Call it a tale of two top vaccine makers from the very same city. Biological E, however a further enterprise from Hyderabad soon after Bharat Biotech, is now gearing up to commence its Covid vaccine supplies. Bharat Biotech’s Covaxin was created in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Biological E’s Corbevax on the other hand, is the outcome of clinical trials carried out by Biological E on the vaccine candidate, which contains an antigen in-licensed from BCM Ventures – Baylor College of Medicine’s integrated industrial group from the US apart from an adjuvant (an ingredient added in some vaccines to enhance immune response) from Dynavax Technologies, a US-based enterprise. Corbevax is a protein subunit vaccine, a recognized technologies and deployed in other vaccines like Hepatitis B and HPV vaccines.
On June 3rd, the Indian government finalised an arrangement with Biological E. The agreement was to provide the Indian government with 300 million doses of their vaccines among August and December 2021.
The Narendra Modi government had also announced an advance payment of Rs 1,500 crore to be made to reserve these doses. Mansukh Mandaviya, the newly-appointed Union Health Minister, even visited the BE facility amongst other people on June 27th and tweeted about his evaluation of the assistance for boosting vaccine production in the nation.
Taking time out from her busy schedule, Biological E Managing Director Mahima Datla responded to some of the queries from TheSpuzz Online on the status of the company’s vaccine development, the timelines in terms of supplies committed, exports, inclusion of children in the research and the vaccine pricing.
Datla, who has spent lengthy years in the vaccine business, wears quite a few hats. Other than overseeing the strategic operations at BE, she is also a board member of GAVI (Global alliance for vaccines and immunization), a member of FICCI (Federation of Indian Chambers of Commerce and Industry) committee, a GHIT (Global Health Innovative Technology) fund board member, which is a Japanese government innovation healthcare fund for enhancing international access to healthcare.
And more locally, in her home state of Telangana, the Vice-Chairman of the Life Sciences Advisory Committee place in location by the state government. Here are the edited excerpts:
What is the existing status and the projected timelines on the availability of your vaccine and that of Johnson and Johnson, which you will be generating?
Phase-III trials for Corbevax vaccine are underway and we count on to apply for EUL (Emergency Use License) towards finish of August 2021 and safe the EUL by September 2021. We will provide a minimum of 300 million doses to the government of India by December 2021 following the obtainment of the EUL. While in 2021, the provide would be mainly for domestic purposes, in 2022 we will be exporting a portion of the production as per commitments to the Quad (vaccine partnership nations – America, India, Australia and Japan- to strengthen and help nations in the Indo-Pacific area) and COVAX (a international vaccine-sharing alliance co-led by the World Health Organisation).
On the J&J vaccine, we are not at liberty to disclose details on this. The production, trials & provide program of the Janssen candidate will be finalized by J&J.
What is the production capacity for your vaccine?
For Corbevax, when we count on to fill at a price of 75 Million doses/month at the time of launch, we anticipate more than one hundred million doses/month beginning February 2022.
Are there any export commitments for your vaccine?
We at present have no export commitments but are probably to have visibility/commitments closer to getting pre-qualification from the WHO, which is anticipated in Q1 2022.
So, you are intending to touch a month-to-month production of more than one hundred million doses by February 2022?
Our vaccine production till December 2021 would be restricted to the fill price of 75 million doses/month. But we anticipate more than one hundred million doses/month beginning February 2022.
What about the pricing of your vaccine?
Biological E (BE) has a lengthy and richly textured history of supporting public well being applications for more than 5 decades. BE manufactures more than 2 million doses of vaccine each and every day and this enables for massive economies of scale. The very same has permitted us to bring down the price to completely immunize a kid with pentavalent from $10.50 in 2001 to about $2 now. The reduce rates have saved UNICEF and GAVI about $500 million more than 5 years. The lowered price combined with the enhanced availability has helped successfully immunize a lot of LICs (Low Income Countries) and LMICs (Low and Middle Income Countries) such as India. While it is also early to comment on the pricing, we can assure that the efficiencies that we achieve in big scale manufacturing i.e. contribution of all the overhead expenses (manpower, CAPEX, utilities, upkeep, testing) to bigger quantity of vaccine doses enables us to give the vaccines at likely the most very affordable price tag for comparable vaccine provide commitment.
Besides this, the mechanism of pricing was constructed to pass-on the advantage gained out of the funding by BIRAC , CEPI, and COVID Suraksha.
Given that India does not have, as however, an authorized vaccine for children – So as portion of your clinical trials, are children integrated or are these trials only for adults?
Yes, we are going to request the DCGI (Drug Controller General of India) permission for initiation of study in children for security and immunogenicity. The trials would be initially for the adolescents (age group 12-18) followed by enrolling of children (age 5-12), hence expanding the age group to 5-18.
Does your capacity (75 million doses a month to one hundred million) rely also on any contract manufacturing or is it all your personal capacity?
It is totally BE manufacturing capacity.
Many main vaccine suppliers will see oversupplies in 2022, so do you believe when your capacity gets to one hundred million a month you will keep competitive and be in a position to provide even if vaccine rates are forced to soften even more due to oversupply?
We do not envision an oversupply in 2022 as there are quite a few nations outdoors India be it in low earnings or reduce-middle earnings groups who have quite poor vaccine coverage.