With over 9 lakh Covid-19 cases, India is currently the third-worst affected country in the world. As the numbers continue to rise, a ray of hope has appeared with India’s very own Covid-19 vaccine candidate that’s being developed by Bharat Biotech India (BBIL), a Hyderabad based biotech company that’s working with Indian Council of Medical Research (ICMR) and the National Virology Institute (NIV). In the meantime, India has continued to send medical aid to different parts of the world in the form of locally manufactured medicines, equipment and trained manpower.
As per the latest reports, the Central Drugs Standards Control Organisation (CDSCO) has permitted Bharat Biotech to conduct Phase 1 and 2 of human clinical trials, which is scheduled to start across India in the next few days.
India’s potential Covid-19 vaccine candidate
Covaxin, created and developed by Bharat Biotech, is the first indigenous candidate in our fight against Covid-19. This also happens to be the first vaccine candidate to get approvals for human clinical trials in India. According to Bharat Biotech, the SARS-CoV-2 virus strain was isolated at NIV, Pune and was subsequently transferred to BBIL for vaccine development. The potential vaccine was manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level-3) Containment Facility located in Genome Valley, Hyderabad.
The firm explains that the vaccine contains an inactivated virus, which means the virus does not have the ability to infect a human being or multiply in numbers, as it is already dead. However, introducing it to the immune system will activate antibodies that can fight active coronavirus.
Different Stages of Approval
After undergoing a series of pre-clinical testing, Bharat Biotech approached the drug control administration CDSCO for an approval to proceed to the next level of testing i.e. human trials. The trial, which started today, will be done in two phases. Phase 1 will be done in small groups of individuals, where the dosage of the vaccine will be determined. The medical team will monitor the effectiveness and side effects of the vaccine according to the dosage. Phase 2 will include a wider group of people where they will be classified according to various characteristics like age and sex.
When will it be ready for deployment?
This massive and possibly multi-year immunisation programme is expected to start with the elderly and other vulnerable groups of people, including frontline medical workers. Adar Poonawala of Pune’s Serum Institute said that they don’t want to rush anything. He said, “We are confident of announcing a safe and effective vaccine for India and the world, but that is at least 6 months away.” He also emphasised that the timelines might shift depending on the success of the clinical trials. But considering everything, he expects nationwide deployment in the next 6-8 months.
The government, as of now, is yet to announce a national policy on COVID-19. Health experts believe that the government’s flagship health scheme, Ayushman Bharat, will be the way forward to undertake the vaccination program. In addition to that, the vaccines will also be made available for private hospitals, but the public might have to pay a premium for that.
Other vaccine candidates from India
Apart from Bharat Biotech, Zydus Cadila, Serum Institute of India and five other indigenous firms are in the early stages of vaccine development. Panacea Biotech, another biotech company developing a vaccine, is in the preclinical stage.
A different sign of hope
Although India has crossed 9 lakh Covid-19 cases (as of the publication of this article), the recovery rate is increasing steadily. As of today, around 5,62,000 individuals have recovered from coronavirus, which takes the recovery rate to a healthy 63.58%. For a country with the third most cases of the coronavirus, the recovery rate is very high compared to other countries of the world.
What happens next?
Researchers around the world are developing more than 155 vaccines against the coronavirus, and 23 vaccines are in human trials. The vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective vaccine by next year. It’s easy to see that the pace at which the vaccine is being developed is unprecedented. Such vaccines usually take years, if not decades to get approvals. Even for the Ebola virus, the most recent vaccine approved for use by WHO, got approved for use in 2019, five years after Phase 1 trials began.
In India, although ICMR has backtracked its initial claim of Covaxin’s deployment by August 15, the vaccine, even if made available by 2021, would still be a historic achievement.