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NEW DELHI : With covid-19 pandemic entering into second year, pharmaceutical companies across the world are developing more than 300 vaccines against the coronavirus. According to the latest update of landscape of novel coronavirus vaccines candidate development worldwide, compiled and maintained by WHO, 126 vaccines are in clinical development and 194 vaccines are in pre-clinical development stages.  

While India has developed Covaxin and manufacturing covishield, several new vaccines are in the offing.  The covid-19 vaccine tracker and landscape compiles detailed information of each covid-19 vaccine candidate in development by closely monitoring their progress through the pipeline. 

Explaining the phases of clinical trials, Dr Gagandeep Kang, the vice chair, Coalition for Epidemic Preparedness Innovations (CEPI), a global non-profit aiding vaccine development platform for the covid-19 pandemic, and professor at the Christian Medical College (CMC), Vellore, Tamil Nadu said that the first and foremost are pre-clinical studies--these are done in animals and are primarily for safety/ toxicity, bit can also include animal disease models. “Phase 1 in humans: these are small studies to evaluate vaccine safety. These can include 20-40 people and if the vaccine causes reactions, it will not progress. Phase 2 studies in humans, these are studies that measure the immune response to the vaccines, they are also used to decide the number of doses, and what is in each dose. Usually these have a few hundred participants," said Kang. 

 “Phase 3 studies in humans, people are given the vaccine and you wait for them to develop disease. Because disease is unpredictable, you need to have a few thousand people and do the studies in places where disease is likely. If vaccinated people get less disease than unvaccinated ones, then you know the vaccine is working. 

After these studies are done, then the vaccine manufacturer can apply for a license, and when they have, they can start to make the vaccine. After the vaccine is licensed, safety continues to be monitored, and you can also see how the vaccine performs in real-life--this is called an effective study," she said. 

According to the latest update with WHO, some Indian vaccines are in the pre-clinical trial phases. For example, vaccine manufacturer Indian Immunologicals and Griffith University in Australia have partnered to develop a potential vaccine candidate against covid-19. The partners intend to create a live attenuated vaccine using codon de-optimisation technology, which would offer longer protection with a single dose. The vaccine is expected to provide long-lasting protection with a single dose administration with an anticipated safety profile similar to other licensed vaccines for active immunisation.  

Similarly, Bharat Biotech and Thomas Jefferson University of Philadelphia have signed an exclusive deal to develop a new vaccine candidate for covid-19 invented at Jefferson. The novel vaccine has been developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. Biological E and Cadila healthcare is also developing a vaccine which is in pre clinical trial phase. 

There are also some Indian vaccines that are in the Phase 1/ 2 clinical trial phases. UK based SpyBiotech, a company with a novel vaccine platform to target infectious diseases, cancer and chronic diseases in partnership with the Serum Institute of India (SIIPL) that is manufacturing covishield has a vaccine in Phase I/II trial. SII and US based Codagenix Inc. are conducting Phase 1 Trials.  

The department of Biotechnology (DBT), ministry of science and technology is supporting the vaccine development. “DBT is backing many covid-19 vaccines’ development programs such as Mission COVID Suraksha program. We are fostering technological innovation in biotechnology in India. The department is also providing support towards scale-up and clinical studies," said Dr.  Renu Swarup, Secretary, DBT. 

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