Indian pharma well-placed to develop, manufacture COVID-19 vaccine; but it must guard against rushing trials
Some experts told Firstpost that the government is willing to fast-track regulation, which is a risk they are willing to take, after completing 'due protocols to check the safety of the drug'
Global scientists and researchers are on the hunt for a safe and effective vaccine for the novel coronavirus, as countries ease restrictions, in an attempt to up-lift economies.
With the virus spreading over 180 countries, the race to find a vaccine has been fast-tracked with UK's Oxford-AstraZeneca candidate the clear frontrunner, which is now already on large-scale, late-stage trials.
World Health Organisation’s (WHO) chief scientist, Soumya Swaminathan, has dubbed the Oxford-AstraZeneca experimental vaccine as the “world’s leading candidate and most advanced in terms of development.”
Another contender, not far behind, is the US National Institutes of Health (NIH) and Moderna Inc, with their experimental trials for a vaccine underway in collaboration with American pharmaceutical giant Pfizer and European biotechnology company BioNTech.
As per The Wall Street Journal, researchers have said that the coronavirus vaccine from Pfizer and BioNTech SE have shown “promising signs” of working in an early-stage study.
While global biotech and pharmaceutical giants are already showing progress with their vaccine trials, India is not far behind, with at least seven Indian companies — Zydus Cadila, Serum Institute, Biological E, Bharat Biotech, Indian Immunologicals, Mynvax and Panacea Biotec — all working on a vaccine.
Where does India stand in the global vaccine race?
COVAXIN, which has recently made headlines, is India’s first “indigenous” candidate vaccine, developed by Hyderabad-based Bharat Biotech International (BBIL). It is all set to start human trials from this month.
Ahmedabad-based Zydus Cadila Healthcare has recently also received the go-ahead from the DCGI for human clinical trials, according to PTI.
Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer in terms of dosage, is one of the partner firms for AstraZeneca’s and Oxford’s COVID-19 vaccine candidate. The vaccine has now entered its final phase of human trials.
India seems to have made good progress and is already working with other countries in developing a vaccine for the novel coronavirus. But what makes India an ideal partner for global pharmaceutical companies?
How has India emerged as the top choice for global players?
According to a report by the Indian Brand Equity Foundation, the pharmaceutical sector in India supplies over 50 percent of the global demand for various vaccines, 40 percent of the generic demand for the US, and 25 percent of all medicines for the UK.
India currently enjoys one of the top positions in the global pharmaceuticals market, with over 80 percent of the antiretroviral drugs used to combat AIDS (Acquired Immune Deficiency Syndrome) being supplied by Indian pharmaceutical firms.
This makes India an ideal choice for manufacturing vaccines as historically, the needed for lower health costs have contributed to countries like the US, UK to shift their manufacturing to overseas sites like India. Currently, according to the WHO, about 140 vaccines are in different stages of trials around the world, with 16 vaccines candidates have entered late-stage trials-clinical trials. Of these 16, five are being studied in China, three in the US, two in the UK, and one each in Australia, Germany, and Russia.
In the early days, when India started its vaccine programmes in the 1960s, it had partnered with global bodies like WHO, which allowed international technology to be supplied to developing countries free of cost, said Dr Kuppusamy Mosuvan, Managing Director of Hyderabad-based firm Tergene Biotech.
Dr Vincent Dammai, president, Biosimilars & Biologics Inc who is currently based in the US told Firstpost that India was always seen as a global partner and with the Indian government protecting Indian manufacturers, by discouraging international companies from setting up a manufacturing base in the country, this helped the industry grow in the country.
“As it stands today, India has skilled labour, sophisticated manufacturing infrastructure, and is connected to the global distribution network to attract large investments. A combination of all these features makes Indian biotech companies highly attractive” said the US-based doctor, Dammai.
But there's a hitch.
ICMR's ambitious 15 August deadline
Recently, the ICMR had said that it wanted to launch, COVAXIN, developed by Bharat Biotech, for “public health use latest by 15 August”.
According to a study by scientific journal PLOS One, vaccine development, on an average, takes 10.71 years from the preclinical phase, and has a success rate of six percent.
Some experts that Firstpost spoke to said that the government is willing to fast-track regulation, which is a risk they are willing to take, after completing "due protocols to check the safety of the drug".
“The government can speed-up regulation if it feels the drug is safe for consumption after evaluation of the data,” said Dr Naveen Thacker, Executive Director of the International Pediatric Association.
But to evaluate if a vaccine is safe, data should be ready, which can only be done if Phase 1, 2, and 3 trials are done, which according to most experts takes about four months to complete.
Dr Anant Bhan, a researcher in global health, bioethics, and health policy, spoke to Firstpost in this article about the extreme urgency of the situation. “It’s understandable for a pandemic of this scale. But we can’t compromise on the safety and the efficacy aspects. Collapsing the entire process to just 45 days is unlikely, and almost impossible,” he said.
While some have raised alarm bells over the deadline given by the ICMR, others explain how this is a path that can be used by the government for ‘emergency purposes for restricted use'.
‘Emergency-use authorisation’ for restricted use only
The ICMR has defended the 15 August deadline, saying that it is important to expedite the clinical trials for a promising indigenous vaccine in the larger public interest. All other vaccine candidates across the globe have been similarly fast-tracked, it said.
Although most say that the deadline given is almost impossible for public use, the government can allow ‘emergency-use authorisation’ of vaccines, but with “restrictions in place”.
For example, only certain age groups with no comorbid conditions can be given a dosage. The government, on its discretion, can allow the emergency authorisation of the vaccine, for “vulnerable groups,” said Dr Vikram Paradkar, senior vice-president, Technical Operations of Biological E.
India is not the only country to make use of such emergency powers. Recently, China’s military has received the green light to use a COVID-19 vaccine candidate developed by its research unit and CanSino Biologics after clinical trials proved it was safe and showed some efficacy, reports Reuters. China’s Central Military Commission has approved the use of the vaccine by the military on 25 June for a period of one year.
Mosuvan told Firstpost, “It is in my 40 years of experience that the government will likely allow restricted licensing to be given to vulnerable groups like military, hospital staff workers, while the company will continue to test the drug in Phase 3 trials."
Once Phase 3 is over, then the company (in this case, Bharat Biotech) will be allowed to approach the government for mass-production for the common public after there is enough data to prove that the vaccine is safe. “That is my prediction, for now, we can only wait and see what actually happens.” Mosuvan added.
"Ultimately, this is all a trial and error method, which works purely on data. Without data, it is hard to say for sure which vaccine will work. Data is collected through these trials. So without trials, there is no data for us to say for sure if a vaccine is ready for use." noted Paradkar
Most experts remain optimistic, saying they trust India’s scientists and researchers and predict the vaccine will hit the markets by year-end or “at most, mid-2021.”
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