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Priyanka Sharma

Covovax trials on for 2-6-year-olds, says Poonawalla

Serum Institute of India CEO Adar Poonawalla (Photo: PTI)

Edited excerpts from an interview:

Which Covid vaccine are you working on for children? What is their present status?

We are manufacturing Covovax, an adjuvant for the Novavax vaccine for children. Recently, the DCGI (Drug Controller General of India) granted emergency use approval for Novavax’s protein-based covid-19 vaccine for adolescents and individuals aged 12 years and older in India. Based on the vaccines’ favourable safety profile and more than 90% efficacy rate, we are also doing trials in the age group of 2-6, 7-11 and 12-18 years. Results for clinical trials for the age group of 7-11 and 12-18 years are out. So far, Covovax has been approved by DCGI for children above 12 years of age.

Tell us about your journey in developing Covishield.

The journey has been exhilarating and challenging at the same time. We are glad to have played an instrumental role in the world’s fight against the pandemic. However, there have been challenges as well. Right from choosing to go with at-risk manufacturing to obtaining regulatory approvals, procuring raw materials in a global lockdown, setting up facilities, and securing logistical, infrastructural and financial avenues that can withstand and deliver the demand has been a herculean task.

Today, the milestones we have achieved in containing the spread make every challenge that we faced worthwhile.

Our facilities are well-equipped with state-of-the-art technology to manufacture covid-19 as well as other vaccines. The production facilities are continuously upgraded to ensure compliance with GMP (good manufacturing practice) regulations and have been accredited by the WHO.

Adding on to the enormity of our production prowess at Hadapsar, our new multifunctional production facility in Manjri is the largest single-use bioreactor-based vaccine fill-and-finish line in the world.

This includes cell culture bioreactors up to 6,000L. This has allowed us the flexibility to produce vaccines in more than one plant, thus facilitating the production of a large number of doses and taking us a step closer to achieving our goal.

How many vaccine doses have you supplied to the government under the COVAX facility of GAVI?

So far, we have produced 1.9 billion doses and supplied 1.65 billion doses of vaccine to India, COVAX and many other countries

How many Covishield doses are in stock? How many vaccines have you supplied across the globe?

At present, we have a stockpile of more than 200 million doses of Covishield. We have exported over 100 million doses of Covishield to more than 71 countries so far.

What are your future plans, global collaborations, and vaccines in the pipeline apart from covid vaccines?

We have a robust portfolio of non-covid-19 vaccines, which were deferred by two years because our facilities were diverted towards covid-19 vaccines. That said, we’ve got the meningitis vaccine, HPV, which is a vaccine for cervical cancer for women, and we’ve got travellers’ vaccine in the pipeline. Add to that, we are also working on the dengue monoclonal vaccine. Furthermore, we have partnered with the University of Oxford for the manufacturing of the malaria vaccine, which is currently under phase-II trials.

Do you see the threat of the fourth covid wave in India? Will you be able to meet the requirements if the need arises?

We have a stockpile of more than 200 million doses of Covishield. Our production for Covovax is ongoing as we expect demand for children and for COVAX countries. That said, our current capacity stands at 4 billion doses annually—making us better prepared to address any unforeseen demand in case of future outbreaks.

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