World Health Organisation lists a total of 160 vaccines currently in development and various stages of Research and Development all over the world by different countries. This is the biggest vaccine development effort in history, while the pandemic continues. Out of these, 139 are working at ‘preclinical evaluation’, that is, the vaccine candidates are being tested on the animals. While Two Indian vaccine candidates successfully completed the trail and get approval to move to another stage for the clinical trial. Although COVAXIN is not listed in the WHO, the vaccine Indian Government was pushing. When the reason was asked, the WHO representative said that they have a list of criteria and attributes that are considered for the evaluation and prioritization of the COVID-19 vaccine, which, unfortunately, Covaxin didn’t clear. But they didn’t mention which criteria Covaxin did not meet.
Globally, there are 21 vaccine candidates reached the clinical evaluation stage – where the candidate begins to be tested on humans. According to the guideline of WHO, the vaccines clinical trials are done in three phases –
- Phase I – the testing is carried out in small numbers of healthy adults to check the properties of vaccine, tolerability, and to test if it will be safe to administer the vaccine
- Phase II – it is done in large numbers to test if the vaccine candidates do produce an immune response to the subject, while again checking for the safety.
- Phase III – the test is done on the large number to fully assess the safety and efficacy of the vaccine candidate.
Out of the 21 vaccine candidate, 2 have reached the third phase by the Chinese Company Sinovac’s trial in Brazil and the AstraZeneca, a British Sweden Drug Company. On the other hand, the University of Oxford viral vector in England reached Phase II/III and Phase III trial in Brazil and South Africa.
These vaccines will come up with an immune response to the body of the coronavirus patients. While the viral vector that uses the virus to convert the coronavirus genes into cells. The viral vector offered by the University of Oxford and AstraZeneca looks more promising as compared to other vaccine candidates.
However, the failure rate in the development of a vaccine is still very high, which in fact makes vaccine development even more expensive. According to the analysis of past vaccine development project, it almost took an average of 10.71 years from the preclinical stage to the market entry with the probability of 6%.
So far, the US and Germany are at the top who invested most of the money for vaccine development by, 1,122 million USD and 997 million USD, respectively. The actual cost of getting an epidemic infectious disease vaccine from preclinical to the early clinical stage is substantially lower as compared to successfully leading the vaccine from clinical to the end-stage. It can vary from $23 million – $295 million range.
Russia’s Sechenov University has claimed that the human trial round of the world’s first novel coronavirus vaccine has been successfully completed. The trail was produced by Russia’s Gamaleya Institute of Epidemiology and Microbiology, a research center in Moscow on June 18.
There were two groups on which the test has been done. The first group of 18 volunteers has been vaccinated on June 18 and the second group of 20 were vaccinated on June 23. For the human trials- the exact virus strain and dosages have been given to the participants they need to be exposed are determined and approved by the regulatory authorities. It was the same method that has been used for developing vaccines for seasonal flu, typhoid, malaria, etc. The participants have been kept isolated on the campus for 28 days and proper psychological support has been given to them. Though some participants reported headaches and elevated blood temperature, these symptoms resolved completely within 24 hours of vaccine administration. The participants will soon be discharged, the first group on July 15 and the second on July 20. After discharge, they will be monitored for 6 more months.
There is a light of hope for all!!
The Indian government letter to try to speed up the clinical trials on vaccine candidates, in collaboration Hyderabad based pharmaceutical company. In this historically unparalleled global race for Vaccine. India is still some distance behind. The Indian government plan to roll out the vaccine by August 15 is debunked. But if India will be able to create a vaccine by 2021. That will still be historic.