Besides, Covishield and Covaxin, which are available in India, regulator Drugs Controller General of India (DCGI) has also approved Russia’s Sputnik V.
Paul said that the vaccine was being developed with the help of the department of biotechnology and the company has a capacity to make around 70 million doses per month. “It is a significant development. They are old manufacturers of children’s vaccines and have a major capacity,” Paul said, adding that Biological E will be submitting data of phase one and two clinical trials soon.
When contacted, Biological E did not comment. The Hyderabad-based vaccine major is gearing up to make 1.5 billion doses of multiple candidates of Covid-19 vaccines: One billion for Texas-based Baylor College of Medicine (BCM)'s recombinant protein vaccine candidate and about 500 million doses for Johnson & Johnson (J&J) unit Janssen Pharmaceutical's vaccine candidate. Last October, Mahima Datla, managing director (MD) of Biological E had told Business Standard, “We used the pichia pastoris (a yeast) platform to express BCM’s candidate. We have experience of large scale manufacturing using this platform, having supplied millions of doses and we could scale up easily.”
She added that one of the advantages of this candidate is that it is easy to scale up.
“The United States, through the DFC (Development Finance Corporation), will work with Biological E, to finance increased capacity to support Biological E’s effort to produce at least one billion doses of Covid-19 vaccines by the end of 2022 with Stringent Regulatory Authorization (SRA) and/or World Health Organization (WHO) Emergency Use Listing (EUL), including the Johnson & Johnson vaccine,” a White House statement had said sometime back. xPaul also said the government was making a renewed effort to talk to global suppliers and manufacturers of vaccines. “We are in active talks with major suppliers along with domestic vaccine makers. The policy has become more liberal from their point of view now,” Paul added.
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