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PRIYA ABRAHAM
DIRECTOR, The National Institute of Virology, PUNE
We could not take the vaccine directly to humans; we had to convince animal rights activists on using monkeys for safety trials
After successfully isolating the original Wuhan strain, Abraham and her team went on to isolate several variants of concern and interest linked to Covid-19, laying the foundations for India’s self-reliance in vaccine development. “On March 9, 2020, we isolated the Wuhan strain. By April-end, we had transferred it to Bharat Biotech for Covaxin development. Today, we have nearly 400 Covid virus isolates, characterised and stored for future research,” says Abraham, whose foray into research was preceded by medical education from CMC, Vellore.
Growing up in Visakhapatnam, Abraham would climb trees, rocks and even tried her hand at pool. “We are two sisters and our parents raised us to be independent,” she mentions. The childhood grooming came in handy at NIV, where she had been in charge for only two months when the pandemic struck. The onward journey was long but rewarding as NIV went on to share Covid-19 virus isolates with Bharat Biotech to enable the making of Covaxin, standardise the first Covid real-time PCR test and develop the first Covid antibody testing kit to facilitate national serosurveys that reflected population vulnerability to Covid-19. But research outcomes often accompanied costs, physical and mental. Abraham recounts the capturing of wild monkeys for pre-clinical animal studies as one of the most challenging phases. “This was an emergency and one could not just take any vaccine directly to humans. So, we embarked on the monkey study to test its safety. Animal rights activists flooded us with angry emails and we had to spend a lot of time convincing everyone of the urgency,” says Abraham. This path-breaking work enabled subsequent regulatory approvals for phase 1, 2 and 3 human trials on Covaxin, which today is India’s first indigenous Covid-19 vaccine. The search for monkeys, Abraham says, began from Pune and ended miles away in the forest division of Nanded and Nagpur!
PADMA PRIYA
DIRECTOR, NATIONAL INSTITUTE FOR RESEARCH IN TB, Chennai
For Covishield’s combined phase 2/3 trials, I had to prepare multiple sites, train a massive workforce in human trials
“Ours was a field job. As leader of Covishield’s combined phase 2/3 trials, I had to prepare multiple sites, train a massive workforce in the rigours of human trials, ensure the wellbeing of every trial participant and manage adverse events in case of complications,” says Padma, who has been at the National Institute for Research in Tuberculosis (NIRT) for nearly 25 years.
In the Director’s role at NIRT, a 65-year-old institute famous for clinical trial expertise, Padma Priya not only handled Covishield phase 2/3 human studies, but also ensured evidence-based paperwork that became the basis for the Drug Controller General of India’s emergency use authorisation to Covishield. Later, the ICMR selected NIRT among the key centres tasked with tracking early receivers of Covaxin post regulatory approvals and rollout in India, starting January 16, 2021.
“Covaxin was rolled out even before the phase 3 trial data came out. To ensure monitoring and tracking of early Covaxin recipients, the ICMR chose select institutions across states to set up war rooms and guide people in management of complications. For Tamil Nadu, NIRT was the designated institute,” says Padma.
Born in Tamil Nadu to a father who was in the Army and a mother who was a history teacher, Padma managed to encourage her daughter to study biotechnology. She feels more and more women must opt for STEM (science, technology, engineering and math) disciplines and break barriers.
Padma Priya herself led the BCG vaccine trial in 1,100 elderly Indians when Covid vaccines were still not available for them. The idea was to offer protection to vulnerable populations while the government unveiled a graded vaccine policy. “BCG vaccines reduced hospitalisation, disease severity and Covid mortality in participants,” says Padma, whose core area of research remains tuberculosis.
NIRT, which in the past was headed by Soumya Swaminathan, currently WHO chief scientist, is presently testing a TB vaccine and researching stool-based diagnosis for paediatric TB.
