Co-developing Covaxin has instilled India’s self-confidence of becoming much more than the world’s pharmacy into a vaccine superpower, Director-general of the Indian Council of Medical Research (ICMR) Balram Bhargava told The Hindu.
Hailing the public-private partnership experience and trust between ICMR and Bharat Biotech, Bhargava said it has instilled “self-confidence in us that India is now much more than the pharmacy of the world. It is also a vaccine superpower.”
The ICMR chief said the success has acted as a “catalyst” to move up the value chain and take a leap into drug or vaccine discovery. “This confidence in being able to develop new vaccines from scratch now pervades the industry and the academia, and it is the right time to use our learnings from these experiences to develop new vaccines for other diseases and scale them up,” he added.
Bhargava’s remarks come a day after the World Health Organisation (WHO) said it was expecting additional information from Bharat Biotech and asserted that it cannot ‘cut the corners’ before recommending a Covid-19 vaccine for emergency use. The Hyderabad-based company has had submitted EOI (Expression of Interest) to the WHO on April 19 for the Covaxin vaccine’s Emergency Use Listing (EUL).
“When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant EUL to the vaccine,” WHO said in a tweet. WHO said the timeframe for its EUL procedure depends on how quickly a company producing the vaccine can provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy, and suitability for low- and middle-income countries.
Meanwhile, the scientific evidence on Covaxin has been published in over 15 papers has been appreciated by international academia and includes vaccine efficacy against emerging variants. “These publications in highly acclaimed peer-reviewed global scientific literature cover the entire spectrum of vaccine development, whether it be preclinical development, small-animal studies, hamster studies, large animal studies, all phases of clinical trials, including the phase-III trial, which is one of the largest in the world. These studies also include the vaccine’s efficacy against the emerging virus variants, Alpha, Beta, Gamma, Delta.”
Last month, Bharat Biotech said it has submitted all data on Covaxin to the WHO for EUL and is awaiting feedback from the global health watchdog. “COVAXIN clinical trial data was fully compiled & available in June 2021. All data was submitted for EUL application to WHO in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” it said in a tweet. “We are diligently working with the WHO to obtain EUL at the earliest,” the company added.
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