Bharat Biotech aims to deliver 3.5 crore Covaxin doses in September, likely to scale up to 5 crore by October

"Inactivated vaccine is one of the toughest vaccine to produce in the world. We are doing our best. We geared up Hyderabad, now Ankaleshwar and Bangalore. Bangalore little let down us, but now it is back in action. Most important is that we need good facility and good human resource. In September, we are going to do 3.5 crore doses of Covaxin. And by October we are going to reach 5 crore, by what we had anticipated, it got delayed," Ella told said.

He added that Bharat Biotech has got the license for both drug substance and fill and finish, so it is doing both in Ankalswar. In Bangalore, the firm only has drug substance and not fill and finish, so drug substance will move either to Ankaleswar or to Hyderabad for fill and finish.

Enlisting the challenges the company is facing leading to delay in production, Ella said, "There is a lot of human resource crunch, training needs to be done. Human resource is equally important as a lot of virology is involved, more than 200 tests need to be done for quality control."

Meanwhile, talking on the technology transfer that the company is doing to ensure more companies can begin manufacturing Covaxin to help India fight the pandemic, Ella said, it is not easy to do technology transfer and ask someone to produce as it is a highly skill-oriented job. “Everyone is asking me to do technology transfer, yes I am doing that, but their capacities are very miniscule and a lot of them do not have good human resource to get into the program. We are doing both training of human resource and doing the technology transfer also," he explained.

The government had earlier announced that as part of its policy to augment the domestic production of COVID-19 vaccine, it has proactively encouraged Public Sector Undertakings (PSUs) as well as private companies to enter into technology transfer agreements with Indian vaccine manufacturers.

Two Central government PSUs, namely Indian Immunologicals Ltd (IIL) and BIBCOL have entered into a technology transfer agreement with Bharat Biotech. In addition, one state government undertaking Haffkine Institute, has also entered into an agreement with Bharat Biotech.

All these technology transfer agreements have been actively promoted and assisted by the Central government, which has also extended substantial financial assistance to all the 3 Undertakings. As a result of the proactive intervention, Indian Immunologicals Limited will be in a position to start production of Covaxin from September while Haffkine Institute and BIBCOL will begin production from November.

The government currently engaged in proactive dialogue with Bharat Biotech and some other PSUs as well as private companies to execute technology transfer agreements. This would further enhance and augment the production of Covaxin in the country.

Commenting on the tie up and the firm’s ability to augment manufacturing of the vaccine, Ella said that "We are very much interested in the country, it is not that we are selfish people and we want to make just money. We want to be in the business and we want the people on the other side to be able to absorb the technology."

He added the pharma firm is working with a lot of other companies like Haffkine, BIBCOL, Indian immunologicals, and if all of them come well and partner to produce the doses, the 10 crore doses by December target should be achievable.

Bharat Biotech had in May end said that is has submitted an Emergency Use Listing (EUL) application with the World Health Organization (WHO) and expects the regulatory approvals by the July-September quarter.

Commenting on the additional information sought by WHO, Ella said, "We are a private company in India, where we have done everything ourself, right from development to trials, of course ICMR and NIV helped us. But all the trials were done by ourself, so do not compare us with multi nationals like Pfizer, Moderna or an Astra Zeneca. We are an Indian company, we are learning the game, meeting the global standards. We have answered all the questions WHO asked, it is a procedural issue now. They will go through the document, they will ask questions, we are happy to answer them , whatever they asked we have answered all of them."

Apart from the currently available injectable dose of Covaxin, Bharat Biotech is also working on introducing a nasal vaccine, which is currently under trials. Ella shared further details on the vaccine and if it will be made available for children. He said, "We have not tested the nasal vaccine on children , it is only for adults and Phase2 and 3 trials are going on right now. We will come back on trying the nasal on the children after seeing the success of nasal vaccine on adults.”

He added that Covaxin trials, both Phase 2 and 3, for children between 2 and 18 years have just got completed. The blood samples are now going back to the plant to be analysed. By September end the the vaccine maker will be able to submit the dossier to the Drugs Controller General of India (DCGI) with all the data points on trials on children, he said.

According to Ella, Bharat Biotech is the "first company to do the trial on children between 2-18 yrs, safety profile data has been submitted to DCGI, It is probably the best and safest for children."

Bharat Biotech is also working on another innovation, in which it plans to experiment with a two dose vaccine, where one dose will be nasal and the other will be the injectable Covaxin. Ella said, "It is for the first time in the world that we are able to do a clinical trial like this. Give us 2 months time, we will be able to tell you whether it is working or not working.”

He said if it works, then it is a revolutionary concept, because dose one will be injectable protecting lower lungs and down and then the second dose will be nasal, which will help in stopping the transmission.

“So this is a new research. Give us the time to understand the science. Unless we know the patients and till the clinical data comes out I cannot answer any questions. Certainly, this is a radical thinking. We are thankful to the regulatory authorities to allow us to carry out such clinical research, to look at this positively," Ella said.