Cobid19 Vaccine: There are 13 experimental Covid-19 vaccines in clinical trials and 129 are in the pre-clinical evaluation stage as of June 22, according to the data from the World Health Organization.
Coronavirus Vaccine: The whole world is grappling with the spread of coronavirus pandemic. Scientists, health experts, researchers, health agencies and pharmaceutical companies across the globe are working at an unprecedented speed, days and nights, to develop vaccines for Covid-19. According to the data from the World Health Organization, there are 13 experimental Covid-19 vaccines in clinical trials and 129 are in the pre-clinical evaluation stage as of June 22. On Monday, the Drugs Controller General of India (DCGI), the country’s drug regulator, approved Bharat Biotech to conduct phase I and II of human clinical trials of its Covaxin vaccine, making it India’s first indigenous Covid-19 vaccine candidate. The company said it will begin human trials from July across the country.
Covaxin development process:
Bharat Biotech developed Covaxin in collaboration with the National Institute of Virology (NIV). In early May, NIV had transferred a strain of novel coronavirus of an asymptomatic patient, after isolation, to Bharat Biotech; the company then worked on it to develop an “inactivated” vaccine—which uses an inactivated virus. The inactivated candidate for the vaccine was produced and manufactured at Bharat Biotech’s high-containment facility (Bio-Safety Level 3) at Genome Valley, Hyderabad.
“Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus, said a company official as reported by The Indian Express.”It just serves to the immune system as a dead virus and mounts an antibody response towards the virus,” he added. “Inactivated vaccines usually have a better safety record.”
After that Bharat Biotech conducted pre-clinical testing on animals like guinea pigs and mice to find out if it was safe. Then the firm approached the Central Drugs Standard Control Organisation for permission to conduct human trials.
Bharat Biotech is expected to begin Phase I and Phase II of human clinical trials for Covaxin in July. However, the company has not finalised the time frame for the full process—for testing and final approval.
Like, drugs, the development of a vaccine also goes through four stages of testing. It starts with pre-clinical testing and ends with phase III studies conducted on thousands of patients.
After receiving the regulator’s nod, the company has to keep monitoring the use of vaccine on patients and submit the report, to check any long-term unintended adverse effects of the product.
Other Indian companies in the Covid-19 vaccine race:
In the fight against coronavirus, many Indian pharma companies are also working to develop vaccines for Covid-19. Cadila Healthcare was the first Indian company to announce a vaccine candidate. It has already started the pre-clinical trials. Serum Institute and Panacea Biotec are also working on developing Covid-19 vaccines.
Where Covaxin stands against other vaccine candidates, globally?
DCGI approval to Covaxin gives hope of an indigenously developed Covid-19 vaccine, even as India is reeling under the surge of coronavirus cases in the country. Covaxin is at an advanced stage of testing. Bharat Biotech’s other two vaccine candidates, which the firm is developing in collaboration with global players, are still in the pre-clinical stage. But when you compare Covaxin with other Covid-19 vaccine candidates globally, it is far behind. AstraZeneca’s ChAdOx1-S is the frontrunner. The vaccine candidate, which AstraZeneca is developing in collaboration with the University of Oxford, is already at phase III trials. Moderna is also close to starting phase III trials of its LNP-encapsulated mRNA vaccine. According to data from WHO, there are as many as six other Covid-19 vaccines which are between Phase I and Phase II trials and at least five are in Phase I trials.