Biological E is awaiting a communication from the World Health Organization, which will kickstart the next round of approval process to get an emergency use listing (EUL) for Corbevax.

An EUL from the WHO will pave the way for wider acceptance and quicker adoption of the vaccine, especially in countries with limited regulatory facilities.

Last week (June 1), the company completed its pre-submission meeting with the WHO, Lakshminarayan Neti, BE Chief Operating Officer, told BusinessLine, speaking from Geneva. In fact, the audit of its manufacturing plant had been done earlier, he added.

Outlining the process ahead, company representatives said the WHO will now send a letter of agreement for the company to accept and confirm that it will send its dossier. And once the company makes its submission, the EUL process will begin.

India’s Serum Institute and Bharat Biotech have received an EUL from the WHO. BE’s Corbevax has been a late entrant, but Neti says the approvals in India for different age groups completes its data set. In fact, last week, Corbevax was also approved as India’s first heterologous booster – it could be given to people who had been vaccinated with either Covaxin or Covishield.

“During the (WHO) review there will be incremental information that will be asked for and will be supported,” he said. This is not entirely unfamiliar territory for BE, it has seven pre-qualified vaccines and has been supplying multilateral agencies, he said.

Corbevax is given to 12-14-year-olds. And, though it has been approved by the Drug Controller General of India, it needs a recommendation from the Centre to be included in the adult vaccination programme. Armed with the booster approval, Neti said the company was in discussions to include Corbevax to vaccinate older age groups as well.

On additional supplies, he said: “We have lot of headroom to serve India and the global community.” The company’s stated production stands at 100 million (10 crore) a month.

Biological E has an alliance with Johnson & Johnson on the Janssen Covid-19 vaccine, and as part of the Quad vaccine partnership, it was to make available 8 million vaccines by October 2021. Giving an update, Neti said BE’s part of the engagement was “about making the product and making sure on compliance of the facilities are as per the requirement. All of our check-boxes we have ticked and made the product ready. The market side of it is something that J&J will be responsible for”.

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