PRAGYA DHRUV YADAV
HEAD, BIOSAFETY LEVEL 4 LAB, NIV, PUNE
We created India’s first anti-SARS-Cov2 antibody test when only two such testing kits were available in the world
Today, as India’s foremost bio-risk manager, Pragya stands on the frontline in the war against Covid. She is the principal researcher who led the charge against SARS-Cov2, managed pressures inside NIV’s lab where scientists risked everything they had, to secure India’s safety, and conducted research to enable Covaxin development. “Our team mounted timely diagnostic support for Covid-19, created India’s first antibody test when only two such testing kits were available in the world, isolated the Wuhan strain and aided the generation of indigenous diagnostic kits, screening of anti-Covid compounds and development of Covaxin,” says the 44-year-old, the first woman from her family to complete higher education.
Pragya mentions with pride how she boarded her maiden flight in 2006 to travel to the United States CDC for BSL 4 management training. Upon return, she set up India’s first BSL 4 lab, leading several outbreak investigations from Congo fever, Kyasanur Forest Disease and Nipah to Zika and now SARS-Cov2.
“I still remember that day. My father’s vision was bearing fruit. The first BSL 4 lab was operationalised in 2013,” remembers Pragya, who left home in UP’s Tanda to pursue post-graduation at RML Avadh University, Ayodhya, and PhD in biotechnology from Pune University.
Pragya says she is lucky to have served the country in tough times. “I will never forget that journey. The challenges of conducting India’s first preclinical study on monkeys and Syrian hamsters to determine the immunogenicity and efficacy of a vaccine candidate (Covaxin) in animal models were humongous. It was lockdown time. Capturing and transporting monkeys, arranging X-ray machines and experts to monitor them, everything was an uphill task,” says the WHO consultant, who also assisted in the validation of BSL 3 labs in Bhutan and Nepal.
The findings of the animal study helped in Covaxin’s progression to human trials and the realisation of India’s dream of self-reliance in Covid vaccine development.
Not just this, Pragya also personally led genome sequencing from the first SARS-Cov2 case in India and isolated Alpha, Beta, Delta and Omicron variants of concern. The virus neutralising the efficacy of Covaxin and Covishield was finally determined on the basis of these very isolates.
NIVEDITA GUPTA
HEAD, VIROLOGY, ICMR, New Delhi
Threats from people whose Covid therapies I rejected, the emails I got for disqualifying poor quality kits... it was too much at times
Though she had earlier pioneered the establishment of landmark Viral Research and Diagnostic Labs (VRDLs) in India, the scale-up of Covid testing facilities was an altogether new challenge as science about the virus was evolving daily.
“During my early years at ICMR, I began working on VRDLs. I always believed these would prove an asset to India one day. In 2009, when H1N1 hit us, India had just one testing lab, the NIV, Pune. By 2013, we had set up 15 and later, an expansive ICMR scheme allowed national viral diagnosis capacity to touch 106 VRDLs. This network came in handy when Covid struck. We quickly launched training workshops through VRDLs and reached the current strength of 3,200 government and private labs that can test Covid,” explains Nivedita, an MBBS from Lady Hardinge Medical College and a PhD in molecular medicine.
The road from medicine to research is normally less taken. But, to Nivedita, this progression came naturally as she was born into science. “My father, CM Gupta, was the first Indian scientist to publish in the prestigious Science journal. He did his doctoral work with Nobel laureate Har Gobind Khorana but declined Harvard’s teaching offer to return and serve his motherland,” says the unassuming scientist, who aided India’s transformation from Covid test kit importer in March 2020 to surplus producer today and also burnt the midnight oil scouting for the right Covid-19 samples.
“To develop a vaccine, you need to first isolate the virus. For that, you need a sample from a highly infectious person to get the right amount of viral load. We spent sleepless nights spotting samples from international travellers and positioning them at NIV, Pune, in time for research,” says Nivedita, whose team’s resilient efforts enabled NIV to isolate the original Wuhan strain on March 9, 2020, heralding India on to the Covaxin journey.
Ask Nivedita how she managed her turbulent Covid response journey, she smiles, “With my mother, husband and brother as companions.”
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