Emergency use approval in India paves way for Bharat Biotech to take Covaxin global

The emergency use approval (EUA) of Covaxin in India will further strengthen its credibility and validate Bharat Biotech’s intent to make the indigenous vaccine popular in other parts of the world, says GlobalData, a leading data analytics and research company. 

Recently, Bharat Biotech has applied for regulatory approval to conduct clinical trials in Bangladesh and has applied for EUA in the Philippines. In addition, it has partnered with Brazil’s Precisa Medicamentos for the distribution of 12 million doses of Covaxin. 

According to GlobalData’s COVID-19 Dashboard, as of 2 February 2021, Brazil had 9,229,322 confirmed cases, the third-highest number of confirmed cases globally. Bangladesh had 535,583 confirmed cases and the Philippines had 527,272 confirmed cases. 

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “As of 2 February 2021, Bharat Biotech’s Covaxin is one of the only two vaccines having received EUA in India. Considering that Covaxin is extensively distributed as part of the vaccination drive in India, the level of confidence about Covaxin safety and efficacy has risen drastically, and this will further help it expand into other markets. It is also likely that the countries being targeted by Bharat Biotech are not the key markets from the global vaccine players’ perspective as their focus is more towards developed nations and fulfilling demand is also a significant constraint at the moment.” 

Bharat Biotech aims to produce 700 million doses of Covaxin in 2021. India intends to supply COVID-19 vaccines to friendly countries such as Mauritius, the Philippines and Myanmar. Overall, 0.81 million doses of Covaxin will be provided free of cost as a goodwill gesture. 

Mr Khadayate concludes: “Covaxin will face stiff competition in India from Serum Institute of India’s (SII) Covishield, Dr. Reddy’s Laboratories Ltd.’s Sputnik V (in Phase II/III) and Zydus Cadila’s ZyCov-D (in Phase III). As a result, Bharat Biotech is relentlessly pursuing expansion into other markets through Indian government partnerships or commercial partnerships. 

“Notably, further expansion into other countries will depend on the efficacy data of Covaxin from its Phase III trial, which is expected by March 2021. Bharat Biotech understands that the reputation gained during this pandemic will be long lasting and improve its market presence globally.”