COVAXIN global push in top-gear: Bharat Biotech eyeing US trials, interest from 11 nations

Bharat Biotech, the developer of COVAXIN, is in advanced negotiations with the US FDA (Food and Drug Administration) for conducting small-scale phase-III clinical trials of COVAXIN in the US, sources close to the development have said on Monday. The Indian vaccine maker has also held extensive bilateral consultations with Hungary & Brazil too for seeking regulatory approvals for COVAXIN in the respective countries.

According to ANI, Bharat Biotech has expressed confidence as they have data of persistence of antibody even after 6 to 8 months and the company is one of the few to publish papers on four COVID-19 variants. Moreover, 11 companies from seven countries have expressed their interest in the technology transfer and production of COVAXIN, according to sources.

In order to further strengthen trust in COVAXIN, Bharat Biotech has submitted 90% of documents to World Health Organisation (WHO) for obtaining emergency use listing for the COVAXIN vaccine, sources said while adding that it has already received regulatory approval from 11 countries. Bharat Biotech is confident of obtaining the emergency use listing from WHO and the remaining documents in this regard will be submitted in June.

Speaking on the development over WHO's approval, Dr Raches Ella, Bharat Biotech's Business Development and International Advocacy Head, said COVAXIN is likely to get approval from the WHO by the end of the third or fourth quarter of 2021.

The emergency use approval can be a gamechanger amid the COVID-19 crisis as it is likely to encourage countries to import COVAXIN, facilitate its manufacturing abroad and ease global travel for those vaccinated with it.

Dr Raches Ella also said that paediatric trials of COVAXIN will commence in June. This assumes development as several leading medical experts have commented that the third wave is most likely to affect children. Bharat Biotech is planning to ramp up the manufacturing capacity to 700 million doses by the end of this year, Dr Raches Ella said. 

Last week, Bharat Biotech announced the setting up of an additional manufacturing unit of COVAXIN in Gujarat to boost the production of its COVID-19 vaccines. It has set an aim to produce 200 million doses of COVAXIN within a year, with the vaccine availability at the Ankleshwar facility to commence from the fourth Quarter of 2021. With the addition of a manufacturing plant in Gujarat, Bharat Biotech has now ramped up the production of COVAXIN to 1 billion doses per annum.