vaccine to mankind after obtaining substantial evidence by the scientist. The success results of phase I and phase II might lead to larger clinical trials. The licensure timelines will be set out upon receiving regulatory approvals.
Researchers around the world are developing more than 145 vaccines against the coronavirus, and 19 vaccines are in human trials. Vaccines typically require years of research and testing before reaching the clinic. Scientists are racing against the time to produce a safe and effective vaccine by next year. Antibody produced in response to a vaccine SARS-CoV-2 coronavirus had begun in January with the deciphering of the SARS-CoV-2 genome. The first vaccine safety trials in humans started in March, but the road ahead remains uncertain. Some trials may not produce clear results but a few may succeed in stimulating the immune system to produce effective antibodies against the virus.
The process of testing a vaccine involves pre-clinical testing, safety trials, efficacy trials, approval of the vaccine, warps speed and combined phases some coronavirus vaccines are now in phase I/II trials in the world. They are tested for the first time on hundreds of people. The major types of vaccines include genetic vaccines (use of one or more of the coronavirus’s own genes, to provoke an immune response), viral vector vaccines (vaccines that use a virus, to deliver coronavirus genes into cells to provoke an immune response), protein-based vaccines (vaccines that use a coronavirus protein or a protein fragment to provoke an immune response), inactivated virus phase-III (inactivated rabies virus engineered to carry proteins from the coronavirus) and repurposed virus vaccines (vaccines already in use for other diseases which may also protect against Covid-19).
It is a matter of great pride that COVID-19 has produced millions of warriors and saviours across the globe. It has also united these dedicated souls under the banner of humanism. Bharat Biotech is a reputed drug manufacturer which has provided remedies to infections like rotavirus, hepatitis, Zika, Japanese encephalitis and others. The recent Indian effort toward developing Covaxin has received global attention. It is fondly hoped that the recent efforts for making vaccine by internationally reputed manufacturers would produce better results in order to protect mankind from the coronavirus in the near future.
(The writer is Associate Professor and Head, Department of Botany, Government First Grade College for Women, Vijayanagar 4th Stage, Mysuru)